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

VSEngineering 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

Engineering Contradiction:
Improveconvenience for preparing solid dosage formsVSAvoidflowability
Core Design Contradiction:
Ease of manufactureVSEase of operation

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

Inventive Principle:
Principle #35Parameter changes

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

Inventive Principle:
Principle #24Intermediary (Mediator)

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

Engineering Contradiction:
Improvemanufacturing process complexityVSAvoidtablet quality (weight uniformity, hardness, friability)
Core Design Contradiction:
Device complexityVSManufacturing precision

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

Inventive Principle:
Principle #35Parameter changes

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

Engineering Contradiction:
Improveformulation compatibilityVSAvoidtablet quality
Core Design Contradiction:
Adaptability or versatilityVSManufacturing precision

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

Inventive Principle:
Principle #35Parameter changes

Data Source

PatentEP4647067A1Granular serenoa repens extract
Publication Date: 2025.11.12 TRADICHEM IND SERVICES SL
  • EP4647067A1 patent drawingFigure 1~2
  • EP4647067A1 patent drawing
  • EP4647067A1 patent drawing

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.