Abstract

FORMULATION AND EVALUATION OF KETOROLAC TROMETHAMINE MOUTH DISSOLVING TABLET

Chandraprakash Pathariya*, Kuldeep Chaurasiya and Dr. Kapil Purohit

ABSTRACT

Novel mouth dissolving tablets of Ketorolac with adequate mechanical strength were prepared, optimized and evaluated for various in-vitro parameters. Ketorolac was identified by various organoleptic, physicochemical and spectrophotometeric methods. The solubility of Ketorolac was determined in different solvent systems. The calibration curve of Ketorolac was prepared. No significant shifts were observed on the mixing and storage. Mouth Dissolving Tablets, Ketorolac Tromethamine was prepared by wet granulation method with the addition of dried Plantago ovata mucilage as a natural super disintegrating agent and binding agent, along with other excipients. prepared granules was subjected to the micromeritic properties were determined using a bulk density and tapped density apparatus and flow properties (angle of repose, compressibility index and Hausner ratio) as per methods described. The tablets were evaluated for their physical appearance and quality control parameters (thickness, weight variation, hardness, Friability, disintegration time, dispersion time and wetting time). The thickness of the tablet was found 2.02 to 2.42 mm. The average weight variation of the prepared tablet was found 1.24 to 1.74 mg. So it was predicted that all the formulation exhibited uniform weight with low standard deviation values within the acceptable variation as per USP. The hardness of the prepared tablet varied from 4.2 to 4.9 kg/cm2, which showed tablets have satisfactory strength to withstand with the applied mechanical shocks. Plantago Oveta was added in the formulations to facilitate a breakup or disintegration of the tablet when it contacts with water or saliva in mouth. The in-vitro disintegration time of all the formulations varied between 18.31 ± 0.25 sec to 14.72 ± 0.73sec. It is observed that as the quantity of disintegrants increased the disintegration time was decreases. The in-vitro wetting time was also studied to know the process of disintegration. The in-vitro wetting time of all the formulations varied between 23.92 ± 0.48 to 19.24 ± 0.65. The drug content of all formulations was determined spectrophotometrically at 322 nm. It varied from 91.2 % to 98.7% per tablet. In-vitro drug release experiments were performed at 37±0.5oC in paddle type dissolution apparatus. The results showed that all the formulations release the drug within 5 minutes. The maximum drug release was found in formulation MD-2 (98.73%) also MD-1 was found 95.23%.

Keywords: Novel, Mouth Dissolving Tablets, Ketorolac, Plantago Oveta.