Pharmaceutical Composition Stabilization via pH Control
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Solution Overview
Problem
Pemafibrate, a compound used for treating dyslipidemia and NAFLD, is unstable under low pH environments, making it challenging to maintain stability in pharmaceutical compositions, which can lead to decomposition and adverse side effects.
Innovation Solution
Formulating a pharmaceutical composition with a pH value of 7 or more by using neutral to basic pharmaceutically acceptable carriers such as cellulose, starch, crospovidone, and antacids to stabilize pemafibrate, ensuring its stability and efficacy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If pemafibrate is formulated in a low pH environment, then the pharmaceutical composition can be stable, but pemafibrate decomposes and loses efficacy
Solution Approach 1:
The patent changes the pH parameter of the pharmaceutical composition from low pH to high pH (pH 7 or more). This parameter change resolves the contradiction by creating an environment where pemafibrate remains stable while maintaining the overall stability of the pharmaceutical composition. The high pH environment prevents decomposition of pemafibrate while ensuring the composition remains stable during storage and handling.
2Loss of time
If pemafibrate is stored for a long time after production, then distribution and administration are facilitated, but pemafibrate decomposes due to instability
Solution Approach 1:
By changing the pH parameter to 7 or more, the patent enables long-term storage of pemafibrate without decomposition. This parameter change allows the pharmaceutical composition to be produced in advance, stored for extended periods, and administered when needed, thereby reducing loss of time while maintaining pemafibrate stability throughout the storage period.
3Ease of manufacture
If conventional formulation methods are used, then production is simplified, but pemafibrate decomposes and produces adverse side effects
Solution Approach 1:
The patent applies a simple parameter change (pH to 7 or more) that simultaneously achieves ease of manufacture and prevention of decomposition. This approach maintains formulation simplicity while eliminating harmful decomposition products and adverse side effects, as the high pH environment naturally stabilizes pemafibrate without requiring complex additional steps.
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 composition maintains pemafibrate's stability and effectiveness, reducing decomposition products and adverse effects, thereby providing a stable and effective treatment for dyslipidemia and NAFLD.
Implementation Method 1
a pH value of a solution produced by dissolving or dispersing the pharmaceutical composition in water is 7 or more
Data Source
AI summary
Provided is a pharmaceutical composition containing pemafibrate, a salt thereof or a solvate thereof and having excellent storage stability. The pharmaceutical composition is provided to contain pemafibrate, a salt thereof or a solvate thereof, wherein a pH value of a solution produced by dissolving or dispersing the pharmaceutical composition in water is 7 or more.