MUMBAI, India, Sept. 14 -- Intellectual Property India has published a patent application (202641101962 A) filed by Rama Krishna Garlapati; Yerragopu Naga Surekha; Dr. A. Prathyusha; Dr. M. V. Nagabhushanam; Dr. U. Neeraja Kamakshi; M. Beena Devi; Ch. Adilakshmi; Sk. Sanjuda; Dr. V. Mounika; and Hindu College Of Pharmacy on August 24, 2026, for "leuprolide Acetate-Loaded Biodegradable Polymeric Microspheres Incorporated Into Mucoadhesive Buccal Films For Controlled Drug Delivery In Pediatric Central Precocious Puberty.
Inventors include Rama Krishna Garlapati; Yerragopu Naga Surekha; Dr. A. Prathyusha; Dr. M. V. Nagabhushanam; Dr. U. Neeraja Kamakshi; M. Beena Devi; Ch. Adilakshmi; Sk. Sanjuda; and Dr. V. Mounika.
The application for the patent was published on September 11, 2026, under issue no. 37/2026.
Abstract: A biodegradable microsphere-loaded mucoadhesive buccal film containing leuprolide acetate is disclosed. The invention relates to a novel, non-invasive drug delivery system designed to provide controlled and sustained systemic delivery of the gonadotropin-releasing hormone (GnRH) agonist leuprolide acetate through the buccal mucosa. The system comprises leuprolide acetate encapsulated within biodegradable polymeric microspheres formed from poly(lactic-coglycolic acid) (PLGA), chitosan, polycaprolactone (PCL), or combinations thereof, which are subsequently incorporated into a flexible, mucoadhesive buccal film matrix. The microsphere component functions as a protective carrier for the peptide drug, enhancing its stability against enzymatic degradation and enabling controlled, sustained release. The buccal film is engineered using biocompatible mucoadhesive polymers along with suitable plasticizers and optional permeation enhancers and stabilizing excipients to ensure adequate adhesion to the buccal mucosa, improved residence time, and patient acceptability. Upon application, the film adheres to the buccal surface, allowing gradual release of microspheres and subsequent diffusion of leuprolide acetate across the mucosal membrane. Three representative embodiments are described, including PLGA-based microspheres, chitosan-based microspheres, and PCL-based microspheres, each offering distinct release kinetics and biodegradation profiles. The formulation is particularly designed for pediatric use in conditions requiring suppression of gonadotropindependent pubertal progression, including central precocious puberty, offering a potential alternative to injectable depot therapies. The system may be optimized by adjusting critical formulation parameters such as microsphere particle size, drug encapsulation efficiency, polymer composition, mucoadhesive strength, buccal residence time, and in vitro drug release behavior to achieve desired therapeutic performance.
Disclaimer: Curated by HT Syndication.
