Stable corticosteroid mixtures
AssigneeVerus Pharmaceuticals, Inc.
InventorsMalcolm Hill, Cynthia LiCalsi
Life of this patent
Estimating the term…
Abstract
A corticosteroid mixture, such as a budesonide solution, is prepared by the active and inactive ingredients of the mixture under oxygen-depleted conditions. The resulting mixture demonstrates superior stability of the active pharmaceutical ingredient corticosteroid. The invention provides novel methods of manufacturing corticosteroid mixtures, wherein the resulting mixtures possess superior stability as compared to known methods.
Claims70
A process of preparing a corticosteroid mixture, comprising mixing ingredients of the corticosteroid mixture in a mixing vessel under oxygen-depleted conditions to produce the corticosteroid mixture, wherein the ingredients include as starting materials corticosteroid and water.
A corticosteroid mixture which loses no more than about 2% of corticosteroid potency after exposing the corticosteroid mixture to accelerated conditions of 40° C. and 75% relative humidity for a stability testing period of at least about 3 months.
A corticosteroid mixture which contains no more than 1.0% of impurities after exposing the corticosteroid mixture to accelerated conditions of 40° C. and 75% relative humidity for a stability testing period of at least about 3 months.
Dependencies are inferred from the claim text.