Formulation Development and Evaluation of Transdermal Patch Containing Amlodipine Besylate

Shaikh, Imran (2008) Formulation Development and Evaluation of Transdermal Patch Containing Amlodipine Besylate. Masters thesis, Periyar College of Pharmaceutical Sciences for Girls, Tiruchirapalli.


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The present study Cardiovascular drugs have relatively low therapeutic indices, which place responsibility on the dosage forms for maintaining the drug blood level within narrow limit .Conventional dosage forms suffer from variations in the absorption and thus leading to wide fluctuation in the plasma drug concentration. Amlodipine Besylate, is an antihypertensive drug, having calcium channel blocking activity is therapeutically active even at very low doses. E.g.: 5-10mg/day which is one of the essential requirements of a drug candidate for use in transdermal delivery systems. In vivo studies carried out also using F2, F3 and F4 and better release was shown only by F2 formulation. The in vivo studies demonstrate the transdermal drug delivery system gives sustained plasma concentration and avoid wide fluctuation of plasma concentration of amlodipine in rabbits as diffusion of the drug was extended over a long period at control rate and it followed a pattern close to zero order release profile. The results of the skin irritation studies indicate that neither the adhesive nor amlodipine have any noticeable irritation on the rabbit skin for the 48 hours study periods. Skin irritation and / or edema was not observed during skin irritation test. Hence, amlodipine films can be used in long term management of cardio vascular diseases, necessitating long term therapy by nullifying the common adversities of the drug. Stability studies revealed that the drug content in formulation F2 degraded respectively by 0.76%, 1.40% and 1.90% in a period of 90 days. Hence, finally conclude that the study shows the feasibility of formulating rate controlled transdermal drug delivery system for amlodipine besylate in order to achieve improved bioavailability and nullifying the common adversities of the drug.

Item Type: Thesis (Masters)
Uncontrolled Keywords: Transdermal Patch Containing Amlodipine Besylate; Cardiovascular drugs
Subjects: PHARMACY > Pharmaceutics
Depositing User: Ravindran C
Date Deposited: 25 Sep 2017 16:27
Last Modified: 25 Sep 2017 16:27

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