Enhanced Stability Ready-to-Use Injectables of Melphalan
Legal Citation
Summary of the Inventive Concept
A novel approach to stabilize melphalan formulations, providing improved stability, safety, and efficiency in ready-to-use injectables for cancer treatment.
Background and Problem Solved
The original patent, 'Ready to use injectable formulations of melphalan and processes for preparation thereof', provides a foundation for stable melphalan formulations. However, the existing formulation still faces limitations in terms of degradation and stability. The new inventive concept addresses these limitations by introducing pH-adjusting agents, optimized solvent systems, and antimicrobial preservatives to enhance stability and shelf life.
Detailed Description of the Inventive Concept
The new inventive concept comprises a system for stabilizing melphalan formulations, a method for preparing ready-to-use injectable formulations, a melphalan formulation kit, and a process for preparing stable ready-to-use injectable formulations. These innovations involve the use of pH-adjusting agents to maintain a pH range of 5.0 to 7.0, solvent systems comprising polyethylene glycol, ethanol, and water, and preservatives such as benzyl alcohol and phenol. These components work synergistically to reduce degradation, enhance stability, and provide antimicrobial properties.
Novelty and Inventive Step
The new claims introduce novel pH-adjusting agents, optimized solvent systems, and antimicrobial preservatives, which are not present in the original patent. These innovations provide an inventive step over the existing formulation, enabling improved stability, safety, and efficiency in ready-to-use injectables.
Alternative Embodiments and Variations
Alternative embodiments may include using different pH-adjusting agents, solvent systems, or preservatives. Variations of the melphalan formulation kit could include different packaging configurations or reconstitution methods. Additionally, the inventive concept could be adapted for use with other pharmaceutical compounds or in different therapeutic areas.
Potential Commercial Applications and Market
The enhanced stability ready-to-use injectables of melphalan have significant commercial potential in the cancer treatment market. The improved stability and shelf life of these formulations can reduce costs associated with formulation preparation, storage, and transportation, while also enhancing patient safety and convenience. The target industries include pharmaceutical companies, hospitals, and cancer treatment centers.
CPC Classifications
| Section | Class | Group |
|---|---|---|
| A | A61 | A61K9/08 |
| A | A61 | A61K9/0019 |
| A | A61 | A61K31/198 |
| A | A61 | A61K47/10 |
| A | A61 | A61K47/183 |
| A | A61 | A61K47/32 |
Section 103 Obviousness Analysis (PHOSITA)
Field of Art
Pharmaceutical formulation chemistry, specifically injectable drug preparation with a focus on stability, solvent systems, and preservation techniques for chemotherapeutic agents
Person of Ordinary Skill (PHOSITA) Profile
A pharmaceutical formulation chemist with advanced degree, expertise in injectable drug preparation, knowledge of stability optimization techniques, and understanding of solvent interactions and preservation methods for sensitive pharmaceutical compounds
Obviousness Rationale
A person having ordinary skill would recognize that the PTD's variations represent predictable modifications to the existing melphalan formulation methodology. The proposed changes in pH adjustment, solvent composition, and preservative selection are logical extensions of known pharmaceutical formulation strategies. These modifications would be considered routine optimization within the standard problem-solving approach of pharmaceutical development.
Obvious Combinations & Variations
Original Patent Information
| Patent Number | US 11,857,677 |
|---|---|
| Title | Ready to use injectable formulations of melphalan and processes for preparation thereof |
| Assignee(s) | RK PHARMA INC. |