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Abstract
Griseofulvin is a poorly soluble antifungal antibiotic drug, the solubility of which can be enhanced by complexation with β-cyclodextrin. The inclusion complex was prepared by coprecipitation method in various molar ratios of 1:1, 2:1, 3:1, and 1:2 of the drug and β-cyclodextrin, respectively. The inclusion complex was characterized and evaluated by UV-VIS spectral studies and FT1R. The in vitro drug release studies indicated that the 1:2 molar ratio complex form of the drug significantly increased the dissolution rate when compared to the free form. The acute toxicity studies clearly indicated that the β-cyclodextrin complex was nontoxic and the safety range was close to other Griseofulvin formulations. The in vivo study of the β-cyclodextrin was carried out in both animals and human beings by administering in four different rabbits and volunteers, respectively. Pellets made with Griseofulvin-β-cyclodextrin complex also showed a significant increase in the dissolution of the drug, revealing that β-cyclodextrin plays an important role in the solubilization of Griseofulvin.