Article Sidebar
Article Details
Issue
Section
Articles
A. AFRICAN HEALTH SCIENCES OPEN ACCESS POLICY
While African Health Sciences has been freely accessible online there have been questions on whether it is Open Access or not. We wish to clearly state that indeed African Health Sciences is Open Access. There are key issues regarding Open Access needing clarification for avoidance of doubt:
- 1. Henceforth, papers in African Health Sciences will be published under the CC BY (Creative Commons Attribution License) 4.0 International. See details on https://creativecomons.org/)
- 2. The copyright owners or the authors grant the 3rd party (perpetually and in advance) the right to disseminate, reproduce, or use the research papers in part or in full, format/medium as long as:
- No substantive errors are introduced in the process
- Attribution of authorship and correct citation details are given
- The referencing details are not changed.
Should the papers be reproduced in part, this must be clearly stated.
- 3. The papers will be freely and universally accessible online in an easily readable format such as XML in at least one widely recognized open access repository such as PUBMED CENTRAL.
B. ABRIDGED LICENCE AGREEMENT BETWEEN AUTHORS AND African Health Sciences
I submitted my manuscript to African Health Sciences and would like to affirm that:
1.0 I am authorized by my co-authors to enter into these arrangements.
2.0 I guarantee, on behalf of self and co-authors:
- That the paper is original, and has not been published in any other peer-reviewed journal; nor is it under consideration by other journal (s). It does not infringe existing copyright or any other person’s rights
- That we are/I am the sole author(s) of the paper and with authority to enter into this agreement. My granting rights to African Health Sciences is not in breach of any other obligation
- That the paper contains nothing unlawful, or libelous. Nor anything that would constitute a breach of contract, confidence or commitment given to secrecy, if published
- That I/we have taken care to ensure the integrity of the article.
3.0 I and all co-authors, agree that the paper, if accepted for publication, shall be licensed under the Creative Commons Attribution License 4.0. (see https://creativecommons.org/)
Main Article Content
Pharmacokinetic interactions between chloroquine, sulfadoxine and pyrimethamine and their bioequivalence in a generic fixed-dose combination in healthy volunteers in Uganda
Abstract
Background: A pre-packaged fixed-dose formulation of chloroquine (CQ) and sulfadoxine/pyrimethamine (S/P) combination (Homapak) is widely used for the treatment of falciparum malaria in Ugandan children. It is however a product whose pharmacokinetics and interactions have not been studied.
Objectives: To explore possible pharmacokinetic interactions between CQ and S/P during co-administration, and to determine their bioavailability in the locally made Homapak compared to the Good Manufacturing Practice (GMP) made formulations.
Methods: Thirty-two adult healthy volunteers were randomized into four groups and given single oral doses of fixed-dose CQ+S/P combination (Homapak), or GMP formulations of S/P (Fansidar), CQ (Pharco), or their combination. Plasma samples were followed for 21 days, analysed by HPLC-UV methods, with pharmacokinetic modeling using the WinNonlin software.
Results: Sulfadoxine in Homapak was more rapidly absorbed (ka = 0.55 h-1) than in Fansidar + CQ (ka = 0.27 h-1, p=0.004), but not more than S in Fansidar alone group (ka = 0.32 h-1, p=0.03). No significant differences were observed in the other pharmacokinetic parameters of S, P and CQ when given together or separately. The relative bioavailability of CQ and S in Homapak showed bioequivalence to reference formulations.
Conclusions: There were no pharmacokinetic interactions between CQ, S and P when the compounds were given together, however, more investigations would be needed to explore this further. Compared with GMP made drugs, both S and CQ are bioequivalent in Homapak, the Ugandan made fixed-dose formulation. Furthermore, the absorption of S was more rapid which could be advantageous in malaria treatment.
Keywords: sulfadoxine, pyrimethamine, chloroquine, bioequivalence, pharmacokinetic interactions
African Health Sciences Vol. 6(2) 2006: 86-92
Objectives: To explore possible pharmacokinetic interactions between CQ and S/P during co-administration, and to determine their bioavailability in the locally made Homapak compared to the Good Manufacturing Practice (GMP) made formulations.
Methods: Thirty-two adult healthy volunteers were randomized into four groups and given single oral doses of fixed-dose CQ+S/P combination (Homapak), or GMP formulations of S/P (Fansidar), CQ (Pharco), or their combination. Plasma samples were followed for 21 days, analysed by HPLC-UV methods, with pharmacokinetic modeling using the WinNonlin software.
Results: Sulfadoxine in Homapak was more rapidly absorbed (ka = 0.55 h-1) than in Fansidar + CQ (ka = 0.27 h-1, p=0.004), but not more than S in Fansidar alone group (ka = 0.32 h-1, p=0.03). No significant differences were observed in the other pharmacokinetic parameters of S, P and CQ when given together or separately. The relative bioavailability of CQ and S in Homapak showed bioequivalence to reference formulations.
Conclusions: There were no pharmacokinetic interactions between CQ, S and P when the compounds were given together, however, more investigations would be needed to explore this further. Compared with GMP made drugs, both S and CQ are bioequivalent in Homapak, the Ugandan made fixed-dose formulation. Furthermore, the absorption of S was more rapid which could be advantageous in malaria treatment.
Keywords: sulfadoxine, pyrimethamine, chloroquine, bioequivalence, pharmacokinetic interactions
African Health Sciences Vol. 6(2) 2006: 86-92
