J Clin Pharmacol
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DRUG DEVELOPMENT

Ensuring Supplies of Quality Diethylcarbamazine Citrate (DEC)

Mary Ellen Kitler, PhD, FCP and Nevio Zagaria, MD

From the DEC Project, WHO Global Program to Eliminate Lymphatic Filariasis, Strategy Development and Monitoring for Eradication and Elimination (CEE), Control, Prevention, and Eradication (CPE), World Health Organization, Geneva, Switzerland.

In 1997, the World Health Organization (WHO) made a commitment to eliminate lymphatic filariasis. The WHO Global Program to Eliminate Lymphatic Filariasis (WHO-FIL) needed a reliable supply of diethylcarbamazine citrate (DEC) of known acceptable quality at an affordable price, so in August 1999, it started the DEC Project. Today's standards required development of a modern stability-indicating assay method for DEC and for DEC tablet dissolution. ADD Advanced Drug Delivery Technologies (Switzerland) developed a high-pressure liquid chromatography assay, which was independently validated and is in the United States Pharmacopoeia 25 (2002). After a global search, the project found that almost all existing and potential DEC active pharmaceutical ingredient (API) and tablet manufacturers are in low-income countries. The project constructed an audit team to conduct on-site audits to assess good manufacturing practices according to European Union standards. National/state inspectors accompany the audit team. The team prequalified one DEC API manufacturer and three DEC tablet manufacturers. The project plans to increase the number of prequalified DEC manufacturers. Now, WHO-FIL only purchases from prequalified manufacturers. Consolidation of several national program DEC requirements into a limited international competitive bid reduced the price for DEC tablets between 30% and 45%, compared to previous small-scale WHO purchases.

Key Words: Diethylcarbamazine citrate • lymphatic filariasis • World Health Organization • on-site audits • good manufacturing practices

Address for reprints: Mary Ellen Kitler, PhD, FCP, Maison des Truites, CH 1182 Gilly, Switzerland.


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