ABSTRACT
L'insuffisance rénale chronique est une maladie grave et fréquente qui est d'autant plus élevée chez les patients diabétiques et notamment de type 2 parmi lesquels la moitié souffre d'une insuffisance rénale chronique (IRC) définie par un débit de filtration glomérulaire (DFG) inférieur à 60 ml/mi /1.73 m2 et/ou une microalbuminurie ⥠30 mg/g. La metformine étant le traitement de première intention, son adaptation posologique à la fonction rénale est primordiale. Afin de définir un outil fiable pour les prescripteurs,nous avons évalué les recommandations des résumés des caractéristiques produit (RCP) de 46 spécialités et celles de 3 sociétés savantes internationales. Les RCP de 3 spécialités émettent des recommandations claires, 2 ne sont pas précisent et 41 recommandent une adaptation à la fonction rénale des patients âgés. Les sociétés savantes recommandent une utilisation de la metformine jusqu'à une valeur de DFG de 30 ml/min. Cette étude a montré que les RCP étaient peu fiables et que les prescripteurs devaient davantage se baser sur des recommandations d'experts validées. Un des rôles du pharmacien hospitalier est de diffuser les recommandations et d'aider le prescripteur dans le choix du meilleur traitement adapté à la fonction rénale des patients
Subject(s)
Metformin , Patients , Renal Insufficiency, ChronicABSTRACT
Background: Metformin hydrochloride tablets are the most commonly prescribed drug for the management of Type II Diabetes Mellitus. This has resulted in increased importation and manufacturing of various brands of the tablets in Nigeria. Objective: To evaluate the pharmaceutical quality of different brands of metformin hydrochloride tablets available in Abuja, Nigeria. Method: Ten brands of metformin hydrochloride tablets were purchased and subjected to pharmaceutical quality evaluations such as friability, hardness, disintegration and dissolution tests. Content of active pharmaceutical ingredient (API) was determined using spectrophotometric analysis as well as reverse phasehigh performance liquid chromatography (RP-HPLC).Results: All the brands were elegantly labelled, packaged and within their shelf lives. With exception of one brand, they all had NAFDAC registration number. The weight uniformity, friability, hardness and disintegration time values for all the brands were within acceptable limits. Three brands of the products released less than 70 % of their API after 45 min and therefore failed the dissolution test. There was disparity between content assay results using UV spectrophotometry and HPLC. HPLC results showed that only brand failed the test by having 86 % of the API while with UV spectrophotometry; four brands failed the test.Conclusion: This investigation suggest that four brands of metformin hydrochloride tablets available in Abuja, did not met official specifications even though only one brand was implicated by HPLC analysis. Consequently, this research would recommend continuous sentinel surveillance of metformin tablets and the use of HPLC for product analysis for its high sensitivity and accuracy
Subject(s)
Chromatography, High Pressure Liquid , Metformin , Nigeria , SpectrophotometryABSTRACT
A new emulsion gelation method was used to prepare gel beads for a highly water-soluble drug metformin hydrochloride using sodium alginate as the polymer. The gel beads containing oil was prepared by gently mixing or homogenizing oil and water phase containing sodium alginate which was then extruded into calcium chloride solution to produce gel beads. The effects of factors like type of oil and percentage of oil on the morphology and release characteristics were investigated. A variety of oils were used to study the effect on the sustaining property of the formed beads. The oil entrapped calcium alginate gel beads showed good sustained release. Scanning electron photomicrographs demonstrated minute oil globules on the beads and also through the inner surface of the beads. The beads also showed floating behavior depending on the type of the oil that have been used for the preparation