Hydrocortisone oral liquid formulations
Inventors
Radosavljevic, Danka • Brynjelsen, Sean • BHATTACHARYA, Romona • Kathala, Kalyan
Assignees
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Publication Number
US-12133914-B2
Publication Date
2024-11-05
Expiration Date
Abstract
Provided herein are oral liquid formulations of hydrocortisone. Also provided herein are methods of making and using hydrocortisone oral liquid compositions for the treatment of certain diseases including endocrine disorders, rheumatic disorders, collagen diseases, dermatologic diseases, and others.
Core Innovation
The invention relates to a method of treating a disease or condition in a subject in need thereof by administering a liquid pharmaceutical composition. The oral liquid comprises hydrocortisone or a pharmaceutically acceptable salt thereof and a nonaqueous liquid carrier present in an amount of from about 70% weight by weight (% wt) to about 99.9% wt, and the composition contains less than 5% wt of water.
The disease or condition comprises endocrine disorders, including primary or secondary adrenocortical insufficiency, congenital adrenal hyperplasia, non-suppurative thyroiditis, and hypercalcemia associated with cancer. The disclosed formulations emphasize hydrocortisone oral nonaqueous liquid compositions using selected nonaqueous carriers and very low water content.
The disclosed approach is supported by formulation characteristics and stability-related constraints described in the document summary, including storage in unopened and opened containers under refrigerated, room/ambient, and accelerated conditions while maintaining hydrocortisone performance and total impurities at constrained levels. The formulations further include preservative options such as antimicrobials, antioxidants, and chelating agents, along with flavoring and sweetener components to improve palatability.
Claims Coverage
The independent claim covers a treatment method using an oral hydrocortisone liquid in a nonaqueous liquid carrier with less than 5% wt water for endocrine disorders. The claim set includes six inventive features, with dependent refinements adding carrier constituents, administration route limitations, and quantitative hydrocortisone concentration and dosage ranges.
Oral hydrocortisone nonaqueous liquid for endocrine disorders with less than 5% wt water
A method of treating a disease or condition in a subject, comprising administering an oral liquid pharmaceutical composition comprising hydrocortisone or a pharmaceutically acceptable salt and a nonaqueous liquid carrier present at from about 70% wt to about 99.9% wt, where the composition contains less than 5% wt of water, and where the disease or condition comprises endocrine disorders.
Administration by oral and specified enteral tubes
The method includes administering orally or via a nasogastric, jejunostomy, or gastrostomy tube.
Nonaqueous liquid carrier includes selected components
The nonaqueous liquid carrier includes propylene glycol, glycerin, polyethylene glycol (PEG), alcohol, or a combination thereof.
Hydrocortisone concentration about 1 mg/mL
Hydrocortisone or a pharmaceutically acceptable salt is present at about 1 mg/mL in the liquid pharmaceutical composition.
Hydrocortisone dose about 1 mg/m²/day to about 50 mg/m²/day
Administering includes providing a dose of hydrocortisone or a pharmaceutically acceptable salt at about 1 mg/m²/day to about 50 mg/m²/day.
Endocrine disorder scope includes multiple specified conditions
The endocrine disorders comprise primary or secondary adrenocortical insufficiency, congenital adrenal hyperplasia, non-suppurative thyroiditis, or hypercalcemia associated with cancer.
Across the independent and dependent claim coverage, the core inventive concept is an oral hydrocortisone liquid formulation with a nonaqueous liquid carrier and less than 5% wt water for endocrine disorders, further refined by specific carrier constituents, administration routes, and quantitative constraints on hydrocortisone concentration and dosage, and by specifying enumerated endocrine disorder types.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Treating a disease or condition in a subject where the disease or condition comprises endocrine disorders.
Treating primary or secondary adrenocortical insufficiency.
Treating congenital adrenal hyperplasia.
Treating non-suppurative thyroiditis.
Treating cancer-associated hypercalcemia.
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