Formulation and Optimization of Hydrochlorothiazide Mouth Dissolving Tablets by Using Co-Processed Superdisintegrantsby Jasmine Kaur Bhatia, Rupinder Kaur, Sukhdev Singh, Rajwinder Kaur, India.

摘要

The mouth dissolving tablets (MDTs) usually dissolve in the oral cavity within 15 seconds to 3 minutes. In another words a MDT is tablet that dissolves or disintegrate in the oral cavity without the need of water or chewing. Recently formulation scientist recognized that single component excipients do not always provide the required performance. Hence, there is a need to have excipients with multiple characteristics built into them such as better flow, lowo moisture sensitivity, superior compressibility and rapid disintegration ability. Co-processing is based on the novel concept of two or more excipients interacting at the sub particle level, the objective of which is to provide a synergy of functionality improvement as well as masking the undesirable properties of individual. Co-processing excipients could lead to formation of excipients with superior properties compared with the simple physical mixture component. Co-processed particles of SSG and Crospovidone were prepared using a solvent i.e. Isopropyl Alcohol, which were used as a direct compressible excipients in mouth dissolving tablet formulation. The two super disintegrates were mixed in varied proportion (according to 32 factorial design) by constant stirring until all the solvent was evaporated. The semi dried mixture of super disintegrates was passed through mesh screen size no. 60 and dried in tray dryer at 60°C. A two factor three level (32) factorial design is being used to optimize the formulation. Nine such different proportionate mixtures of super disintegrants were prepared accordingly. The concentration of processed Super disintegrants was then optimized for DT 35 secs. and friability 0.5% and used to formulate mouth dissolving tablet by direct compression method using other commonly used excipients and evaluated for disintegration time, wetting time, tablet hardness and percent friability. A decrease in disintegration time, % friability and wetting time was noted with tablet prepared by co-processed super disintegrants when compared with tablet formulated using SSG, Crospovidone alone or as compare to their physical mixtures.