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.
Highlights
The human gastrointestinal (GI) microflora or microbiota is a complex community of microorganisms comprising of up to 500 bacterial species with approximately two million genes, known as the microbiome [1]
Torque measurements observed in this study indicate shellac alone required the most energy to Torque in The this study indicate shellac of alone required most energy to melt process, asmeasurements can be seen inobserved high melt viscosity shellac wasthe reduced on addition melt process, as can be seen in
The high melt viscosity of shellac was reduced on addition of the Biocare Bifidobacterium Probiotic powder to the system, whereby a relatively marginal but of the Biocare® Bifidobacterium Probiotic powder to the system, whereby a relatively marginal but proportional decrease in melt viscosity from 75% torque to 72% and 61% torque was observed for proportional decrease in melt viscosity from 75% torque to 72% and 61% torque was observed for samples with 25% (w/w) and 50% (w/w) probiotic powder included, respectively
Summary
The human gastrointestinal (GI) microflora or microbiota is a complex community of microorganisms comprising of up to 500 bacterial species with approximately two million genes, known as the microbiome [1]. It is estimated that between 1000 and 1150 dominant bacterial species largely remain confined to the distal gut (colon). Of all the functional gastrointestinal disorders, irritable bowel syndrome has received the most interest in terms of the role of microflora in pathogenesis and of probiotics in therapy [2]. Irritable bowel syndrome (IBS) is a relatively common gastroenterological disorder predominantly dominated by symptoms such as abdominal pain, diarrhea or constipation, and bloating. The exact pathophysiology is uncertain, but possible mechanisms involve altered gut motility, visceral hypersensitivity and exaggerated stress response [3]. Probiotics seem to improve IBS symptoms and quality of life [4]
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