Plastic Container Water Vapor Permeability for Pharmaceutical Stability
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Solution Overview
Problem
Pharmaceutical preparations containing alcohols and triglycerides in glass containers are prone to breakage and moisture absorption, leading to phase separation and reduced shelf life, especially in humid environments, which is a challenge for portable medications and storage stability.
Innovation Solution
The use of plastic containers with water vapor permeability of not more than 3.0 g/m²/24h, specifically made of cycloolefin polymers or cycloolefin copolymers, which maintain stability and prevent phase separation in oily-alcoholic preparations, ensuring storage stability for at least 6 months at 40°C and 75% relative humidity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If glass containers are used for pharmaceutical preparations, then chemical inertness and transparency are improved, but breakage resistance and portability are worsened
Solution Approach 1:
The patent changes the material parameter from glass to specific plastic materials (polyethylene, polypropylene, polyvinylidene chloride) with controlled water vapor permeability (≤3.0 g/m²/24h at 37°C), maintaining chemical inertness while improving breakage resistance and portability
Solution Approach 2:
The patent uses composite packaging systems combining plastic containers with aluminum foil seals and cap closures, creating a multi-layer structure that provides both mechanical strength and chemical barrier properties
2Ease of manufacture
If plastic containers with high water vapor permeability are used, then ease of manufacture and cost are improved, but storage stability and prevention of phase separation are worsened
Solution Approach 1:
The patent specifies precise parameter ranges for plastic materials, particularly water vapor permeability (≤3.0 g/m²/24h at 37°C) and alcohol permeability (≤10.0 g/m²/24h at 37°C), to balance manufacturability with storage stability and prevent phase separation
Solution Approach 2:
The patent introduces aluminum foil seals and cap closures as intermediary barrier layers between the plastic container and the external environment, reducing water vapor and alcohol permeability while maintaining ease of manufacture
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 selected plastic materials effectively reduce water absorption, preventing phase separation and ensuring the stability of pharmaceutical preparations containing alcohols and triglycerides, meeting storage requirements and extending shelf life.
Implementation Method 1
plastic materials with a water vapor permeability of not more than 3.0 g/m 2 /24 h at 37° C and an alcohol permeability of not more than 10.0 g/m 2 /24 h at 37° C
Data Source
Figure 1~2
AI summary
The present invention relates to a pharmaceutical preparation, comprising a mixture of at least one pharmaceutical active ingredient, at least one alcohol component and at least one triglyceride component, in a plastic container, characterized in that the plastic has a water vapor permeability of no more than 3.0 g/m2/24h (measured on a film 100 µm thick at 40°C and 90% relative humidity).