Formulation and in vitro-in vivo evaluation of rosuvastatin calcium incorporated cyclodextrin, solid lipid and chitosan based drug delivery systems

Cardiovascular diseases are the main reasons of death worldwide. Considering that many of the active pharmaceutical ingredients (APIs) used for the treatment of the such severe diseases have poor aqueous solubility which leads to insufficient treatment with poor bioavailability data. Therefore, there is a need for formulation of novel drug delivery systems for the enhancement of the efficacy with lowering the side effects of the APIs. In this study Rosuvastatin Calcium (RCa) which is one of the most effective cholesterol-lowering statin group agents was selected as a model drug aiming to prevent the coronary heart diseases with the reduction of the abnormal levels of lipids in the blood. For the enhancement of the efficacy of the API with lowered side effects, cyclodextrin (CDs) complexes, solid lipid nanoparticles (SLNs), polymeric nanoparticles with chitosan (Cs), were formulated. Characteristic properties of CDs complexes as well as the nanoparticles were revealed in detail. And also, stability of the formulations prepared were evaluated during the storage period of 3 months. Cytotoxic evaluations were also conducted with the MTT tests on Caco-2 cell lines. Ex vivo permeation performances on Caco-2 cell lines as well as in vivo pharmacokinetic studies were also evaluated on selected formulations. The comprehensiveness of the study and uniqueness of selected drug delivery systems are the major original values of our project. And since there is no study has done for the in vitro-in vivo efficiency of the CD-polymer based drug delivery systems for the RCa improves the originality of the study.