Enhanced Aqueous Pharmaceutical Formulation of Hydrocortisone Sodium Phosphate and Monothioglycerol

Publication ID: 24-11857555_0006_PTD
Published: October 28, 2025
Category:Direct Improvements & Enhancements

Legal Citation

pr1or.art Inc., “Enhanced Aqueous Pharmaceutical Formulation of Hydrocortisone Sodium Phosphate and Monothioglycerol,” Published Technical Disclosure No. 24-11857555_0006_PTD, Published October 28, 2025, available at https://archive.pr1or.art/24-11857555_0006_PTD
This technical disclosure describes improvements that would be readily apparent to a Person Having Ordinary Skill In The Art (PHOSITA) when considered in combination with the foundational architecture disclosed in U.S. Patent No. 11,857,555.

Summary of the Inventive Concept

The inventive concept discloses improvements and enhancements to the original aqueous pharmaceutical formulation of hydrocortisone sodium phosphate and monothioglycerol, focusing on increased stability, efficiency, and safety.

Background and Problem Solved

The original patent disclosed an aqueous pharmaceutical formulation of hydrocortisone sodium phosphate and monothioglycerol. However, the formulation had limitations, such as potential degradation of hydrocortisone sodium phosphate, impurities, and pH instability. The new inventive concept addresses these limitations by introducing a system for preparing the formulation, enhancing stability, and providing a pharmaceutical kit and administration system.

Detailed Description of the Inventive Concept

The inventive concept comprises a system for preparing the aqueous pharmaceutical formulation, which includes a mixing unit for combining hydrocortisone sodium phosphate and monothioglycerol in a predetermined ratio, and a filtration unit for removing impurities from the resulting formulation. Additionally, the inventive concept includes a method for enhancing the stability of the formulation by adding an antioxidant to prevent degradation of hydrocortisone sodium phosphate. A pharmaceutical kit is also provided, comprising vials containing hydrocortisone sodium phosphate and monothioglycerol, along with instructions for combining the contents in a predetermined ratio. Furthermore, the inventive concept includes an aqueous pharmaceutical formulation with a pH-adjusting agent to maintain the pH within a range of 5.5 to 6.5. Finally, a system for administering the formulation to a patient at a controlled rate is disclosed.

Novelty and Inventive Step

The new claims introduce novel and non-obvious improvements to the original patent, including the preparation system, stability enhancement method, pharmaceutical kit, and administration system. These innovations provide a significant advancement in the field of aqueous pharmaceutical formulations.

Alternative Embodiments and Variations

Alternative embodiments of the inventive concept may include different mixing ratios, alternative antioxidants, or varying pH-adjusting agents. Additionally, the pharmaceutical kit could be modified to include additional components or instructions for specific patient populations.

Potential Commercial Applications and Market

The enhanced aqueous pharmaceutical formulation of hydrocortisone sodium phosphate and monothioglycerol has significant commercial potential in the pharmaceutical industry, particularly in the treatment of allergic reactions, inflammatory skin conditions, and immunosuppressive therapy. The target market includes pharmaceutical companies, hospitals, and healthcare providers.

Original Patent Information

Patent NumberUS 11,857,555
TitleAqueous pharmaceutical formulation of hydrocortisone sodium phosphate and monothioglycerol
Assignee(s)Antares Pharma, Inc.