In-vitro Release Characterization of Ketorolac Tromethamine Loaded Matrix Tablets

The present investigation highlighted the formulation and release characterization of Ketorolac Tromethamine loaded matrix tablet. Various formulations of tablets were prepared by direct compression method along with Kollidon SR and Hydroxy Propyl Methyl Cellulose (HPMC) as release retardant polymers. Each of the formulated tablets contains 50mg Ketorolac Tromethamine. The evaluation involved physical properties studies (weight variation, thickness, length, width, hardness, friability, and drug content) of tablets and in vitro release kinetics assessment. The USP paddle method was operated at 50 rpm selected to perform the dissolution test and 900 ml phosphate buffer of pH 7.4 was used as dissolution medium. The drug release from each formulation was analyzed by using release kinetics theories. All formulations followed Higuchi release kinetics. When the release data was plotted into Korsemeyer-Peppas equation, then it was confirmed that F-1 to F-5 exhibited fickian type drug release whereas F-6 exhibited nonFickian type drug release. The in-vitro release studies revealed that the formulation F-4 can be taken as an ideal or optimized formulation of sustained release tablets. Furthermore, the dissolution of the formulation-4 was performed in SLS (1%, 1.5%, and 2%) medium, which was observed gradually decreasing release rate as concentration of SLS medium increased. INTRODUCTION: Ketorolac Tromethamine is a novel Non-steroidal anti-inflammatory drug (NSAID) with potent analgesic & modest anti-inflammatory activity. In postoperative pain it has equaled the efficacy of morphine, but does not interact with opioid receptors & is free of respiratory depressant, dependence producing, hypertensive & constipating side effects. In short lasting pain, it has compared favorably with aspirin. Ketorolac Tromethamine is dihydrolizine carboxylic acid derivatives structure related to indomethacine . Ketorolac have a chiral center and is used as a racemate marketed under the name Toradol the (-)-s isomer has many times greater analgesic potency than the (+)R-isomer . Ketorolac Tromethamine is off-white crystalline powder and has a pK value of 3.49. Ketorolac is quite lipophilic with a log PC (partition coefficient) value of 2.72 . Ketorolac Tromethamine is extremely soluble in aqueous solution at pH 4-8, with a very long self-life at 25°C. However it is light sensitive with decarboxylation, especially in the presence of oxygen . Matrix tablets offer a great potential as oral controlled drug delivery systems due to easy and low cost of production like conventional rapid release tablets. Various controlled release agents including natural and synthetic polymers (HPMC, Kollidon SR etc) have used in production of matrix tablets for soluble and insoluble drugs for years .