Abstract

The main objective of the present research work was to formulate and evaluate a controlled release matrix type transdermal patch of Metformin hydrochloride. Transdermal drug delivery can be efficiently used for the active agents which cause severe gastric irritation and undergo rapid first pass metabolism, hence the transdermal patches of Metformin hydrochloride were prepared by using a combination of a hydrophilic polymer HPMC K₄M, hydrophobic polymer Ethyl cellulose and natural polymer chitosan along with propylene glycol as a plasticizer and Tween 80 as a permeation enhancer. The drug-excipients compatibility studies were performed by FT-IR. Nine different formulations were prepared using single polymer as well as combination of two polymers in 1:2 ratio. Out of the nine formulations, F8 and F9 did not form intact patches. The prepared formulations F1 to F7 were evaluated for weight variation, thickness, folding endurance, % flatness, moisture content, moisture uptake, drug content and in vitro diffusion studies. In vitro drug release test was carried for 24hours and formulation F6 showed 92.38% drug release at the end of 24hours. Formulation F6 was thus selected as the best formulation depending on the drug release and other properties. Release kinetic studies revealed that the drug release from F6 followed zero order kinetics and Korsmeyer-Peppas model with release exponent value n=1.017, which shows that release pattern of patches follows super case II transport. The patch exhibited negligible skin irritation as well as good in vitro drug permeation rate across the rat skin. Stability study was conducted for F6 formulation as per ICH guidelines and showed no significant changes during study. From the study, it can be concluded that the prepared matrix type transdermal patches of Metformin hydrochloride might be a potential formulation for the management of patients with type 2 Diabetes mellitus.

Keywords

Metformin Hydrochloride, Diabetes Mellitus, Matrix Type Transdermal Patch, In Vitro Drug Release, Skin Irritation, In Vitro Drug Permeation

Cite This Article

James, J.E., Mahalingan, K. (2016). Formulation and Evaluation of Transdermal Drug Delivery System of an Anti-Diabetic Drug, International Journal for Pharmaceutical Research Scholars (IJPRS), 5(3), 63-70.