MUMBAI, India, July 24 -- Intellectual Property India has published a patent application (202611056009 A) filed by Ms. Disha Nailwal; Aarti Mehta; Profdrafroze Alam; Dr. Mehta Parulben Durgashankar; Dr. R. Ramprasad; Priyanka Maheshkumar Kushwaha; Tasneem Ahmad; Nayyar Parvez; Mr. Sushant Shamrao Dhandore; Dr. Bimal Debbarma; Dr. Atul Kumar Gangwar; and Dr Sanjay Kisanrao Bais on May 02, 2026, for Design And Evaluation Of Press-Coated Chronotherapeutic Tablets Of Pantoprazole For Nocturnal Acid Breakthrough.
Inventors include Ms. Disha Nailwal; Aarti Mehta; Profdrafroze Alam; Dr. Mehta Parulben Durgashankar; Dr. R. Ramprasad; Priyanka Maheshkumar Kushwaha; Tasneem Ahmad; Nayyar Parvez; Mr. Sushant Shamrao Dhandore; Dr. Bimal Debbarma; Dr. Atul Kumar Gangwar; and Dr Sanjay Kisanrao Bais.
The application for the patent was published on July 17, 2026, under issue no. 29/2026.
Abstract: The present invention discloses a press-coated chronotherapeutic tablet of pantoprazole sodium engineered to provide pulsatile drug release for the treatment of nocturnal acid breakthrough in gastroesophageal reflux disease patients. The formulation comprises a pantoprazole sodium inner core, alkalinised with sodium bicarbonate, enclosed within a press-coated outer shell comprising hydroxypropyl methylcellulose K15M, guar gum, and ethylcellulose. The outer shell undergoes time-dependent hydration and erosion upon gastrointestinal fluid contact, generating a programmable lag time of five to six hours followed by rapid drug release. A 3² full factorial design was applied to optimise polymer concentration and coat weight. The optimised formulation exhibited a lag time of 5.5 hours and released 92.4% of pantoprazole sodium within 60 minutes post-lag. FTIR and DSC analyses confirmed drug-excipient compatibility and physical stability. This chronotherapeutic system aligns peak drug plasma levels with nocturnal acid secretion, offering superior clinical outcomes.
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