Ensifentrine Particle Sterilization for Stable Inhalation Formulations
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Solution Overview
Problem
There is a need for a suitable method to sterilize a liquid pharmaceutical composition comprising ensifentrine particles, as existing methods like terminal sterilization and dry gamma-ray sterilization cause degradation of the formulation.
Innovation Solution
A process involving dry heat sterilization of ensifentrine particles followed by aseptic compounding with a sterile liquid vehicle to produce a sterile liquid pharmaceutical composition suitable for inhalation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If terminal sterilization or dry gamma-ray sterilization is used, then sterility is achieved, but formulation degradation occurs
Solution Approach 1:
The sterilization process is segmented into two distinct stages: first, dry heat sterilization of the ensifentrine particles alone (heating at 100-220°C); second, aseptic compounding with the sterile liquid vehicle. This segmentation allows each component to be sterilized by the most suitable method without subjecting the complete formulation to degrading sterilization conditions.
Solution Approach 2:
The ensifentrine particles are sterilized by dry heat treatment before being combined with the liquid vehicle. This preliminary sterilization action on the particles eliminates the need for terminal sterilization of the complete formulation, thereby preventing formulation degradation while ensuring sterility.
2Reliability
If dry heat sterilization is applied to the complete formulation, then sterility is achieved, but particle degradation occurs
Solution Approach 1:
The process separates the sterilization of particles from the formulation assembly. Only the ensifentrine particles undergo dry heat sterilization (heating at 100-220°C), while the liquid vehicle is sterilized separately by aseptic processing. This prevents the complete formulation from being subjected to high-temperature sterilization that would degrade particle integrity.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The process achieves a sterile liquid pharmaceutical composition with a high sterility assurance level and minimal degradation, ensuring the ensifentrine particles remain effective for respiratory treatments.
Implementation Method 1
heating ensifentrine particles at a temperature of from 100° C. to 220° C. to obtain sterile ensifentrine particles
Data Source
AI summary
The present invention relates to a process for producing a sterile liquid pharmaceutical composition suitable for administration by inhalation comprising ensifentrine particles, wherein the process comprises: (a) heating ensifentrine particles at a temperature of from 100° C. to 220° C. to obtain sterile ensifentrine particles; and (b) combining the sterile ensifentrine particles with a sterile liquid vehicle to produce the sterile liquid pharmaceutical composition suitable for administration by inhalation. A process for producing an ampule comprising the sterile liquid pharmaceutical composition is also described.