Formulation and Optimization of Fast Dissolving Tablets of Olanzapine Using Vacuum Drying Technique by 2 Factorial Design

The purpose of this research was to develop fast dissolving tablets of olanzapine and to optimize the processing variables. Tablets containing olanzapine, camphor, crosscarmellose, and directly compressible lactose were prepared by direct compression technique. The tablets were compressed and later exposed to vacuum. Sublimation of camphor from tablets resulted in superior fast dissolving tablets. The tablets were evaluated for percentage friability, wetting time, and disintegration time. In this investigation, a 2 full factorial design was used to investigate the joint influence of 2 formulation variables: amount of camphor and crosscarmellose. A checkpoint batch was also prepared to prove the validity of the evolved mathematical model. The results of multiple linear regression analysis revealed that for obtaining a rapidly disintegrating dosage form, tablets should be prepared using an optimum concentration of camphor and a higher percentage of crosscarmellose. The systematic formulation approach helped in understanding the effect of formulation processing variables. INTRODUCTION: The tablet is the most widely used dosage form because of its convenience in terms of self-administration, compactness, and ease in manufacturing. However, geriatric and pediatric patients experience difficulty in swallowing conventional tablets, which leads to poor patient compliance. To alleviate this problem, the tablets are expected to dissolve or disintegrate in the oral cavity without drinking water. Mouth dissolve tablets (MDT) or melt in mouth or fast dissolving tablet or rapid dissolving tablet, is the name coined for these tablets. These are novel types of tablets that disintegrate/dissolve/disperse in saliva. They are also suitable for the mentally ill, the bedridden, and patients who do not have easy access to water. The benefits, in terms of patient compliance, rapid onset of action, increased bioavailability, and good stability make these tablets popular as a dosage form of choice in the current market 1, . The basic approach used in the development of fast dissolving tablets is the use of superdisintegrants . The alternative approach is to maximize the pore structure of the tablet matrix either by freeze drying or vacuum drying techniques . Freeze drying is cumbersome and it yields a fragile and hygroscopic product. Therefore, it was decided to adopt the vacuum-drying technique in the present investigation. Vacuum drying is usually adopted after addition of a subliming agent