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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
pharmacology, toxicology and pharmaceutics
Development of fixed dose combination tablets containing zidovudine and lamivudine for paediatric applications
International Journal of Pharmaceutics, Volume 370, No. 1-2, Year 2009
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Description
In view of the lack of suitable paediatric antiretroviral formulations on the market, a novel fixed dose combination (FDC) tablet containing 300 mg zidovudine (AZT) and 160 mg lamivudine (3TC) was developed to improve dosing accuracy and allow flexible drug dosing in function of the body weight of paediatric HIV patients as recommended by WHO. Rectangular tablets with multiple fraction bars were designed and each tablet can be broken into 8 subunits, each subunit containing a drug dose corresponding to a body weight of 5 kg. These fast-disintegrating subunits can easily be administered to children after dispersion in a liquid or mixing with food. In vitro quality control of the FDC tablets was determined and a crossover bioavailability study using 18 adult volunteers was performed after oral administration of the novel FDC tablet and a Duovir tablet. The results of the study showed that the novel tablets as well as its subunits disintegrated fast (<20 s). After 30 min dissolution, AZT and 3TC released from Duovir® and the novel tablets was above 95%, the similarity factors f2 were above 50 for both AZT and 3TC. A tablet breakability test showed low weight variability (125.1 ± 5 mg, R.S.D. = 4.4%), with limited weight loss (0.3%). There was no significant difference in pharmacokinetic parameters (Cmax, tmax and AUC0-12 h values) between Duovir and the novel tablets formulated for paediatric applications. © 2008 Elsevier B.V. All rights reserved.
Authors & Co-Authors
Kayitare, Egide
Rwanda, Butare
University of Rwanda
Vervaet, C.
Belgium, Ghent
Universiteit Gent
Ntawukulilyayo, J. D.
Rwanda, Butare
University of Rwanda
Seminega, Benoit
Rwanda, Butare
University of Rwanda
Bortel, Van
Belgium, Ghent
Heymans Institute of Pharmacology
Remon, Jean Paul
Belgium, Ghent
Universiteit Gent
Statistics
Citations: 41
Authors: 6
Affiliations: 3
Identifiers
Doi:
10.1016/j.ijpharm.2008.11.005
ISSN:
03785173
Research Areas
Food Security
Health System And Policy
Infectious Diseases
Maternal And Child Health