Enhanced Radiopharmaceutical Composition and Preparation Method
Legal Citation
Summary of the Inventive Concept
The present invention relates to an improved radiopharmaceutical composition of tetrofosmin or its pharmaceutically acceptable salts, exhibiting enhanced stability and shelf-life, and a novel method for its preparation, addressing the limitations of the existing patent.
Background and Problem Solved
The original patent disclosed a radiopharmaceutical composition of tetrofosmin, but it had limitations in terms of stability and shelf-life. The new inventive concept addresses these limitations by introducing improvements in the composition and preparation method, thereby providing a more efficient and reliable radiopharmaceutical product.
Detailed Description of the Inventive Concept
The enhanced radiopharmaceutical composition comprises tetrofosmin or its pharmaceutically acceptable salts, formulated with a pH adjusting agent to maintain a pH range of 5.5 to 7.5, thereby improving the radiolabeling efficiency. The composition exhibits improved stability and shelf-life when stored at a temperature range of -20°C to 4°C for at least 12 months. The novel method for preparing a lyophilized kit for radiopharmaceutical composition involves the use of a biocompatible reductant, selected from a group consisting of ascorbic acid, sodium metabisulfite, and glutathione. The system for radiopharmaceutical composition preparation is designed for single-use and is sterile, comprising a container for storing the lyophilized kit, a 99mTc-pertechnetate solution, and a reconstitution device.
Novelty and Inventive Step
The new inventive concept introduces several novel features, including the use of a pH adjusting agent, the selection of a biocompatible reductant, and the design of a single-use, sterile system for radiopharmaceutical composition preparation. These features are not obvious from the original patent and provide a significant improvement over the existing technology.
Alternative Embodiments and Variations
Alternative embodiments of the inventive concept may include the use of different pH adjusting agents, reductants, or container materials. Variations of the system for radiopharmaceutical composition preparation may include different reconstitution devices or methods for storing the lyophilized kit.
Potential Commercial Applications and Market
The enhanced radiopharmaceutical composition and preparation method have significant commercial potential in the field of nuclear medicine, particularly in diagnostic imaging and therapy. The target industries include pharmaceutical companies, hospitals, and research institutions.
CPC Classifications
| Section | Class | Group |
|---|---|---|
| A | A61 | A61K51/0478 |
| A | A61 | A61K9/19 |
| A | A61 | A61K31/66 |
| A | A61 | A61K51/025 |
Section 103 Obviousness Analysis (PHOSITA)
Field of Art
Radiopharmaceutical composition design and preparation, specifically involving technetium-99m (99mTc) radiolabeling techniques, with expertise in pharmaceutical formulation, stability optimization, and diagnostic imaging agent development
Person of Ordinary Skill (PHOSITA) Profile
A professional with advanced degrees in pharmacy, radiopharmaceutical sciences, or chemical engineering, possessing knowledge of radioisotope chemistry, pharmaceutical formulation techniques, and diagnostic imaging technologies
Obviousness Rationale
A person having ordinary skill would recognize that the PTD's variations represent predictable extensions of the source patent's core radiopharmaceutical composition technology. The disclosed modifications involving pH adjustment, temperature range optimization, and alternative reductant selection represent standard engineering approaches to improving pharmaceutical stability and radiolabeling efficiency. These variations would be considered routine optimization techniques within the established technological framework of the original patent.
Obvious Combinations & Variations
Original Patent Information
| Patent Number | US 11,857,647 |
|---|---|
| Title | Pharmaceutical composition comprising tetrofosmin and pharmaceutically acceptable salts thereof |
| Assignee(s) | Jubilant Draximage Inc. |