Laburpena
Comparative chemical and pharmaceutical equivalence study on ten brands of piroxicam capsules was carried out. The aim of the study was to determine whether the brands are comparable with each other on the basis of their physico-chemical properties. The chemical and pharmaceutical equivalences of ten brands of piroxicam capsules were assessed by evaluating the uniformity of weight, dissolution rate, content identification and the chemical assay of the capsules. All the ten brands complied with British Pharmacopoiea standard for uniformity of weight. The thin layer chromatographic test for content identification showed that nine of the brands contain only piroxicam while one brand contains an additional compound apart from the labeled piroxicam. The ultraviolet procedure for content identification showed that only two brands complied with the official specification. Five brands complied with specification for the content assay of the active ingredient. However, only two brands complied with the official specification of 70%w/v dissolution at 45 minutes. The result obtained from this study showed that only the innovator brand meets all the specifications. Moreover, only five of the other brands can be regarded as chemical equivalent of the innovator. The result obtained in this study underscores the need for registration and post market surveillance of products circulating in the drug market.
Keywords: Chemical equivalency, piroxicam, pharmaceutical equivalence, UV spectroscopy.
Résumé
L’étude comparative avait pour but d’évaluer l’équivalence chimique et pharmaceutique sur dix genres de capsules de piroxicam. L’objectif de cette étude était de déterminer si les genres sont comparable l’un l’autre sur la base leurs propriétésphysico-chimiques. Ces équivalences étaient faite en évaluant l’uniformité du poids, le taux de dissolution, l’indentification des excipients et l’analyse chimique des capsules. Tous les 10 genres satisfaisaient le standard de la pharmacopée Britanique d’uniformité du poids. Le test de chromatographie de couches légeres pour l’identification des excipients montraient que neuf de ces genres contenaient seulement le piroxicam alors que un seul contenait un composé additionel autre que le piroxicam. La procédure ultraviolete pour l’identification des excipients montraient que seulement deux des genres satisfaisaient aux spécifications officielles. Cinq genres satisfaisaient avec la spécification de
l’analyse des composantes actives. Cependant, seulement deux genres satisfaisaient la spécification officielle de 70% w/v de dissolution en 45 minutes. Le résultat obtenu de cette étude montre que seul la marque innovée satisfait toutes les spécifications. En plus, seule cinq d’autres genres peuvent etre régardés comme chimiquement équivalent á l’innovateur.Ce résultat indique le besion d’enregistrement et une surveillance des produits ou médicaments sur le marché.
Correspondence: Dr. O.M. Adegbolagun, Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Ibadan, Ibadan, Nigeria. Email: duplag03@yahoo.com
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