MUMBAI, India, July 30 -- Intellectual Property India has published a patent application (202621074694 A) filed by Mr. Harsh Kumar Brahmbhatt; Dr. Satyajit Sahoo; Vishwa Patel; and Dr. Salaj Khare on June 16, 2026, for A Terbinafine Hydrochloride-Loaded Transdermal Patch Formulation And A Validated Rp-Hplc Method For Quantitative Estimation And Quality Evaluation Thereof.
Inventors include Mr. Harsh Kumar Brahmbhatt; Dr. Satyajit Sahoo; Vishwa Patel; and Dr. Salaj Khare.
The application for the patent was published on July 24, 2026, under issue no. 30/2026.
Abstract: The present invention relates to a Terbinafine Hydrochloride-loaded transdermal patch formulation and a validated reverse-phase high-performance liquid chromatographic (RP-HPLC) method for quantitative estimation and quality evaluation thereof. The transdermal patch comprises Terbinafine Hydrochloride as an active pharmaceutical ingredient, one or more film-forming polymers, one or more plasticizers, and one or more permeation enhancers to provide sustained antifungal drug delivery through the skin. In a preferred embodiment, the formulation comprises Hydroxypropyl Methylcellulose (HPMC K15M), Polyvinyl Pyrrolidone (PVP K30), Polyethylene Glycol 400, and Oleic Acid, and is prepared by a solvent casting technique to obtain a flexible matrix-type transdermal film. The optimized formulation exhibits uniform drug distribution, satisfactory mechanical properties, enhanced permeation, and sustained drug release over 24 hours. The invention further provides a validated RP-HPLC method employing a C18 column, acetonitrile-phosphate buffer mobile phase, and UV detection at 224 nm for assay determination, drug content analysis, dissolution studies, permeation studies, stability evaluation, and routine quality control of the transdermal patch. The developed formulation and analytical method provide a stable, reproducible, and industrially applicable pharmaceutical system for effective transdermal delivery and quantitative evaluation of Terbinafine Hydrochloride.
Disclaimer: Curated by HT Syndication.
