APIs and Excipients

Medicines and excipients are inseparable, with few exceptions - one cannot exist without the other. The Pharmaceutical Quality Group and other international bodies have developed good manufacturing practice (GMP) standards and guidelines to facilitate the effective supply of excipients. This article discusses the definition and significance of excipients, and highlights the importance of implementing the correct excipient manufacturing controls and standards.

The aim of this work was to investigate the compactibility, compressibility and drug release behaviour of different fractions of a commercially available ethyl cellulose.

In this study, the authors investigated the compression behavior of excipients with different molecular weights using the modified Fraser-Suzuki function and correlated the S-parameter of this function with Young's modulus.

Using melt extrusion to prepare glass solutions of poorly water-soluble drugs with hydrophilic excipients offers an exciting and advantageous alternative to existing formulation methods such as spray-drying and co-melting. Investigating potential methods to increase water solubility begins early in drug development. Techniques described in this paper show how only a small quantity of drug can be used to determine its suitability for melt extrusion, allowing the method to be considered at the same time as salt screening and particle size reduction work, and could speed up the formulation process.

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.