Abstract

SYSTEMATIC OPTIMIZATION OF FORMULATION OF INCLUSION COMPLEXES CONTAINING AN ANTI-DIABETIC DRUG

*Nirmala P., Marina Koland and Narendra C.

Abstract

Glipizide (GZ), a BCS class II antidiabetic drug was formulated as inclusion complexes using HPβ-CD by physical mixture and solvent evaporation method. The effects of various excipients PEG 10000, HPβCD, PVP k30 and PEG 6000 on the solubility of Glipizide were investigated. The factorial design of experiment was applied to know the interaction effect of the excipients on the solubility of GZ. FTIR, DSC, H NMR, XRD, drug content and dissolution studies were performed. PEG 6000 was found to enhance the solubility of the drug only by 3.8 folds. The polynomial equation and experimented data concluded that HPβCD alone was sufficient to enhance the solubility of GZ. The formation of an inclusion complex of GZ with HPβCD was confirmed by FTIR, DSC and H NMR studies. The XRD results supported the finding of FTIR spectra and NMR spectras. The complex formed using solvent evaporation technique entrapped 100 percent of the drug within the cavity of the HPβCD carrier molecule. The inclusion complex shows a significant increase in the drug dissolution compared to physical mixture and pure drug. It was concluded that HPβCD is most useful for enhancing the solubility and thus drug release from its inclusion complex.

Keywords: PEG 10000, HP?CD, PVP k30 and PEG 6000.