Handbook of Pharmaceutical Manufacturing Formulations - Over-the-Counter Products (Volume 5 of 6)

The fifth volume in the series, this book covers over-the-counter products, which include formulations of products classified by the US FDA under the OTC category. 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 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.
Content: Book Cover; Half-Title; Title; Copyright; Dedication; Preface to the Series; Preface to the Volume; About the Author; Acknowledgments; Table of Contents; Part I Regulatory Guidance; Part II Over-the-Counter Product Formulations; Part III Appendix.
Abstract: The fifth volume in the series, this book covers over-the-counter products, which include formulations of products classified by the US FDA under the OTC category. 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 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