MUMBAI, India, Oct. 26 -- Intellectual Property India has published a patent application (202641123476 A) filed by Dr. Shaik Harun Rasheed; Dr. Vajrala Leela Lakshmi; Mr. Poola Hema Kumar; Dr. Munija Pancheddula; Ms. V. Sai Meghana; Dr. Ajay Babu Chirumella; Mr. Vadate Janardhan Naik; Mr. Chetan Jp; Ms. Sandhyarani Deekonda; and Dr. S. Shiva Kumar on October 15, 2026, for A Novel Gastro-Retentive Floating Tablet Formulation Of Tenofovir Using Sustained-Release Polymers.

Inventors include Dr. Shaik Harun Rasheed; Dr. Vajrala Leela Lakshmi; Mr. Poola Hema Kumar; Dr. Munija Pancheddula; Ms. V. Sai Meghana; Dr. Ajay Babu Chirumella; Mr. Vadate Janardhan Naik; Mr. Chetan Jp; Ms. Sandhyarani Deekonda; and Dr. S. Shiva Kumar.

The application for the patent was published on October 23, 2026, under issue no. 43/2026.

Abstract: The present invention relates to a gastro-retentive floating tablet formulation of Tenofovir using sustained-release polymers, developed to prolong gastric residence time and provide sustained drug release. The formulation comprises Tenofovir, HPMC K4M as a matrix-forming sustained-release polymer, sodium bicarbonate as a gas- generating agent, and pharmaceutically acceptable excipients. Floating tablets were prepared by a granulation process followed by compression. Six formulations (F1– F6) were developed and evaluated for pre-compression, post-compression, floating characteristics, and in-vitro drug release. The formulations exhibited floating lag times ranging from 21–58 seconds and buoyancy exceeding 24 hours. Among the formulations, F5 demonstrated the optimized performance, with a floating lag time of 21 ± 1 seconds, buoyancy for approximately 24 hours, and 98.94 ± 1.21% cumulative drug release over 24 hours. Drug-release data were analyzed using different kinetic models, with the release following the Higuchi model and exhibiting a non-Fickian diffusion mechanism according to the Korsmeyer–Peppas model. Accelerated stability studies conducted as per ICH Q1A(R2) at 40 ± 2°C and 75 ± 5% relative humidity for three months demonstrated satisfactory stability of the optimized formulation. The invention provides a gastro-retentive floating tablet system for the sustained oral delivery of Tenofovir.

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