Studies on the formulation of oral drugs which show low solubility

This study aimed develop innovative formulations with low solubility active agent is atorvastatin calcium, formulations of this in vitro release experiment was to compare the permeability properties of commercial formulation. Studies have been conducted for preparation and quality control of atorvastatin calcium containing self micro/nano emulsion drug delivery systems (SMEDDs) and preparation of pellet formulations by the method of solidification of microemulsified systems that can be administered by peroral route for treatment of primary hypercholesterolemia, will be compared with the commercial formulation. Firstly the methods was developed and validated in selected active ingredients by HPLC. Atorvastatin calcium's solubility studies were done in various oil phases, surfactans, cosurfactans and buffers. After working with the solubility studies, triangle phase diagrams were drawn with specified compounds and three formulations were decided that the highest area value. Thermodynamic stability of study results was observed phase separation and examined physicochemical properties of this formulation. The amount of ingredients of SMEDD formulation was performed by HPLC. SMEDD formulation's stability studies were carried out long term and accelerated stability for six months. Pellet formulation studies were conducted with microemulsion components adsorbed solid-phase were determined by solubility studies and the amount of water was determined according to viscosity of microemulsion formulation. Pellet formulations were prepared by solid phase adsorbed microemulsion. Studies were made to specify physicochemical properties of this formulation. Stability and amount of content studies was carried out. The active ingredient of atorvastatin calcium, developed SMEDD formulation and pellet formulations was studied in vitro release studies and compared with the commercial formulation. In vitro permeation studies were carried out with the Caco-2 cells for absorption studies of active ingredient of atorvastatin calcium, the pellet formulation, SMEDD formulations and commercial formulation. Cytotoxicity studies were conducted for atorvastatin calcium, SMEDD formulation, pellet formulation and commercial formulations for 0., 24., 48.,72. hours. As a result of all the studies performed, it was concluded that the findings are SMEDD and SMEDD- pellet formulations containing of the AtrCa, promising in the treatment of hypercholesterolaemia formulations with further studies to be done in the future.