title: Development and evaluation of intestinal targeted mucoadhesive microspheres of Bacillus coagulans.
abstract: BACKGROUND
  Intestinal targeted mucoadhesive microsphere of probiotics may provide numerous associated health benefits.
  
  
  OBJECTIVE
  To develop mucoadhesive microspheres that will deliver viable probiotic cells into gut protectively against harsh environmental conditions of stomach for extended period.
  
  
  METHODS
  Core mucoadhesive microspheres of Bacillus coagulans were prepared using hypromellose, following coacervation and phase separation technique and were then coated with hypromellose phthalate to achieve their site-specific release. Microspheres were evaluated for percent yield, entrapment efficiency, surface morphology, particle size and size distribution, flow property, swelling property, mucoadhesion property by the in vitro wash-off and the ex vivo mucoadhesive strength tests, in vitro release profile and release kinetic, in vivo probiotic activity, and stability. The values for kinetic constant and regression coefficient of model-dependent approaches and the difference factor, the similarity factor, and the Rescigno index of model-independent approaches were determined for accessing and comparing in vitro performance.
  
  
  RESULTS
  Microsphere formulation batches have percent yield value between 56.26% and 69.13% and entrapment efficiency value between 66.95% and 77.89%. Microspheres were coarser with spherical shape having mean particle size from 28.03 to 48.31 μm. In vitro B. coagulans release profile follows zero-order kinetics and depends on the grade of hypromellose and the B. coagulans-to-hypromellose ratio. Experimental microspheres rendered adequate stability to B. coagulans at room temperature.
  
  
  CONCLUSIONS
  Microspheres had delivered B. coagulans in simulated intestinal condition following zero-order kinetics, protectively in simulated gastric condition, exhibiting appreciable mucoadhesion in intestinal condition, which could be useful to achieve site-specific delivery for extended period.
authors.affiliation: Department of Pharmaceutical Technology, Jadavpur University, Kolkata, West Bengal, India.
authors.forename: Sk Md Athar
authors.initials: SM
authors.lastname: Alli
authors.forename: Sk Md Ajhar
authors.initials: SM
authors.lastname: Ali
authors.forename: Amalesh
authors.initials: A
authors.lastname: Samanta
mesh_terms: D000268:Adhesiveness; D000704:Analysis of Variance; D000818:Animals; D001407:Bacillus / Q000737:chemistry*; D003692:Delayed-Action Preparations / Q000737:chemistry*; D006801:Humans; D007413:Intestinal Mucosa / Q000378:metabolism*; D051379:Mice; D008863:Microspheres; D008954:Models, Biological; D009093:Mucus / Q000378:metabolism*; D010316:Particle Size; D019936:Probiotics / Q000737:chemistry*
chemical_list: D003692:Delayed-Action Preparations