Kaale, Eliangiringa;
Hope, Samuel M.;
Jenkins, David;
Layloff, Thomas
Implementation of 350–2500 nm diffuse reflectance spectroscopy and High‐Performance Thin‐Layer Chromatography to rapidly assess manufacturing consistency and quality of cotrimoxazole tablets in Tanzania
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Medientyp:
E-Artikel
Titel:
Implementation of 350–2500 nm diffuse reflectance spectroscopy and High‐Performance Thin‐Layer Chromatography to rapidly assess manufacturing consistency and quality of cotrimoxazole tablets in Tanzania
Beteiligte:
Kaale, Eliangiringa;
Hope, Samuel M.;
Jenkins, David;
Layloff, Thomas
Erschienen:
Wiley, 2016
Erschienen in:Tropical Medicine & International Health
Beschreibung:
<jats:title>Abstract</jats:title><jats:sec><jats:title>Objective</jats:title><jats:p>To assess the quality of cotrimoxazole tablets produced by a Tanzanian manufacturer by a newly instituted quality assurance programme.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>Tablets underwent a diffuse reflectance spectroscopy procedure with periodic quality assessment confirmation by assay and dissolution testing using validated <jats:styled-content style="fixed-case">HPTLC</jats:styled-content> techniques (including weight variation and disintegration evaluations).</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Based on results from the primary test methods, the first group of product was <80% compliant, whereas subsequent groups reached >99% compliance.</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>This approach provides a model for rapidly assuring product quality of future procurements of other products that is more cost‐effective than traditional pharmaceutical testing techniques.</jats:p></jats:sec>