Encyclopedia of Pharmaceutical Technology

Third Edition

Cover Image
Published
October 2006
ISBN
9780849393983
Edition
Third
Pages
4370
Size
8 1/2 x 11 in
Format
Hardcover
1835 illustrations

Chapter 1

21 CFR Part 11 Revisited
21 Code of Federal Regulations (CFR) Part 111 has been discussed at length in the pharmaceutical industry over the past years, within the companies as well as in working groups across company borders, industry associations, seminars, and conferences. By ...
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Chapter 2

Absorption Enhancers
There is enormous literature on the use of absorption enhancers. Here, the most important absorption enhancers for topical, transdermal and mucosal drug delivery are reviewed.
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Chapter 3

Absorption of Drugs
In the first edition of this encyclopedia the section on absorption covered a range of topics that included discussion of the cell membrane, parenteral and enteral absorption, clinical factors, and pharmacokinetic characterization of absorption.
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Chapter 4

Adsorption at Solid Surfaces: Pharmaceutical Applications
Adsorption at solid surfaces is involved in nearly every aspect of pharmaceutical development, from formulation design, process development, and manufacturing to storage of finished dosage forms. Achieving content uniformity, especially for low‐dose drugs,...
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Chapter 5

Adverse Drug Reactions
Adverse drug reactions (ADRs) are types of adverse drug events (ADEs).1 ADEs include ADRs, medication errors, and other drug-related problems. ADEs are the negative consequences of drug misadventures. Henri Manasse defined drug misadventure as the ...
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Chapter 6

Advertising and Promotion of Prescription and Over-the-Counter Drug Products
Pharmaceutical companies aggressively market their products to assure that everyone who needs to know about them receives information in a timely way. The marketing of drugs has many aspects that are unique in the world of product marketing:
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Chapter 7

Alternative Medicines
Although alternative medicine has the oldest healing practices, it is regaining popularity against a background of rapidly increasing technology in conventional medicine. For conventional health care practitioners, accepting the validity of alternative ...
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Chapter 8

Amorphous Pharmaceutical Systems
Interest in amorphous pharmaceutical systems has been steadily growing over the last 10 years.1 This is mainly because of:An increased understanding of amorphous systems in allied disciplines (e.g., food science and materials science).Greater prevalence ...
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Chapter 9

Analytical Procedures: Validation
To the pharmaceutical world, the meaning of analytical methods validation is the process to confirm that a method does what it purports to do, that is, to document through laboratory studies that the measurement procedure can reliably assess the identity, ...
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Chapter 10

Animals in Drug Development
The use of animals in scientific investigation has been traced back to several centuries BC. For instance, the writings of Aristotle (384–322 BC) and Erasitratus (304–258 BC) indicate that they had studied the anatomy of various animals.1 Early ...
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Chapter 11

Aseptic Processing: Validation
Aseptic processing is a widely used methodology in the health care industry for the preparation of sterile materials. The term aseptic processing as it is applied in the pharmaceutical industry refers to the assembly of sterilized components and product ...
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Chapter 12

Autoxidation and Antioxidants
By definition, oxygen is an absolute requirement for aerobic life, but it may also be viewed as toxic under certain conditions. A chemical reaction that usually takes place at ambient temperature between atmospheric oxygen and an organic compound is ...
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Chapter 13

Bioabsorbable Polymers
Addressed in this article are polymers that, because of their current and future applications, require that they interface with living tissues for predetermined periods. Obviously, the physical presence of these polymers in the biological environment must ...
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Chapter 14

Bioavailability of Drugs and Bioequivalence
The U.S. Food and Drug Administration defines “bioavailability” as “the rate and extent to which the active ingredient or active moiety is absorbed from a drug product and becomes available at the site of action.” 1,2,3 Because, in practice, it is rare ...
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Chapter 15

Biodegradable Polymers as Drug Carriers
A wide variety of delivery systems have been developed for the purpose of prolonging the release and, ultimately, bioavailability of drugs to the body. Examples include the transdermal patch, oral dosage forms such as osmotic pumps and swellable ...
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Chapter 16

Biologic Fluids: Analysis
Biomedical drug analysis has been important for many years and has become the cornerstone for the development and formulation of new chemical entities.1 However, escalating interest, most recently as a component of patient care, has launched drug assay to ...
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Chapter 17

Biopharmaceutics
Biopharmaceutics is the study of the interrelationship of the physicochemical properties of the drug [active pharmaceutical ingredient, (API)] and the drug product (dosage form in which the drug is fabricated) based on the biological performance of the ...
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Chapter 18

Biosynthesis of Drugs
Metabolism is the series of pathways operating when biological systems synthesize their constituents. Biosynthesis is the experimentally established pathway of formation of secondary metabolites; where experimental proof is absent, the term biogenesis is ...
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Chapter 19

Biotechnology and Biological Preparations
The scientific revolution in drug discovery and product development that occurred at the end of the 20th century, i.e., the advent and full realization of biotechnology, continues unabated into the 21st century. The growth has been remarkable in ...
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Chapter 20

Biotechnology-Derived Drug Products: Formulation Development
In the development of a formulation, the degradation of the protein is assessed under several conditions to determine under which conditions the active compound is most stable. Typically, variations in pH, ionic strength, buffer components, tonicifiers, ...
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Chapter 21

Biotechnology-Derived Drug Products: Stability Testing, Filling, and Packaging
The present article will continue the discussion of the development of the formulation, with a focus on the requirements for stability testing and manufacturing to be able to successfully deliver the final formulated product to patients.
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Chapter 22

Biotransformation of Drugs
The term biotransformation of drugs can be defined as the chemical conversion of drugs to other compounds in the body. However, this definition excludes degradation due to any inherent chemical instability of drugs in biological media. These conversions ...
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Chapter 23

Bio-Validation of Steam Sterilization
The science that underpins steam sterilization is well known and has been long established. It is the preferred method of sterilization in the pharmaceutical industry; it is used for sterilization of aqueous products in a wide variety of presentations, ...
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Chapter 24

Blood Substitutes: Fluorocarbon Approach
Fluorocarbon emulsions provide a safe, efficient, and cost-effective passive means of delivering oxygen in vivo that does not depend on the collection of human or animal blood. Perfluorocarbons (PFCs, also designated as fluorocarbons or perfluorochemicals)...
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Chapter 25

Blood Substitutes: Hemoglobin-Based Oxygen Carriers
Successful allogeneic blood transfusion, one of the most important life-saving procedures of modern medicine, was first reported in 1818.1 Its use grew steadily until the 1990s, when it peaked and reached a plateau. Today, more than 12 million units of ...
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Chapter 26

Blow-Fill-Seal: Advanced Aseptic Processing
Blow-Fill-Seal (BFS) technology was developed in the early 1960s and was initially used for filling many liquid product categories, such as non-sterile medical devices, foods, and cosmetics. The technology has now developed to an extent that BFS systems ...
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Chapter 27

Buffers, Buffering Agents, and Ionic Equilibria
It is well known that many drugs are unstable when exposed to certain acidic or basic conditions, and such information is routinely gathered during the preformulation stage of development. When such instabilities are identified, one tool of the ...
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Chapter 28

Calorimetry in Pharmaceutical Research and Development
Calorimetry is the measurement of energy changes within a material that are either manifested as exothermic (heat liberating) or endothermic (heat consuming) events (Table 1). Changes in energy (not absolute energies) are conventionally determined, and ...
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Chapter 29

Capsules, Hard
Hard or two-piece capsules were first produced on an industrial-scale in U.S.A. in the 19th century and are now produced throughout the world.1 Hard capsules are welcomed by consumers because of their elegant appearance and shape, which are easy to ...
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Chapter 30

Capsules, Soft
Soft gelatin capsules (Softgels) offer the possibility of delivering a liquid in a solid oral dosage form. Softgel's ability to enhance bioavailability not only makes it the preferred dosage form for new chemical entity with poor bioavailability owing to ...
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Chapter 31

Carcinogenicity Testing: Past, Present, and Future
This article presents an historical overview of cancer, carcinogenicity testing, and human cancer causes. Cancer has been known for a very long time, but the awareness of human carcinogenicity caused by chemicals is a phenomenon of the 20th century. This ...
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Chapter 32

Chiroptical Analytical Methods
The word chiroptical is descriptive of the techniques that use optical detection devices that are selective toward optically active (chiral) materials and/or molecules. They are used for structural investigation and analytical determination. There are ...
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Chapter 33

Chromatographic Methods of Analysis: Gas Chromatography
The word “chromatography” is derived from the Greek words “chroma” and “graphein,” which mean “color” and “to write,” respectively, or “color writing.” The initial use of the term is attributed to Tswett,1 who separated colored bands of plant pigments on ...
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Chapter 34

Chromatographic Methods of Analysis: High Performance Liquid Chromatography
Chromatography is a technique to separate individual components in a mixture. High-performance liquid chromatographic (HPLC) methods are usually preferred over other methods of quantitative analysis. The methods are usually very specific to the analyte or ...
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Chapter 35

Chromatographic Methods of Analysis: Thin Layer Chromatography
Thin layer chromatography (TLC) consists of the sample solution being applied as a spot or band on the origin of a layer spread on a support (the plate). After evaporation of the sample solvent, the plate is placed in a sealed chamber or tank that ...
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Chapter 36

