CO-AMORPHOUS DISPERSIONS OF AMLODIPINE AND ATORVASTATIN: PREPARATION, CHARACTERIZATION, STABILITY EVALUATION AND FORMULATION
Pinal H. Sukharamwala*, Sudha B. S.
ABSTRACT
The aim of present research was to prepare co amorphous system of amlodipine besylate (AML) and atorvastatin calcium (ATR) by different methods and to evaluate stability of drugs when tablets were stored at room condition and under controlled condition. The co amorphous system was prepared by three different methods viz rotary flash evaporation, solvent evaporation under room condition and by melt quenching technique. Solubility studies were carried out with co amorphous forms and physical mixture of AML and ATR. The optimized formula from our previous study1 was considered and total eight formulations were prepared employing either physical mixture or co amorphous forms of AML and ATR. Formulation blend was compressed into tablet by direct compression method using cross povidone or sodium starch glycolate as superdisintegrant. All the three methods have resulted in co amorphous precipitation of active ingredients with increase in their solubility and in vitro drug release from the tablet formulations. Pre and post compression studies were satisfactory for all the formulations. Tablets were found to be stable (12 months at room condi ion nd mon h C C nd
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