Cynthia Marisca Muntu and Esti Hendradi and Riesta Primaharinastiti (2015) VALIDASI PROSES PEMBUATAN DAN PENETRASI PATCH TIPE MATRIKS NATRIUM DIKLOFENAK. Jurnal Ilmiah Sains & Teknologi, 8 (2). pp. 31-39. ISSN 0216-1540

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Abstract

The aim of this study was to prove that the penetration test of diclofenac sodium matrix type transdermal patch fulfilled the acceptance criteria of formulation process validation (coefficient of variance (CV) of diclofenac sodium penetration f1ux). Diclofenacsodiummatrix type transdermal patch was prepared by mixing of ethyl cellulose and polyvinylpyrrolidone aspolymer base, polyethylene glycol 400 as plasticizer and mixing of diclofenac sodium as active ingredient to menthol solution as enhancer. The first composition of patch was contained ratio polymer ethyl cellulose and polyvinylpyrrolidone of 7:3 (Formula I) and the second composition of patch was contained ratio polymer ethyl cellulose and polyvinylpyrrolidone of 6:4 (Formula II). The evaluation included physical characteristics of patch(organoleprics, moisture content, surface homogenity using Scanning Electron Microscope (SEM), drug content and content uniformity) and penetration test. The penetration of diclofenac sodium through Wistar rat skin membrane was determined by dissolution test, which was carried out using apparatus type 5-paddle overdisk in phosphate buffer pH 7.4 (37±0.5'C, 50 rpm). The process validation was carried out for 3 days, with 3 times replication. From the results of penetration tests showed CV of diclofenac sodium penetration f1ux<6% (both of Formula I and Formula II) and one-way ANOVA analysis showed no significant difference of sodium diclofepac patch (p=0,745 for formula I and p=0,315 for formula II) were performed on 3 different days. This study revealed that penetration test of two formulas diclofenac sodium matrix type transdermal patch fulfilled the acceptance criteria of formulation process validation

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