FORMULATION AND EVALUATION OF ROSUVASTATIN ORODISPERSIBLE TABLETS

Rosuvastatin is a member of the drug class statins, used to treat high cholesterol and to prevent cardiovascular disease. The objective of present study is to develop orodispersible tablets of Rosuvastatin using different types of superdisintegrants to enhance the disintegration and dissolution of Rosuvastatin to improve bioavailability of the drug. Many trials were made to prepare a satisfactory rosuvastatin orodispersible tablet using direct compression and wet granulation method. Prepared tablets were evaluated for various parameters like 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 prepared by wet granulation showed very poor flow properties. Various superdisintegrants were used including croscarmellose (CCS), sodium starch glycolate (SSG) and crospovidone (CP), the latter found to be the best in term of showing the fastest disintegration time. Among the two diluents utilized, it was found that mannitol was the best one in preparing rosuvastatin tablet with fastest disintegration time in mouth. The optimized selected formula (F11) was prepared using 15% w/w crospovidone, by direct compression showed 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 an acceptable hardness and friability, so it was selected as the best formula. The overall results showed that crospovidone was the best superdisintegrant of showing the shortest disintegration time while mannitol was the best diluent in preparing Rosuvastatin orodispersible tablet and this suggested the possibility of utilizing the selected best formula (F11) in the preparation of Rosuvastatin orodispersible tablet as a new dosage form for oral administration.