Clinical Data Management Systems
This article is intended to be an overview of clinical data management systems and the processes they support. Data management systems are highly dependent on the size and complexity of the organization using them. Systems can range from a set of SAS data ...
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Chapter 37

Clinical Evaluation of Drugs
The process of developing a new drug, from the identification of a potential drug candidate to postmarketing surveillance, is extremely complex. The drug development process requires input from various members of a multidisciplinary team and the conduct ...
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Chapter 38

Clinical Pharmacokinetics and Pharmacodynamics
Therapeutics relates drug administration to physiological effects, both beneficial and toxic, in patient populations. The important intervening steps or processes, which occur following drug dosing that lead to therapeutic effects in the body, are ...
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Chapter 39

Clinical Supplies Manufacture: GMP Considerations
The Federal Food, Drug, and Cosmetic Act (the Act), Title 21, U.S. Code, section 301 et. seq., establishes that a drug shall be deemed to be adulterated if “…the methods used in, or the facilities or controls used for, its manufacture, processing, packing,...
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Chapter 40

Coacervation and Phase Separation
Polymer coacervation is a long established, and widely used, method for reversible gelification and microencapsulation of biological materials such as liquid and solid drug compounds or cells. Coacervation is defined, by IUPAC, as the separation of ...
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Chapter 41

Cocrystals: Design, Properties and Formation Mechanisms
The design of pharmaceutical crystals that possess different molecular components is valuable to control pharmaceutical properties of solids without changing the covalent bonds. These multiple component crystals, crystalline complexes, or cocrystals often ...
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Chapter 42

Colloids and Colloid Drug Delivery System
The term colloid applies broadly to systems containing at least two components, in any state of matter, one dispersed in the other, in which the dispersed component consists of large molecules or small particles. These systems possess certain ...
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Chapter 43

Coloring Agents for Use in Pharmaceuticals
There is evidence that the coloring of pharmaceuticals has been practiced since antiquity, and although the use of colorants in medicinals produces no direct therapeutic benefit, the psychological effects of color have long been recognized.
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Chapter 44

Complexation: Cyclodextrins
Complexation is one of several ways to favorably enhance the physicochemical properties of pharmaceutical compounds. It may loosely be defined as the reversible association of a substrate and ligand to form a new species. Although the classification of ...
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Chapter 45

Complexation: Non-Cyclodextrins
Complexation processes, also known as complexation, are based on the ability of many well-known drugs to interact and to form new complex drugs with altered properties in comparison with a drug alone. The pharmaceutical technology and the pharmaceutical ...
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Chapter 46

Computer Systems Validation
Computer systems validation, as established in 21 Code of Federal Regulation (CFR) Part 11.10(a) and defined in the recent draft United States (US) Food and Drug Administration (FDA) guideline,1 is one of the most important requirements applicable to ...
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Chapter 47

Computer-Assisted Drug Design
Drug discovery and development are extremely time-consuming and costly processes. For every drug that reaches the market, there are more than 10,000 compounds synthesized, characterized, and tested for biological effects. Hundreds of millions of dollars ...
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Chapter 48

Computers in Pharmaceutical Technology
The computer has become a very common tool in all areas of science and technology, and there seems to be no end in sight for future applications. With the proliferation of the Internet and the developments in computer technology and manufacturing, the ...
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Chapter 49

Continuous Processing of Pharmaceuticals
In the pharmaceutical industry, production processes are traditionally based on batch‐type procedures, whereas continuous processing has fewer applications. An important factor contributing to the limited introduction of continuous production is that it ...
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Chapter 50

Contract Manufacturing
Exciting changes are occurring in the pharmaceutical industry. Due to new advances in technology the industry is expanding more rapidly than ever before. For example, scientists are now using computers to manipulate molecules instead of having to go into ...
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Chapter 51

Cooling Processes and Congealing
The purpose of this article is to introduce the major concepts and applications of cooling and congealing processes in the pharmaceutical industry. A cooling and congealing process must follow any process involving a melt. The melt-congealing technique ...
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Chapter 52

Coprecipitates and Melts
The bioavailability of a poorly water-soluble drug is often limited by its dissolution rate, which in turn is controlled by the surface area available for dissolution. The effect of the particle size of a drug on its dissolution rate and its biological ...
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Chapter 53

Corrosion of Pharmaceutical Equipment
Corrosion, the degradation of a material's properties or mass over time because of environmental effects, is a costly reality that effects every industry. A study issued by the Federal Highway Administration (FHWA) in 2002 conservatively estimates the ...
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Chapter 54

Cosmetics and Their Relation to Drugs
Under the Food, Drug, and Cosmetics Act (FDCA, 21 U.S. Code 301), the Food and Drug Administration (FDC) of the United States has the authority to regulate foods, prescription (Rx) drugs, over-the-counter (OTC) drugs, and cosmetics. The FDA also ...
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Chapter 55

Cosolvents and Cosolvency
Cosolvents are defined as water-miscible organic solvents that are used in liquid drug formulations to increase the solubility of poorly water-soluble substances or to enhance the chemical stability of a drug. Cosolvency, then, refers to the technique of ...
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Chapter 56

Crystal Habit Changes and Dosage Form Performance
A crystalline particle is characterized by definite external and internal structures. Habit describes the external shape of a crystal, whereas polymorphic state refers to the definite arrangement of molecules inside the crystal lattice. Crystallization is ...
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Chapter 57

Crystallization: General Principles and Significance on Product Development
Understanding crystallization processes is important for the rational formulation and process development, as well as the chemical and physical stability of pharmaceutical products. While thermodynamics describes the equilibrium behavior of a system, ...
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Chapter 58

Crystallization: Particle Size Control
Crystallization is the main separation and purification step for the manufacturing of drug substances. The particle size distribution (PSD) obtained during crystallization is influenced by a combination of various mechanisms that occur during ...
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Chapter 59

Dendrimers
Dendrimers are highly branched macromolecules that can be subdivided into three architectural components: a central core branched cell, interior branch cells, and branch cells possessing surface groups. The term dendrimers was coined in the early 1980s by ...
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Chapter 60

Dental Products
A considerable number of products are now recommended for use in the oral cavity. Products for caries control are widely used and include fluorides in dentifrices and mouthwashes. Plaque control is achieved through the use of chemical agents such as ...
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Chapter 61

Dissolution and Dissolution Testing
Dissolution tests are one of the most commonly used tests in the characterization of drugs and in the quality control of certain dosage forms. During the late 1960s, it was accepted that dissolution data should be determined by studying the rate at which ...
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Chapter 62

DNA Probes for the Identification of Microbes
In 1997 and the first quarter of 1998, what we hereafter refer to as DNA probes were used primarily by those performing genetic-related research.1 Today (mid-2000), oligonucleotide (DNA, RNA, and related) probes in several guises are a growth industry in ...
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Chapter 63

Dosage Form Design: A Physicochemical Approach
Over the past several years, the fraction of new drug products that are new chemical entities has steadily decreased, reflecting the tremendous cost required to bring new chemical entities to the marketplace. Increased understanding of drug metabolic and ...
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Chapter 64

Dosage Forms and Basic Preparations: History
The creation and manufacture of dosage forms has been at the center of pharmacy practice for the past thousand years. For American pharmacists of the nineteenth century, secundem artem, or the acronym “S.A.” in physicians’ prescriptions, instructed them ...
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Chapter 65

Dosage Forms: Lipid Excipients
Biologically, lipids function as structural elements in plants and animals, transport vehicles, mediators of chemical reactions, energy sources, and as messenger molecules. It is from an understanding of these functions that lipids have been applied to ...
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Chapter 66

Dosage Forms: Non-Parenterals
Dosage form is a drug delivery system designed to deliver the active ingredient to the body and, upon administration should deliver the drug at a rate and amount that assures the desired pharmacological effect. Such dosage forms are manufactured under ...
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Chapter 67

Dosage Forms: Parenterals
Parenteral is derived from the two words “para” and “enteron” meaning to avoid the intestine. Parenteral articles are defined according to the USP 24/NF19 “as those preparations intended for injection through the skin or other external boundary tissue, ...
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Chapter 68

Dosage Regimens and Dose-Response
Drugs are administered for their pharmacological effects. In some cases, however, drug therapy includes the risk of undesirable side effects, with each drug having inherently different risks associated with its use. Therefore, it is the objective of ...
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Chapter 69

Dressings in Wound Management
Throughout history, diverse materials of animal, vegetable, and mineral origin ranging from hot oils and waxes reported in the Ebers papyru1 through animal membranes and faeces of the Middle Ages to the picked oakum of the 19th century; have been used to ...
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Chapter 70

Drug Abuse
Drug abuse may manifest at one of several different levels. Habituation involves a distinct and possibly harmful pattern of use. Drug abuse has been defined as a pattern of problem use that results in health consequences, social problems, or both. Drug ...
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Chapter 71

Drug Delivery Systems: Neutron Scattering Studies
Classic light and, to a lesser extent, X-ray scattering are widely used in the pharmaceutical sciences to investigate the structure and behavior of colloidal and polymeric drug delivery systems. Small angle neutron scattering (SANS), however, despite its ...
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Chapter 72

Drug Delivery: Buccal Route
A drug can be administered via many different routes to produce a systemic pharmacologic effect. The most common method of drug administration is via the peroral route, in which the drug is swallowed and enters the systemic circulation primarily through ...
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Chapter 73

