MUMBAI, India, July 7 -- Intellectual Property India has published a patent application (202621070580 A) filed by Pranali Laxman Sakate; Dr. Archana Swapnil Murgunde; Dr. Sandeep Ravindra Kane; Dr. Vikas Rajkumar Dhole; Imran Faiyaj Mulla; Manali Dattatray Pandit; and Dr. Shrinivas Krishna Mohite on June 05, 2026, for Quality By Design Approach For Fabrication Of Aprepitant Buccal Films.
Inventors include Pranali Laxman Sakate; Dr. Archana Swapnil Murgunde; Dr. Sandeep Ravindra Kane; Dr. Vikas Rajkumar Dhole; Imran Faiyaj Mulla; Manali Dattatray Pandit; and Dr. Shrinivas Krishna Mohite.
The application for the patent was published on July 03, 2026, under issue no. 27/2026.
Abstract: The present invention discloses a mucoadhesive buccal film composition comprising Aprepitant for management of chemotherapy- induced nausea and vomiting (CINV). The present invention discloses a mucoadhesive buccal film composition comprising Aprepitant (45 mg) incorporated into a polymeric matrix of Pullulan, Polyvinyl Alcohol, and HPMC E15 with PEG 400, propylene glycol, and Tween 80, prepared by solvent casting method. Formulation optimization employs a Quality by Design approach using Central Composite Design. The optimized film (PVA 500 mg, Pullulan 30 mg) demonstrates folding endurance of 368 times, rapid disintegration (32.48 seconds), drug content of 90.98 percent, surface pH of 6.78, and cumulative ex vivo drug release of 80.91 percent within 180 minutes through goat buccal mucosa. Drug release follows zero-order kinetics (R-squared 0.9938). Accelerated stability studies confirm maintenance of quality attributes for three months. The formulation offers a non-invasive alternative to oral dosage forms, bypassing first-pass metabolism and improving bioavailability for CINV management.
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