Catatan

This book is Volume 1 of the comprehensive Handbook of Pharmaceutical Manufacturing Formulations series, specifically focusing on compressed solid pharmaceutical products, particularly tablets. It is designed as both a practical and theoretical guide for the pharmaceutical industry, regulatory authorities, and educational institutions. The book is organized into four main parts. Part I, Regulatory and Manufacturing Considerations, discusses the principles and rationale of bioequivalence (BE) testing, specific bioequivalence testing protocols based on FDA guidelines for various solid dosage forms, Good Manufacturing Practice (GMP) audit templates based on European Union guidelines, as well as detailed guidance on tablet formulation processes, dissolution testing specifications, and lists of approved excipients. Part II, Manufacturing Formulations, presents hundreds of comparative formulations and manufacturing prototypes for various widely used solid pharmaceutical products, including immediate-release and controlled-release tablets, complete with quantities per unit and manufacturing instructions. Part III, Tablet Coating Formulations, provides guidelines and formulations for different tablet coating techniques, including cellulose-based coatings such as hydroxypropyl methylcellulose (HPMC), sugar coatings, and enteric coatings. Part IV, Composition of Approved Proprietary Products in the United States, contains the compositions of leading branded pharmaceutical products approved in the United States, serving as comparative references for generic product developers. Overall, this book provides valuable information and practical guidance for the formulation, manufacturing, quality control, and development of solid pharmaceutical dosage forms.

Keywords: Pharmaceutical Manufacturing, Compressed Solid Products, Tablet Formulation, Bioequivalence, Good Manufacturing Practice, Tablet Coating, Immediate-Release Tablets, Controlled-Release Tablets.