Effect of Food and a Monoglyceride Emulsion Formulation on Danazol Bioavailability
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A lipid emulsion formulation of danazol increased bioavailability fourfold in fasted subjects, while food increased bioavailability threefold for the capsule formulation.
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Abstract
The bioavailability of a single 100-mg dose of danazol delivered from the commercial formulation (hard gelatin capsule) and from an experimental lipid emulsion formulation of danazol was studied in 11 healthy female volunteers in both fed and fasted states. The emulsion formulation (fasted) increased bioavailability fourfold compared with the capsule (P = .0001); the difference, however, was not significant in the fed state. Food increased the bioavailability of the capsule formulation more than threefold over fasted administration (P = .0001). In a separate study of 12 female volunteers, single doses of the emulsion formulation of danazol administered with food demonstrated essentially dose-proportional pharmacokinetics over the dose range studied (50-200 mg). The authors conclude that factors that increase the extent of solubilization lead to significant enhancement in the bioavailability of danazol.
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Cited by (11)
- Danazol 2022
- Non-linear Increases in Danazol Exposure with Dose in Older vs. Younger Beagle Dogs: The Potential Role of Differences in Bile Salt Concentration, Thermodynamic Activity, and Formulation Digestion 2014
- Ionic liquids provide unique opportunities for oral drug delivery: structure optimization and in vivo evidence of utility 2013
- Luminal Lipid Phases after Administration of a Triglyceride Solution of Danazol in the Fed State and Their Contribution to the Flux of Danazol Across Caco-2 Cell Monolayers 2012
- Traitements des localisations urologiques de l'endométriose 2009
- Improved understanding of the effect of food on drug absorption and bioavailability for lipophilic compounds using an intestinal pig perfusion model 2008
- Lipid-based Formulations for Danazol Containing a Digestible Surfactant, Labrafil M2125CS: In Vivo Bioavailability and Dynamic In Vitro Lipolysis 2008
- Effect of liquid volume and food intake on the absolute bioavailability of danazol, a poorly soluble drug 2005
- In vivo in vitro correlations for a poorly soluble drug, danazol, using the flow-through dissolution method with biorelevant dissolution media 2005
- A Study of the Complexation Between Danazol and Hydrophilic Cyclodextrin Derivatives 1996
- Absorption of Danazol After Administration to Different Sites of the Gastrointestinal Tract and the Relationship to Single‐ and Double‐Peak Phenomena in the Plasma Profiles 1993
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