Sterilization of corticosteroids with reduced mass loss
AssigneeVerus Pharmaceuticals, Inc.
InventorsMalcolm Hill, Cynthia LiCalsi
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Abstract
Novel methods of sterilizing corticosteroid solutions resulting in improved final yield of active corticosteroid ingredient.
Claims73
A process of making a sterilized solution of corticosteroid, comprising filtering a compounded corticosteroid solution through a filter to produce the sterilized corticosteroid solution, wherein the mass loss between the starting corticosteroid solution and the sterilized corticosteroid solution is less than about 30%.
A method of reducing the mass loss of corticosteroid in a sterilization process, comprising filtering a starting corticosteroid solution through a filter to produce a sterilized corticosteroid solution, wherein a mass loss of corticosteroid of less than about 30% is achieved.
A process of making a sterilized solution of corticosteroid, comprising filtering a compounded corticosteroid solution comprising a starting mass of corticosteroid through a filter to produce the sterilized corticosteroid solution, whereby the concentration of the sterilized corticosteroid solution is at least about least about 95%, at least about 96%, at least about 97%, at least about 97.5%, at least about 97.7%, at least about 97.9%, e.g. about 98.2±0.5% or more of the concentration of corticosteroid in the compounded corticosteroid solution.
A method of reducing the loss in concentration of corticosteroid in a sterilization process, comprising filtering a compounded corticosteroid solution comprising a starting mass of corticosteroid through a filter to produce a filtered corticosteroid solution, wherein the filtered corticosteroid solution has a concentration that is at least about 90.0% of the theoretical concentration based on the starting mass of the corticosteroid.
A process of making a sterilized solution of corticosteroid, comprising subjecting a compounded corticosteroid solution to conditions wherein the mass loss between the starting corticosteroid solution and the sterilized corticosteroid solution is less than about 30%, less than about 25%, less than about 20%, less than about 15%, less than about 10%, less than about 5%, less than about 3%, less than about 2% or about 1% or less.
A method of reducing the nass loss of corticosteroid in a sterilization process, comprising subjecting a compounded corticosteroid solution to conditions wherein a mass loss of corticosteroid of less than about 30%, less than about 25%, less than about 20%, less than about 15%, less than about 10%, less than about 5%, less than about 3%, less than about 2% or about 1% or less is achieved.
A process of making a sterilized solution of corticosteroid, comprising subjecting a compounded corticosteroid solution to conditions wherein the concentration of the sterilized corticosteroid solution is at least about 95%, at least about 96%, at least about 97%, at least about 97.5%, at least about 97.7%, at least about 97.9%, e.g. about 98.2±0.5% or more or more of the theoretical concentration based upon the starting mass of corticosteroid.
A method of reducing the loss in concentration of corticosteroid in a sterilization process, comprising subjecting a compounded corticosteroid solution to conditions wherein the concentration of the corticosteroid in the corticosteroid solution has a concentration that is at least about 95%, at least about 96%, at least about 97%, at least about 97.5%, at least about 97.7%, at least about 97.9%, e.g. about 98.2±0.5% or more or more of the theoretical concentration based upon based on the starting mass of the corticosteroid.
Dependencies are inferred from the claim text.