Formulation and characterization of mouth dissolving tablets of Diacerein by Frosta technique using Diacerein: β-Cyclodextrin solid dispersion

Highly plastic granules that can be compressed into tablets at low pressure were developed to make mouth dissolving tablets (MDTs) by compression method. In formulation of MDTs by Frosta technique, perlitol SD 200, maltrin QD M 580 and sucrose solution (30% w/v) were used as plastic material, water penetration enhancer and a wet binder respectively. Maltrin QD M 580 and pearlitol SD 200 were mixed in different proportions (10:90, 20:80, 30:70, 40:60 and 50:50). Mouth dissolving tablets (batches FT1-FT5) were prepared by wet granulation method using optimized Diacerein: β-cyclodextrin solid dispersion (1:2 ratio, Batch DK3). The prepared Diacerein:β- cyclodextrin solid dispersion were characterized by Fourier transform infrared spectroscopy, differential scanning calorimetry, and powder X-ray diffraction and reveals reduction in drug crystallinity which might be responsible for improved dissolution properties. Evaluation of the tablets showed that all the tablets were found to be within official limits and the optimized batch FT3 (Containing 30% maltrin QD M 580 and 70% pearlitol SD 200) exhibited a disintegration time of 14.67 sec, percentage friability of 0.645%, wettability of 12 sec and 98.54 % drug release at the end of 60 minutes. The stability study conducted as per the ICH guidelines for six months and the formulations were found to be stable. The results showed that mouth dissolving tablets of Diacerein was successfully prepared by Frosta technique and improve the bioavailability of drug.

Author(s): Khemchand Gupta* and Indrajeet Singhvi

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