Formulation and Evaluation of Transdermal Drug Delivery System of Nateglinide for Controlled Release Application

Abstract

The present study aimed to develop and evaluate transdermal patches of Nateglinide for controlled and sustained drug delivery. Transdermal drug delivery systems (TDDS) offer a non-invasive alternative to conventional dosage forms by improving bioavailability and reducing dosing frequency through bypassing hepatic first-pass metabolism. In this study, various polymer-based matrix patches were formulated using agar, HPMC K-100, guar gum, ethyl cellulose, and Eudragit RS, along with suitable plasticizers. The prepared formulations were evaluated for physicochemical and mechanical properties including thickness uniformity, weight variation, moisture content, swelling behavior, tensile strength, folding endurance, surface pH, and drug content uniformity. In vitro drug release studies were performed using the paddle over disk method in phosphate buffer (pH 7.4) for 24 hours. The results demonstrated uniform film characteristics with thickness ranging from 0.401 to 0.631 mm and drug content between 94.95% and 102.32%, indicating uniform drug distribution. Swelling studies showed significant hydration capacity, while mechanical testing confirmed adequate tensile strength and excellent folding endurance across all formulations. Surface pH values remained within the skin-compatible range, ensuring safety for dermal application. In vitro release studies revealed sustained drug release up to 24 hours, with formulation F8 exhibiting the highest release (89.03%).Overall, the developed transdermal patches of Nateglinide showed promising results for controlled drug delivery, with optimized formulations providing sustained release, good mechanical strength, and acceptable skin compatibility, suggesting their potential for once-daily therapeutic application.

Keywords: Transdermal patches, drug delivery system, skin permeability, penetration enhancers, sustained release, microneedles, pharmaceutical innovation