Assessment of the drug storage facilities and quality of generic co-formulation tablets (Stavudine, Lamivudine, Nevirapine) at HIV/AIDS treatment centers in Uganda.

Abstract

The study investigated the storage facilities and the quality of co-formulation tablets containing stavudine, lamivudine, and nevirapine at four treatment centres in Uganda. A cross-sectional survey of drug storage conditions at four distribution centres randomly selected from the four regions of Uganda was done using a checklist developed from the guidelines for good drug storage practices. Drug batches were sampled at the time of the survey and one month after storage and analysed for quality using appearance, uniformity of weight, dissolution rate and drug content. All treatment centres had satisfactory storage design but lacked facilities for monitoring temperature and humidity. Air-conditioning facilities were also lacking. Batches investigated had average weight deviation of less than 5%; content of active pharmaceutical ingredients lay between 90-110%% and the dissolution rate was greater than 80% in 45 min both on delivery and after one month of storage. The quality of co-formulation tablets containing stavudine, lamivudine and nevirapine was of good quality. However, the storage facilities at the HIV/AIDS treatment centres were inadequate. They need to be provided with facilities to monitor temperature and humidity as the antiretroviral programme expands to cover broader spectrum of drugs.