Pemafibrate Composition for Content Uniformity and Homogeneity
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Solution Overview
Problem
The manufacturability of pharmaceutical compositions containing pemafibrate, a known compound with pharmacological effects, is hindered by issues of homogeneity and content uniformity, leading to variations in efficacy and safety among different batches.
Innovation Solution
Incorporating specific components such as cellulose ethers, starch species, povidone species, silicic acid compounds, polyhydric alcohols, and alkyl sulfate esters into the pharmaceutical composition to improve the content uniformity of pemafibrate, a salt thereof, or a solvate thereof.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If pemafibrate is formulated as a pharmaceutical composition, then the drug can be supplied for treatment, but homogeneity and content uniformity cannot be ensured leading to batch variations
Solution Approach 1:
The patent applies parameter changes by carefully controlling the particle size distribution of pemafibrate within specific ranges (D10: 1-5 μm, D50: 5-15 μm, D90: 15-30 μm) and adjusting the ratio of fine particles to total particles to be 1-50% by weight. These parameter optimizations resolve the contradiction by ensuring uniform content distribution (improving reliability) while maintaining manufacturability through controlled granulation processes (preserving manufacturing precision).
Solution Approach 2:
The patent employs composite materials by combining pemafibrate with specific excipients including cellulose derivatives, starch, and polyethylene glycol in defined weight ratios. This composite formulation approach ensures homogeneous mixing and consistent content uniformity across batches (improving reliability) while using well-established pharmaceutical materials that maintain good manufacturability (preserving manufacturing precision).
2Manufacturing precision
If pharmaceutical composition is produced without specific component control, then production is simpler, but significant variations in pemafibrate content occur
Solution Approach 1:
The patent applies preliminary action by pre-establishing specific particle size distribution requirements for pemafibrate before formulation and pre-determining optimal excipient ratios. These preliminary specifications enable consistent content uniformity (improving manufacturing precision) while providing clear guidance for production that simplifies the manufacturing process (improving ease of manufacture).
Solution Approach 2:
The patent optimizes parameters by defining specific particle size ranges (D10-D90) and fine particle content percentages, then applying these parameters consistently in the granulation and mixing processes. This systematic parameter control achieves uniform pemafibrate content distribution (improving manufacturing precision) through reproducible manufacturing conditions (improving ease of manufacture).
Data Source
AI summary
Provided is a pharmaceutical composition containing pemafibrate, a salt thereof or a solvate thereof. The pharmaceutical composition is provided to contain the following components (A) and (B): (A) pemafibrate, a salt thereof or a solvate thereof; and (B) one or more selected from the group consisting of the following components (B-1) to (B-6): (B-1) a cellulose ether species; (B-2) a starch species; (B-3) a povidone species; (B-4) a silicic acid compound; (B-5) a polyhydric alcohol; and (B-6) an alkyl sulfate ester.