Development, formulation and quality evaluation of a lyophilized PSMA-11 kit for rapid radiolabeling with [68Ga]Gallium
Article Type:
Research/Original Article (دارای رتبه معتبر)

 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.


 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.


 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.


 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.

Iranian Journal of Nuclear Medicine, Volume:31 Issue: 1, Winter-Spring 2023
61 to 69  
دانلود و مطالعه متن این مقاله با یکی از روشهای زیر امکان پذیر است:
اشتراک شخصی
با عضویت و پرداخت آنلاین حق اشتراک یک‌ساله به مبلغ 750,000ريال می‌توانید 50 عنوان مطلب دانلود کنید!
اشتراک سازمانی
به کتابخانه دانشگاه یا محل کار خود پیشنهاد کنید تا اشتراک سازمانی این پایگاه را برای دسترسی نامحدود همه کاربران به متن مطالب تهیه نمایند!
  • حق عضویت دریافتی صرف حمایت از نشریات عضو و نگهداری، تکمیل و توسعه مگیران می‌شود.
  • پرداخت حق اشتراک و دانلود مقالات اجازه بازنشر آن در سایر رسانه‌های چاپی و دیجیتال را به کاربر نمی‌دهد.
In order to view content subscription is required

Personal subscription
Subscribe for 50 € euros via PayPal and download 50 articles during a year.
Organization subscription
Please contact us to subscribe your university or library for unlimited access!