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Development of Ropinirole (Free Base) Transdermal Patch Using Blends Of Hydroxypropyl Methylcellulose/Eudragits And It'S In Vitro/ In Vivo Characterization
Objective: The objective of this study was to prepare and evaluate a matrix type transdermal patch of ropinirole using blends of hydroxypropylmethylcellulose (HPMC) and Eudragit RL 100 and HPMC and Eudragit ERS100. Materials and Methods: Ropinirole free based used as the drug entity was prepared from its hydrochloride salt. Suitability of the polymers in the form of drug-excipient compatability was determined prior to formulation development using FTIR. Patches were developed using solvent evaporation technique. Limonene was used as a penetration enhancer . Moisture absorption, moisture content and mechanical properties, drug content, in vitro drug release, drug-excipient compatibility, in vitro skin permeation were the in vitro parameters measured. Short - termstability, skin irritation and in vivo drug release were measured with oneop timized formulation . Results and discussion : Ropinirole free base was used successfully in the preparation of the patches. FTIR studies indicated no interaction between the drug and the polymers of this study. Formulations developed were strong and not brittle with uniform drug release. Patches containing higher HPMC generally showed higher drug release and permeation. Drug release and permeation decreased with increase in the concentrations of Eudragits. Drug release studies indicated Higuchi model for all the patches with a diffusion mechanism of non-fickian type. Short-term stability studies indicated that ropinirole was stable in the patches. Patches did not cause any skin irritation. In vivo the optimized patch sustained drug release for 24 hours upon one time administration. Conclusion: Clinically viable ropinirole transdermal patch can be successfully prepared from its base form using HPMC/Eudragits.
Keywords
Drug Release, QbD, Permeation, Parkinsonism, Permeation Enhancer.
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