Enhanced Aqueous Pharmaceutical Formulation of Hydrocortisone Sodium Phosphate and Monothioglycerol
Legal Citation
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.
Section 103 Obviousness Analysis (PHOSITA)
Field of Art
Pharmaceutical formulation chemistry, specifically aqueous injectable steroid preparations with stabilizing agents and precise compositional control
Person of Ordinary Skill (PHOSITA) Profile
A pharmaceutical chemist with expertise in injectable drug formulations, knowledge of steroid stability, experience with pharmaceutical excipients, and understanding of chemical preservation techniques
Obviousness Rationale
A skilled practitioner would recognize that the PTD's variations represent predictable engineering improvements to the source patent's core pharmaceutical formulation. The disclosed modifications such as adding filtration, antioxidants, and pH control are standard optimization techniques in pharmaceutical development. These variations would be considered routine problem-solving within the ordinary skill of a pharmaceutical formulation chemist seeking to enhance drug stability and manufacturing processes.
Obvious Combinations & Variations
Original Patent Information
| Patent Number | US 11,857,555 |
|---|---|
| Title | Aqueous pharmaceutical formulation of hydrocortisone sodium phosphate and monothioglycerol |
| Assignee(s) | Antares Pharma, Inc. |