Dewi Rashali and Esti Hendradi and Yuwono (2013) Process Validation of Diclofenac Sodium Patch Membrane Type With Menthol as Enhancer. In: Proceeding the 3rd International Conference on Pharmacy and Advanced Pharmaceutical Sciences. Faculty of Pharmacy Gadjah Mada University, Yogyakarta, pp. 104-109. ISBN 978-602-1594-01-8

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Abstract

The aim of this study was to prove that diclofenac sodium patch membrane type with menthol as enhancer have fullfilled the acceptance criteria of process validation. Methods: Diclofenac sodium patch membrane type was prepared by mixing diclofenac sodium as active ingredient with additives such as alginate sodium as drug reservoir, hydroxy propyl methyl cellulose as rate controlling membrane, propilenglicol as plasticizer and menthol as enhancer. The evaluation included organoleptics test, drug content of diclofenac sodium patch in first layer (drugreservoir), moisture content, homogenity test, drug content of diclofenac sodium patch and drug release. Release of diclofenac sodium by dissolution test, which was carried out using apparatus type S-paddle overdisk in phosphate buffer pH 7,4 (37 + 0,50C, 50 rpm). The process validation was carried out for 3 days with 3 times replication. Result: Fluks of diclofenac sodium release about 3,866 + 0,004. From the overall results of test showed that CV <67o and one way ANOVA analysis showed no significant difference of diclofenac sodium patchs were performed on 3 different days with 3 times replication. Conclusion: Process of manufacturing of diclofenac sodium patch membrane type with menthol as enhancer has been validated.

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