Overview

The fourth volume in the six-volume Handbook of Pharmaceutical Manufacturing Formulations, this book covers semi-solid drugs. It includes formulations of ointments, lotions, gels, and suppositories, 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 manufacturing semi-solid drugs, the common elements of formulations. The section on regulatory and manufacturing guidance deals with such topics as changes to approved NDAs and aNDAs, post-approval changes to semisolid drugs, SUPAC for non-sterile semisolid dosage form equipment, stability testing of drugs substances and drug products, guidelines on evaluation of stability data in retest periods, skin irritation and sensitization testing of generic transdermal products, and photosafety testing, in addition to providing quick tips on resolving the common problems in formulating semisolid products.

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9781280079054

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