Drug Delivery: Controlled Release
Over the past decades, the treatment of illness has been accomplished by administering drugs to the human body via various pharmaceutical dosage forms, like tablets. These traditional pharmaceutical products are still commonly seen today in the ...
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Chapter 74

Drug Delivery: Fast-Dissolve Systems
Orally disintegrating tablets (ODTs) rapidly disintegrate in the mouth without chewing upon oral administration and without the need for water, unlike other drug delivery systems and conventional oral solid immediate-release dosage form.1 ODT dosage forms,...
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Chapter 75

Drug Delivery: Liquid Crystals in
The liquid crystalline state combines properties of both liquid and solid states. The liquid state is associated with the ability to flow, whereas the solid state is characterized by an ordered, crystalline structure.1 Crystalline solids exhibit short as ...
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Chapter 76

Drug Delivery: Monoclonal Antibodies
The selective delivery of drugs to their site of action should increase their therapeutic effectiveness while minimizing unwanted side-effects. In the early 1900s, Paul Ehrlich proposed the potential use of antibodies as carriers of biological agents to ...
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Chapter 77

Drug Delivery: Monoclonal Antibodies in Imaging and Therapy
The concept of targeted drug delivery may be considered to have originated with the proposed “magic bullet” of Paul Ehrlich for specific eradication of the spirochete of syphilis at the beginning of the 20th century.1 Yet this vision of targeted drug ...
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Chapter 78

Drug Delivery: Mucoadhesive Hydrogels
This article focuses on defining the principles of bioadhesive delivery systems based on hydrogels to biological surfaces that are covered by mucus. An overview of the last decade's discoveries on mucoadhesion and applications of mucoadhesive hydrogels as ...
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Chapter 79

Drug Delivery: Nanoparticles
Nanoparticles are small colloidal particles which are made of non-biodegradable and biodegradable polymers. Their diameter is generally around 200 nm. One can distinguish two types of nanoparticles (Fig. 1): nanospheres, which are matrix systems; and ...
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Chapter 80

Drug Delivery: Nasal Route
Today, nasal drug delivery is receiving much attention from the pharmaceutical industry. About 2% of the overall drug delivery is administered via the nasal route. A survey1 among decision makers in the pharmaceutical industry highlights the importance of ...
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Chapter 81

Drug Delivery: Needle-Free Systems
Needle-free drug delivery was first proposed as early as the mid-19th century1 and was demonstrated to work many decades ago with one of the first major patents filed by Lockhart in the 1930s.2 At first glance, it is a concept both highly attractive and ...
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Chapter 82

Drug Delivery: Ophthalmic Route
Delivery of medication to the human eye is an integral part of medical treatment. The delivery of drug to the site of action has been practiced since ancient times, which successively advanced in a variety of ophthalmic dosage forms. The writings ...
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Chapter 83

Drug Delivery: Oral Colon-Specific
Historically, oral ingestion has been the most convenient and commonly used method of drug delivery. For sustained- as well as controlled-release systems, the oral route of administration has received the most attention. This is because of greater ...
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Chapter 84

Drug Delivery: Oral Route
Oral drug delivery is the most desirable and preferred method of administering therapeutic agents for their systemic effects. In addition, the oral medication is generally considered asf the first avenue investigated in the discovery and development of ...
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Chapter 85

Drug Delivery: Parenteral Route
The United States Pharmacopoeia 24 1 defines a small-volume injectable (SVI) as “an injection that is packaged in containers labeled as containing 100 ml or less.” Therefore, all sterile products packaged in vials, ampuls, syringes, cartridges, bottles, ...
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Chapter 86

Drug Delivery: Pulmonary Delivery
New dispersible formulations and drug aerosol delivery devices for inhaleable peptides, proteins and various small molecules have, in the past decade, become of increasing interest for the treatment of systemic and respiratory diseases. These include, but ...
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Chapter 87

Drug Delivery: Pulsatile Systems
Historically, extended release dosage forms were developed, which release the drug continuously over longer periods of time. These dosage forms offer many advantages, such as the nearly constant drug levels at the site of action and therefore minimization ...
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Chapter 88

Drug Delivery: Rectal Route
Although administration via the peroral route is the most commonly targeted goal of new drug and dosage form research and development, oral administration is not always feasible or desirable. The potential for oral dosage form development is severely ...
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Chapter 89

Drug Delivery: Topical and Transdermal Routes
Over the past 3 decades there have been significant advances in the science of dermal and transdermal drug delivery. Much of this research has been reviewed and published elsewhere. 1,2,3,4,5,6,7,8,9 This chapter, therefore, will concentrate on more ...
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Chapter 90

Drug Delivery: Tumor-Targeted Systems
Unsatisfactory therapeutic efficacy and substantial systemic toxicity have been the major hurdles in developing small molecule anticancer drugs. An ideal approach to overcome these hurdles is to develop drugs that only target tumor cells without altering ...
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Chapter 91

Drug Delivery: Vaginal Route
Vaginal dosage forms have been developed and used clinically for many years in local therapy and the systemic delivery of systemically effective drugs. Pharmaceutical dosage forms available for intravaginal delivery consist primarily of those used to ...
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Chapter 92

Drug Design: Basic Principles and Applications
Drug design and discovery techniques have evolved considerably in recent years but they have progressed in two opposite directions. On the one hand, considerable intellectual and financial efforts have been made to implement a rational sequence of events ...
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Chapter 93

Drug Development Management
The most successful new drug-development programs require competent, caring, people-oriented leaders at all levels. Overwhelming social science data show that this approach will optimize productivity, efficiency, and creativity, while fostering employee ...
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Chapter 94

Drug Information Systems
All those with an interest in the pharmaceutical sciences need up-to-date and reliable drug information, not only for their own research and studies, but also for communicating with their healthcare colleagues and patients. In this chapter, we will ...
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Chapter 95

Drug Interactions
The term drug interaction is applied most frequently to those situations in which the actions of one drug are altered by the concurrent use of another (drug–drug interactions), and to those situations in which the actions of nutrients affect drugs or vice ...
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Chapter 96

Drug Master Files
In most cases, in order to market a new drug or generic drug in the United States, the manufacturer must file a drug application with the Food and Drug Administration (FDA). The FDA must review and approve the drug application. In support of the ...
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Chapter 97

Drug Safety Evaluation
Drug safety evaluation is the determination of the safety of drugs for use as therapeutic agents in humans or animals through the conduct of laboratory studies in animals and in vitro systems.
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Chapter 98

Dry Powder Aerosols: Emerging Technologies
The delivery of pharmaceutical aerosols as a dry powder is no longer perceived as the “second best” method to deliver drugs to the lung. This is because of the mounting technologies, which are capable of making stable powders of respirable size and ...
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Chapter 99

Drying and Dryers
Many pharmaceutical operations, including those used to produce active pharmaceutical ingredients and excipients, use water or organic solvents as essential processing aids. However, the continued presence of these processing aids may hamper downstream ...
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Chapter 100

Economic Characteristics of the R&D Intensive Pharmaceutical Industry
This article presents a brief sketch of the economics of the R&D intensive ethical pharmaceutical industry, highlighting its dynamic characteristics. The approach taken here minimizes the use of static analysis, and thus avoids the use of pure or perfect ...
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Chapter 101

Effervescent Pharmaceuticals
Effervescent tablets are uncoated tablets that generally contain acid substances and carbonates or bicarbonates, and that react rapidly in the presence of water by releasing carbon dioxide. They are usually dissolved or dispersed in water before ...
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Chapter 102

Elastomeric Components for the Pharmaceutical Industry
The primary function of elastomeric components used by the pharmaceutical industry, which includes both drugs and medical devices, is to protect and deliver. Elastomeric components are typically primary packaging components; that is, they are or may be in ...
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Chapter 103

Electrical Power Systems for Pharmaceutical Equipment
Electrical power systems that serve pharmaceutical equipment must be safe, reliable, functional, predictable, flexible, clean, and sometimes validated. The electrical power systems have voltages ranging from 120 to 69,000 V. Pharmaceutical plants in the ...
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Chapter 104

Electroanalytical Methods of Analysis: Polarography and Voltammetry
Voltammetry is a term that encompasses all measurements based on controlled electrolysis at a microelectrode. Polarography, first introduced by the Czech electrochemist Jaroslav Heyrovsky in 1922, is voltammetry at a special form of mercury microelectrode,...
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Chapter 105

Electroanalytical Methods of Analysis: Potentiometry
Potentiometry is a method of electroanalytical measurement in which the equilibrium voltage of the cell consisting of an indicator electrode and a proper reference electrode is measured using a high-impedance voltmeter, i.e., effective at zero current. ...
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Chapter 106

Electrochemical Detection for Pharmaceutical Analysis
In order to bring a drug product from the discovery stage to the commercial market, many analytical methods must be employed. The analytical chemist develops methodology for quality control, stability testing, pharmacokinetics, identification, and ...
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Chapter 107

Electrostatic Charge in Pharmaceutical Systems
Solids become charged mechanically through contact with surfaces. Likewise, charged droplets are produced when a liquid is sprayed. Electrification of powders during processing is affected by many physicochemical parameters and creates problems in ...
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Chapter 108

Emulsions and Microemulsions
An emulsion is a heterogeneous preparation composed of two immiscible liquids (by convention described as oil and water), one of which is dispersed as fine droplets uniformly throughout the other. Emulsions are thermodynamically unstable and revert back ...
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Chapter 109

