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Mesoporous Pravastatin Solid Dispersion Granules Incorporable Into Orally Disintegrating Tablets
Hojun Song1, Cheol Moon2, Beom-Jin Lee3
1College of Pharmacy, The Catholic University of Korea, Bucheon 14662, Republic of Korea.
Journal of Pharmaceutical Sciences
|March 14, 2018
Summary
Researchers developed porous pravastatin granules using spray-drying and ammonium bicarbonate sublimation. These granules enable the creation of orally disintegrating tablets (ODTs) with rapid disintegration and dissolution.
Area of Science:
- Pharmaceutical Technology
- Materials Science
Background:
- Orally disintegrating tablets (ODTs) offer improved patient compliance.
- Developing ODTs with challenging drugs like pravastatin requires innovative formulation strategies.
Purpose of the Study:
- To prepare porous granules of pravastatin using spray-drying.
- To evaluate the suitability of these granules for orally disintegrating tablets (ODTs).
Main Methods:
- Pravastatin sodium was dispersed in D-mannitol with ammonium bicarbonate via spray-drying.
- Porous granules (PSDGs-A) were formed due to ammonium bicarbonate sublimation.
- PSDGs-A were blended with ODT excipients and directly compressed into tablets.
Main Results:
- Spray-dried granules exhibited mesoporosity, high surface area, and suitable physical properties for tableting.
- The resulting ODTs (PSDGs-A-ODTs) showed rapid disintegration and quick initial dissolution.
- The formulation process was straightforward, with no tableting issues encountered.
Conclusions:
- Mesoporous pravastatin granules prepared via spray-drying and sublimation are effective for ODT development.
- This formulation approach offers a viable technology for creating drug delivery systems like ODTs.
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