Enhanced Radiopharmaceutical Composition and Preparation Method

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.

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.

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.

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 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.

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.