Formulations for injectable combination product containing acetaminophen and ibuprofen

Ready-to-administer acetaminophen/ibuprofen formulations with sulfite antioxidants and buffering agents in flexible polymeric containers address the need for stable, terminally sterilizable injectable products, ensuring long-term storage stability.

WO2026142931A1PCT designated stage Publication Date: 2026-07-02HIKMA PHARMACEUTICALS USA INC
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Patent Information

Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
HIKMA PHARMACEUTICALS USA INC
Filing Date
2025-12-18
Publication Date
2026-07-02

AI Technical Summary

Technical Problem

There is an unmet demand for an acetaminophen/ibuprofen combination product that is supplied in a polymeric infusion container, particularly one that offers long-term storage stability and can be terminally sterilized after filling, and there is a need for ready-to-administer injectable formulations suitable for intravenous use.

Method used

The development of ready-to-administer parenteral liquid formulations comprising acetaminophen and ibuprofen, with an antioxidant like a sulfite compound and a buffering agent at physiological pH, which are terminally sterilized in flexible polymeric infusion containers, ensuring stability during long-term storage.

Benefits of technology

The formulations maintain stability and integrity during terminal sterilization and long-term storage, meeting the demand for stable, ready-to-administer injectable products in polymeric containers.

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Abstract

The present disclosure relates to liquid formulations containing acetaminophen and ibuprofen. In particular, the present disclosure relates to liquid formulations comprising acetaminophen, ibuprofen, and a sulfite compound. Such liquid formulations are suitable for parenteral (e.g., intravenous) administration. The present disclosure also relates to terminally-sterilized acetaminophen / ibuprofen liquid formulations. The present disclosure also relates to methods of treating patients by administration of such formulations and polymeric infusion containers, including flexible polymeric infusion containers, containing such formulations.
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