Enzyme Immunoassay and Related Bioanalytical Methods
Enzyme immunoassay, a bioanalytical method incorporating an antigen–antibody reaction to capture the analyte of interest and an enzyme reporter system to detect the captured analyte, is one of the most widely used immunoassay formats. The method is ...
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Chapter 110

Equipment Cleaning
Cleaning of process equipment has been part of the good manufacturing practices (GMPs) for pharmaceutical manufacturing for many years. 1,2 This has included recommendations for written procedures, cleaning logs, and appropriate design of equipment to ...
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Chapter 111

European Agency for the Evaluation of Medicinal Products (EMEA)
After the Second World War, the idea of a “United States of Europe” was promulgated and in 1957, the Treaty of Rome was signed instituting the European Economic Community (EEC) between six countries (Germany, Belgium, France, Italy, Luxembourg, and the ...
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Chapter 112

Evaporation and Evaporators
In the general sense, evaporation refers to any change in phase of a component from liquid to gas. Vaporization, sometimes used interchangeably with evaporation, is at times specifically used to designate the total change of a liquid phase to gas (vapor).
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Chapter 113

Excipients for Pharmaceutical Dosage Forms
Medicinal dosage forms, regardless of composition or mode of use, must meet the following requirements that underpin efficacy, safety, and quality: Contain an accurate dose.
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Chapter 114

Excipients: Parenteral Dosage Forms and Their Role
The term pharmaceutical excipient or additive denotes compounds that are added to the finished drug product for a variety of reasons. Most often excipients are major components of the drug product, with the active drug molecule present in a small ...
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Chapter 115

Excipients: Powders and Solid Dosage Forms
Excipients are the additives used to convert pharmacologically active compounds into pharmaceutical dosage forms suitable for administration to patients.1 Although excipients are the non-active ingredients, they are essential in the successful production ...
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Chapter 116

Excipients: Safety Testing
The safety issues concerning pharmaceutical excipients can be classified into three categories: quality, toxicology, and improper use.1 Various regulatory directives address the quality category. In addition, the International Pharmaceutical Excipient ...
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Chapter 117

Expert Systems in Pharmaceutical Product Development
The process of formulation, whether it be for oral products (e.g., tablets and capsules), parenterals [e.g., intravenous (iv) injections], or any one of the myriad of pharmaceutical products, is generically the same. The process begins with some form of ...
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Chapter 118

Expiration Dating
Expiration dating of pharmaceuticals corresponds to the determination of a retest period for drug substances and an expiration dating period or shelf-life for drug products. The shelf-life, or expiration dating period, of a drug product is defined as the ...
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Chapter 119

Extractables and Leachables in Drugs and Packaging
The issue of extractables and leachables in drugs and packaging is one of the most complex, challenging, and often (from a regulatory perspective) perplexing in all of pharmaceutical development. Unlike drug substance related impurities and degradation ...
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Chapter 120

Extrusion and Extruders
Extrusion is the process of forming a raw material into a product of uniform shape and density by forcing it through an orifice or die under controlled conditions. An extruder consists of two distinct parts: a delivery system which transports the material ...
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Chapter 121

Film Coating of Oral Solid Dosage Forms
Polymeric materials have been used to coat pharmaceutical solid dosage forms for decorative, protective, and functional purposes. These thin polymeric film coatings may improve the esthetic appearance and provide easy identification of drug products. ...
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Chapter 122

Filters and Filtration
The separative process of filtration is widely used within the biopharmaceutical industry to remove contaminants from liquids, air, and gases, such as particulate matter but especially microorganisms. Microorganism removal is either required to achieve a ...
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Chapter 123

Flame Photometry
The use of flame photometry as a quantitative tool can be traced to work by Kirchhoff and Bunsen in the early 1860s.1 Its modern history begins, however, in the 1940s, when instruments became available that successfully addressed the problems of ...
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Chapter 124

Flavors and Flavor Modifiers
The use of flavors and flavor modifiers to improve the taste and aroma of foods and pharmaceuticals is an art that dates back several centuries. In large measure, the practice is still the same today and, except for the advent of new semisynthetic ...
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Chapter 125

Fluid Bed Processes for Forming Functional Particles
Fluid bed processors have been used for drying, agglomeration, and coating. In addition to a simple fluid bed, the tumbling, agitating, centrifugal, and spiral flow fluid bed and the spouted bed with or without the draft tube have been developed for ...
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Chapter 126

Food and Drug Administration: Role in Drug Regulation
With a FY2000 budget of $395 billion and employees numbering over 61,000, the Department of Health and Human Services (DHHS) is one of the largest departments in the administrative branch of the United States Government. It is responsible for the ...
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Chapter 127

Fractal Geometry in Pharmaceutical and Biological Applications
Fractals can be considered as disordered systems with a non-integral dimension, called the fractal dimension. An important property of fractal objects is that they are self-similar, independent of scale. This means that if part of them is cutout, and then ...
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Chapter 128

Freeze Drying
Freeze drying, also termed “lyophilization,” is a drying process employed to convert solutions of labile materials into solids of sufficient stability for distribution and storage. A typical production scale freeze dryer consists of a drying “chamber” ...
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Chapter 129

Freeze Drying, Scale-Up Considerations
Product presentation, formulation, and processing are integral in their influences on the outcome of manufacturing a lyophilized product. Activities in development involve knowledge of the clinical and stability requirements, formulation and product ...
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Chapter 130

Gastro-Retentive Systems
Oral controlled release (CR) dosage forms (DF) have been extensively used to improve therapy of many important medications. However, in the case of narrow absorption window drugs, this pharmaceutical approach cannot be utilized, as it requires sufficient ...
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Chapter 131

Gelatin-Containing Formulations: Changes in Dissolution Characteristics
Dissolution parameter or the dissolution profile is one of the important specifications for oral solid dosage forms. Even during aging, dissolution characteristics are required to remain either unchanged or within specifications laid down with reference ...
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Chapter 132

Gels and Jellies
The word “gel” is derived from “gelatin,” and both “gel” and “jelly” can be traced back to the Latin gelu for “frost” and gelare, meaning “freeze” or “congeal.”1 This origin indicates the essential idea of a liquid setting to a solid-like material that ...
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Chapter 133

Generic Drugs and Generic Equivalency
All drugs that are approved for sale generally carry at least two names. The drugs are given a proprietary or trade name given by the company that first develops them. These companies often are referred to as the innovator company. The drug is assigned a ...
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Chapter 134

Genetic Aspects of Drug Development
The science of genetics is currently changing in a way that we cannot neglect when looking at drug development: Traditional genetics was solely concerned with structural variation of genes. New techniques led to the recognition that the expression of ...
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Chapter 135

Geriatric Dosing and Dosage Forms
The word geriatric refers to individuals who are over age 65 years. This has been described as the most heterogeneous population because it constitutes fit, physiologically healthy patients to extremely frail, debilitated patients in long-term care ...
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Chapter 136

Good Clinical Practices (GCPs): An Overview
The Good Clinical Practice (GCP) regulations section in the Code of Federal Regulations (CFR) (21 CFR 312)1 outlines the respective responsibilities of the clinical investigator, the drug sponsor, and the clinical study monitor involved in investigational ...
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Chapter 137

Good Laboratory Practices (GLPs): An Overview
The Good Laboratory Practice Guidelines (GLP) have been in existence for non-clinical safety studies since 1976. 1,2,3,4,5,6,7,8 They have progressed through various transitional phases to become guidelines in some countries and regulatory/statutory ...
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Chapter 138

Good Manufacturing Practices (GMPs): An Overview
The Current Good Manufacturing Practice (cGMP) regulations for finished pharmaceuticals that have been promulgated by the U.S. Food and Drug Administration (FDA) have been a subject of active discussion since they were first published with the passage of ...
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Chapter 139

Handling Hazardous Chemicals and Pharmaceuticals
Over the last few years, legislation on the safety of chemical substances for humans and for the environment has been completed. Chemicals manufactured, imported and, in any way, handled by pharmaceutical and chemical companies are covered by a number of ...
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Chapter 140

Harmonization of Pharmacopeial Standards
Throughout this article, the abbreviation USP, when used alone, signifies the United States Pharmacopeial Convention, Inc. The abbreviation USP in italics and followed by Roman numerals signifies a particular revision of the United States Pharmacopeia. ...
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Chapter 141

Headspace Oxygen Analysis in Pharmaceutical Products
Oxidative chemical degradation of drug substances in pharmaceutical formulations is well documented. Although exact mechanistic details on what governs the promotion of reactions between drug substances (RH) and molecular oxygen in pharmaceutical ...
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Chapter 142

Health Care Systems: Outside the United States
It is quite fascinating how the organization, structure, and financing of health care services can be so very diverse in different countries around the world. One might think that leaders and policymakers would be aware of each other's national health ...
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Chapter 143

Health Care Systems: Within the United States
A national health care system reflects the social, political, economic, and cultural character of a nation. A nation's historical roots and dominant values shape policies and directions for the organization, quality, financing, and access to health care ...
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Chapter 144

Homogenization and Homogenizers
Homogenization encompasses techniques of emulsification of one liquid into another, dispersing solid particles uniformly in a product, and disrupting cell membranes. Traditionally, homogenizers have been used in the pharmaceutical industry for ...
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Chapter 145

