Published Paper Details:

Mouth dissolving tablet or dispersible tablets is a widely acceptable dosage forms which dissolves rapidly in the saliva without water. It enhanced efficacy and bioavailability thus reducing the dose and dosing frequency to minimize the side effects. The purpose of this research was to develop mouth dissolving tablets of Clemastine. Clemastine is also known as Meclastin, is a first-generation antihistaminic drug. It can be used in allergic symptoms including sneezing, runny nose and red, itchy, tearing eyes. In the present study attempt has been made to formulate Clemastine mouth dissolving tablet by direct compression method and optimize mouth dissolving Clemastine tablets containing superdisintegrants viz crosspovidone, Crosscarmellose and Indion 414 in the different ratios (1:1, 1:2 & 1:3) along with directly compressible mannitol (Pearlitol SD200) to enhance mouth feel and to compare the optimized formulation of each superdisintegrant. Compatibility study were done in FT-IR shows that there is no significant interactions occur between clemastine and excipients. The blend of excipients developed were evaluated (pre formulation) was examined for angle of repose, bulk density, tapped density, % compressibility and hausner's ratio. The angle of repose of the developed excipients blend was found to be < 27o, Carr's index in the range of 11-15% and Hausner's ratio in the range of 1.12-1.15. Mouth dissolving tablets of Clemastine fumarate were prepared using the above co-processed superdisintegrants and evaluated. The systematic formulation approach helped in understanding the effect of formulation processing variables. The prepared batches of tablets were evaluated for various parameters like various taste, thickness, hardness, friability, drug content uniformity, wetting time, In vitro disintegration time, and In-vitro dissolution time. All the parameters were found to be within limits. Based on in vitro disintegration time (approximately 30 s), promising formulation F8 was tested for in vitro drug release pattern in pH 6.8 Phosphate buffer and short-term stability (at 400C/75% RH for 3 months).The developed formulation of Clemastine batch F8 (9 % Indion 414) showed good palatability and dispersed within 30 seconds as compared to crosscarmellose sodium and crosspovidone. Based on the in vitro drug release characteristics from clemastine mouth dissolving tablet it was concluded that the Indion 414 has a great potential in the formulation of Mouth dissolving tablets of Clemastine.