Food effect on the bioavailability of two distinct formulations of megestrol acetate oral suspension

Benoit Deschamps1, Naomi Musaji2, John A Gillespie21SFBC Anapharm, Montreal, Canada; 2Strativa Pharmaceuticals, a division of Par Pharmaceutical, Inc., Woodcliff Lake, NJ, USAObjective: Megestrol acetate oral suspension (MAOS) is an appetite stimulant indicated for cachexia in patients with AIDS. It...

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Autores principales:	Benoit Deschamps, Naomi Musaji, John A Gillespie
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2009
Materias:	Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/55a12c7353fa4b819f4d2f60c166c83d
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spelling	oai:doaj.org-article:55a12c7353fa4b819f4d2f60c166c83d2021-12-02T03:11:38ZFood effect on the bioavailability of two distinct formulations of megestrol acetate oral suspension1176-91141178-2013https://doaj.org/article/55a12c7353fa4b819f4d2f60c166c83d2009-09-01T00:00:00Zhttp://www.dovepress.com/food-effect-on-the-bioavailability-of-two-distinct-formulations-of-meg-a3500https://doaj.org/toc/1176-9114https://doaj.org/toc/1178-2013Benoit Deschamps1, Naomi Musaji2, John A Gillespie21SFBC Anapharm, Montreal, Canada; 2Strativa Pharmaceuticals, a division of Par Pharmaceutical, Inc., Woodcliff Lake, NJ, USAObjective: Megestrol acetate oral suspension (MAOS) is an appetite stimulant indicated for cachexia in patients with AIDS. It is available in its original formulation, Megace&reg; (MAOS), and as a nanocrystal dispersion, Megace&reg; ES (MA-ES). Three studies were conducted to evaluate the pharmacokinetic properties of these formulations under fed and fasting conditions.Methods: An open-label, crossover trial was conducted in 24 healthy males randomized to MA-ES 625 mg/5 mL given with a high-calorie, high-fat meal, or after an overnight fast. Blood samples were drawn at multiple time points and pharmacokinetic parameters were determined. Two separate, open-label reference studies evaluated MAOS 800 mg/20 mL in 40 fed or 40 fasting healthy male volunteers.Results: In fasting MA-ES subjects, the average maximum concentration (Cmax) was 30% less than the fed Cmax value. For MAOS, fasting Cmax was 86% less than fed Cmax. In fasting subjects, the area under the curve was 12,095 ng&sdot;h/mL for MA-ES, and 8,942 ng&sdot;h/mL for MAOS. In fed subjects, the absorption of the two formulations was comparable.Conclusion: Bioavailability and absorption are greater for MA-ES than MAOS in fasting subjects. MA-ES may be a preferred formulation of megestrol acetate when managing cachectic patients whose caloric intake is reduced.Keywords: megestrol acetate, bioavailability, cachexia, nanocrystal technology, appetite stimulant Benoit DeschampsNaomi MusajiJohn A GillespieDove Medical PressarticleMedicine (General)R5-920ENInternational Journal of Nanomedicine, Vol 2009, Iss default, Pp 185-192 (2009)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine (General) R5-920
spellingShingle	Medicine (General) R5-920 Benoit Deschamps Naomi Musaji John A Gillespie Food effect on the bioavailability of two distinct formulations of megestrol acetate oral suspension
description	Benoit Deschamps1, Naomi Musaji2, John A Gillespie21SFBC Anapharm, Montreal, Canada; 2Strativa Pharmaceuticals, a division of Par Pharmaceutical, Inc., Woodcliff Lake, NJ, USAObjective: Megestrol acetate oral suspension (MAOS) is an appetite stimulant indicated for cachexia in patients with AIDS. It is available in its original formulation, Megace&reg; (MAOS), and as a nanocrystal dispersion, Megace&reg; ES (MA-ES). Three studies were conducted to evaluate the pharmacokinetic properties of these formulations under fed and fasting conditions.Methods: An open-label, crossover trial was conducted in 24 healthy males randomized to MA-ES 625 mg/5 mL given with a high-calorie, high-fat meal, or after an overnight fast. Blood samples were drawn at multiple time points and pharmacokinetic parameters were determined. Two separate, open-label reference studies evaluated MAOS 800 mg/20 mL in 40 fed or 40 fasting healthy male volunteers.Results: In fasting MA-ES subjects, the average maximum concentration (Cmax) was 30% less than the fed Cmax value. For MAOS, fasting Cmax was 86% less than fed Cmax. In fasting subjects, the area under the curve was 12,095 ng&sdot;h/mL for MA-ES, and 8,942 ng&sdot;h/mL for MAOS. In fed subjects, the absorption of the two formulations was comparable.Conclusion: Bioavailability and absorption are greater for MA-ES than MAOS in fasting subjects. MA-ES may be a preferred formulation of megestrol acetate when managing cachectic patients whose caloric intake is reduced.Keywords: megestrol acetate, bioavailability, cachexia, nanocrystal technology, appetite stimulant
format	article
author	Benoit Deschamps Naomi Musaji John A Gillespie
author_facet	Benoit Deschamps Naomi Musaji John A Gillespie
author_sort	Benoit Deschamps
title	Food effect on the bioavailability of two distinct formulations of megestrol acetate oral suspension
title_short	Food effect on the bioavailability of two distinct formulations of megestrol acetate oral suspension
title_full	Food effect on the bioavailability of two distinct formulations of megestrol acetate oral suspension
title_fullStr	Food effect on the bioavailability of two distinct formulations of megestrol acetate oral suspension
title_full_unstemmed	Food effect on the bioavailability of two distinct formulations of megestrol acetate oral suspension
title_sort	food effect on the bioavailability of two distinct formulations of megestrol acetate oral suspension
publisher	Dove Medical Press
publishDate	2009
url	https://doaj.org/article/55a12c7353fa4b819f4d2f60c166c83d
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Food effect on the bioavailability of two distinct formulations of megestrol acetate oral suspension

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