Drug Development

Christopher C. DeMerlis is a regulatory affairs manager at Colorcon, a division of Berwind Pharmaceutical Services, Inc., 415 Moyer Blvd., West Point, PA 19486, tel. 215.661.2766, fax 215.661.2778.

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

Articles

Natural gums and mucilage are biocompatible, cheap, readily available, and represent a potential source of excipients. The authors examine the functionality of mucilage extracted from the leaves of Hibiscus rosa-sinensis Linn as an excipient in a sustained-release tablet formulation.

Assessing Hibiscus rosa-sinensis Linn as an Excipient in Sustained-Release Tablets

Pharmaceutical manufacturers often avoid putting new excipients in their formulations for fear of more regulatory oversight. IPEC has a solution.

Inside IPEC: New Excipient Evaluation Procedure

However, companies should always be prioritizing prevention, elimination and reduction over recycling and recovery as the most effective ways of making resource efficiency savings.

The road to resource efficiency

Millipore and Novozymes Form Alliance, Applied Biosystems Names President and CEO, More

Company and People Notes: Millipore and Novozymes Form Alliance, Applied Biosystems Names President and CEO, More

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

The US Food and Drug Administration's joint panel of the Nonprescription Drugs Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory Committee voted against recommending approval of the over-the-counter use of Merck & Co.'s “Mevacor” (lovastatin) 20 mg.

FDA Panel Rejects OTC Status for Merck’s “Mevacor”

Company and People Notes: West to reduce workforce, Eli Lilly's CEO and chairman to retire, more...

Company and People Notes: West To Reduce Workforce, Eli Lilly's CEO and Chairman To Retire, More

Company and People Notes: Eisai Acquires MGI Pharma, Ceregene Names CEO, More

Company and People Notes: Boehringer Ingelheim Expands Facility, Regulus Therapeutics Names President and CEO, More

The number of new molecular entities approved by the US Food and Drug Administration is down this year as the pharmaeutical industry continues to face an innovation drought.

2007 Ends with a Drought in New Molecular Entities

Various manufacturing techniques can improve a drug's solubility, thus increasing its bioavailability. The authors examined whether melt granulation can enhance drug solubility using meloxicam as the drug substance and myrj-52 as the binder.

Ingredients