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Formulation and evaluation of Bacillus coagulans-loaded hypromellose mucoadhesive microspheres.

Alli SM - Int J Nanomedicine (2011)

Bottom Line: Core mucoadhesive microspheres of Bacillus coagulans were developed employing several grades of hypromellose, a mucoadhesive polymer, following coacervation and phase separation technique and were subsequently enteric-coated with hypromellose phthalate.Freeze dried B. coagulans cells were successfully formulated as enteric-coated mucoadhesive microspheres with satisfactory physical structure and yield.Test results depict statistically significant effects of the hypromellose grade and their concentration on the performance and release profile of formulations.

View Article: PubMed Central - PubMed

Affiliation: Department of Pharmaceutical Technology, Jadavpur University, Kolkata, West Bengal, India. smatharalli@gmail.com

ABSTRACT
Development of a novel delivery system has been attempted to deliver viable probiotic cells into the gut for a prolonged period of time while maintaining high numbers of viable cells within the formulation throughout the shelf-life of the product and during the gastrointestinal transit. Core mucoadhesive microspheres of Bacillus coagulans were developed employing several grades of hypromellose, a mucoadhesive polymer, following coacervation and phase separation technique and were subsequently enteric-coated with hypromellose phthalate. Microspheres were evaluated for percent yield; entrapment efficiency; in vitro swelling; surface morphology; particle size, size distribution, and zeta potential; flow property, mucoadhesion property by the ex vivo mucoadhesive strength test and the in vitro wash off test; in vitro release profile and release kinetic; in vivo probiotic activity; and stability. The values for the kinetic constant and regression coefficient of model-dependent approaches and the difference factor (f(1)), the similarity factor (f(2)), and the Rescigno index (ξ(1) and ξ(2)) of model independent approaches were determined for comparing in vitro dissolution profiles. Freeze dried B. coagulans cells were successfully formulated as enteric-coated mucoadhesive microspheres with satisfactory physical structure and yield. The viability of B. coagulans was maintained in the simulated gastric conditions and during processing; in simulated intestinal conditions exhibiting mucoadhesion, and controlling and extending the viable cell release following zero-order; and was satisfactorily stable at room temperature. Test results depict statistically significant effects of the hypromellose grade and their concentration on the performance and release profile of formulations.

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Comparative dissolution profile (model dependent, Zero-order kinetic model) of all formulation batches.
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f4-ijn-6-619: Comparative dissolution profile (model dependent, Zero-order kinetic model) of all formulation batches.

Mentions: In simulated gastric fluid TS, the amount of B. coagulans released from the coated microsphere system is negligible, while in simulated intestinal fluid TS, B. coagulans release is almost regulated and extended within the investigational period of 18 hours (Figure 4). This indicates that enteric-coating of microspheres has been competently protecting the viability of B. coagulans in gastric pH, preventing the release of B. coagulans in gastric pH, and releasing B. coagulans in the intestinal pH.


Formulation and evaluation of Bacillus coagulans-loaded hypromellose mucoadhesive microspheres.

Alli SM - Int J Nanomedicine (2011)

Comparative dissolution profile (model dependent, Zero-order kinetic model) of all formulation batches.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC3107721&req=5

f4-ijn-6-619: Comparative dissolution profile (model dependent, Zero-order kinetic model) of all formulation batches.
Mentions: In simulated gastric fluid TS, the amount of B. coagulans released from the coated microsphere system is negligible, while in simulated intestinal fluid TS, B. coagulans release is almost regulated and extended within the investigational period of 18 hours (Figure 4). This indicates that enteric-coating of microspheres has been competently protecting the viability of B. coagulans in gastric pH, preventing the release of B. coagulans in gastric pH, and releasing B. coagulans in the intestinal pH.

Bottom Line: Core mucoadhesive microspheres of Bacillus coagulans were developed employing several grades of hypromellose, a mucoadhesive polymer, following coacervation and phase separation technique and were subsequently enteric-coated with hypromellose phthalate.Freeze dried B. coagulans cells were successfully formulated as enteric-coated mucoadhesive microspheres with satisfactory physical structure and yield.Test results depict statistically significant effects of the hypromellose grade and their concentration on the performance and release profile of formulations.

View Article: PubMed Central - PubMed

Affiliation: Department of Pharmaceutical Technology, Jadavpur University, Kolkata, West Bengal, India. smatharalli@gmail.com

ABSTRACT
Development of a novel delivery system has been attempted to deliver viable probiotic cells into the gut for a prolonged period of time while maintaining high numbers of viable cells within the formulation throughout the shelf-life of the product and during the gastrointestinal transit. Core mucoadhesive microspheres of Bacillus coagulans were developed employing several grades of hypromellose, a mucoadhesive polymer, following coacervation and phase separation technique and were subsequently enteric-coated with hypromellose phthalate. Microspheres were evaluated for percent yield; entrapment efficiency; in vitro swelling; surface morphology; particle size, size distribution, and zeta potential; flow property, mucoadhesion property by the ex vivo mucoadhesive strength test and the in vitro wash off test; in vitro release profile and release kinetic; in vivo probiotic activity; and stability. The values for the kinetic constant and regression coefficient of model-dependent approaches and the difference factor (f(1)), the similarity factor (f(2)), and the Rescigno index (ξ(1) and ξ(2)) of model independent approaches were determined for comparing in vitro dissolution profiles. Freeze dried B. coagulans cells were successfully formulated as enteric-coated mucoadhesive microspheres with satisfactory physical structure and yield. The viability of B. coagulans was maintained in the simulated gastric conditions and during processing; in simulated intestinal conditions exhibiting mucoadhesion, and controlling and extending the viable cell release following zero-order; and was satisfactorily stable at room temperature. Test results depict statistically significant effects of the hypromellose grade and their concentration on the performance and release profile of formulations.

Show MeSH
Related in: MedlinePlus