A laminated polymer film formulation for enteric delivery of live vaccine and probiotic bacteria

de Barros, J. M. S., Scherer, T., Charalampopoulos, D. ORCID: https://orcid.org/0000-0003-1269-8402, Khutoryanskiy, V. V. ORCID: https://orcid.org/0000-0002-7221-2630 and Edwards, A. D. ORCID: https://orcid.org/0000-0003-2369-989X (2014) A laminated polymer film formulation for enteric delivery of live vaccine and probiotic bacteria. Journal of Pharmaceutical Sciences, 103 (7). pp. 2022-2032. ISSN 1520-6017 doi: 10.1002/jps.23997

Abstract/Summary

Live bacterial cells (LBC) are administered orally as attenuated vaccines, to deliver biopharmaceutical agents, and as probiotics to improve gastrointestinal health. However, LBC present unique formulation challenges and must survive gastrointestinal antimicrobial defenses including gastric acid after administration. We present a simple new formulation concept, termed Polymer Film Laminate (PFL). LBC are ambient dried onto cast acid-resistant enteric polymer films that are then laminated together to produce a solid oral dosage form. LBC of a model live bacterial vaccine and a probiotic were dried directly onto a cast film of enteric polymer. The effectiveness at protecting dried cells in a simulated gastric fluid (pH 2.0) depended on the composition of enteric polymer film used, with a blend of ethylcellulose plus Eudragit L100 55 providing greater protection from acid than Eudragit alone. However, although PFL made from blended polymers films completely released low molecular weight dye into intestinal conditions (pH 7.0), they failed to release LBC. In contrast, PFL made from Eudragit alone successfully protected dried probiotic or vaccine LBC from simulated gastric fluid for 2h, and subsequently released all viable cells within 60min of transfer into simulated intestinal fluid. Release kinetics could be controlled by modifying the lamination method.

Item Type	Article
URI	https://reading-clone.eprints-hosting.org/id/eprint/36803
Identification Number/DOI	10.1002/jps.23997
Refereed	Yes
Divisions	Interdisciplinary centres and themes > Chemical Analysis Facility (CAF) > Thermal Analysis (CAF) Life Sciences > School of Chemistry, Food and Pharmacy > School of Pharmacy > Pharmaceutics Research Group Life Sciences > School of Chemistry, Food and Pharmacy > Department of Food and Nutritional Sciences > Food Research Group
Publisher	Wiley
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