CONICET | Buscador de Institutos y Recursos Humanos

Active substances are categorized into four groups, within the Biophamaceutics Classification System (BCS), based upon their solubility and permeability. EMA and WHO consider Class I and III drugs as eligible for a BCS based biowaiver. Therefore multisource formulations containing such a drug may be exempted from proving bioequivalence with the reference product. In lieu of in vivo data, dissolution profiles at recommended pH should be provided for multisource and reference formulations. Metoclopramide, a class I/III drug, is used for the treatment gastro-esophageal reflux, nausea and vomiting. Our research attempted to compare dissolution profiles of multisource metoclopramide tablets with the reference product in three different media. Samples (A-E) of metoclopramide tablets (10mg) were purchased from pharmacies in Bahía Blanca city. Dissolution profiles were performed using USP Apparatus 1 at 50 rpm, in 900 mL of USP buffer solutions (pH 1.2, 4.5 and 6.8). Drug concentration was determined by UV-Vis spectrophotometry at 308.1nm. Analysis of variance was used to evaluate dissolution similarity, in terms of Dissolution Efficiency (DE%). Formulations B, C, D and E were very rapidly dissolving in the three media, whereas sample A was only very rapidly dissolving at pH 6.8, and rapidly dissolving at pH 1.2 and 4.5. The highest dissolution rate and DE% values corresponded to the sample E at pH 4.5 and 6.8, although at pH 1.2 corresponded to sample B. Sample A had the lowest DE% values in the three media. In comparison with the reference (D), samples B and C had higher DE% values in all media, whereas sample E had lower results at pH 1,2. Statistical differences were found between DE% values of samples A, B, E and the reference. Despite the statistical differences found, formulations B, C and E could be considered similar to the reference based on its "very rapid dissolving" status

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