Unit Oral Dose Compositions of Ibuprofen and Famotidine for Acute Pain and Heartburn Reduction

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UNIT ORAL DOSE COMPOSITIONS COMPOSED OF IBUPROFEN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND FAMOTIDINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF FOR THE TREATMENT OF ACUTE PAIN AND THE REDUCTION OF THE SEVERITY AND/OR RISK OF HEARTBURN AND/OR UPSET STOMACH

Application US20260097023A1 Kind: A1 Apr 09, 2026

Inventors

Bernard SCHACHTEL

Abstract

Described herein are unit oral dose compositions that reduce the severity of heartburn and/or upset stomach or the risk of the occurrence of heartburn and/or upset stomach in a human in need of taking ibuprofen or the pharmaceutically acceptable salt thereof for the treatment of acute pain wherein the human is not experiencing heartburn and/or upset stomach prior to the oral administration of the unit oral dose composition comprising orally administering to the human of a unit oral dose composition comprising (i) ibuprofen or the pharmaceutically acceptable salt thereof, wherein the amount of ibuprofen or the conjugate base of ibuprofen of the pharmaceutically acceptable salt of ibuprofen is a dosage from about 50 mg to about 400 mg per unit oral dose composition and (ii) famotidine or the pharmaceutically acceptable salt thereof, wherein famotidine or the conjugate acid of famotidine of the pharmaceutically acceptable salt of famotidine is at a dosage from about 3 mg to about 20 mg per unit oral dose composition, wherein the dissolution rate of famotidine or the conjugate acid of famotidine of the pharmaceutically acceptable salt of famotidine in the unit oral dose composition in said human at a specified time within 45 minutes of administration of said unit oral dose composition to said human is greater than the dissolution rate of ibuprofen or the conjugate base of ibuprofen of the pharmaceutically acceptable salt of ibuprofen in the unit oral dose composition in said human at the same specified time.

CPC Classifications

A61K 31/426 A61K 9/0053 A61K 9/2077 A61K 9/2086 A61K 31/138 A61K 31/167 A61K 31/192 A61K 31/194

Filing Date

2025-12-02

Application No.

19405788

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