Formulation development and in vitro evaluation of oral dispersible tablets of Olanzapine by direct compression

The objective of the present work was to formulate mouth dissolving tablet enriched with taste masking agent to provide rapid onset of action of olanzapine increasing its therapeutic efficacy and also increase the compliance amongst geriatric, pediatric and uncooperative patients. Precompression blends of the ODTs were prepared and evaluated for its micromeritic properties. Total four formulations of ODTs were prepared using direct compression (OLODT1 to OLODT4) method. The concentration of the super-disintegrant was varied for formulating the blends. Mannitol was used as the binder as well as sweetener while saccharin sodium was used as the additional taste masking agent in the formulations. All the formulations were subjected to post compression evaluation test and the results indicate that the formulation had hardness of 3 Kg/cm2 , thickness of 3 mm, weight variation in the range of 4.1-5.3 %, friability of less than 1 %, drug content in the range of 97.8 to 98.8 %, wetting time from 28 to 47 seconds with water absorption ratio of more than 75 %, disintegration time of less than 30 seconds and a drug release of more than 80 % over a period of 5 minutes. The formulations were found to be stable under accelerated conditions for a period of 3 months with almost negligible change in the critical parameters.