Handbook of Pharmaceutical Manufacturing Formulations: Liquid Products (Volume 3 of 6), Volume 3

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CRC Press, Apr 27, 2004 - Medical - 256 pages
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The third volume in the six-volume Handbook of Pharmaceutical Manufacturing Formulations, this book covers liquid drugs, which include formulations of non-sterile drugs administered by any route in the form of solutions (monomeric and multimeric), suspensions (powder and liquid), drops, extracts, elixirs, tinctures, paints, sprays, colloidons, emulsions, aerosols, and other fluid preparations from publicly available but widely dispersed information from FDA New Drug Applications (NDA), patent applications, and other sources of generic and proprietary formulations. Each entry begins with a fully validated scaleable manufacturing formula and a summary of manufacturing process. The book provides a detailed discussion on the difficulties encountered in formulating and manufacturing liquid drugs and the common elements of formulation. The section on regulatory and manufacturing guidance deals with the topics of changes to approved NDAs and aNDAs, post-approval changes to semisolid drugs, global manufacturing practices and guidelines, compliance program guidance manual for FDA staff covering drug manufacturing inspections program, waiver of in vivo bioavailability studies for immediate release solid drugs based on a biopharmaceutics classification, in addition to providing quick tips on resolving the common problems in formulating uncompressed drugs.
 

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Contents

Chapter 1 Current Good Manufacturing Practice Considerations in Liquid Manufacturing
3
Chapter 2 Stability Testing of New Drug Substances and Products
7
Chapter 3 Container Closure Systems
17
Chapter 4 Preapproval Inspections
29
Chapter 5 Formulation Considerations of Liquid Products
51
Manufacturing Formulations
59
Index
225
Back cover
233
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About the author (2004)

Pakistani doctor Sarfaraz K. Niazi has been teaching in the field of pharmaceutical sciences for over 34 years. He has published over 100 research articles and over a dozen major books including textbooks and a book on patent filing. He is the recipient of several research recognition awards. He is a licensed practitioner of patent law in the United States and serves the global pharmaceutical and biotechnology industry in the transition of research ideas into useful technology. Niazi holds several major US and worldwide patents for his inventions and writes in the fields of philosophy, sociology, rhetoric and poetry. He is the author of the first book on clinical pharmacokinetics and the largest work on pharmaceutical manufacturing formulations and also on the manufacturing of therapeutic proteins. He holds several fellowship of learned societies and is a reviewer for scientific journals. He writes poetry in several languages and as a hobby translates ancient Urdu and Persian poetry into English.

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