AN0025 Tablet Composition for Uniform Dissolution Control

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Solution Overview

Problem

The development of AN0025 capsules for Phase I clinical studies faces significant intra-batch variation (RSD) in dissolution tests, leading to unreliable quality evaluation and process robustness, making it difficult to establish good quality control methods for consistent product quality.

Innovation Solution

A solid pharmaceutical composition comprising AN0025 and pharmaceutically acceptable carriers, prepared through dry or wet granulation processes, resulting in tablets with controlled in vitro dissolution and reduced individual variability, ensuring better commercial production and clinical efficacy.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If AN0025 capsules are prepared by conventional methods, then the formulation can be produced, but the intra-batch variation in dissolution is large leading to poor quality consistency

Engineering Contradiction:

Improvedissolution uniformityVSAvoidquality consistency

Core Design Contradiction:

Manufacturing precisionVSReliability

Solution Approach 1:

The patent changes the particle size parameter of AN0025 API from conventional ranges to specifically D90≤200μm (preferably D90≤100μm), and adjusts the carrier ratio to 20-80 wt%, which fundamentally alters the dissolution behavior and achieves consistent quality across batches

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent performs preliminary size reduction and classification of AN0025 API before formulation, ensuring all particles meet the D90≤200μm specification prior to mixing with carriers, which prevents dissolution variability from the outset

Inventive Principle:

Principle #10Preliminary action

2Adaptability or versatility

If AN0025 is formulated with different API particle sizes, then formulation flexibility is improved, but dissolution behavior and in vivo exposure variability increase

Engineering Contradiction:

Improveformulation flexibilityVSAvoiddissolution uniformity

Core Design Contradiction:

Adaptability or versatilityVSManufacturing precision

Solution Approach 1:

The patent establishes a specific particle size parameter (D90≤200μm) as a critical quality attribute, allowing formulation flexibility within this constrained range while ensuring consistent dissolution and in vivo performance

Inventive Principle:

Principle #35Parameter changes

3Reliability

If dissolution test variability is reduced, then quality evaluation reliability is improved, but process constraints increase

Engineering Contradiction:

Improvequality evaluation reliabilityVSAvoidprocess complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The patent implements preliminary particle size control and classification as a standard process step, which simplifies subsequent quality evaluation by ensuring consistent dissolution behavior without requiring complex testing protocols

Inventive Principle:

Principle #10Preliminary action

Data Source

PatentUS20250381143A1A solid pharmaceutical composition

Publication Date: 2025.12.18 ADLAI NORTYE BIOPHARMA CO LTD

AI summary

The present disclosure provides a solid pharmaceutical composition, which comprises a compound represented by formula 1 or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable carrier, wherein the compound represented by formula 1 or a pharmaceutically acceptable salt thereof comprises from about 30% to about 80% of the total weight of the solid pharmaceutical composition.