ABSTRACT

The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume Three, Liquid Products is an authoritative and practical guide to the art and science of formulating drugs for commercial manufacturing. With thoroughly revised and expanded content, this third volume of a six-volume set, compiles data from FDA and EMA new drug applications, patents and patent applications, and other sources of generic and proprietary formulations including author’s own experience, to cover the broad spectrum of cGMP formulations and issues in using these formulations in a commercial setting. A must-have collection for pharmaceutical manufacturers, educational institutions, and regulatory authorities, this is an excellent platform for drug companies to benchmark their products and for generic companies to formulate drugs coming off patent.

Features:

       Largest source of authoritative and practical formulations, cGMP compliance guidance and self-audit suggestions

       Differs from other publications on formulation science in that it focuses on readily scalable commercial formulations that can be adopted for cGMP manufacturing

       Tackles common difficulties in formulating drugs and presents details on stability testing, bioequivalence testing, and full compliance with drug product safety elements

       Written by a well-recognized authority on drug and dosage form development including biological drugs and alternative medicines

part I|165 pages

Regulatory and Manufacturing Guidance

chapter 2|3 pages

Oral Solutions and Suspensions

chapter 3|12 pages

The FDA Drug Product Surveillance Program

chapter 4|10 pages

Changes to Approved NDAs and ANDAs

chapter 6|10 pages

Container Closure Systems

chapter 7|5 pages

Material for Containers

chapter 10|1 pages

Stability Testing for New Dosage Forms

chapter 12|9 pages

Evaluation of Stability Data

chapter 15|3 pages

EDQM Certification

chapter 19|3 pages

Bioequivalence Testing Protocols

chapter 20|2 pages

Dissolution Testing of Liquid Dosage Forms

chapter 21|27 pages

Approved Excipients in Liquid Forms

part II|198 pages

Manufacturing Formulations

chapter 22|197 pages

Manufacturing Formulations