Drug Development

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Articles

The European Fine Chemicals Group (EFCG) issued a position paper on excipients used in pharmaceutical manufacturing at CPhI Worldwide last week.

European Fine Chemicals Group Issues Position Paper on Excipients

David R. Schoneker is chairman of the International Pharmaceutical Excipients Council of the Americas. He also is director of global regulatory affairs at Colorcon.

As China emerges as a significant supplier of pharmaceutical ingredients, it must assure other countries of the safety of its excipients.

Excipient Control Strategies in China

Amidst debate, the European Pharmacopoeia Commission is working to include physical or "functionality-related characteristics" of exipient materials in its monographs.

Functionality-Related Characteristics of Excipients

Orally disintegrating tablets (ODTs) continue to attract attention as an alternative to conventional oral dosage forms.

Advancing ODT Technology

The authors review methods for reducing analysis time and increasing throughput that are reliable and maintain data integrity.

Achieving Ultrafast Liquid Chromatography

Polysaccharide-based chiral stationary phases have been developed that comprise chiral selectors immobilized on their support rather than being physically coated. These materials are completely solvent stable, thereby increasing selectivity and and enabling the development of new chiral selectors that have been too unstable in a coated form for general use.

Polysaccharide-Based Chiral Chromatography Media in HPLC and SFC

The combination of supercritical fluid chromatography with chiral separation media offers several analytival advantages over traditional liquid chromatography techniques.

Supercritical Fluid Chiral Separations

Ultrahigh pressure liquid chromatography maximizes efficiency, but, as defined by the resolution equation, the stationary phase is still a crucial consideration when attempting to resolve mixtures of compounds.

Using Selectivity to Optimize UHPLC Separations

High performance liquid chromatography has become an efficient technique at the production scale, and simulated moving bed chromatography provides several benefits during processing.

Simulated Moving Bed Chromatography: A Powerful Unit Operation

Angie Drakulich was editorial director of Pharmaceutical Technology.

More than 100 people attended this week’s Regulatory Affairs Conference by the International Pharmaceutical Excipients Council of the Americas to discuss the latest trends and challenges in the excipient supply chain.

APIs and Excipients