APIs and Excipients

A new set of proposed GMP standards for excipents may present more problems than benefits.

A global drug master file system may pave the way for faster qualifications of new excipients and the industry's acceptance of their use in drug therapies.

The authors discuss the physiocomechanical characteristics of three commonly used pharmaceutical excipients and describe the effects of variables on their physiocomechanical stability.

To aid the fomulation scientist in selecting the optimal excipients for the preparation of vaginal products, the authors have compiled a list of all presently available vaginal excipients, including their functional categories and regulatory status.

USP ensures the microbiological quality of products by way of the development, proposal, and acceptance of general information chapters.

Developments in technology and increased industry standards have changed the regulation, quality control, and perception of excipients in the past 25 years.

Using formulations containing various types of lactose and dibasic calcium phosphate, the authors investigated the effects of lubricant level, lubrication time, and compression speed on tablet weight, hardness, and friability.