ABSTRACT
To overcome the limitations of the conventionally used methods for evaluation of orally administered colon-targeted delivery systems, a novel dissolution method using probiotics has been recently reported. In the present study, universal suitability of this medium composed of five different probiotics is established. Different delivery systems - mini tablets, liquisolid compacts, and microspheres coated with different polysaccharides - were prepared and subjected to sequential dissolution testing in medium with and without microbiota. The results obtained from fluid thioglycollate medium (FTM)-based probiotic medium for all the polysaccharide-based formulations showed statistically similar dissolution profile to that in the rat and goat cecal content media. Hence, it can be concluded that the developed FTM-based probiotic medium, once established, may eliminate the need for further animal sacrifice in the dissolution testing of polysaccharide-based colon-targeted delivery system.
ABSTRACT
The objective of this study was to identify and optimize formulation and process variables affecting characteristic and scale up of nanosuspension manufacturing process on bead mill considering industrial perspective. Box-Behnken design was used for this study. Formulation factors evaluated were ratio of polymer to drug and ratio of surfactant to drug, whereas process parameters were milling time and milling speed. Responses measured in this study include zeta potential and, particle size distribution d(90). The ANOVA test reveals that ratio of polymer to drug and milling speed has significant effect on zeta potential whereas milling time and milling speed has significant effect on the particle size distribution of nanosuspension. The X-RD pattern of drug milled at high and low speed reveals no form conversion when compared to unmilled drug. The Box-Behnken design used in this study helped in identifying the factors affecting the particle size distribution d(90), zeta potential and, scalability of nanosuspension. The derived polynomial equation and contour graph aid in predicting the values of selected independent variables for preparation of optimum nanosuspension formulations with desired properties.
