Compositions for delivery of a cortisol antagonist
OwnerPer Marin, Tomas Landh +1inventors
InventorsPer Marin, Tomas Landh, Ivan Ostholm
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Abstract
The present invention relates to compositions for controlled release of a cortisol antagonist comprising at least one release rate controlling substance together with said cortisol antagonist and methods of preventing or treating metabolic syndrome, diabetes mellitis type II or symptoms or complications thereof in a mammal, which method comprises administering such a composition to said mammal in an amount effective to treat one or more of the clinical manifestations of metabolic syndrome or diabetes mellitis type II as well as complications thereof.
Claims35
A composition for controlled release of a cortisol antagonist comprising at least one release rate controlling substance together with said cortisol antagonist.
A composition as claimed in any preceding claim wherein the cortisol antagonist is ketoconazole.
A composition as claimed in any preceding claim which provides an in vitro release of cortisol antagonist which is sustained for at least 2 hours.
A composition as claimed in any preceding claim which provides an in vivo uptake of cortisol antagonist which is sustained for at least 2 hours.
A composition as claimed in any preceding claim wherein circulating plasma levels of cortisol antagonist do not reach pharmaceutically effective levels until more than 30 mins after administration of said composition to a patient.
A composition as claimed in any preceding claim wherein at least one of the release rate controlling substances is a solid, semi-solid, amorphous, liquid crystalline or liquid matrix, preferably a solid or semi-solid matrix, in which the cortisol antagonist is dispersed.
A composition as claimed in any preceding claim wherein at least one of the release rate controlling substances is a lipid.
A composition as claimed in any preceding claim wherein the release rate controlling substances is a fatty acid ester wherein the fatty acid component is a saturated or unsaturated fatty acid having between 6 and 26 carbon atoms.
A composition as claimed in any preceding claim wherein at least one of the release rate controlling substances is a mono- or di-glyceride.
A composition as claimed in any preceding claim wherein at least one of the release rate controlling substances is a polymer.
A composition as claimed in any preceding claim which is adapted for oral administration to a mammal, particularly a human.
A composition as claimed in any preceding claim which retains a substantially unitary form on administration and throughout the controlled release of the cortisol antagonist.
A method of making a composition for controlled release of a cortisol antagonist, which method comprises mixing said cortisol antagonist with at least one release rate controlling substance.
The use of a cortisol antagonist and a release rate controlling substance in the manufacture of a medicament allowing controlled release of said cortisol antagonist for the treatment of metabolic syndrome or diabetes mellitis type II.
Dependencies are inferred from the claim text.