The Development of a Melt-Extruded Shellac Carrier for the Targeted Delivery of Probiotics to the Colon

Hot melt extrusion (HME) is considered an efficient technique in developing solid molecular dispersions, and has been demonstrated to provide sustained, modified and targeted drug delivery resulting in improved bioavailability. However, most commercial enteric or pH-responsive polymers are relativel...

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Main Authors: Noel M. Gately, James E. Kennedy
Format: Article
Language:English
Published: MDPI AG 2017-09-01
Series:Pharmaceutics
Subjects:
Online Access:https://www.mdpi.com/1999-4923/9/4/38
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author Noel M. Gately
James E. Kennedy
author_facet Noel M. Gately
James E. Kennedy
author_sort Noel M. Gately
collection DOAJ
description Hot melt extrusion (HME) is considered an efficient technique in developing solid molecular dispersions, and has been demonstrated to provide sustained, modified and targeted drug delivery resulting in improved bioavailability. However, most commercial enteric or pH-responsive polymers are relatively difficult to process or have high Glass Transition Temperature (Tg) values, making their use with temperature-sensitive drugs, probiotics or biologics not viable. Shellac is a natural thermoplastic, and after a review of current literature on the pharmaceutical HME process, a possible gap in the knowledge of the use of shellac to produce dosage forms by means of HME was identified. This work explores the possibility of SSB® 55 pharmaceutical-grade shellac as a melt-extrudable encapsulation polymer to entrap freeze-dried probiotic powder and to determine bacterial cell viability post-processing. Well-defined strands were produced from the physical mixture of shellac and Biocare® Bifidobacterium Probiotic. FTIR clarified that there are no significant interactions between the probiotic and polymer. All of the samples demonstrated less than 5% degradation over 24 h at pH of both 1.2 and 6.8. At pH 7.4, both loaded samples gave a similar dissolution trend with complete degradation achieved after 10–11 h. Following five-month storage, 57.8% reduction in viability was observed.
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spelling doaj.art-c74bf49807314196b76b9dfbec8cdb442022-12-22T02:56:50ZengMDPI AGPharmaceutics1999-49232017-09-01943810.3390/pharmaceutics9040038pharmaceutics9040038The Development of a Melt-Extruded Shellac Carrier for the Targeted Delivery of Probiotics to the ColonNoel M. Gately0James E. Kennedy1Materials Research Institute, Athlone Institute of Technology, Co. Westmeath N37 HD68, IrelandMaterials Research Institute, Athlone Institute of Technology, Co. Westmeath N37 HD68, IrelandHot melt extrusion (HME) is considered an efficient technique in developing solid molecular dispersions, and has been demonstrated to provide sustained, modified and targeted drug delivery resulting in improved bioavailability. However, most commercial enteric or pH-responsive polymers are relatively difficult to process or have high Glass Transition Temperature (Tg) values, making their use with temperature-sensitive drugs, probiotics or biologics not viable. Shellac is a natural thermoplastic, and after a review of current literature on the pharmaceutical HME process, a possible gap in the knowledge of the use of shellac to produce dosage forms by means of HME was identified. This work explores the possibility of SSB® 55 pharmaceutical-grade shellac as a melt-extrudable encapsulation polymer to entrap freeze-dried probiotic powder and to determine bacterial cell viability post-processing. Well-defined strands were produced from the physical mixture of shellac and Biocare® Bifidobacterium Probiotic. FTIR clarified that there are no significant interactions between the probiotic and polymer. All of the samples demonstrated less than 5% degradation over 24 h at pH of both 1.2 and 6.8. At pH 7.4, both loaded samples gave a similar dissolution trend with complete degradation achieved after 10–11 h. Following five-month storage, 57.8% reduction in viability was observed.https://www.mdpi.com/1999-4923/9/4/38therapeutic deliveryshellacprobioticsmelt extrusion
spellingShingle Noel M. Gately
James E. Kennedy
The Development of a Melt-Extruded Shellac Carrier for the Targeted Delivery of Probiotics to the Colon
Pharmaceutics
therapeutic delivery
shellac
probiotics
melt extrusion
title The Development of a Melt-Extruded Shellac Carrier for the Targeted Delivery of Probiotics to the Colon
title_full The Development of a Melt-Extruded Shellac Carrier for the Targeted Delivery of Probiotics to the Colon
title_fullStr The Development of a Melt-Extruded Shellac Carrier for the Targeted Delivery of Probiotics to the Colon
title_full_unstemmed The Development of a Melt-Extruded Shellac Carrier for the Targeted Delivery of Probiotics to the Colon
title_short The Development of a Melt-Extruded Shellac Carrier for the Targeted Delivery of Probiotics to the Colon
title_sort development of a melt extruded shellac carrier for the targeted delivery of probiotics to the colon
topic therapeutic delivery
shellac
probiotics
melt extrusion
url https://www.mdpi.com/1999-4923/9/4/38
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