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Formulation and evaluation of sublingual tablets containing Sumatriptan succinate
Shailesh T Prajapati1, Parth B Patel, Chhagan N Patel
1Department of Pharmaceutics and Pharmaceutical Technology, Shri Sarvajanik Pharmacy College, Gujarat, India.
International Journal of Pharmaceutical Investigation
|February 2, 2013
Summary
This study successfully taste-masked Sumatriptan succinate using solid dispersion and ion exchange methods. The developed sublingual tablets offer improved bioavailability and a potential alternative to oral Sumatriptan succinate for migraine relief.
Area of Science:
- Pharmaceutical Sciences
- Drug Delivery Systems
- Formulation Development
Background:
- Sumatriptan succinate, a selective 5-HT1 receptor agonist, is effective for acute migraine treatment.
- Oral administration of Sumatriptan succinate exhibits low bioavailability (~15%) due to significant first-pass metabolism.
- The drug possesses an intensely bitter taste, posing challenges for patient compliance.
Purpose of the Study:
- To mask the bitter taste of Sumatriptan succinate.
- To develop a fast-acting, taste-masked sublingual tablet formulation.
- To enhance the bioavailability of Sumatriptan succinate by bypassing first-pass metabolism.
Main Methods:
- Taste masking achieved via solid dispersion with mannitol and ion exchange using Kyron T 114.
- Formulation included menthol and sodium saccharine for palatability.
- Tablets prepared by direct compression and evaluated for physical, chemical, and in vitro release parameters.
Main Results:
- Optimized batches showed rapid in vitro disintegration (28-34 seconds).
- Maximum drug release achieved within 10 minutes (solid dispersion) and 14-15 minutes (ion exchange).
- In-vivo taste masking and compatibility studies (FTIR, DSC) confirmed formulation stability.
Conclusions:
- Both solid dispersion and ion exchange methods effectively taste-masked Sumatriptan succinate.
- The developed sublingual formulation demonstrated improved taste and palatability.
- The sublingual tablets represent a promising alternative to oral Sumatriptan succinate, potentially improving bioavailability.
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