Effect of Food and a Monoglyceride Emulsion Formulation on Danazol Bioavailability

Autor:	Bruce M. Berger, Mark Rogge, Alexander W. Boddy, William N. Charman
Rok vydání:	1993
Předmět:	Adult Pharmacology Danazol Chemistry Pharmaceutical Biological Availability Capsule Capsules Monoglyceride Dosage form Bioavailability chemistry.chemical_compound chemistry Pharmacokinetics Food Oral administration Emulsion medicine Humans Emulsions Female Pharmacology (medical) medicine.drug
Zdroj:	The Journal of Clinical Pharmacology. 33:381-386
ISSN:	0091-2700
DOI:	10.1002/j.1552-4604.1993.tb04673.x
Popis:	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.
Databáze:	OpenAIRE
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