| چکیده انگلیسی مقاله |
Introduction: Recently, [68Ga]Gallium lyophilized kit has been widely practiced as it simplifies the radiolabeling process. Thus, our aim is to develop, formulate and evaluate a single-vial lyophilized kit (EZYKit PSMA) for the preparation and radiolabeling of [68Ga]Ga-PSMA-11.Methods: Two commercially available [68Ge/68Ga] Generators used in this study were from ITG and Eckert & Ziegler with a current [68Ga]Gallium elution activity of 222 MBq and 1480 MBq, respectively. Initially, EZYkit-PSMA radiolabeling parameters were optimized, and the Glass Transition Temperature (Tg) of the optimized PSMA-11 formulation was determined. Quality assessment of EZYkit-PSMA, including physical appearance, quantitative assay of the active ingredient, radiochemical purity, pH, sterility, endotoxin, and storage stability, were also established.Results: Optimization of radiolabeling parameters showed that the highest radiochemical purity was achieved with 0.35 ml and 0.75 ml of 1.5 M acetate buffer and 10 µg PSMA-11 for both ITG and Eckert & Ziegler Generator, respectively. The quality assessment results of EZYkit-PSMA were within the specifications except for the physical appearance, where it appears to be structurally collapsed. This study discussed two main factors that contributed to the collapsed lyophilized cake.Conclusion: Despite the physical appearance, EZYkit-PSMA was successfully developed, and the quality meets the pharmaceutical standards. EZYkit-PSMA showed high stability over 6 month's storage period in both the fridge and freezer. Overall, using EZYkit-PSMA for radiolabeling with [68Ga]Gallium simplified the whole radiolabeling procedure and reduces process time and error with high labelling yield and efficiency. |
| نویسندگان مقاله |
Muhammad Fakhrurazi Ahmad Fadzil |
Pharmacy Department, Institut Kanser Negara, 4, Jalan P7, Presint 7, 62250 Wilayah Persekutuan Putrajaya, Malaysia
Ooi Xin Yue |
Pharmacy Department, Institut Kanser Negara, 4, Jalan P7, Presint 7, 62250 Wilayah Persekutuan Putrajaya, Malaysia
Zaitulhusna Md Safee |
Pharmacy Department, Institut Kanser Negara, 4, Jalan P7, Presint 7, 62250 Wilayah Persekutuan Putrajaya, Malaysia
Nik Muhammad Fitri |
Pharmacy Department, Institut Kanser Negara, 4, Jalan P7, Presint 7, 62250 Wilayah Persekutuan Putrajaya, Malaysia
Noratikah Mat Ail |
Pharmacy Department, Institut Kanser Negara, 4, Jalan P7, Presint 7, 62250 Wilayah Persekutuan Putrajaya, Malaysia
Jaleezah Idris |
Nuclear Medicine Department, Institut Kanser Negara, 4, Jalan P7, Presint 7, 62250 Wilayah Persekutuan Putrajaya, Malaysia
Nor Idayu Razali |
Nuclear Medicine Department, Institut Kanser Negara, 4, Jalan P7, Presint 7, 62250 Wilayah Persekutuan Putrajaya, Malaysia
Hamdi Noor |
Nuclear Medicine Department, Institut Kanser Negara, 4, Jalan P7, Presint 7, 62250 Wilayah Persekutuan Putrajaya, Malaysia
Wan Hamirul Bahrin |
Medical Technology Division, Malaysian Nuclear Agency, 43000 Kajang, Bangi, Malaysia
Rahimah Rahim |
Medical Technology Division, Malaysian Nuclear Agency, 43000 Kajang, Bangi, Malaysia
Muhamad Faiz Othman |
Faculty of Pharmacy, MARA University of Technology (UiTM), Bandar Puncak Alam, Selangor, 42300 Puncak Alam, Malaysia
Zarif Ashhar |
Pharmacy Department, Institut Kanser Negara, 4, Jalan P7, Presint 7, 62250 Wilayah Persekutuan Putrajaya, Malaysia
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