Enhanced Pharmaceutical Compositions for Improved Stability and Administration
Legal Citation
Summary of the Inventive Concept
This inventive concept discloses improved pharmaceutical compositions comprising an antibody, glycine, acetate buffer, and polysorbate 80, with additional components and modifications to enhance stability, facilitate administration, and expand storage conditions.
Background and Problem Solved
The original patent disclosed pharmaceutical compositions with limited stability and administration flexibility. The present inventive concept addresses these limitations by introducing pH-adjusting agents, stabilizing agents, and viscosity-reducing agents to create more robust and user-friendly formulations.
Detailed Description of the Inventive Concept
The new claims introduce a pH-adjusting agent to maintain a pH range of 4.6 to 5.5 during storage, ensuring the composition remains stable over time. Additionally, a stabilizing agent can be added to enhance long-term stability. The antibody concentration can be increased to at least 200 mg/ml, allowing for more efficient dosing. A system for storing the composition at controlled temperatures is also disclosed. Furthermore, a viscosity-reducing agent can be incorporated to facilitate administration to patients.
Novelty and Inventive Step
The new claims provide a non-obvious improvement over the original patent by introducing specific components and modifications that address the limitations of the original composition. The combination of these elements provides a significant enhancement in stability, administration, and storage flexibility.
Alternative Embodiments and Variations
Alternative embodiments may include varying the pH-adjusting agent, stabilizing agent, or viscosity-reducing agent to optimize the composition for different storage conditions, dosing regimens, or patient populations. The system for storing the composition could also be adapted for use with different container materials or temperature control devices.
Potential Commercial Applications and Market
The enhanced pharmaceutical compositions disclosed in this inventive concept have significant commercial potential in the biopharmaceutical industry, particularly for companies developing antibody-based therapies. The improved stability, administration, and storage flexibility of these compositions can reduce production costs, increase patient convenience, and expand market reach.
CPC Classifications
| Section | Class | Group |
|---|---|---|
| A | A61 | A61K39/39591 |
| A | A61 | A61K47/12 |
| A | A61 | A61K47/183 |
| A | A61 | A61K47/26 |
| C | C07 | C07K16/244 |
| C | C07 | C07K2317/76 |
Section 103 Obviousness Analysis (PHOSITA)
Field of Art
Pharmaceutical biotechnology, specifically antibody formulation and composition design, involving protein stability, buffer systems, and drug delivery technologies
Person of Ordinary Skill (PHOSITA) Profile
A skilled practitioner with advanced degrees in pharmaceutical sciences or biochemical engineering, experienced in protein formulation, familiar with antibody stabilization techniques, and knowledgeable about excipient interactions and pharmaceutical composition optimization
Obviousness Rationale
A person having ordinary skill would recognize that the PTD's modifications represent predictable engineering solutions to known challenges in antibody formulation. The disclosed variations leverage standard pharmaceutical techniques for enhancing protein stability, adjusting composition parameters, and improving administration characteristics. These modifications represent incremental improvements using well-established methodological approaches within the antibody pharmaceutical domain.
Obvious Combinations & Variations
Original Patent Information
| Patent Number | US 11,857,625 |
|---|---|
| Title | Pharmaceutical compositions |
| Assignee(s) | UCB BIOPHARMA SRL |