Prototipe Kit Radiofarmaka EDTMP

Summary

This video outlines the development of the EDTMP radiopharmaceutical kit, a breakthrough product aimed at diagnosing and treating bone cancer. The research began in 2019, progressing through phases like formulation, quality testing, and preclinical trials. Unlike previous products, the EDTMP kit can be produced in advance and marked with isotopes in hospitals, overcoming limitations related to half-life and transportation. The speaker emphasizes the product's potential to reduce dependence on imports and improve the nation's healthcare independence, offering significant benefits for cancer patients across Indonesia.

Takeaways

• 😀 The EDTMP radiopharmaceutical kit was developed to combat cancer, specifically bone cancer, by using radiolabeled isotopes for diagnostic and therapeutic purposes.
• 😀 The research and development process for the EDTMP kit began in 2019 with initial stages focusing on characterization, formulation, and testing.
• 😀 The EDTMP kit is manufactured under strict sanitary conditions in a clean room, with a process involving sterilization, formulation, pH measurement, and freeze-drying to produce a dry kit.
• 😀 After preparation, the EDTMP kit undergoes several quality tests, including visual, sterility, pyrogenicity, and radiochemistry tests to ensure effectiveness and safety.
• 😀 When combined with isotopes like technetium-99m, the EDTMP kit is used for diagnosing metastatic bone cancer. With other isotopes like samarium-153 and lutetium-177, it becomes a therapeutic tool for bone cancer.
• 😀 Currently, the EDTMP kit is undergoing preclinical and clinical testing, and is not yet available for widespread distribution.
• 😀 The motivation behind the development of the EDTMP kit is to address issues related to the short half-life of isotopes and the logistical challenges of transporting radiopharmaceuticals to distant hospitals.
• 😀 The EDTMP kit offers flexibility by being able to be labeled with isotopes at the point of use in hospitals, ensuring its efficacy in remote areas.
• 😀 The ultimate goal is to create a breakthrough product that reduces dependence on imported radiopharmaceuticals, increasing the nation’s self-sufficiency in medical technology.
• 😀 The development of the EDTMP kit is a collaborative effort involving doctors, pharmaceutical companies, and regulators, with a focus on meeting clinical standards and ensuring accessibility to hospitals across Indonesia.
• 😀 Once the product passes production validation and clinical trials, it will be available for broader distribution, benefiting patients in various regions and reducing reliance on imports.

Q & A

What is the purpose of the EDTMP kit mentioned in the script?

The EDTMP kit is developed to fight cancer, specifically bone cancer, by detecting metastatic cancer and providing therapy for bone cancer using radioisotope solutions like technetium 99m, samarium 153, and lutetium 177.

When did the development of the EDTMP kit begin?

The development of the EDTMP kit started in 2019, beginning with the characterization of the kit, followed by formulation and testing.

What are the main stages in the development of the EDTMP kit?

The main stages include characterization, formulation, sterilization, pH measurement, filtration, freeze drying, labeling, and quality testing.

What are the key quality tests performed on the EDTMP kit?

The quality tests include visual inspection, sterility test, pyrogenicity test, and radiochemical testing to ensure the kit is clear, free from pathogens, and meets the required radiochemistry standards (above 95%).

How does the EDTMP kit help diagnose cancer?

The EDTMP kit, when mixed with a radioisotope like technetium 99m, can be used as a diagnostic agent to detect the presence of bone cancer by identifying metastatic cancer cells in the bones.

What makes the EDTMP kit different from previous radiopharmaceutical products?

The EDTMP kit is a breakthrough because it can be prepared on-site in hospitals by adding radioisotopes, whereas previous products were combined and labeled in a central location, limiting transportation due to short half-lives of isotopes.

What are the benefits of the EDTMP kit being produced in a dry form?

The dry form of the EDTMP kit allows for easier transportation and on-site formulation at hospitals, ensuring that it can be used even in distant areas without the need for direct distribution from the production site.

What is the current stage of the EDTMP kit's development?

Currently, the EDTMP kit is undergoing preclinical testing, including biodistribution tests and in vitro testing against cancer cells. It is also being tested for toxicity before moving to clinical trials.

Why is there a need for the EDTMP kit in Indonesia?

There is a need for the EDTMP kit in Indonesia because it will help reduce the country's reliance on imported radiopharmaceuticals and increase national independence in the development of cancer diagnostic and therapeutic tools.

What is the next step after preclinical testing for the EDTMP kit?

After preclinical testing, the next step will be clinical trials, followed by regulatory approval and registration with the POM Agency, after which private parties can develop and distribute the product in hospitals.