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Risperidone solid dispersion for orally disintegrating tablet: its formulation design and non-destructive methods of
Ziyaur Rahman1, Ahmed S Zidan, Mansoor A Khan
1Division of Product Quality and Research, Center of Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, USA.
International Journal of Pharmaceutics
|August 31, 2010
Summary
Non-destructive techniques effectively evaluated risperidone solid dispersions (SD) with methyl-β-cyclodextrin (MBCD). These solid dispersions were successfully incorporated into orally disintegrating tablets (ODT) for enhanced risperidone release.
Area of Science:
- Pharmaceutical Technology
- Materials Science
- Analytical Chemistry
Background:
- Risperidone solid dispersions (SD) with methyl-β-cyclodextrin (MBCD) aim to improve drug release.
- Orally disintegrating tablets (ODT) offer an alternative drug delivery route for faster absorption.
- Non-destructive analytical techniques are crucial for efficient quality control in pharmaceutical formulations.
Purpose of the Study:
- To assess non-destructive techniques for evaluating risperidone-MBCD solid dispersions.
- To investigate the incorporation of these solid dispersions into orally disintegrating tablets (ODT).
- To evaluate the impact of formulation components on ODT performance and drug release.
Main Methods:
- Solvent evaporation method for preparing risperidone-MBCD solid dispersions.
- Characterization using SEM, FTIR, NIR, NIR-CI, PXRD, and DSC.
- Development of chemometric models (Partial Least Squares) using NIR data for component quantification.
- Formulation of ODTs with various diluents and superdisintegrants.
Main Results:
- Reduced crystallinity in risperidone-MBCD solid dispersions confirmed by DSC and XRD.
- FTIR confirmed no chemical interaction between risperidone and MBCD.
- Accurate quantification of risperidone and MBCD in SDs using NIR-chemometric models (R² > 0.9965).
- NIR-CI confirmed homogeneity in both SD and ODT formulations.
- Optimal ODT performance achieved with mannitol and Kollidon® CL-SF.
Conclusions:
- Non-destructive techniques, particularly NIR spectroscopy, are suitable for quality control of risperidone-MBCD solid dispersions.
- The developed ODT formulations demonstrate potential for faster risperidone release.
- Formulation excipients significantly influence the disintegration properties of the ODTs.
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