Handbook of Pharmaceutical Manufacturing Formulations: Over-the-Counter Products Vol. V

The fifth volume in the six-volume Handbook of Pharmaceutical Manufacturing Formulations, this book covers over-the-counter products, which include formulations of products classified by the US FDA under OTC category, 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 OTC products, the common elements of formulation. The section on regulatory and manufacturing guidance deals with the topics of cGMP practices for the OTC drug products, formulations of solid oral dosage forms, oral solutions and suspensions, validation of cleaning process, in addition to providing quick tips on resolving the common problems in formulating OTC drugs.