Handbook of Pharmaceutical Manufacturing Formulations: Semisolids Products (Volume 4 of 6)

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. INV STAT: Not yet published Pharmaceutical formulations remain as much an art today as they have evolved into complex science. With exponential growth of generic formulations, the need for ready formulations has increased. Essentially an authoritative and practical guide to the art and science of formulating drugs, the six-volume handbook contains the Bill of Materials and Manufacturing Directions for over 2000 drug formulations, including a number of biotechnology and patented drugs. The author has painstakingly assembled these volumes from FDA New Drug Applications, patent applications and other sources of generic and proprietary formulations, all supplemented by his 30-plus years of experience in pharmaceutical formulations Each volume of the series is divided into two parts: the section on regulatory and manufacturing guidelines and the section on formulations. The series covers issues related to generic manufacturing of drugs including cGMP compliance, pre-approval inspections, stability testing, bioequivalence testing, packaging commodity development, changes to aNDAs, SUPAC for equipment, and a large number of other relevant and current topics of interest to the pharmaceutical industry. Each category of drug formulations, classified in separate volumes, is analyzed for the common difficulties in formulating drugs. This book is the first of its kind published in the pharmaceutical literature and is a must collection for all pharmaceutical manufacturers, educational institutions, and regulatory authorities. Companies with large formulation teams will find this book an excellent platform for benchmarking their own products and generic companies will find this book an excellent source of information prior to embarking on formulating drugs coming off patent; this book will make the difference in the filing of the aNDAs in the shortest possible time. This book is also an excellent teaching tool, not only for those working in the manufacturing environment but also in academia. Annotation Pharmaceutical formulations remain as much an art today as they have evolved into complex science. With exponential growth of generic formulations, the need for ready formulations has increased. Essentially a cookbook for making drugs, the six-volume handbook contains the recipes and process steps for over 2000 drugs, including a number of biotechnology drugs. This first volume covers tablets, both coated and uncoated and oral powders. The author has painstakingly assembled this book from FDA New Drug Applications, patent applications and the BASF book of generic formulations, all supplemented by his 30-plus years of experience in pharmaceutical formulations The fourth volume in the six-volume Handbook of Pharmaceutical Manufacturing Formulations, this book covers semi-solid drugs. It includes ointments, lotions, gels, and suppositories, from publicly available but widely dispersed information from FDA New Drug Applications (NDA), patent applications, and the BASF book of generic formulations. Each entry begins with a fully validated scaleable manufacturing formula that includes compendial specification requirement for each ingredient, in-process controls for manufacturing and release of product, a summary of manufacturing process, and details of packaging. v. 1. Compressed solid products v. 2. Uncompressed solid products v. 3. Liquid products v. 4. Semisolid products v. 5. Over-the-counter products v. 6. Sterile products.