Intellectual Property India Publishes Patent Application for Rectal Probiotic Suppository Formulation Comprising Multi-Strain Lactobacillus/Bifidobacterium In Cocoa Butter Base For Localized Treatment Of Ulcerative Colitis There Of.

MUMBAI, India, Sept. 14 -- Intellectual Property India has published a patent application (202641103345 A) filed by Dr. Pasala Praveen Kumar; Pentyala Akhil Surya; Purru Bhavi Teja; Patil Navya Sree; Pennahobilappa Gari Jayasimha Gari Jahnavi; Dr. Bhargav Eranti; Dr. Karumuri Taraka Sunil Kumar; and Raghavendra Institute Of Pharmaceutical Education And Research on August 27, 2026, for Rectal Probiotic Suppository Formulation Comprising Multi-Strain Lactobacillus/Bifidobacterium In Cocoa Butter Base For Localized Treatment Of Ulcerative Colitis There Of..

Inventors include Dr. Pasala Praveen Kumar; Pentyala Akhil Surya; Purru Bhavi Teja; Patil Navya Sree; Pennahobilappa Gari Jayasimha Gari Jahnavi; Dr. Bhargav Eranti; and Dr. Karumuri Taraka Sunil Kumar.

The application for the patent was published on September 11, 2026, under issue no. 37/2026.

Abstract: The present invention discloses a novel rectal probiotic suppository formulation and method of preparation thereof for the localized treatment• of ulcerative colitis. The formulation comprises a twelve-strain Lactobacillus and Bifidobacterium probiotic blend with prebiotic inulin providing 0.5 billion CFU per unit, incorporated in a cocoa butter base (186 mg) with microcrystalline cellulose (5% w/w) and cetyl alcohol (2% w/w) in a 200 mg suppository unit. The suppositories are prepared by an aseptic cold-mold technique: trituration of probiotic powder with excipients, incorporation into cocoa butter melted at 30-35 degrees C, cold solidification at 4 degrees C, and storage at 4 degrees C to preserve probiotic viability. The formulation exhibits: melting point 33.5-35 degrees C, hardness 2.5-3.0 kg, and liquefaction time 19- 25 minutes. In vivo evaluation in acetic acid-induced ulcerative colitis in Wistar rats demonstrated significant reduction in Disease Activity Index scores, macroscopic colonic damage, myeloperoxidase, and malondialdehyde levels, with significant restoration of reduced glutathione, catalase, and superoxide dismutase activity. Histopathological examination confirmed mucosal healing and reduced inflammatory infiltration. Therapeutic efficacy was superior to standard sulfasalazine therapy, supporting this formulation as a targeted, localized therapeutic approach for distal ulcerative colitis and inflammatory bowel disease. Keywords: Ulcerative colitis; Probiotic suppositories; Multi-strain Lactobacillus; Bifidobacterium; Cocoa butter base; Acetic acid-induced colitis; Localized drug delivery; Antioxidant; Anti- inflammatory; Inflammatory bowel disease; Rectal delivery.

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