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Published on: February 3, 2023
Polyols as filler-binders for disintegrating tablets prepared by direct compaction
Gerad K Bolhuis1, Erik G Rexwinkel, Klaas Zuurman
1Department of Pharmaceutical Technology and Biopharmacy, University of Groningen, Groningen, the Netherlands. g.k.bolhuis@rug.nl
Drug Development and Industrial Pharmacy
|March 11, 2009
Summary
Directly compressible (DC) polyols like isomalt and mannitol are effective filler-binders for disintegrating tablets. While DC mannitol offers faster disintegration and dissolution, DC isomalt presents fewer adhesion issues.
Area of Science:
- Pharmaceutical Technology
- Materials Science
Background:
- Polyols are common tablet excipients, but specific directly compressible (DC) forms are preferred for disintegrating tablets.
- This study evaluates DC forms of isomalt, lactitol, mannitol, sorbitol, and xylitol as filler-binders.
Purpose of the Study:
- To assess the suitability of various directly compressible (DC) polyols as filler-binders in disintegrating tablets.
- To compare the compactibility, lubricant sensitivity, and drug release properties of different DC polyols.
Main Methods:
- Tablets were compressed using a compaction simulator and motorized hydraulic press.
- Disintegration times and dissolution rates were measured according to European Pharmacopoeia (Ph.Eur.) standards.
- Theophylline was used as a model drug to evaluate filler-binder performance in tablet formulations.
Main Results:
- DC isomalt, mannitol, and sorbitol demonstrated adequate compactibility and low lubricant sensitivity.
- Tablets made with DC lactitol and xylitol exhibited insufficient crushing strength for practical application.
- DC isomalt and mannitol showed reduced hygroscopicity and capping tendency compared to DC sorbitol, making them more convenient.
- Tablets containing DC mannitol showed faster disintegration and drug dissolution but more adhesion problems than those with DC isomalt.
Conclusions:
- Directly compressible (DC) isomalt and mannitol are the most suitable filler-binders for disintegrating tablets manufactured via direct compaction.
- The choice between DC isomalt and DC mannitol depends on balancing drug release rates with potential adhesion issues.
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