{"paper_id":"85ea0065-3494-4dd8-9055-5dae1541d210","body_text":"Abstract\nThis study explored the potential of β-cyclodextrin to improve the aqueous solubility and dissolution of danazol, investigated a simple and less expensive method for preparation of a danazol-β-cyclodextrin binary system, and explored the potential application of a danazol-β-cyclodextrin binary system as a single-dose emergency contraceptive. Phase solubility analysis indicated formation of a first-order soluble complex with stability constant 972.03 M−1, while Job's plot affirmed 1∶1 stoichiometry. The hyperchromic shift in the UV-Vis spectrum of danazol in the presence of β-cyclodextrin indicated solubilization capability of β-cyclodextrin for danazol. The extrinsic Cotton effect with a negative peak at 280.7 nm confirmed the inclusion of danazol in the asymmetric locus of β-cyclodextrin.1H-nuclear magnetic resonance analysis suggested that the protons of the steroidal skeleton of danazol display favorable interactions with the β-cyclodextrin cavity. The danazol-β-cyclodextrin binary system was prepared by kneading, solution, freeze-drying, and milling methods. The extent of the enhancement of dissolution rate was found to be dependent on the preparation method. Dissolution studies showed a similar relative dissolution rate (2.85) of the danazol-β-cyclodextrin binary system prepared by the freeze-drying and milling (in the presence of 13% moisture) methods. In a mouse model, the danazol-β-cyclodextrin binary system at 51.2 mg/kg (equivalent to a 400-mg human dose) showed 100% inhibition of implantation when given postcoitally. 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London: Pharmaceutical Press and Washington, DC: American Pharmaceutical Association; 2000: 165–168.\nAuthor information\nAuthors and Affiliations\nCorresponding author\nAdditional information\nPublished: May 11, 2007\nRights and permissions\nAbout this article\nCite this article\nJadhav, G.S., Vavia, P.R. & Nandedkar, T.D. Danazol-β-cyclodextrin binary system: A potential application in emergency contraception by the oral route. AAPS PharmSciTech 8, 35 (2007). https://doi.org/10.1208/pt0802035\nReceived:\nAccepted:\nDOI: https://doi.org/10.1208/pt0802035","source_license":"CC0","license_restricted":false}