Jubilant Draximage Inc.

The present invention provides a radioisotope generator system with enhanced safety features and implements such system. In particular, the present invention provides a radioisotope generator system comprising a surface that comprises three ports: an evacuation port, a loading port, and a saline flush port. The saline flush port is permanently connected with the loading port so that the rinsing solution can be placed on the saline port and pass it through the Mo-99 vial to minimize the wastage of the Mo-99. The present invention provides a robust design of the three-port radioisotope generator, which is cost-effective and ensures improved safety from needle contamination.

The embodiments of the present invention disclose a conjugate compound of formula X-J-MAA, wherein X is a diagnostic or therapeutic radioisotope; J is an optional chelating agent; and MAA is macroaggregated albumin particles. The invention also discloses sterile and stable ready to use or reconstituted radiopharmaceutical composition of X-J-MAA and manufacturing process thereof, preferably the invention relates to radiopharmaceutical compositions of 99m Tc. The prepared radiopharmaceutical compositions exhibit desirable technical attributes like stability, radiochemical purity, less impurities, pH, better bio-distribution and desirable average particle size for further administration to patients for therapeutic and diagnostic use.

The present invention relates to a stable pharmaceutical composition of tetrofosmin or pharmaceutically acceptable salts thereof. It also relates to a lyophilized non-radioactive kit which upon reconstitution with 99mTc-pertechnetate solution gives a stable 99mTc-tetrofosmin radiopharmaceutical composition. It also provides process for the preparation of said radiopharmaceutical compositions and their use in diagnostic imaging procedures. The compositions provide desirable technical attributes such as stability, purity, high radiochemical purity (RCP) and desired bio-distribution. The composition comprises less than 1% w/w dioxo tetrofosmin (TFS-2) content and less than 1% w/w mono-oxo tetrofosmin content.

The present invention provides a closed loop generation and/or infusion system comprising a radionuclide generator, an activity detector, a controller, a dose calibrator, a pump, eluant source and an automated elution system controlled by software and hardware for generation and infusion of a radionuclide for administering a dose of generated radionuclide into a subject for diagnosing a peripheral arterial disease in a subject suffering from or suspected of suffering from peripheral arterial disease and/or metabolic disease via Positron Emitting Tomography (PET) or Single-photon emission computed tomography (SPECT) imaging technologies. More particularly, the present invention provides methods of determining whether a subject is suffering or at a risk of developing a peripheral arterial disease by performing quantitative assessment of blood flow in lower extremities or limbs of the subject; wherein the quantitative assessment is performed by analyzing one or more images and providing a severity score; and wherein the analysis of the one or more images is performed by using an automated system.

Embodiments of the present invention provide for assessing the state of an 82 Rb elution system. In certain embodiments, a system begins an assessment that comprises an elution, and a metric may be measured. This metric may be a concentration of 82 Rb, 82 Sr, or 85 Sr in a fluid that is eluted from the generator, the volume of the fluid that is eluted from the generator, or the pressure of the fluid flowing through at least one portion of the system. If the assessment is completed, an output may be generated on a user interface that recommends a course of action, or no course of action, based on a result of the assessment. Should the assessment not complete successfully because it is interrupted, a 82 Sr/ 82 Rb generator of the system may be halted so as to prevent a user from performing an end-run around these quality control mechanisms of the 82 Rb elution system.

The present invention provides a conjugate compound comprising a nanoparticulated enhanced permeability and retention (EPR) agent, which is an albumin, conjugated with one or more chelating agents, one or more target specific ligands and one or more detectable agents and optionally comprising one or more heterobifunctional crosslinkers and one or more pharmaceutically acceptable therapeutic agents. Further, the present invention provides a radiopharmaceutical composition and a kit comprising the said conjugate and also provides application of the same in diagnosis and therapy of various disease like cancer.

The invention discloses to radiopharmaceutical composition of Fluorine-18 (F18) labelled styrylpyridine compounds, preferably F18 Florbetapir, that are free of undesirable nitrosamine drug substance related impurities (NDSRI) and other undesirable nitrosamine impurities. The disclosed radiopharmaceutical composition is used as a medicament for the treatment or diagnosis of a disease or condition associated with build-up of amyloid-β (Aβ) aggregates.

The present invention relates to a medical radioisotope transport system that securely holds the radiopharmaceutical imaging system or medical elution system to the floor of a vehicle and ensures the protection of the elution system during transportation. More particularly, the present invention relates to a mobile adaptation kit, comprising a floor frame assembly installed in a transport vehicle configured to support a mobile medical radioisotope elution system; and a T-bar that slides inside and out of the floor frame assembly, wherein the T-bar comprises a gasket and nylon sheets. The floor frame assembly comprises a floor frame that is installed and remains within the vehicle or van; a floor frame cover; an angled rail; a pivoting piece; a quick-release pin with a high-capacity pin that locks one end of the T-bar in place with the floor frame; and a locking mechanism, in order to safely and securely transport radiopharmaceuticals and medical imaging system, ensuring compliance to the regulatory and quality requirements. The transport system is easy to use and addresses the complexities involved in prior available methods for transportation of radiopharmaceutical imaging systems or medical radioisotope elution systems.

Present invention relates to safety features for radiopharmaceutical dispensing system, wherein dispensing system comprises a controller, a source of radiopharmaceutical and other components. The controller is configured to perform automated quality control of the system to ensure that the system complies quality control before radioactive dose dispensing. The quality control comprises scanning the dispensing system, network or connected devices for an unauthorized connection, malware and ensure that system is free of any such cybersecurity threat before dispensing a radioactive dose.

Embodiments of the present invention provide for assessing the state of an 82 Rb elution system. In certain embodiments, a system begins an assessment that comprises an elution, and a metric may be measured. This metric may be a concentration of 82 Rb, 82 Sr, or 85 Sr in a fluid that is eluted from the generator, the volume of the fluid that is eluted from the generator, or the pressure of the fluid flowing through at least one portion of the system. If the assessment is completed, an output may be generated on a user interface that recommends a course of action, or no course of action, based on a result of the assessment. Should the assessment not complete successfully because it is interrupted, a 82 Sr/ 82 Rb generator of the system may be halted so as to prevent a user from performing an end-run around these quality control mechanisms of the 82 Rb elution system.