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 of cleaning process, in addition to providing quick tips on resolving the common problems in formulating OTC drugs.
SUMMARY OR ABSTRACT
Text of Note
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. 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.