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COMPARATIVE STUDY ON THE PREPARATION AND CHARACTERIZATION OF INCLUSION COMPLEXES OF BCS CLASS II DRUG WITH CYCLODEXTRINS

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Abstract (2. Language): 
Fenofibrate (FFB) is an effective lipid regulating agent. Chemically it is 2-[4-(4-chloro benzoyl]-2 methyl propanoic acid, 1-methyl ethyl ester. It belongs to BCS class II and require enhancement in solubility and dissolution rate for increasing its oral bioavailability. In the present work, β- Cyclodextrin (β-CD) and Hydroxy Propyl β- Cyclodextrin (HP β-CD) complexes of FFB were prepared and evaluated for solubility and dissolution rate .The aqueous solubility was increased linearly as a function of the concentration of cyclodextrins. Physical characterization of solid inclusion complexes of FFB was studied by DSC and IR. An increase of 21 and 30 fold in the dissolution rate of FFB was observed with FFB- β-CD (1:3) - F6 and FFB- HP β-CD (1:3) - F12 prepared by kneading method respectively. The increase in the dissolution rate of the drug may be due to increase of wettability, the hydrophilic nature of carriers and also due to possibility of reduction in drug crystallinity.
FULL TEXT (PDF): 
420-425