Maula Eka Sriyani
National Nuclear Energy Agency

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BIOLOGICAL SAFETY EVALUATION OF 99mTc-DTPA-KETOCONAZOLE FOR DIAGNOSIS OF FUNGAL INFECTION Maula Eka Sriyani; Hendris Wongso; Eva Maria Widyasari; Rizky Juwita Sugiharti; Iim Halimah; Iswahyudi Iswahyudi; Ahmad Sidik; Epy Isabela; Witri Nuraeni
Indonesian Journal of Physics and Nuclear Applications Vol 1 No 3 (2016)
Publisher : Fakultas Sains dan Matematika Universitas Kristen Satya Wacana

Show Abstract | Download Original | Original Source | Check in Google Scholar | Full PDF (786.579 KB) | DOI: 10.24246/ijpna.v1i3.138-144

Abstract

Infectious diseases have become one of the leading cause of mortality around the world, including in the Southeast Asia. One of the microbial that cause infection is fungi. Occasionally, deep-seated fungal infection is difficult to detect using conventional diagnosis methods and therefore leads to inaccurate detection. Our previous research was conducted in order to obtain the labeled compound of 99mTc-DTPA-Ketoconazole with a high radiochemical purity (98.40 ± 0.86%). Moreover, the in-vitro assays showed that 99mTc-DTPA-Ketoconazole can potentially bind to Candida albicans. On the other hand, in clinical routine use, diagnostic kit should be safe for the patients. Consequently, this research was conducted to determine the biological safety parameters of 99mTc-DTPA-Ketoconazole on the animal study, including single dose and acute toxicity test, sterility, and apirogenicity test. The results showed that both the single dose at 34.6 μCi and dose until 149 times of the single dose did not stimulate the toxic response to the animals. In addition, the sterility data revealed that there was no microbial growth after 7 days of incubation at 37°C as well as fungal growth after 14 days of incubation at 25°C. Furthermore, the apirogenicity test using rabbits revealed that there was no increase in temperature more than 0.6°C for each animal and not more than 1.5°C of total increase of temperature for all the animals. It is concluded that the 99mTc-DTPA-Ketoconazole is satisfy the requirements of biological safety of a radiopharmaceutical and therefore was acceptable for fungal detection in nuclear medicine.
Biological Safety Evaluation of 99mTc-DTPA-Ketoconazole for Diagnosis of Fungal Infection Maula Eka Sriyani; Hendris Wongso; Eva Maria Widyasari; Rizky Juwita Sugiharti; Iim Halimah; Iswahyudi Iswahyudi; Ahmad Sidik; Epy Isabela; Witri Nuraeni
Indonesian Journal of Physics and Nuclear Applications Vol 2 No 1 (2017)
Publisher : Fakultas Sains dan Matematika Universitas Kristen Satya Wacana

Show Abstract | Download Original | Original Source | Check in Google Scholar | Full PDF (363.153 KB) | DOI: 10.24246/ijpna.v2i1.1-8

Abstract

Infectious diseases have become one of the leading cause of mortality around the world, including in the Southeast Asia. One of the microbial that cause infection is fungi. Occasionally, deep-seated fungal infection is difficult to detect using conventional diagnosis methods and therefore leads to inaccurate detection. Our previous research was conducted in order to obtain the labeled compound of 99mTc-DTPA-Ketoconazole with a high radiochemical purity (98.40 ± 0.86%). Moreover, the in-vitro assays showed that 99mTc-DTPA-Ketoconazole can potentially bind to Candida albicans. On the other hand, in clinical routine use, diagnostic kit should be safe for the patients. Consequently, this research was conducted to determine the biological safety parameters of 99mTc-DTPA-Ketoconazole on the animal study, including single dose and acute toxicity test, sterility, and apirogenicity test. The results showed that both the single dose at 34.6 μCi and dose until 149 times of the single dose did not stimulate the toxic response to the animals. In addition, the sterility data revealed that there was no microbial growth after 7 days of incubation at 37°C as well as fungal growth after 14 days of incubation at 25°C. Furthermore, the apirogenicity test using rabbits revealed that there was no increase in temperature more than 0.6°C for each animal and not more than 1.5°C of total increase of temperature for all the animals. It is concluded that the 99mTc-DTPA-Ketoconazole is satisfy the requirements of biological safety of a radiopharmaceutical and therefore was acceptable for fungal detection in nuclear medicine.
Biological Evaluation of 99mTc-Kanamycin for Infection Imaging Eva Maria Widyasari; Iim Halimah; Rizky Juwita Sugiharti; Maula Eka Sriyani; Isti Daruwati; Iswahyudi Iswahyudi; Epy Isabela; Witri Nuraeni
Indonesian Journal of Physics and Nuclear Applications Vol 2 No 1 (2017)
Publisher : Fakultas Sains dan Matematika Universitas Kristen Satya Wacana

Show Abstract | Download Original | Original Source | Check in Google Scholar | Full PDF (381.372 KB) | DOI: 10.24246/ijpna.v2i1.34-41

Abstract

Kanamycin antibiotic was radiolabeled successfully with radioisotope technetium-99m for the potential use as radiopharmaceuticals for infection imaging. 99mTc-kanamycin complexes was prepared 93 % radiochemical purities by direct labelling using 5 mg kanamycin and 30 µg SnCl2. The reaction occurred at alkaline condition (pH=9) and under room temperature for 30 min to achieve high radiochemical purity. Radiochemical purity and stability of 99mTc-kanamycin was determined by ascending paper chromatography using Whatman 3 paper as the stationary phase, and acetone as the mobile phase to separate the radiochemical impurities in the form of 99mTc-pertechnetate. While impurities in the form of 99mTc-reduced were separated using the stationary phase ITLC-SG and 0.5 N NaOH as mobile phase. This study aimed to determine biological characteristic of 99mTc-kanamycin radiopharmaceutical. In vitro cell studies showed that the change of kanamycin structure after labeling with technetium-99m did not give a specific influence to the potency of kanamycin as an antibiotic. In addition on uptake study, a significantly higher uptake of 99mTc-kanamycin with S. aureus than E. coli. Biodistribution of 99mTc-kanamycin complexes was studied on normal and infection mice at 15, 30, 60 and 120 min post-injections. The biodistribution of 99mTc-kanamycin in infection mice showed that the complex accumulated in the infection sites. These results show that 99mTc-Kanamycin radiopharmaceutical have a potential application for infection diagnosis.