FORMULATION AND EVALUTION OF FAST DISSOLVING ORAL FILM OF KETOROLAC TROMETHAMINE

Abstract

Ketorolac (KT) is currently administered orally in the form of tablets or as intramuscular injections in multiple divided doses for short term management of post-operative pain.IR spectrum of ketorolac tromethamine was recorded using Bruker spectrophotometer. Melting point of ketorolac tromethamine was determined by capillary method. UV-Visible spectral analysis of ketorolac tromethamine was done by using Elico double beam UV-Visible spectrophotometer 1800 model (Optiglass U.K Limited).Accurately weighed 100 mg of ketorolac tromethamine was taken in 100 ml volumetric flask and dissolved in q.s. 100 ml of citrophosphate pH 6.5 to prepare a stock solution of 1000 ppm. From the above stock solution aliquots of 0.2, 0.4, 0.6, 0.8, 1, 1.2, 1.4 1.6 and 1.8 were transferred separately into 10 ml volumetric flasks and volume was made up to 10 ml with citrophosphate pH 6.5 to get the standard solutions of 2 to 18µg/ml respectively. Physical mixture of ketorolac tromethamine, PVP and HPMC E15LVwas prepared in the ratio of 1:1:1 and IR spectrum was recorded in the range from 4,000 to 400 cm-1.32 factorial design shall be used to prepare 9 different batches for assessing the influence of critical variables: PVP (X1) and HPMC E15LV (X2).Fast dissolving films were prepared by solvent casting method Aqueous solution I was prepared by dissolving polymer HPMC E15LV and PVP in 5 ml distilled water with stirring to produce a clear solution. The thickness of each film was measured at three different locations the thickness of the film was measured by micrometre screw gauge. The in-vitro disintegration time of film strips was determined by the visual method. The film strip was placed in a glass Petri dish containing 25 ml of distilled water at37°C. ketorolac tromethamine was carried out by USP type II Dissolution apparatus i.e. paddle type 100 containing 500 ml of the simulated salivary fluid (pH 6.5) as a dissolution medium, maintained at 37 ± 0.5°C.The stability study of prepared fast dissolving film of ketorolac tromethamine was carried out at 40/75(°C/RH) and for one month.
KEY WORDS: ketorolac tromethamine, fast dissolving tablet, HPMC E15LV, PVP.