Pemafibrate Storage Stability in Moisture-Sensitive Packaging
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Solution Overview
Problem
The storage stability of pemafibrate in pharmaceutical compositions is compromised by interactions with cellulose species, particularly at high humidity, leading to increased decomposition products, which is unpredictable from chemical structures alone.
Innovation Solution
Storing a pharmaceutical composition containing pemafibrate and cellulose in a tight package that suppresses moisture entry, thereby reducing the formation of decomposition products and enhancing stability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If pemafibrate is co-formulated with cellulose species in a pharmaceutical composition, then the pharmaceutical composition can be produced with common excipients, but storage stability deteriorates at high humidity due to interaction between pemafibrate and cellulose species
Solution Approach 1:
The patent extracts the harmful factor (moisture) from the storage environment by using a tight package that suppresses moisture entry, thereby preventing the interaction between pemafibrate and cellulose species that occurs at high humidity
Solution Approach 2:
The tight package creates a protected environment that isolates the pharmaceutical composition from external moisture, effectively creating a stable storage condition that prevents decomposition reactions
2Stability of the object's composition
If the pharmaceutical composition is stored in a tight package that suppresses moisture entry, then storage stability of pemafibrate is improved, but packaging complexity increases
Solution Approach 1:
The patent employs a tight package with moisture-barrier properties that can be implemented as flexible packaging materials or thin-film coatings, providing effective moisture protection without requiring complex rigid structures
Data Source
AI summary
Provided is a novel technique for improving storage stability of a pharmaceutical composition containing pemafibrate, a salt thereof or a solvate thereof and a cellulose species. A pharmaceutical preparation obtained by storing a pharmaceutical composition containing the following components (A) and (B) in a tight package: (A) pemafibrate, a salt thereof or a solvate thereof; and (B) a cellulose species.