Abstrakt
Background: This study was undertaken with the objective of evaluating the pharmaceutical and chemical equivalence of some commercially available loratadine tablets, and offers a possible explanation for the therapeutic failure of the drug products.
Method: The equivalence of eight brands of loratadine hydrochloride tablets labelled A to H was assessed and compared with the Innovator brand labelled I. Visual observation and uniformity of weight tests were carried out on the tablets, mechanical properties were assessed using friability and crushing strength tests as parameters. Release properties of the tablets were assessed by disintegration and dissolution tests. Assay was based on non-aqueous titration procedure using crystal violet solution indicator.
Result: All the brands studied were white in colour with different shapes and lustre, and complied with the official specification for uniformity of tablet weight. Friability tests showed that only brand G lost more than 1% of its initial weight, while brands A and E failed the crushing strength test. Brand C did not undergo complete disintegration within 15 minutes, while brands A, B, F and G had less than 70% of the active drug content still in solution after 45 minutes. Two of the brands had active drug content between officially specified range of 98.5% and 101.5% for loratadine tablets.
Conclusion: There was a large variation in the pharmaceutical properties of the commercially available loratadine hydrochloride tablets that were selected for this study. Six of the brands evaluated exhibited poor pharmaceutical properties. Generally, only two of the brands were pharmaceutically equivalent with the innovator brand.
Keywords: Loratadine tablets, non-aqueous titration, pharmaceutical equivalence, therapeutic failure
Résumé
But: Cette étude a été entreprise dans le but d’évaluer l’équivalence pharmaceutique et chimique de certains comprimés de loratadine
commercialement disponibles, et offre une explication possible de l’échec thérapeutique de ces produits pharmaceutiques.
Méthode: L’équivalence de neuf marques de comprimés de chlorhydrate de loratadine étiquetées A à I (marque Innovator) a été évaluée. Les tests d’observation visuelle et d’uniformité de poids ont été effectués sur les comprimés, les propriétés mécaniques ont été évaluées à l’aide des essais de friabilité et de résistance à l’écrasement en tant que paramètres. Les propriétés de sortie des comprimés ont été évaluées par des tests de désintégration et de dissolution. L’analyse a été basée sur la procédure de titrage non aqueux en utilisant un indicateur de solution cristal violet.
Résultat: Toutes les marques étudiées étaient de couleur blanche avec des formes et lustre différentes, et conformaient avec la spécification officielle d’uniformité de poids du comprimé. Les tests de friabilité ont montré que seule la marque G a perdu plus d’1% de son poids initial, tandis que les marques A et E ont échoué au test de résistance à l’écrasement. La marque C n’a pas subir une désintégration complète en 15 minutes, tandis que les marques A, B, F et G avaient moins de 70% de la teneur en substance active encore en solution après 45 minutes. Deux des marques avaient contenu de médicament actif entre la marge spécifiée officiellement de 98,5% et 101,5% pour les comprimés de loratadine.
Conclusion: Il y avait une grande variation dans les propriétés pharmaceutiques des comprimés de chlorhydrate de loratadine commercialement disponibles qui ont été sélectionnés pour cette étude. Six des marques évaluées présentaient des propriétés pharmaceutiques pauvres. Généralement, seulement deux des marques étaient de manière pharmaceutique équivalente avec le médicament de marque innovateur.
Mots-clés: Comprimés loratadine, titrage non aqueux, équivalence pharmaceutique, échec thérapeutique
Correspondence: Dr. Oladapo A. Adetunji, Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, University of Ibadan, Ibadan, Nigeria. E-mail: adetunjioladapo@gmail.com
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