Hot melt extrusion (HME) is considered an efficient technique in developing solid molecular\ndispersions, and has been demonstrated to provide sustained, modified and targeted drug delivery\nresulting in improved bioavailability. However, most commercial enteric or pH-responsive polymers\nare relatively difficult to process or have high Glass Transition Temperature (Tg) values, making their\nuse with temperature-sensitive drugs, probiotics or biologics not viable. Shellac is a natural\nthermoplastic, and after a review of current literature on the pharmaceutical HME process, a possible\ngap in the knowledge of the use of shellac to produce dosage forms by means of HME was identified.\nThis work explores the possibility of SSBÃ?® 55 pharmaceutical-grade shellac as a melt-extrudable\nencapsulation polymer to entrap freeze-dried probiotic powder and to determine bacterial cell\nviability post-processing. Well-defined strands were produced from the physical mixture of shellac\nand BiocareÃ?® Bifidobacterium Probiotic. FTIR clarified that there are no significant interactions\nbetween the probiotic and polymer. All of the samples demonstrated less than 5% degradation over\n24 h at pH of both 1.2 and 6.8. At pH 7.4, both loaded samples gave a similar dissolution trend with\ncomplete degradation achieved after 10ââ?¬â??11 h. Following five-month storage, 57.8% reduction in\nviability was observed.
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