Abstract
Obesity is presently a global epidemic, which is associated with many major co-morbid disorders. Orlistat is used for the treatment of obesity. Fast disintegrating mini-tablets are compressed tablets of size up to 3mm that disintegrate rapidly and can be swallowed without water for better patient compliance. The objective of the present work is to develop the fast disintegrating Orlistat mini-tablets that can be administered whole as a unit dose sachet. Orlistat has a very less aqueous solubility, and to enhance the solubility and stability different methods were tried. In that, Orlistat β-cyclodextrin (1:2M) complex was found to be more feasible to prepare, 3mm mini-tablets each containing 6mg Orlistat, [20 mini-tablets for 120mg dose sachet]. Nine formulation trials using novel co-processed excipients were done. No drug excipients interaction was found by the XRD and IR Spectrum. The optimized formulation (ORDT-9) mini-tablets were evaluated for weight variation, hardness, friability, drug content and wetting time, all the results were within the standard limits. The in vitro disintegration and dissolution tests results of the optimized formulation containing the 40% of ludiflash have shown to be disintegrating in 55 seconds and releasing the 86% of drug within 10 minutes. And in the comparative in-vitro dissolution study with the existing marketed product the optimized formulation (ORDT-9) was releasing three fold faster and complete drug was released in the 15 minutes. Hence, the developed fast disintegrating mini-tablets of Orlistat with enhanced dissolution rate could be a viable ready-to-use single dose sachet dosage form, for better patient compliance.
