PT  - JOURNAL ARTICLE
AU  - Chinna Reddy Palem
AU  - Shweta Patel
AU  - Varsha B. Pokharkar
TI  - Solubility and Stability Enhancement of Atorvastatin by Cyclodextrin Complexation
DP  - 2009 May 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 217--225
VI  - 63
IP  - 3
4099  - http://journal.pda.org/content/63/3/217.short
4100  - http://journal.pda.org/content/63/3/217.full
SO  - PDA J Pharm Sci Technol2009 May 01; 63
AB  - The objective of the study was to increase the solubility, stability, and dissolution rate of atorvastatin calcium (ATN Ca), a poorly water-soluble 3-hydroxy 3-methyl glutaryl CoA (HMG-CoA) reductase inhibitor through inclusion complexation with β-cyclodextrin (β-CD). The phase solubility profile indicated that the solubility of ATN Ca was significantly increased in the presence of β-CD and was classified as AL-type, indicating the 1:1 stoichiometric inclusion complexes. Solid complexes prepared by physical mixing, kneading, co-evaporation, and freeze-drying methods were characterized using differential scanning calorimetry, fourier transform infrared spectroscopy, and powder X-ray diffractometry. In vitro studies showed that the solubility and dissolution rate of ATN Ca were significantly improved by complexation with β-CD with respect to the drug alone. In contrast, freeze-dried product showed higher solubility and dissolution rates than the other complexes. ATN Ca unit dosage form was developed and evaluated for physico-chemical properties, stability, and dissolution rate. The stability of tablets was studied and no significant changes were detected in the dissolution profile of tablets after 1 month.