Formulation and Development of Rosuvastatin Fast Dissloving Tablets using Natural Super Disintegrates

Abstract

Rosuvastatin is in category of the drug class. It is used to treat high cholesterol and to block cardiovascular disease. The main aim of this study is to develop oral dispersible tablets of Rosuvastatin using different types of super disintegrates to enhance the disintegration and dissolution of Rosuvastatin to improve bioavailability of the drug. Many trials were made to prepare a satisfactory rosuvastatin oral dispersible tablet using direct compression and wet granulation method. Formulate tablets were examine with different parameters such as weight variation, hardness, friability, wetting time, in vitro disintegration time, drug content, water absorption ratio and in vitro drug release. Formulas prepared by direct compression showed good flowability, while formulas were prepared by wet granulation showed with very poor flow properties. Numerous super disintegrates were used such as cross carmellose (CCS), sodium starch glycolate (SSG) and cross povidone (CP), then latter found to be the best in term of showing the fastest disintegration time. Among the two-diluents mannitol was found to be the best one in preparing rosuvastatin tablet with fastest disintegration time in mouth. The optimized selected formula (F11) was prepared by using 15% w/w cross povidone, by direct compression resulted that the shortest disintegration time in mouth (11 seconds), superior drug release profile [the time required for 80% of the drug to be released (t80%) and percent drug dissolved in 2 min (D2min) were 6 min. and 56 %respectively]. In addition to that the selected formula had shown acceptable hardness and friability, hence it is selected as the best formula. The overall results showed that cross povidone was the best super disintegrate of showing the shortest disintegration time while mannitol was the best diluent in preparing Rosuvastatin oral dispersible tablet and this suggested the possibility of utilizing the selected best formula (F11) in the preparation of Rosuvastatin oral dispersible tablet as a new dosage form for oral administration.