TY - JOUR T1 - Influence of β-cyclodextrin Complexation on Glipizide Release from Hydroxypropyl Methylcellulose Matrix Tablets JF - PDA Journal of Pharmaceutical Science and Technology JO - PDA J Pharm Sci Technol SP - 472 LP - 491 VL - 61 IS - 6 AU - H.N. Shivakumar AU - B.G. Desai AU - Saumyak Pandya AU - S.S. Karki Y1 - 2007/11/01 UR - http://journal.pda.org/content/61/6/472.abstract N2 - Glipizide was complexed with β-cyclodextrin in an attempt to enhance the drug solubility. The phase solubility diagram was classified as AL type, which was characterized by an apparent 1:1 stability constant that had a value of 413.82 M-1. Fourier transform infrared spectrophotometry, differential scanning calorimetry, powder x-ray diffractometry and proton nuclear magnetic resonance spectral analysis indicated considerable interaction between the drug and β-cyclodextrin. A 23 factorial design was employed to prepare hydroxypropyl methylcellulose (HPMC) matrix tablets containing the drug or its complex. The effect of the total polymer loads (X1), levels of HPMC K100LV (X2), and complexation (X3) on release at first hour (Y1), 24 h (Y2), time taken for 50% release (Y3), and diffusion exponent (Y4) was systematically analyzed using the F test. Mathematical models containing only the significant terms (P < 0.05) were generated for each parameter by multiple linear regression analysis and analysis of variance. Complexation was found to exert a significant effect on Y1, Y2, and Y3, whereas total polymer loads significantly influenced all the responses. The models generated were validated by developing two new formulations with a combination of factors within the experimental domain. The experimental values of the response parameters were in close agreement with the predicted values, thereby proving the validity of the generated mathematical models. ER -