Fixed-dose combination tablets of nevirapine, lamivudine, and stavudine
Background: To develop a fixed-dose combination formulation (FDCs) containing three antiretroviral drugs, including nevirapine, lamivudine, and stavudine in a single tablet (GPO-VIR S30™). The new combination tablet was aimed to reduce the cost of treatment and the number of tablets taken per day.
Methods: The new three-drugs FDCs tablet, GPO-VIR S30™ was developed which contains nevirapine 200 mg, lamivudine 150 mg, and stavudine 30 mg in a single tablet. The quality and the stability, both under the accelerated and ambient conditions, were studied. The content uniformity and the release profiles of each drug were determined. The cost of treatment when using GPO-VIR S30™ was also compared with the use of each single drug prescribed separately.
Results: The new FDC tablet could be successfully formulated. The content of each active ingredient contained in GPO-VIR S30™ tablets was found to be uniform. The dissolution profiles showed that all active ingredients were completely dissolved within 5 minutes. All active ingredients were found to be stable following the stability testing programs under a 6 months-accelerated condition (40°C, 75% RH) and a 2 years-ambient condition (25°C, 50% RH). The monthly cost of treatment when prescribing a tablet of GPO-VIR S30™ twice daily was 30 US dollars, while the use of single drug, i.e. two nevirapine 200 mg tablets, two lamivudine 150 mg tablets, and two stavudine 30 mg capsules per day cost 345 US dollars.
Conclusions: Successful development of nevirapine 200 mg, lamivudine 150 mg, and stavudine 30 mg in a single combination tablet offers an alternative in antiretroviral therapy. The reduction in the cost and the number of pills taken per day can improve patient adherence and promote access to antiretroviral therapy.
Srinarong, P
P Srinarong, S Prayngam, P Chunhacha, A Naranuntarat, N Suwanpidokkul, P Arunothayanun, A Eksaengsri, K Kraisintu
Research and Development Institute, Government Pharmaceutical Organization, Bangkok, Thailand