Formulation And Characterization Of Multilayered Controlled Release Topical Patch For Cure Of Cardiac Disease

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Mr. More Swapnil Maruti , Dr. Mrunal K Shirsat

Abstract

Transdermal drug delivery system (TDDs) is novel specified dosage forms, when drug deliver through the skin at controlled rate to the systemic circulation as applied to the intact skin. The aim of this research was to develop and evaluate a matrix type of multilayered transdermal drug delivery system containing trandolapril and verapamil Hydrochloride. The formulations containing combination of both drugs were formulated by using different polymers like Sodium alginate, Methyl cellulose, Chitosan in different ratios by solvent evaporation technique. Glycerin, PVP (polyvinylpyrrolidone) and polyethylene glycol 400 were used as plasticizers. The prepared formulated multilayered transdermal patches were physically evaluated for thickness, weight variation, drug content, flatness, tensile strength, folding endurance, and water vapour transmission rate. The in-vitro drug release study was carried out by using Franz diffusion cell. The invivo pharmacokinetic sudy animal sudy, skin irritation study and stability study were also developed. The release kinetic study of multilayered transdermal patch confirmed the prepared patch was followed supercase II transport mechanism of diffusion kinetics with sustained release within specific time period and observed deviation from Fickinan mechanism of drug release. The multilayered transdermal patch produced higher bioavailability and was applied on the rat skin, it was found that increased concentration of drug in rat blood plasma was due to the rapid absorption of drug, which was identified by better Cmax and lower tmax values. The pharmacokinetic parameters of prepared multilayered transdermal patch TVP1 was indicated that both drug released and absorbed more than 90 % from 0 to 8th h trandolapril. The drug verapamil Hcl was not released during 0 – 6th h and was starting to absorb and peak plasma concentration was reached upto 20th h. The result of AUC represents the total integrated area under the blood concentration-time profile. It indicated the total amount of drug reaches to the systemic circulation after administration. Thus, it is crucial parameter in identifying the bioavailability of drug from any dosage form. Statistically, AUC0-t of the formulation TVP1 was significantly higher (p<0.05). The AUC0-t values were observed to significantly high and result showed concentration of drug was within therapeutic effective range for a longer period of time for treatment of hypertension. The stability study of prepared multilayered transdermal patch was performed in different temperature as per guideline of ICH guideline. There was little bit change or degradation of concentration or amount of drug component in formulation.

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