Granular Serenoa Repens Extract for Direct Compression Tablets
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Solution Overview
Problem
Existing Serenoa repens extracts are poorly flowable and difficult to formulate into solid pharmaceutical dosage forms, particularly tablets, due to their poor tableting properties, leading to issues such as poor weight uniformity, low hardness, and high friability.
Innovation Solution
A process involving roller compaction is used to convert Serenoa repens solid extract into granules, improving flowability and compressibility, allowing for the preparation of tablets through direct compression.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If Serenoa repens extract is formulated as solid extracts by combining lipidosterolic oily extract with a carrier, then the extract becomes more convenient for preparing solid dosage forms, but the resulting powder has poor flowability and tableting properties
Solution Approach 1:
The invention changes the physical state of the extract from powder to granules through a granulation process, fundamentally altering the physical parameters (particle size, shape, density) to achieve both good flowability and tableting properties simultaneously
Solution Approach 2:
The invention uses an intermediary granulation process that acts as a mediator between the oily extract carrier combination and the final tablet formulation, creating granules that bridge the gap between poor powder flowability and required tabletting characteristics
2Device complexity
If Serenoa repens extract is used in direct compression for tablet preparation, then the manufacturing process is simplified, but the tablets exhibit poor weight uniformity, low hardness, and high friability
Solution Approach 1:
The invention changes the physical form of the extract from powder to granules, which fundamentally alters the compressibility and flow characteristics, enabling direct compression to produce tablets with excellent weight uniformity, hardness, and low friability
3Adaptability or versatility
If conventional excipients are used with Serenoa repens extract for tablet formulation, then the formulation appears complete, but the tablets still show poor weight uniformity and high friability due to poor powder flowability
Solution Approach 1:
The invention changes the physical state from powder to granules, which fundamentally improves the flowability parameter. This allows conventional excipients to function properly and achieve excellent tablet quality with good weight uniformity and low friability
Data Source
Figure 1~2

AI summary
The invention relates to a process for preparing Serenoa repens extract granules comprising roller compaction of a Serenoa repens solid extract. The invention also relates to the granular Serenoa repens obtainable with such process. The invention also relates to the use said granular product for the preparation of a pharmaceutical composition, to a pharmaceutical composition containing it and to a process for preparing Serenoa repens compositions using said granules. Additionally, the invention further relates to said Serenoa repens pharmaceutical compositions for use in therapy.