Alogliptin Gel Capsule Composition for Solubility and Uniformity
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Solution Overview
Problem
Current pharmaceutical compositions of alogliptin face challenges with stability, solubility, dissolution rate, and content uniformity, leading to low bioavailability and short-term stability, particularly during the tablet compression process.
Innovation Solution
A pharmaceutical composition comprising alogliptin with croscarmellose sodium and other excipients such as hydroxypropyl cellulose, hydroxypropyl methyl cellulose, and magnesium stearate, formulated into solid oral dosage forms like tablets or capsules, optimized with specific ratios and combinations to enhance solubility, bioavailability, and stability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If alogliptin is formulated in conventional tablets, then manufacturing is simple, but solubility and dissolution rate are poor
Solution Approach 1:
The patent changes the physical state of alogliptin from conventional solid tablet form to a gel formulation, altering the physical parameters of the dosage form to improve solubility and dissolution rate while maintaining manufacturing feasibility through standardized gel capsule filling processes
Solution Approach 2:
The invention uses composite gel formulations combining alogliptin with gelatin or hydroxypropyl methyl cellulose as the gel matrix, creating a composite material system that enhances solubility and dissolution characteristics compared to conventional pure drug tablets
2Ease of manufacture
If alogliptin is formulated in conventional tablets, then production is straightforward, but content uniformity and stability are poor
Solution Approach 1:
The patent transitions from conventional tablet compression to gel capsule formulation, changing the manufacturing parameters to eliminate compression-related uniformity issues and improve content homogeneity through gel matrix incorporation
Solution Approach 2:
The gel matrix acts as an intermediary carrier that uniformly distributes alogliptin throughout the capsule, improving content uniformity and stability while maintaining straightforward capsule filling manufacturing processes
3Ease of manufacture
If alogliptin is formulated in conventional tablets, then manufacturing is simple, but bioavailability is low
Solution Approach 1:
The patent changes the dosage form from solid tablet to gel capsule, altering the physical and chemical parameters to enhance drug dissolution and absorption, thereby improving bioavailability while maintaining manufacturing simplicity through standard capsule filling techniques
Data Source
AI summary
The present invention relates to pharmaceutical compositions comprising alogliptin or a pharmaceutically acceptable salt thereof and at least one pharmaceutically acceptable excipient.