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Granulometric Analysis After Spontaneous Disintegration of Tablets Containing Micronized Purified Flavonoid Fraction
João Vitor Santana da Silva1, Adriane Dos Santos Francisco1, Isabella Mourão Machado Valle1
1Faculdade de Farmácia, Universidade Federal do Rio de Janeiro, Rio de Janeiro, BRA.
Cureus
|January 28, 2026
Summary
Micronization of diosmin/hesperidin (MPFF) impacts drug absorption. The SIZE study found significant particle size differences among manufacturers, affecting therapeutic efficacy and highlighting the need for standardization.
Area of Science:
- Pharmacology
- Pharmaceutical Sciences
- Drug Delivery
Background:
- Micronized purified flavonoid fraction (MPFF), containing diosmin and hesperidin, treats chronic venous insufficiency.
- Micronization improves diosmin solubility and bioavailability, enhancing therapeutic effectiveness.
- Variations in micronization processes across manufacturers can impact drug efficacy.
Purpose of the Study:
- To evaluate the particle size distribution of MPFF tablets (900/100 mg diosmin/hesperidin).
- To compare MPFF products from four Brazilian pharmaceutical manufacturers.
Main Methods:
- Simulated dissolution using a spontaneous disintegration method.
- Granulometric analysis via optical microscopy and image analysis.
- Particle size categorization at 5 and 15 minutes post-disintegration.
Main Results:
- Significant differences in particle size distribution were observed between manufacturers.
- The reference product exhibited a higher percentage of fine particles (1-5 µm range).
- Finer particle size is associated with potentially faster dissolution and improved absorption.
Conclusions:
- Particle size is critical for drug solubility and bioavailability.
- Differences in micronization processes directly influence the therapeutic efficacy of MPFF.
- Standardized regulations for micronization are essential for ensuring consistent product quality and effectiveness.
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