Abstract

FORMULATION AND EVALUATION OF ORODISPERSIBLE TABLET OF ROSUVASTATIN

Syeda Tasmiya Yaseen Huda, R. Uma Prabha* and Surinder Kaur

ABSTRACT

Rosuvastatin often expose a problem of low bioavailability (absolute bioavailability 20%) as its dissolution is one of the rate limiting factor, so the purpose of this study is to make an attempt at formulating and evaluating Rosuvastatin Orodispersible Tablets to improve its bioavailability with high patient compliance. Rosuvastatin is a lipid-lowering medication that belongs to the statin class of drugs. It is used to minimise the risk of cardiovascular disease and manage excessive cholesterol levels by reducing the liver's production of endogenous cholesterol. Rosuvastatin is also used to lower cholesterol levels in the blood, such as low-density lipoprotein (LDL) cholesterol ('bad cholesterol') and triglycerides, while increasing high-density lipoprotein (HDL) cholesterol ('good cholesterol'). With the use of superdisintegrants, orodispersible tablets were prepared via direct compression. Nine distinct formulations were developed by altering the concentrations of three different superdisintegrants while keeping the total weight of the tablet the same. FTIR studies ruled out the possibility of drug polymer incompatibility. Pre and post compression evaluation parameters were employed to all of the formulated tablets. In vitro drug release of all formulations were carried out. The drug-polymer compatibility was verified using FTIR investigations. The results of all of the prepared tablets were satisfactory and within official limits. Among the nine formulations, F7 was selected as the best formulation as it has lesser wetting time, disintegration time and higher %CDR when compared to other formulations. F7 was found to be stable at 40 °C ± 2 °C and 75 ± 5 % RH for a period of 1 month. According to the findings of this study, prepared tablets with a lower concentration of Crospovidone are better and more effective than conventional tablets in terms of patient compliance and rapid action. The Kinetic studies showed that all the formulations followed zero order kinetics and the nature of the drug transport was found to be super case-II transport which indicates that the drug release depends on swelling, relaxation and erosion of polymer.

Keywords: Formulation; FTIR studies; In vitro drug release; Rosuvastatin, Orodispersible tablets; Superdisintegrants.