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.
Patent Information
- Authority / Receiving Office
- AU · AU
- Patent Type
- Applications
- Current Assignee / Owner
- VERONA PHARMA
- Filing Date
- 2021-02-26
- Publication Date
- 2026-07-09
AI Technical Summary
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.
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.
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.