Monday, 13 March 2017

Quality Evaluation of Diclofenac Formulations Manufactured in DR Congo



Diclofenac sodium, the first phenylacetic acid derivative developed as an anti-inflammatory agent, is an inhibitor of cyclooxygenase extensively used for its analgesic, antipyretic and antiinflammatory activities. It is a potentnon-steroidal anti-inflammatory drug, extensively used for the treatment ofactive rheumatoid arthritis and osteoarthritis, ankylosing spondylitis, non-articular rheumatism and sport injuries. DS is one of the most consumed drugs by the population in DR Congo. 

Diclofenac FormulationsThe literature reports few studies on the effect of humidity and temperature on the stability of DS.The purpose of this study was to evaluate thequality of three generics of 50 mg DS tablets manufactured in DR Congo in comparison to the original formulation Voltarène® from Novartis Pharma. Drug content and drug release were determined at the time of their collection and at 3 and 6 months during their storage under the accelerated-aging conditions of temperature and relative humidity (RH) recommended by the WHO for climatic zone IVB (40°C/75% RH)

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