Handbook of Pharmaceutical Manufacturing Formulations - Semisolid 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 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.
Content: Book Cover; Half-Title; Series; Title; Copyright; Dedication; Preface to the Series; Preface to the Volume; About the Author; Contents; 1 Changes to Approved New Drug Applications or Abbreviated New Drug Applications; 2 Postapproval Changes to Semisolid Drugs; 3 Scale-Up and Postapproval Changes for Nonsterile Semisoild; 4 Stability Testing of Drug Substances and Drug Products; 5 Guidelines for Evaluation of Stability Data in Retest Periods; 6 Skin Irritation and Sensitization Testing of Generic Transdermal Drug Products; 7 Photosafety Testing; 8 Guidance on Formulating Semisolid Drugs.
Abstract: The fourth volume in the six-volume Handbook of pharmaceutical manufacturing formulations 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.