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Characterization and compaction behaviour of nimesulide crystal forms.

Piera Di Martino¹, Roberta Censi, Christine Barthélémy

¹Laboratorio di Tecnica Farmaceutica, Dipartimento di Scienze Chimiche,Via S. Agostino, 62032 Camerino, Italy. piera.dimartino@unicam.it

International Journal of Pharmaceutics

|June 23, 2007

Summary

Researchers explored new crystalline forms of nimesulide, a nonsteroidal anti-inflammatory drug (NSAID). A novel form derived from dioxane solvate significantly improved nimesulide

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Area of Science:

Pharmaceutical Sciences
Materials Science
Solid-State Chemistry

Background:

Nimesulide is a widely used nonsteroidal anti-inflammatory drug (NSAID) in oral formulations.
Understanding different crystalline forms is crucial for drug development and efficacy.

Purpose of the Study:

To investigate novel crystalline forms of nimesulide.
To characterize their physicochemical and technological properties.
To assess the impact of different forms on tableting performance.

Main Methods:

Crystallization from ethanol and dioxane solutions.
X-ray powder diffraction (XRPD) for structural analysis.
Differential Scanning Calorimetry (DSC) and thermo-gravimetric analysis (TGA) for thermal properties.
Solid-state Nuclear Magnetic Resonance ((13)C-CPMAS NMR) for conformational analysis.
Tableting studies to evaluate compressibility and tabletability.

Main Results:

A new crystalline form of nimesulide was obtained from ethanol, distinct from the reference sample.
Nimesulide formed a solvate when crystallized from dioxane, characterized by multiple conformational isomers.
The form obtained from desolvation of the dioxane solvate demonstrated improved compressibility and tabletability.
This novel form mitigated capping phenomena observed in other nimesulide forms under high compression.

Conclusions:

Different crystallization solvents yield distinct nimesulide forms with varying physicochemical properties.
The desolvated dioxane solvate form offers superior technological properties for solid oral formulations.
This improved form has the potential to enhance the manufacturing process and performance of nimesulide tablets.