Handbook of Pharmaceutical Manufacturing Formulations: Sterile Products (Volume 6 of 6)

The sixth volume in the six-volume Handbook of Pharmaceutical Manufacturing Formulations, this book covers the sterile products, which include formulations of injections, ophthalmic products and other products labeled as sterile, 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 sterile products, the common elements of formulation. The section on regulatory and manufacturing guidance deals with the topics inspection of sterile products manufacturing facilities, new drug application for sterilized products, in addition to providing quick tips on resolving the common problems in formulating sterile products as well as the scope of details included in the series for all dosage forms The Second Volume In The Six-volume Handbook Of Pharmaceutical Manufacturing Formulations, This Book Covers Uncompressed Solids, Which Include Formulations Of Powders, Capsules, Powders Ready For Reconstitution And Other Similar Products 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 Uncompressed Drugs And The Common Elements Of Formulations. 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. Essentially 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. Sterile Drugs, Volume 6 covers sterile products including injectibles and ophthalmic products. The author has painstakingly assembled this book from FDA New Drug Applications, patent applications and the BASF book of generic formulations v. 1. Compressed solid products v. 2. Uncompressed solid products v. 3. Liquid products v. 4. Semisolid products v. 5. Over-the-counter products v. 6. Sterile products.