Liquid pharmaceutical composition comprising ensifentrine and glycopyrrolate

A stable inhalable liquid pharmaceutical composition with ensifentrine and glycopyrrolate is achieved by suspending ensifentrine particles and dissolving glycopyrrolate at a low pH, addressing stability issues and ensuring consistent dose delivery for respiratory disorder treatment.

AU2021227456B2Pending Publication Date: 2026-07-09VERONA PHARMA
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Patent Information

Application Number
AU2021227456
Authority / Receiving Office
AU · AU
Patent Type
Applications
Current Assignee / Owner
Priority Date
2020-02-27
Filing Date
2021-02-26
Publication Date
2026-07-09
Estimated Expiration
2041-02-26

AI Technical Summary

Technical Problem

Existing inhalable liquid pharmaceutical compositions, particularly those containing ensifentrine and glycopyrrolate, face challenges in stability and consistent dose delivery due to unpredictable formulation processes, especially when stored over time.

Method used

A liquid pharmaceutical composition is formulated with ensifentrine particles suspended in an aqueous diluent and glycopyrrolate dissolved at a low pH, with a concentration of glycopyrrolate less than or equal to 5.0 mg/mL, and a pH of 3.0 to 6.0, using a citrate buffer for stability, ensuring both compounds remain stable for at least three months.

Benefits of technology

The formulation achieves stability of ensifentrine and glycopyrrolate, allowing for consistent dose delivery by inhalation, suitable for treating respiratory disorders such as COPD and asthma.

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Abstract

The present invention relates to a liquid pharmaceutical composition suitable for administration by inhalation comprising: (i) ensifentrine particles; (ii) glycopyrrolate; and (iii) a diluent, which diluent comprises water, wherein: the glycopyrrolate is dissolved in the diluent; the concentration of glycopyrrolate is less than or equal to 5.0 mg / mL; and the pH of the liquid pharmaceutical composition is from 3.0 to 6.0. The invention also relates to a nebuliser comprising the liquid pharmaceutical composition.
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Citation Information

Patent Citations

  • Drug combination

    WO2014140648A1

  • Liquid inhalation formulation comprising RPL554

    WO2016042313A1