Handbook of Pharmaceutical Manufacturing Formulations - Vol 6 of 6

Summary

This publication :-

• Maintains the largest reference on pharmaceutical formulations
• Lists readily accessible formulations as chemical entities, dosage forms or pharmacological classifications
• Provides instant substantial time and cost savings in pharmaceutical research and development
• Speeds generic drug formulation regulatory submissions

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.

Contents

Sterile Manufacturing Practice

Sterile Pharmaceutical Formulations