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AssigneeNorton Healthcare Limited
InventorsAdrian Ashley, Paul Lamb, Donald MacDonald, John Miller, Martin J. Oliver, Mathew Pollard
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The present invention provides a method for the sterilization of a labile glucocorticosteroid, which method comprises heat-treating by moist heat the labile glucocorticosteroid in the form of a suspension for a sterilizing-effective time. The methods and compositions according to the invention are useful as therapeutic tools to prevent, reverse, and/or reduce the symptoms of allergic and/or inflammatory conditions in a mammalian patient. The invention also provides methods and compositions, which may be manipulated and fine-tuned to fit the condition(s) to be treated while producing fewer side effects.
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A sterile aqueous suspension comprising a glucocorticosteroid obtained by a method comprising a step of applying moist heat to an aqueous suspension of a glucocorticosteroid for a sterilizing-effective time, wherein at least 70% of the glucocorticosteroid is in the form of a suspension during heating and at least one surfactant is present in the aqueous suspension during heating, wherein the particle size of the glucocorticosteroid in the sterile aqueous suspension is such that the Dv100 is less than 20 μm, the Dv90 is less than 10 μm and the Dv50 is less than 5 μm.
A sterile aqueous budesonide suspension obtained by a method comprising a step of heating an aqueous suspension of budesonide at a concentration of from about 15 mg/ml to about 150 mg/ml at a temperature of from about 101° C. to about 145° C. for about 2 to about 180 minutes, wherein at least 70% of the budesonide is in the form of a suspension during heating and at least one surfactant is present in the aqueous suspension during heating.
A suspension of a labile glucocorticosteroid in a solvent, wherein an amount of the labile glucocorticosteroid per unit of solvent is present such that at least 50% of the labile glucocorticosteroid is suspended in the solvent.
Dependencies are inferred from the claim text.