Formulation and Evaluation of Ketorolac Tromethamine Sustained Release Matrix Tablet using Hibiscus Rosa–Sinensis Leaves Mucilage and HPMC E50

Ketorolac tromethamine SR tablets were prepared by direct compression technique and were found to be good without chipping, capping, and sticking. • Drug-excipient interaction studies were carried out by FT-IR in order to indicate the compatibility of drug with the polymers. The results revealed that the drug and polymers were satisfactorily compatible, without any significant changes in chemical nature of the drug. • The pre compression parameters like bulk density, tapped density, carr’s index and hausners ratio were determined and were found to be with in I.P limits. All the formulations from F1-F6 showed good flow properties. • The post compression parameters of the tablet like weight variation, thickness, hardness, friability, assay, were carried out and the values were found to be within IP limits. • It was observed that by increasing the concentration of polymers had retarding effect on the drug release from the polymer matrices. • In vitro dissolution studied were carried out for all the formulations (F1-F6) and it was observed that among all formulations F6 is able to sustain50% of drug for a period of 8 hrs. • The data obtained from in vitro dissolution studies of formulations (F1-F6) were fitted to first order, zero order, Higuchi, and peppas equations. • All the formulations F1-F6 showed good correlation for Higuchi kinetics. This indicated that the drug release mechanism was predominantly diffusion controlled. • All the formulations followed non-fickian type of diffusion. CONCLUSION: Sustained release matrix tablets of Ketorolac Tromethamine were successfully prepared by direct compression method. All the matrix formulations were subject to quality control tests such as hardness, weight variation, friability, thickness, drug content, and in vitro release studies. All the physical parameters complied with pharmacopoeial specifications and the in vitro release data was fitted into various kinetic models. Formulation containing 60% of Hibicus mucilage is able to sustain 50% of drug over a period of 8 hrs. FT-IR studies proved that no physical incompatibility exited between the drug and excipients