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

Gately, Noel, Kennedy, James·2017·Pharmaceutics
DOI 10.3390/pharmaceutics9040038PMC PMC5750644
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Abstract

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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Crossref · 10.3390/pharmaceutics9040038

Cites

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Figures

Figure 1 Schematic illustration of the APV twin-screw extruder and extrusion conditions used to compound SSB® 55 pharmaceutical-grade shellac.
Figure 1 Schematic illustration of the APV twin-screw extruder and extrusion conditions used to compound SSB® 55 pharmaceutical-grade shellac.CC BY · PubMed Central
Figure 2 Extruder torque readings (n = 3) observed during processing of virgin SSB® 55 pharmaceutical-grade shellac and compounded Biocare® Bifidobacterium Probiotic at concentrations of 0%, 25% and 50% (w/w) in the shellac matrix.
Figure 2 Extruder torque readings (n = 3) observed during processing of virgin SSB® 55 pharmaceutical-grade shellac and compounded Biocare® Bifidobacterium Probiotic at concentrations of 0%, 25% and 50% (w/w) in the shellac matrix.CC BY · PubMed Central
Figure 3 Overlaid thermograms of virgin SSB® 55 pharmaceutical-grade shellac and compounded Biocare® Bifidobacterium Probiotic at concentrations of 25% and 50% (w/w) in the shellac matrix.
Figure 3 Overlaid thermograms of virgin SSB® 55 pharmaceutical-grade shellac and compounded Biocare® Bifidobacterium Probiotic at concentrations of 25% and 50% (w/w) in the shellac matrix.CC BY · PubMed Central
Figure 4 FTIR spectra for Biocare® Bifidobacterium Probiotic powder (blue line–middle), 100% melt-extruded SSB® 55 shellac (black line–top) and probiotic compounded with shellac at the highest loaded combined sample (50% w/w) (green line–bottom).
Figure 4 FTIR spectra for Biocare® Bifidobacterium Probiotic powder (blue line–middle), 100% melt-extruded SSB® 55 shellac (black line–top) and probiotic compounded with shellac at the highest loaded combined sample (50% w/w) (green line–bottom).CC BY · PubMed Central
Figure 5 Complex viscosity versus frequency (Hz) curves at 70 °C for SSB® 55 shellac and Biocare® Bifidobacterium Probiotic blends.
Figure 5 Complex viscosity versus frequency (Hz) curves at 70 °C for SSB® 55 shellac and Biocare® Bifidobacterium Probiotic blends.CC BY · PubMed Central
Figure 6 Viscosity versus shear rate at 70 °C of samples produced with SSB® 55 shellac and Biocare® Bifidobacterium Probiotic blends.
Figure 6 Viscosity versus shear rate at 70 °C of samples produced with SSB® 55 shellac and Biocare® Bifidobacterium Probiotic blends.CC BY · PubMed Central
Figure 7 Average degradation profiles (n = 3) for Biocare® Bifidobacterium Probiotic/shellac matrix across 3 pH ranges.
Figure 7 Average degradation profiles (n = 3) for Biocare® Bifidobacterium Probiotic/shellac matrix across 3 pH ranges.CC BY · PubMed Central
Figure 8 Growth of bifidobacteria from 50% sample formulation. Data points are averages from two independent fermentations.
Figure 8 Growth of bifidobacteria from 50% sample formulation. Data points are averages from two independent fermentations.CC BY · PubMed Central

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Citations

Cites

Show all 2 references

Research works printed but not linked: 22

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Metadata

Authors
Gately, N., & Kennedy, J.
Venue
Pharmaceutics
Publisher
MDPI AG
Published
2017-09-22
Volume
9
Issue
4
Pages
38
ISSN
1999-4923
DOI
10.3390/pharmaceutics9040038
PMC
PMC5750644
Cited by
33
References
2
Language
en
Licence
creativecommons.org/licenses/by/4.0/ (vor)
Funders
Science Foundation Ireland Research Frontiers programme (RFP.1_MTR_3347)

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CoChat. (2026). Citation check: The Development of a Melt-Extruded Shellac Carrier for the Targeted Delivery of Probiotics to the Colon. https://app.cochat.ai/papers/10.3390/pharmaceutics9040038
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Gately, N., & Kennedy, J. (2017). The Development of a Melt-Extruded Shellac Carrier for the Targeted Delivery of Probiotics to the Colon. Pharmaceutics. https://doi.org/10.3390/pharmaceutics9040038