Hot-Melt Extrusion Technology
Hot-melt extrusion is one of the most widely applied processing techniques in the plastics industry. Joseph Brama invented the extrusion process for the manufacturing of lead pipes at the end of the eighteenth century. However, hot-melt extrusion was not ...
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Chapter 146

Hydrogels
Hydrogels are three-dimensional and hydrophilic polymer networks capable of swelling in water or biological fluids and retaining a large amount of fluids in the swollen state.1 The water content in the equilibrium of swelling affects different properties ...
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Chapter 147

Hydrolysis of Drugs
The term “hydrolysis” describes a chemical reaction in which a chemical bond is split (lysis) via the addition of water. This reaction is one of the most important routes of drug decomposition, as it occurs frequently in active ingredients and excipients ...
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Chapter 148

Immunoassay
Immunoanalytical methods that are based on the selective, reversible binding of small molecules (drugs) or macromolecules by biologically derived antibodies have revolutionized the field of biomedical analysis. Immunoassays have allowed the determination ...
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Chapter 149

In Vitro–In Vivo Correlation
The aim of this article is to investigate:The notions of in vitro in vivo correlation (IVIVC).
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Chapter 150

Inhalation: Dry Powder
Drug delivery to the lung has been historically aimed at controlling local respiratory disease where the central airways may be as suitable a target for drug deposition as the deeper lung. With little exception, currently marketed inhalation products ...
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Chapter 151

Inhalation: Liquids
Using the inhalation route to deliver therapeutic aerosols is a common practice in the treatment of patients with various airway diseases. Drug delivery via inhalation offers many advantages in the administration of pharmaceutical compounds, because the ...
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Chapter 152

Iontophoresis
Iontophoresis is a method of transferring substances to and from the body for therapeutic or diagnostic purposes by applying an electric potential to enhance their movement across biological membranes. The most common applications of iontophoresis involve ...
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Chapter 153

Isolators for Pharmaceutical Application
The use of isolators in research and manufacturing in the health care and life science industries continues to develop rapidly. An overview shows many new applications being conceived, designed, constructed, and set into operation to satisfy many ...
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Chapter 154

Isomerism
Isomers are defined as molecules of identical atomic compositions (molecular formulas), but with different bonding arrangements of atoms or orientation of their atoms in space. Based on this definition, several types of isomerism are possible including ...
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Chapter 155

Laboratory Information Management System (LIMS)
This article describes what a Laboratory Information Management System (LIMS) is and provides a discussion on building vs. buying a LIMS. It also discusses the cost of a LIMS system, how to write a user requirements specification (URS), how to assess the ...
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Chapter 156

Laminar Airflow Equipment: Applications and Operation
The number and complexity of pharmaceutical manufacturing and compounding processes requiring protection from airborne contaminants has increased substantially in recent years. Because pathogenic viable and non-viable contamination may be readily ...
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Chapter 157

Lead Optimization in Pharmaceutical Development: Molecular and Cellular Approaches
Sensible lead candidate selection for preclinical development and registration should reduce the high rate of drug attrition, the cost of which increases with the distance that the failed drug candidate has proceeded down the research and development ...
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Chapter 158

Lens Care Products
Contact lenses are made of polymeric materials designed and fabricated to correct vision. Because these lenses are removed from the eye after a prescribed wear time, lens care products are required to clean, disinfect and rinse them prior to reinsertion ...
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Chapter 159

Liquid Oral Preparations
Various types of formulations, both aqueous and non-aqueous, have been placed under the rubric of “liquid oral preparations,” including solutions, suspensions, and emulsions. These formulations are primarily employed to enhance the oral bioavailability of ...
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Chapter 160

Lozenges
Lozenges are solid preparations that contain one or more medicaments, usually in a flavored, sweetened base, and that are intended to dissolve or disintegrate slowly in the mouth. They can be prepared by molding (gelatin and/or fused sucrose and sorbitol ...
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Chapter 161

Materials of Construction for Pharmaceutical Equipment
Materials required in the fabrication of equipment and associated systems dedicated to the production of pharmaceutical products should be capable of withstanding the temperature, pressure, and chemical corrosiveness of the product to ensure its purity ...
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Chapter 162

Medication Errors
A report issued by the Institute of Medicine1 in November 1999 has drawn unprecedented national attention to the prevalence of medical error, including medication error. The issues and complexities surrounding this problem are compounded by the array of ...
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Chapter 163

Melt Processes for Oral Solid Dosage Forms
The design of pharmaceutical solid dosage form using meltable materials has become increasingly popular as alternative special processes to avoid aqueous or organic solvents. Its application has extended to the processing of solid dispersion, agglomerate, ...
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Chapter 164

Metabolite Identification in Drug Discovery
The challenge in modern drug discovery is not only to rapidly screen through large number of potential lead drug candidates, but also to find out as much information about these compounds as possible. Since a high percentage of drugs fail in the ...
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Chapter 165

Metered Dose Inhalers
Metered dose inhalers (MDIs) are pharmaceutical delivery systems designed for oral or nasal use, which deliver discrete doses of aerosolized medicament to the respiratory tract. The MDI contains the active substance, dissolved or suspended in a liquefied ...
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Chapter 166

Microbial Control of Pharmaceuticals
Pharmaceutically active products (drug products) are expected to be efficacious, however; the presence of microorganisms in these products may have adverse effects on their efficacy. The severity of the effects that microorganisms may have on any ...
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Chapter 167

Microbiologic Monitoring of Controlled Processes
Microbiologic monitoring of controlled pharmaceutical and medical device manufacturing, and pharmacy compounding processes, is mandated in numerous standards and guidelines, 1,2,3 although procedures, limits, and frequencies are not well defined.4 ...
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Chapter 168

Microencapsulation Technology
Microencapsulation technology has been used from 1930s in packaging flavors and vitamins. Since the first commercial product was introduced for the carbonless copying paper,1 the technology has advanced to a new level. Various microencapsulation ...
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Chapter 169

Microsphere Technology and Applications
The range of techniques for the preparation of microspheres offers a variety of opportunities to control aspects of drug administration. The term “control” includes phenomena such as protection and masking, reduced dissolution rate, facilitation of ...
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Chapter 170

Milling of Active Pharmaceutical Ingredients
Physical properties of active pharmaceutical ingredients (APIs) can impact their effectiveness in the body and influence formulation development and design. While some of these properties are not easily adjustable, particle size and surface area can ...
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Chapter 171

Mixing and Segregation in Tumbling Blenders
Mixing of solids is essential to many industries, including pharmaceuticals, ceramics, metallurgy, chemicals, food, cosmetics, coal, and plastics. To give an idea of the magnitude of applications involving granular processes, U.S. worldwide production ...
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Chapter 172

Moisture in Pharmaceutical Products
The earth contains 75% water,1 some of it in pharmaceutical products. With regard to solid dosage forms, pharmaceutical scientists have struggled for years to answer questions on how much is there, in what form is it, and if, when, and how might it ...
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Chapter 173

Nanoparticle Engineering
Technological advances in both biotechnology and molecular biology have yielded a surge in the number of new chemical entities that are produced to treat specific diseases or ailments. However, a growing portion of these new chemical entities display poor ...
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Chapter 174

Neural Computing and Formulation Optimization
The process of formulation, whether for oral products, parenterals, or other pharmaceutical products, is complex and involves the interaction of many ingredient and process variables. As such, it is difficult to understand such systems, let alone develop ...
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Chapter 175

Non-Prescription Drugs
In the 1800s, manufacturers used extravagant promotional techniques, which were reflective of the nation's level of culture and taste, to sell their products. Exaggerated statements regarding the products and its effects were very common. Professional ...
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Chapter 176

Nutraceutical Supplements
Nutraceutical is the term used to describe medicinally or nutritionally functional foods or components thereof, and it may include a food, plant, or naturally occurring material, which may have been purified or concentrated, and it is used for improvement ...
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Chapter 177

Optimization Methods
Optimization of a formulation or process is finding the best possible composition or operating conditions. Determining such a composition or set of conditions is an enormous task, probably impossible, certainly unnecessary, and in practice, optimization ...
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Chapter 178

Orphan Drugs
As drug development costs began to rise in the late 1960s and 1970s with new Food and Drug Administration (FDA) requirements for demonstrating relative safety and efficacy, manufacturers of drugs, biologicals, and diagnostic agents faced a dilemma. How ...
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Chapter 179

Otic Preparations
Otic preparations are commonly used to treat diseases of the external ear and occasionally of the middle ear. Diseases of the ear include cerumen impaction, dermatitis of the external ear canal, and infectious processes. External otitis (swimmers' ear) ...
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Chapter 180

Outsourcing
Outsourcing of pharmaceutical development is big business and getting bigger. Of the over $40 billion per year research and development budget of pharmaceutical companies, about one-fifth, or $8 billion, is presently expended at contract service ...
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Chapter 181

Packaging Materials: Glass
Glass has been used for over 6000 years, dating to ancient times. Through the years and with more knowledge of its technology, glass has become the most widely used drug packaging material. The origin of the first synthetic glass is unknown; however, ...
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Chapter 182

Packaging Systems: Compendial Requirements
Since 1820, the US Pharmacopeial Convention established compendial standards for drugs sold and marketed in the U.S.A. Currently these standards are published in the US Pharmacopeia (USP) and the National Formulary (NF). These publications are currently ...
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Chapter 183

