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Characterization of a crosslinked high amylose starch excipient
P Le Bail1, F G Morin, R H Marchessault
1McGill University, Department of Chemistry, Montreal, Que., Canada.
International Journal of Biological Macromolecules
|October 12, 1999
Summary
Sodium trimetaphosphate (STMP) crosslinked high amylose starch forms tablets that swell in water. This novel excipient enables near zero-order drug release for up to 20 hours, offering sustained delivery.
Area of Science:
- Materials Science
- Pharmaceutical Technology
- Polymer Chemistry
Background:
- Controlled drug release excipients are crucial for effective pharmaceutical formulations.
- High amylose starch offers potential as a matrix-forming excipient due to its unique properties.
Purpose of the Study:
- To investigate the properties of sodium trimetaphosphate (STMP) crosslinked high amylose starch as a controlled release excipient.
- To characterize the swelling behavior and drug release profile of STMP-treated starch tablets.
Main Methods:
- 13C CP/MAS NMR spectroscopy was used to analyze the structure of the excipient.
- Tablet swelling was measured in water at varying STMP concentrations.
- Drug release studies were conducted using the prepared tablets.
Main Results:
- Tablet volume increase correlated with STMP concentration.
- NMR spectra of swollen tablets indicated the presence of both 'V' and 'B' starch polymorphs.
- Near zero-order drug release was achieved for up to 20 hours.
Conclusions:
- STMP crosslinked high amylose starch functions as an effective controlled release excipient.
- Tablet swelling and sustained drug release are attributed to the self-assembly of starch nanomolecular particles.
- Optimized crosslinking provides tablet integrity for prolonged drug delivery.