Pharmaceutical and Analytical Evaluation of Prolonged Release Rosuvastatin-Ca Buccoadhesive Tablets.

ABSTRACT

Rosuvastatin-Ca was prepared in solid dispersion as buccoadhesive tablets to increase its bioavailability and the release of the drug from its buccoadhesive formulae due to its poor aqueous solubility. The solid dispersions were prepared using β-cyclodextrin, polyethylene glycol 6000 and polyethylene glycol 4000 by kneading and solvent evaporation methods and were characterized by differential scanning calorimetry (DSC). They were also prepared using poloxamer 407 as a biocompatible and mucoadhesive carrier by freeze drying method. The buccoadhesive tablets of the drug were formulated using sodium carboxymethyl cellulose, hydroxypropylmethyl cellulose and sodium alginate by direct compression method. The prepared tablets were evaluated for their physical, dissolution, mucoadhesive and swelling properties. An in-vitro release study showed slow and prolonged release of the drug from tablets as compared to marketed formulation. Five formulae were selected for applying the recently reported analytical methods and results were compared statistically with a compendial one.