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Microfluidic Dry-spinning and Characterization of Regenerated Silk Fibroin Fibers
Published on: September 4, 2017
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Silk Fibroin as a Novel Alcohol-Resistant Excipient for Sustained-Release Tablet Formulation
Jan Kozak1,2, Miloslava Rabiskova2, Alf Lamprecht3
1Department of Pharmaceutics, Institute of Pharmacy, University of Bonn, Gerhard-Domagk-Straße 3, 53121, Bonn, Germany.
AAPS Pharmscitech
|August 11, 2019
Summary
Silk fibroin shows promise as an alcohol-resistant excipient for sustained-release drug formulations. This natural polymer prevented dose dumping in tablets containing model drugs when exposed to ethanol, suggesting its suitability for pharmaceutical applications.
Area of Science:
- Pharmaceutical Sciences
- Materials Science
Background:
- Concomitant alcohol intake with sustained-release oral formulations can cause dose dumping.
- Regulatory authorities require alcohol-resistance testing for drug manufacturers.
- Existing alcohol-resistant excipients have a limited range of applications.
Purpose of the Study:
- To evaluate silk fibroin as a potential alcohol-resistant excipient for sustained-release drug formulations.
- To assess the impact of ethanol on drug release from silk fibroin-based tablets.
- To compare the performance of silk fibroin in amorphous solid dispersions versus physical mixtures.
Main Methods:
- Model drugs (oxycodone HCl, tramadol HCl, flurbiprofen) were formulated with silk fibroin into tablets (amorphous solid dispersion or physical mixture).
- Preliminary compactability and tampering-resistance studies were conducted.
- Ethanol-resistance was tested in release media with varying ethanol concentrations (5-40% v/v), and drug release profiles were analyzed using the f2 similarity factor.
Main Results:
- Silk fibroin tablets exhibited good mechanical tampering-resistance, especially from physical mixtures.
- Tablets from amorphous solid dispersions showed chemical tampering-resistance to ethanol extraction.
- No dose dumping was observed in the presence of ethanol; drug release was controlled by swelling and diffusion, slowing with increased ethanol concentration.
Conclusions:
- Silk fibroin demonstrates potential as an effective alcohol-resistant excipient for sustained-release oral drug formulations.
- The use of silk fibroin can mitigate the risk of dose dumping associated with alcohol consumption.
- Further research into silk fibroin-based excipients is warranted for pharmaceutical applications.
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