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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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Scanning electron microscopy of microspheres of formulation batch F1.
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f1-ijn-6-619: Scanning electron microscopy of microspheres of formulation batch F1.

Mentions: Prepared B. coagulans loaded mucoadhesive microspheres were spherical in shape with a smooth surface and had no holes/ruptures on the surface. A scanning electron microscopy photograph of formulation-F1 which enumerates microsphere particle size and morphology is shown in Figure 1.


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

Alli SM - Int J Nanomedicine (2011)

Scanning electron microscopy of microspheres of formulation batch F1.
© Copyright Policy
Related In: Results  -  Collection

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

f1-ijn-6-619: Scanning electron microscopy of microspheres of formulation batch F1.
Mentions: Prepared B. coagulans loaded mucoadhesive microspheres were spherical in shape with a smooth surface and had no holes/ruptures on the surface. A scanning electron microscopy photograph of formulation-F1 which enumerates microsphere particle size and morphology is shown in Figure 1.

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