Vol. 1-Cont. J. Pharm Sci solid - Wilolud Journals

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Tarun Virmani et al: Continental J. Pharmaceutical Sciences 1: 1 - 8, 2007. Table No. 1 – Formulations of Ketoconazole and their complexes in different ratios S.No. Complex Prepared Ratio used 1 KTZ: PM (Physical Mixture) 1:1 2 KTZ- βCD 1:1 3 KTZ-βCD 1:2 4 KTZ-βCD-HCL 1:2:2 5 KTZ-βCD-CITRIC ACID 1:2:1 Fig. 1. Phase solubility diagrams of ketoconazole and β-cyclodextrin in buffer pH 5 and 6 at 37°C. Phase solubility studies Solubility diagrams were obtained according to Higuchi and Connors (1965) in phosphate buffer solutions of pH 5 and 6. Excess KTZ was added to vials containing various concentrations of β-CD. The vials were shaken in a water bath at 37°C until equilibrium was reached (7 days). The content of each vial was filtered (0.22 pm pore size) and the concentration of KTZ in the filtered solutions was measured by UV spectrophotometry at 225 nm. The apparent stability constant of the KTZ-β-CD complex, assuming 1:1 constant, were calculated from the slope of the initial straight portion of the phase solubility diagrams as KH = slope/S0(1 - slope) 2
Tarun Virmani et al: Continental J. Pharmaceutical Sciences 1: 1 - 8, 2007. Fig. 2. Powder X-ray diffraction patterns of the different KTZ-βCD systems: (a) βCD; (b) KTZ; (c) physical mixture (1:1 ); (d) physical mixture ( 1:2); (e) K TZ-βCD (1 : 1 ) complex; (f) KTZ-βCD (1:2) complex; (g) KTZ-βCD-HCI (1:2:2) complex; (h) KTZ-βCD-Citric acid (1:2:1) complex. where So is the solubility of the pure drug (Higuchi and Connors, 1965). All the data are the average of three determinations. Preparation and characterization of solid inclusion complexes and physical mixtures The solid complexes of KTZ-β-CD (1:1, 1:2, molar ratio) and KTZ-β-CD with hydrochloric or citric acid (1:2:2, 1:2:1, molar ratio) was prepared using the spray-drying method as follows: KTZ and β-CD in adequate molar ratio dissolved in ethanol and water, respectively, were mixed before spray drying. Multicomponent complexes were obtained from an aqueous solution of KTZ, β-CD and hydrochloric or citric acid. Physical mixtures of an appropriate amount of KTZ and β-CD were obtained by pulverizing and thereafter mixing both solids in a mixer (5 min at 30 rpm). Powder X-ray diffraction patterns were carried out with a Philips X-ray diffractometer (PW 1710 BASED) using Cu-K radiation. Thermal analysis was performed using a Shimadzu DSC-50 system with a differential scanning calorimeter equipped with a computerized data station (scanning rate 10°C/min). 3
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