Paperless Documentation Systems
The fundamental purpose of documents is communication. Specifically, documents enhance the flexibility of communication. Documents improve the ability to transmit information in two ways. First, a document freezes a sender's message in time so that it may ...
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Chapter 184

Particle Engineering
Particle engineering is a term coined to encompass means of producing particles having a defined morphology, particle size distribution, and composition. In its broadest sense, wet granulation can be considered a means of particle engineering, as it is a ...
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Chapter 185

Particle-Size Characterization
The subject of powder sampling has been addressed extensively in standard reference books. Several companies sell sampling equipment for installation in industrial systems. 1,2,3,4,5,6,7 Even when the sample received by the laboratory is a representative ...
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Chapter 186

Partition Coefficients
A thorough understanding of partition coefficients is important to all research scientists and product development staff in various branches of the pharmaceutical field. The principle and applications are involved in several different areas of current ...
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Chapter 187

Patents: International Perspective
A strong patent system is important to the research-based pharmaceutical industry. The success of the pharmaceutical industry has been based on the discovery of new products that treat human disease states in new and unique ways. The patent system has ...
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Chapter 188

Patents: United States Perspective
The importance of pharmaceutical patents has increased with the dramatic growth of the generic pharmaceutical industry in the United States and the resulting competition between the research-based pharmaceutical industry and the generic pharmaceutical ...
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Chapter 189

Pediatric Dosing and Dosage Forms
The administration of medications to pediatric patients is in many ways difficult because health care providers and parents are faced with many challenges not experienced, or experienced to a lesser degree, than when medications are prescribed for and ...
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Chapter 190

Pelletization Techniques
Historically, the term pellet has been used by a number of industries to describe a variety of agglomerates produced from diverse raw materials, using different pieces of manufacturing equipment. These agglomerates include fertilizers, animal feeds, iron ...
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Chapter 191

Peptides and Proteins: Buccal Absorption
In recent years, proteins and peptides are emerging as a major class of therapeutic agents. Pharmaceutical scientists are faced with the challenges of a) selection of a suitable route of drug delivery and b) formulation of these bioengineered drugs. The ...
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Chapter 192

Peptides and Proteins: Nasal Absorption
With the recent remarkable progress in biotechnology, a class of clinically available peptide and protein drugs has been expanding more than ever. Generally, drugs can be administered via various parenteral or non-parenteral routes, and the choice of the ...
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Chapter 193

Peptides and Proteins: Non-Invasive Delivery
Advances in biotechnology over the past 25 years have produced a number of protein- and peptide-based pharmaceutical products approved for the treatment of a broad spectrum of diseases. As the disciplines of genomics and, more recently, proteomics ...
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Chapter 194

Peptides and Proteins: Oral Absorption
Rapid developments in biotechnology have posed new challenges for pharmaceutical research scientists to develop peptide (>3 amino acids) and protein drugs. Although these peptide and protein drugs are highly potent and specific in their physiological ...
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Chapter 195

Peptides and Proteins: Pulmonary Absorption
The human respiratory tract has the potential to provide the means for non-invasive drug delivery of molecules that could not be efficiently and reproducibly, or rapidly, delivered without injecting them into the body. From the early parts of the 20th ...
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Chapter 196

Peptides and Proteins: Transdermal Absorption
An increasing number of peptides and proteins will be introduced into therapeutics in the forthcoming years. The gradual maturation of the biotechnology industry has led to many advances, not the least of which is that it is now possible, for the first ...
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Chapter 197

Pharmaceutical Data: Mathematical Modeling
The intent of this article is to give the reader an overview of mathematical modeling as it can be applied to pharmaceutical and especially pharmacokinetic data. The emphasis is on the application of non-linear regression techniques for the determination ...
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Chapter 198

Pharmaceutical Excipient Testing: Regulatory and Preclinical Perspective
Pharmaceutical excipients are additives Updated from Pharmaceutical Excipient Testing—A Regulatory and Preclinical Perspective. In Encyclopedia of Pharmaceutical Technology; Swarbrick, J.; Boylan, J.C. (Eds.), 1st Ed., Marcel Dekker, Inc., New York, 2000, ...
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Chapter 199

Pharmaceutical Quality Assurance Microbiology Laboratories
The pharmaceutical microbiologist has an important role in product development, manufacturing process development, ensuring control of microorganisms in the manufacturing environment and routine raw material, inprocess material, and product testing. The ...
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Chapter 200

Pharmacogenomics and Genomic Technologies
The human genome project has generated data unprecedented in its volume and in the promise that it holds in providing a better understanding of the complexity of biological systems. With the ultimate identification of all of the genes in the human genome, ...
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Chapter 201

Pharmacokinetic/Pharmacodynamic Modeling and Simulations in Drug Development
Pharmaceutical industry is faced with more challenges than ever in recent years. The drug industry continues to consolidate and become more competitive.1 Highly publicized lawsuits have heightened sensitivities with respect to the balance between ...
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Chapter 202

Pharmacokinetics: Effects of Food and Fasting
Patient compliance may be improved when drug administration is tied to meal timing and intake. However, depending on the drug, the composition and the size of the meal, and the time of food intake relative to dose administration, the pharmacokinetic ...
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Chapter 203

Pharmacopeial Standards: European Pharmacopeia
The purpose of a pharmacopeia and particularly of the European Pharmacopeia is to promote public health by providing common standards recognized by health authorities and all those concerned with the quality of medicines. Such standards are to be of ...
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Chapter 204

Pharmacopeial Standards: Japanese Pharmacopeia
The Pharmacopeia of Japan (JP), which dates back to 1886, provides the official standards and test methods for regulating the properties and quality of drugs important for medical treatment. In general, the standards set forth in the JP affect not only ...
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Chapter 205

Pharmacopeial Standards: United States Pharmacopeia and National Formulary
United States Pharmacopeia (USP) and National Formulary (NF) standards and specifications relate to the quality, purity and strength, packaging, and labeling of medicines and related articles. a
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Chapter 206

Photodecomposition of Drugs
Numerous compounds degrade when exposed to light. Some light-sensitive drugs are rapidly affected, either by natural light (particularly ultraviolet) or by artificial light (e.g., fluorescent light). This may lead to a change in the physicochemical ...
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Chapter 207

Physiological Factors Affecting Oral Drug Delivery
Thirty years on from the explosion of commercially successful applications of targeted and controlled release pharmaceutical formulations, it is evident that there remains a need for further refinements and innovations in the field of drug delivery. Many ...
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Chapter 208

Pilot Plant Design
A pilot plant design should support three key strategic objectives:Formulation and process developmentClinical supply manufactureTechnology evaluation, scale-up, and transfer
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Chapter 209

Pilot Plant Operation
Several attributes of the pilot plant allow it to serve as a vital function in achieving the key strategic objectives of:
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Chapter 210

Plants as Drugs
Phytomedicine, the use of plants or plant parts to evoke a therapeutic cure or to treat an ailment, has been part of humankind's attempt to free itself of disease for several thousand years. Some references suggest that Neanderthals may have been one of ...
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Chapter 211

Polymeric Delivery Systems for Poorly Soluble Drugs
Many existing drugs are poorly water soluble, and this limits their clinical applications. A large number of newly developed drug candidates are frequently found to be poorly water soluble, making it difficult to test their bioefficacy and to produce ...
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Chapter 212

Polymers in Transdermal Delivery Systems
Polymers are divided into biological and non-biological (synthetic) polymers, each of which is of great importance in our life. Biological polymers form the foundation of our life and provide much food for us. Nowadays, synthetic polymers, hereafter ...
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Chapter 213

Polymorphism: Pharmaceutical Aspects
It had been known since the middle of the 18th century that many substances could be obtained in more than one crystal form, and so the properties of these solids were studied to the fullest extent possible with the characterization tools (e.g., crystal ...
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Chapter 214

Population Pharmacokinetics
Population pharmacokinetics (PPK) is an area of clinical pharmacology, which aims at the quantitative assessment of between and within individual variability in drug absorption, distribution, metabolism, and excretion.1 The purpose of PPK is to provide ...
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Chapter 215

Powder Sampling
Taking a large amount of powder for analysis is expensive and wasteful, and so it must be reduced. Sampling in its strict sense is therefore a simple mass reduction.1
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Chapter 216

Powders as Dosage Forms
Powders are both the simplest dosage forms and the basis of many other solid dosage forms, such as tablets, capsules, etc. Many drugs or ingredients are also in powder form before processing.
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Chapter 217

Preservation of Pharmaceutical Products
Microbial spoilage of pharmaceutical products has been known for many years. Spoilage may result in the deterioration of the product due to loss of potency or to the initiation of an infection in the user. Sterile pharmaceutical products (single dose or ...
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Chapter 218

Process Chemistry in the Pharmaceutical Industry
In the pharmaceutical industry, identification of a development drug candidate (preclinical lead profile, PLP, or early candidate notification, ECN), filing of investigational new drug application (IND), and new drug application (NDA) are important ...
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Chapter 219

Prodrug Design
Drug disposition and metabolism are of essential significance in pharmaceutical research because of the interdependence of pharmacokinetic and pharmacodynamic processes. Limited intestinal absorption, inadequate distribution, fast metabolism, and toxic ...
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Chapter 220

Project Management
New products are developed and introduced in organizations primarily through the use of projects and teams. Research of new technologies and innovation is essentially accomplished through the use of projects as well. The processes for developing and ...
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Chapter 221

