VALIDATION OF ALTERNATIVE APPARATUS FOR IN VITRO DISSOLUTION TEST OF SEMISOLIDS DOSAGE FORMS.

TF26

Fabíola Silva Garcia Praça; José Orestes Del Ciampo; Juliana Maldonado Marchetti; Maria Vitória Lopes Badra Bentley.

Departamento de Ciências Farmacêuticas da Faculdade de Ciências Farmacêuticas da USP de Ribeirão Preto FCFRP-USP

Two factors are accepted by FDA to compare dissolution profiles of solid oral forms (F1: differences f1<15 and F2: similarities f2 > 50) because it has the advantage of characterizing with more precision, the dissolution than those tests based on just one point according to U.S. department of health and human services F.D.A CDER Guidance for industry dissolution testing of immediate release solid dosage forms 1997 and V. Shah et al. 1998. The goal of this work is validation of alternative apparatus for in vitro dissolution test using as reference, Vankel^® enhancer cell meets SUPAC SS Guidelines (patent 5.408.865). Hence, semisolid forms containing 1% of caffeine were prepared in order to study the profiles of the drug from the topical dosage forms. The caffeine release studies (n= 3) were done by using a SR8 Dissolution Test System – Hanson Research, 500 ml of medium with buffer saline pH 7.4 at 37ºC with rotation speed at 50 rpm and synthetic membrane for both apparatus. The alternative apparatus was a PVC tube with 4cm² surface area used together with apparatus 1 (basket shaft) without basket, and apparatus reference was apparatus 2 (paddle) over vankel enhancer cell. After finishing the assay, the percentage of the caffeine released across synthetic membrane was calculated following the equations proposed by MOORE & FLANNER and the difference (f1) and similarity (F2) value factors obtained were 2.67 and 86.6, respectively. Those results indicate that there is no different significant relevance between the profiles of caffeine release through membrane by different apparatus, suggesting that both apparatus can be equivalents to be used in vitro release studies of semisolids dosage forms.