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Journal : Jurnal Kefarmasian Indonesia

Uji Klirens dan Uji Pirogenitas sebagai Bagian dari Penentuan Mutu Biologi Sediaan 90Y-EDTMP Sulaiman Sulaiman; Sri Aguswarini; Karyadi Karyadi; Chairuman Chairuman; Gatot Setiawan; Adang HG; M. Subur
Jurnal Kefarmasian Indonesia VOLUME 8, NOMOR 2, AGUSTUS 2018
Publisher : Pusat Penelitian dan Pengembangan Biomedis dan Teknologi Dasar Kesehatan

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.22435/jki.v8i2.352

Abstract

Cancer is one of the causes of death in Indonesia and even the world. Nuclear medicine techniques with radiopharmaceuticals and SPECT are one of the ways to treat cancer, but their use in Indonesia is not yet popular. Radiopharmaceuticals marked with radionuclide emitting beta (β) radiation are proven to be used for cancer therapy, one that has been developed in PTRR-BATAN is 90Y-EDTMP. Yttrium-90 is used in nuclear medicine by utilizing β radiation (E max 2.28 MeV). The β energy which is produced from the decay process of 90Y radionuclides to 90Zr can kill cancer cells. This study aimed to provide information about the substances biological effects so that preventive measures can be taken to protect humans. This study conducted evaluation of the 90Y-marked radiopharmaceutical (90Y produced from a 90Sr / 90Y generator which is 90Y-EDTMP) encompasses clearance test, pyrogen test, and dose safety test in experimental animals. The clearance test utilized mice, the pyrogen test utilized rabbits, and the dose safety test utilized mice. The results of the clearance test showed that 90Y-EDTMP compound which was excreted in 192 hour was 49.70% through urine and 14.59% through feces. The total excretion of 90Y-EDTMP within 192 hours was 64.57%. Based on the results of clearance tests with calculations, 90Y of 90Sr / 90Y generators in 90Y-EDTMP dosage form had 84.2 hours of half-life, 36.5 hours of an effective half-life and 52.7 hours of a residence time. Pyrogen test results showed pyrogen-free. The 90Y-EDTMP dose safety test showed that the dose is safe and not deadly. The development of 90Y-EDTMP is expected to be improved to produce radiopharmaceuticals for cancer therapy in order to make a real contribution in public health services.
Co-Authors Abdullah Abdullah Adang HG Ade Anggraini Fahmal Adnan Adnan Agustianur Agustianur Ahmad Buchori Ahmad Ridha Akbar Akbar Ali Mustofa Alimudin Laapo Amin Purnawan ANGGERAINI OKTARIDA Anggriani Anggriani Anggun Mareta Anis Sholihah Anjar Candrawati Arifuddin Arifuddin Asnawan Asnawan Aufa Miranti Azhari Yahya Azwar Ananda Bainil Yulina Bambang Budi Rahardjo Bambang Firmansyah Bambang Soewito Chairuman Chairuman Cut Adelina Deny Setiawan Devi Mediarti Dewi Agustina ELIHAMI, ELIHAMI Evada Dewata Fasdarsyah Fasdarsyah Fitria Muchnisa Gatot Setiawan Hafidh Maksum, Hafidh Iman S. Suriawinata Indiyah Muwarni ira damayanti JAROT BUDIASTO Jasman J Ma'ruf Jawiah Jawiah Kahfie Nazaruddin Khalisah Khalisah Kiagus Zainal Arifin Kiagus Zainal Arifin M Adli Abdullah M Jafar M Jafar M. Husen M. Misbah M. Subur M. Thoyib M. Yamin M. Yamin M. Yamin M.Hussin Affan Maitsarana Ishmaturadhwa Makka, Zulvia Maryaningsih Maryaningsih Mela Santi Mimik Umi Zuhroh Mislinawati Mislinawati Misri A. Muchsin Mitra Yadiannur Mohd. Din Muammar Yogi Muazzin Muazzin Muhammad Adli Muhammad Idham Mukhlis Mukhlis Nailil Muna Nasir Nasir Nasir Nasri Nelia Hera Putri Nurhizrah Gistituati Nurmasyitah Nurmasyitah Nurrahmah Nurrahmah Nurul Aini Nyak Indra Onan Christanto Sepang Permana Honeyta Lubis Rahmadi Ali Rahmah Rahmah Ramdania Zafitri Reza Zubaedah Rifka Irhamna Riri Maifiani Ronnie Susman Natawidjaja Rosma ely Rosnani Rosnani Rusdinal Rusdinal Rusli Yusuf Sabna Nulanda safrin safrin Salsabila Muharani Putri Sarikadarwati Sarikadarwati Shavreni Oktadi Putri Siti Remeja Soedirman Soedirman Sri Aguswarini Sri Sumartiningsih Suci Fitriani Sudirman Sudirman Suhria Atmana Sunarso Sugeng Suparjono Suparjono Surni Gayo Syarful Rahmawati Syarifah Habibah Tatik Melinda Tallulembang Teuku Muttaqin Mansur Teuku Muttaqin Mansur Titien Agustina Tursinawati Tursinawati Wida Gerhana Yeni Vera Yenny Nadia Yuliantina Aryani Yusniar Yusniar Yuza Defitri Zulkifli Halid