Protein Binding of Drugs
When a drug reaches the systemic circulation, either after intravenous administration or after absorption following extravascular administration, it can be distributed in the elements of blood (erythrocytes, etc.) or bind to plasma proteins. Blood ...
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Chapter 222

Proteomics: Pharmaceutical Applications
The completion of the Human Genome Project represented a significant milestone in the journey toward understanding the genetic basis of disease. By dissecting the genetic blueprint of an organism, we can begin to understand the gene-derived cellular ...
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Chapter 223

Pyrogens and Endotoxin Detection
A pyrogen is defined as a fever-producing agent. Pyrogens are substances that cause febrile reactions when sufficient amounts enter the circulatory system. Bacterial endotoxin is the most significant pyrogen because of its potency and ubiquity. The ...
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Chapter 224

Quality Assurance of Pharmaceuticals
Whatever you can do or dream you can, begin it. Boldness has genius, power, and magic in it. — Goethe
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Chapter 225

Quality Systems Management
Managing for quality is and always has been a critical task of management no matter what the industry. In the pharmaceutical industry today, achieving quality of products, services, and processes is as important as it ever was; however, today we need to ...
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Chapter 226

Radiochemical Methods of Analysis
In nuclear medicine, drugs containing radioactive metals, metal complexes, and metal conjugates are used fordiagnosis and therapy of various diseases. Radioactive materials used as pharmaceuticals are not only small organic and inorganic molecules but are ...
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Chapter 227

Radiolabeling of Pharmaceutical Aerosols and Gamma Scintigraphic Imaging for Lung Deposition
Inhalation aerosols have been successfully used to deliver drugs to the lung for local and systemic therapeutic effects. In vivo evaluation of pharmaceutical inhalation products is achieved by gamma scintigraphic imaging of the aerosol deposited in the ...
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Chapter 228

Receptors for Drugs: Discovery in the Post-Genomic Era
A paradigm shift has occurred in receptor-based drug discovery based upon the elucidation of the complete human genome and advances in genomics research, which have revealed a plethora of potential new receptors on which to focus drug discovery efforts. ...
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Chapter 229

Rheology of Pharmaceutical Systems
The American Society of Rheology, which was founded in 1929, has defined “rheology” as the science of deformation and flow of matter. Deformation describes the change of matter in terms of shape or volume, or both. If the changes due to deformation are at ...
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Chapter 230

RNAi in Drug Development
RNA interference (RNAi) is a phenomenon comprising the ability of double-stranded RNA (dsRNA) molecules to stimulate eukaryotic gene suppression in a sequence-specific manner. This article will first outline the essential molecular biological principles ...
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Chapter 231

Roller Compaction Technology for the Pharmaceutical Industry
The pharmaceutical industry uses grannulation methods to enlarge and densify small powder particles into larger ones. This improves powder flow so that the material can be processed effectively and efficiently further into solid dosage forms. There are ...
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Chapter 232

Salt Forms: Pharmaceutical Aspects
By definition, a salt is formed from the reaction of an acid with a base. This simple chemical reaction involves either a proton transfer or a neutralizing reaction. Thus a drug, which is either an acid or a base, may form a wide range of salts with ...
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Chapter 233

Scale-Up and Post Approval Changes (SUPAC)
In the process of developing a new drug product, the batch sizes used in the earliest human studies are small. As one proceeds through Phase 1 testing (i.e., the first introduction of a new chemical entity to humans), Phase 2 (discovering an indication ...
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Chapter 234

Scale-Up of Solid Dosage Forms
The development of new drug products goes through many stages. Very early clinical studies may require less than 100 unit doses for proof of concept studies. Powder in a bottle and hand-filled capsule, manual-type approaches, can be acceptable at these ...
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Chapter 235

Secondary Electron Microscopy in Pharmaceutical Technology
The principle of an electron microscope is based on the light microscope except that electrons are used instead of light. The resolving power of any microscope is given by Abbe's equation  = minimum resolvable separation distance; λ = wavelength of the ...
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Chapter 236

Semisolid Preparations
Pharmaceutical semisolid preparations may be defined as topical products intended for application on the skin or accessible mucous membranes to provide localized and sometimes systemic effects at the site of application. In general, semisolid dosage forms ...
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Chapter 237

Solids: Flow Properties
The preparation of essentially all dosage forms involves the handling of solid materials. Among all finished products, solid dosage forms are the most predominant in terms of volume and value. The importance of solid-handling properties, especially flow ...
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Chapter 238

Solid-State NMR in the Characterization of Pharmaceutical Formulations
Solid-state nuclear magnetic resonance (SSNMR) spectroscopy is a powerful technique used in the analysis of solids, and is currently finding more and more applications, particularly in the analysis of pharmaceutical formulations. It is a non-destructive, ...
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Chapter 239

Solubilization of Drugs in Aqueous Media
Therapeutic drugs are often given systemically. Once given systemically, a drug will distribute throughout the body. By distributing in the body, the drug is essentially diluted out from its original concentration in the formulation/dosage form. Hence, ...
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Chapter 240

Solubilizing Excipients in Pharmaceutical Formulations
Formulation design, in general, involves chemistry and engineering, thus requiring an understanding of the variety of excipient chemicals and manufacturing techniques. Drug molecules are often poorly water-soluble and are difficult to effectively ...
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Chapter 241

Spectroscopic Methods of Analysis: Atomic Absorption and Emission Spectrophotometry
Often it is necessary to measure the metal content of different kinds of samples in the pharmaceutical industry. These samples can be actual products that have metals, such as calcium or magnesium added for their therapeutic value or biological samples, ...
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Chapter 242

Spectroscopic Methods of Analysis: Diffuse Reflectance Spectroscopy
In the field of molecular spectroscopy, absorption measurements with electromagnetic radiation covering the wavelengths between 200 nm and 20 µm can be used for analytical applications. By convention, tags such as ultraviolet (UV), visible (VIS), and ...
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Chapter 243

Spectroscopic Methods of Analysis: Fluorescence Spectroscopy
Luminescence processes in molecules can be classified according to the source from which the excitation energy is derived. In photoluminescence, which encompasses fluorescence and phosphorescence, excitation is achieved by the absorption of light by the ...
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Chapter 244

Spectroscopic Methods of Analysis: Infrared Spectroscopy
Infrared (IR) spectroscopy refers broadly to the study of the interaction between matter and infrared radiation. Infrared radiation falls in the region between the visible and microwave parts of the electromagnetic spectrum, with wavelengths from 0.7 to ...
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Chapter 245

Spectroscopic Methods of Analysis: Mass Spectrometry
The dramatically increased expenditures for both in-house and outsourced pharmaceutical research and development (R&D) have led to a sgreater dependence on technology. New technologies are constantly introduced into drug development to address throughput ...
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Chapter 246

Spectroscopic Methods of Analysis: Near-Infrared Spectrometry
In recent years, there has been an increased interest in near-infrared (NIR) spectrometry. New instrumentation and algorithms have made the technique more powerful yet simple to use. The physics of NIR allow the samples to be analyzed as-is with, ...
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Chapter 247

Spectroscopic Methods of Analysis: Nuclear Magnetic Resonance Spectroscopy
Nuclear magnetic resonance spectroscopy plays a vital role in essentially all aspects of pharmaceutical development. In the early stages of lead development, NMR is used as a high throughput tool in the analysis of combinatorial libraries and in screening ...
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Chapter 248

Spectroscopic Methods of Analysis: Ultraviolet and Visible Spectrophotometry
Many compounds of pharmaceutical interest are colorless. In the early part of the 20th century, analytical methods were developed using color-forming reactions and measurement of color for quantitation. With the development of instrumentation and based on ...
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Chapter 249

Starches and Starch Derivatives
Starch is one of the most commonly used excipients in the pharmaceutical industry due to its disintegration and binding properties. A number of sources of starch are commercially available, with corn starch being the most common. An overview of starches ...
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Chapter 250

Statistical Methods
Death and taxes, as the old adage goes, are the only certainties in life. Although this is an overstatement, it does emphasize the uncertain world in which the pharmaceutical scientist lives and works. Faced with “estimates” of product characteristics ...
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Chapter 251

Statistical Process Control and Process Capability
Statistical process control (SPC) provides a statistical approach for evaluating processes and for improving the quality of these processes through elimination of special causes. When SPC is effectively implemented within a company, benefits can be ...
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Chapter 252

Sterilization: Dry Heat
Sterilization means the destruction of all life. The aim of sterilization is to destroy the ability of microorganisms to survive and multiply with the oldest and most recognized agent of destruction being heat.1 Dry heat is the method of choice for ...
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Chapter 253

Sterilization: Ethylene Oxide
The biological activity of ethylene oxide (EtO) was initially observed by Cotton and Roark,1 who detected it as an insecticide, in concentrations ranging from 3.2 mg L−1 to 32.0 mg L−1. In 1937, Gross and Dixon2 requested the patent of EtO as a ...
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Chapter 254

Sterilization: Moist Heat
To sterilize something means to render it “aseptic” (from the Greek word sepsis, putrefaction, preceded by a privative a). In other words, it means to inactivate the micro-organisms that may produce this putrefactive action (in the broadest sense of the ...
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Chapter 255

Sterilization: Radiation
The actions of ionizing radiations on matter and the subsequent interactions of the irradiated molecules are useful for the sterilization of pharmaceutical and surgical supplies. To take maximum advantage of the benefits derived from ionizing radiations, ...
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Chapter 256

Super Disintegrants: Characterization and Function
Disintegrating agents are substances routinely included in tablet formulations and in some hard shell capsule formulations to promote moisture penetration and dispersion of the matrix of the dosage form in dissolution fluids. An oral solid dosage form ...
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Chapter 257

Supercritical Fluid Technology in Pharmaceutical Research
A supercritical fluid (SCF) is a substance whose temperature and pressure are simultaneously above its critical point. Critical temperature (T c) is the highest temperature at which a gas can be converted to a liquid by an increase in pressure. Critical ...
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Chapter 258

Surfactants in Pharmaceutical Products and Systems
Surface-active agents (surfactants) are substances which, at low concentrations, adsorb onto the surfaces or interfaces of a system and alter the surface or interfacial free energy and the surface or interfacial tension. Surface-active agents have a ...
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Chapter 259

Suspensions
A suspension is a particular class or type of dispersion or dispersed system in which the internal or suspended phase is dispersed uniformly by mechanical agitation throughout the external phase (called the suspending medium or vehicle). The internal ...
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Chapter 260

Tablet Compression: Machine Theory, Design, and Process Troubleshooting
The most common method of drug delivery is the oral solid dosage form, of which tablets and capsules are predominant. The tablet is more widely accepted and used compared to capsules for a number of reasons, such as cost, tamper resistance, ease of ...
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Chapter 261

Tablet Evaluation Using Near-Infrared Spectroscopy
Near-infrared spectroscopy (NIRS) continues to grow in importance as a useful analytical technique. It offers unique potential as a rapid, non-destructive method of quantitative and qualitative evaluation. NIRS has been used extensively in the food and ...
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Chapter 262

Tablet Formulation
The best new therapeutic entity in the world is of little value without an appropriate delivery system. Tableted drug delivery systems can range from relatively simple immediate-release formulations to complex extended- or modified-release dosage forms. ...
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Chapter 263

Tablet Manufacture
The compressed tablet is by far the most widely used dosage form, having advantages for both producer and user. However, the manufacture of tablets can be a complex process, since only a few raw materials inherently possess those properties which are ...
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Chapter 264

Tablet Manufacture by Direct Compression
All tablets are made by compressing a particulate solid between two punches in a die of a tablet press. For an active ingredient to be transformed into tablets of satisfactory quality, the formulation must have three essential attributes.
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Chapter 265

Tablet Press Instrumentation
This article is designed to facilitate the understanding of the general principles of tablet press instrumentation and the benefits thereof by the formulators, process engineers, validation specialists, and quality assurance personnel, as well as ...
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Chapter 266

Tablet Testing
A tablet is perhaps the oldest and most common pharmaceutical dosage form. Its popularity is due to its convenience in the administration of a drug without the help or supervision of a health care practitioner, thus providing patients' freedom and a very ...
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Chapter 267

Technology Transfer Considerations for Pharmaceuticals
Technology transfer for pharmaceutical products is a program that has been followed for some time. 1,2,3,4,5,6,7,8 Issues to be considered when organizing the transfer of technology from the research arena to the production and quality assurance ...
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Chapter 268

Thermal Analysis of Drugs and Drug Products
Thermal analysis techniques, in which a physical property is monitored as a function of temperature or time while the analyte is heated or cooled under controlled conditions, are fundamental techniques for the characterization of drugs and drug products, ...
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Chapter 269

Titrimetry
Titrimetry or titrimetric analysis is any method of quantitative chemical analysis in which the amount of a substance is determined by measuring the volume that it occupies or the volume of a second substance that is needed to react completely with the ...
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Chapter 270

Tonicity
Parenteral formulations, both large and small volume, have been discussed in depth in Volume 11 of the Encyclopedia of Pharmaceutical Technology (V 11, pp. 201–217, 217–237). However, no discussion of parenteral formulations is complete without an ...
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Chapter 271

Tooling for Tableting
Introducing high-speed tableting in 24-hr shifts has tremendously increased productivity, which in turn places heavy demands not only on the tablet presses and the compressibility of the tableting materials but also on precision with respect to dimensions ...
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Chapter 272

Trace Level Impurity Analysis
The issue of trace level impurities in active pharmaceutical ingredients (termed “Drug Substances”) and formulations developed for APIs (termed “Drug Products”) is a broad and complex one. Impurities can be both organic and inorganic, and can be ...
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Chapter 273

Transdermal Delivery: Anatomical Site Influence
Transdermal drug delivery (TDD) is known to offer many advantages over the oral and injectable routes for systemic drug delivery. However, the skin is a complex and dynamic organ with marked barrier function, which results in limitations and variations in ...
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Chapter 274

Transdermal Delivery: Sonophoresis
Systemic as well as topical delivery of drugs via the transdermal route is limited by the low skin permeability which is attributed to the stratum corneum (SC), the outermost layer of the skin.1 The SC consists of disk-like dead cells (keratinocytes) ...
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Chapter 275

Transdermal Delivery: Technologies
The advantages of transdermal drug delivery over conventional routes of drug delivery are many folds. Examples of approved transdermal applications are estradiol and testosterone in hormone replacement, clonidine for hypertension, fentanyl and lidocaine ...
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Chapter 276

Ultrasonic Nebulizers
Ultrasonic nebulizers use ultrasonic energy to convert liquid, usually an aqueous solution, into an aerosol for inhalation. They are used to deliver β 2-agonists, corticosteroids, antiallergics, anticholinergics, and antiviral and mucolytic agents to the ...
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Chapter 277

Unit Processes in Pharmacy: Fundamentals
Pharmaceutical manufacturing can be divided into a number of unit process on the basis of a few fundamental principles. The following monograph describes briefly fluid flow and heat and mass transfer.
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Chapter 278

Unit Processes in Pharmacy: Operations
The fundamentals of unit processes have been described elsewhere.1,2 The following is a summary of the major operations. Although it is broad in scope, the abbreviated form of this article has resulted in selected omissions. References are given, wherever ...
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Chapter 279

Vaccines and Other Immunological Products
The concept of vaccination was introduced in the late 18th century by Edward Jenner when he used cowpox virus as a vaccine to protect humans against smallpox virus infections. This led to the development of vaccines over the next 2 centuries to provide ...
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Chapter 280

Validation of Pharmaceutical Processes
Process validation is a requirement of current Good Manufacturing Practices (GMPs) for finished pharmaceuticals (21 CFR 211) and of the GMP regulations for medical devices (21 CFR 820) and therefore applies to the manufacture of both drug products and ...
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Chapter 281

Veterinary Dosage Forms
Veterinary dosage forms are drug preparations designed for use in, or topical application to, one or more species of domestic animal and/or other species of veterinary interest. Although the majority of veterinary dosage forms contain the same drugs as ...
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Chapter 282

Veterinary Pharmaceuticals: Factors Influencing Their Development and Use
Understanding the needs and constraints of animal species and the structure and agencies involved in the regulatory process is crucial for optimizing animal drug development and use. The process leading to approval and marketing of new animal drugs is ...
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Chapter 283

Viral Inactivation Issues in Aseptically Processed Parenterals
Plasma-derived therapeutic proteins are parenteral biologics that are purified on an industrial scale. All biologics derived from human sources, such as plasma, carry the risk of viral contamination. Thus, in order to market a medicinal product derived ...
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Chapter 284

Virtual Screening
Identification of viable chemical leads is one of the key tasks of the early stage of drug discovery. Historically, the lead discovery phase was mainly supported by in vivo experiments that usually resulted in compounds with acceptable efficacy and ...
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Chapter 285

Water for Pharmaceuticals
Water is one of the key utilities in most pharmaceutical facilities. It is used as a solvent, product ingredient, cleaning agent, and for many other applications. Some of those applications require water of higher purity than typically found in municipal ...
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Chapter 286

Water Sorption of Drugs and Dosage Forms
The physical, chemical, and mechanical properties of pharmaceutical drugs and dosage forms are critically dependent on the presence of moisture. Pharmaceutical scientists can cite numerous examples of desirable and undesirable properties that result from ...
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Chapter 287

Waxes
The term wax generally refers to a substance that is a plastic solid at room temperature and a liquid of low viscosity above its melting point. Strictly speaking, a wax is chemically defined as an ester of a monohydric long chain fatty alcohol and a long ...
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Chapter 288

Wet Granulation: End-Point Determination and Scale-Up
Wet granulation is used mainly to improve flow and compressibility of powders, and to prevent segregation of the blend components. Particle size of the granulate is affected by the quantity and feeding rate of the granulating liquid.
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Chapter 289

World Health Organization (WHO): Global Harmonization of Requirements for Medicinal Products
The World Health Organization (WHO) is an intergovernmental specialized agency of the United Nations with 193 member states. Regarding pharmaceutical and biological products, WHO has the global mandate to develop, establish, and promote quality, safety, ...
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Chapter 290

X-Ray Powder Diffractometry
X-rays are electromagnetic radiation lying between ultraviolet and gamma rays in the electromagnetic spectrum. The wavelength of the X-ray region is considered to be between 0.01 and 100 Å.1
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Chapter 291

Zeta Potential
Dispersion systems represent an important class of pharmaceutical dosage forms such as emulsions, suspensions, microspheres, liposomes, and nanoparticles. The medium of these systems is mainly aqueous in nature and the dispersed phase can be either solid ...
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