دورية أكاديمية

Development of in-House Synthesis and Quality Control of [ 99m Tc]Tc-PSMA-I&S.

التفاصيل البيبلوغرافية
العنوان: Development of in-House Synthesis and Quality Control of [ 99m Tc]Tc-PSMA-I&S.
المؤلفون: Plhak E; Division of Nuclear Medicine, Department of Radiology, Medical University of Graz, Auenbruggerplatz 9, 8036 Graz, Austria.; Department of Pharmaceutical Chemistry, Institute of Pharmaceutical Sciences, University of Graz, Schubertstraße 1/EG/0122, 8010 Graz, Austria., Pichler C; Department of Pharmaceutical Chemistry, Institute of Pharmaceutical Sciences, University of Graz, Schubertstraße 1/EG/0122, 8010 Graz, Austria., Gößnitzer E; Department of Pharmaceutical Chemistry, Institute of Pharmaceutical Sciences, University of Graz, Schubertstraße 1/EG/0122, 8010 Graz, Austria., Aigner RM; Division of Nuclear Medicine, Department of Radiology, Medical University of Graz, Auenbruggerplatz 9, 8036 Graz, Austria., Kvaternik H; Division of Nuclear Medicine, Department of Radiology, Medical University of Graz, Auenbruggerplatz 9, 8036 Graz, Austria.
المصدر: Molecules (Basel, Switzerland) [Molecules] 2023 Jan 06; Vol. 28 (2). Date of Electronic Publication: 2023 Jan 06.
نوع المنشور: Journal Article
اللغة: English
بيانات الدورية: Publisher: MDPI Country of Publication: Switzerland NLM ID: 100964009 Publication Model: Electronic Cited Medium: Internet ISSN: 1420-3049 (Electronic) Linking ISSN: 14203049 NLM ISO Abbreviation: Molecules Subsets: MEDLINE
أسماء مطبوعة: Original Publication: Basel, Switzerland : MDPI, c1995-
مواضيع طبية MeSH: Technetium* , Prostatic Neoplasms*/diagnosis, Male ; Humans ; Reproducibility of Results ; Radiopharmaceuticals ; Quality Control
مستخلص: Many radioactive PSMA inhibitory substances have already been developed for PET diagnostics and therapy of prostate cancer. Because PET radionuclides and instrumentation may not be available, technetium-99 m labelled tracers can be considered as a diagnostic alternative. A suitable tracer is [99mTc]Tc-PSMA-I&S, primarily developed for radio-guided surgery, which has been identified for diagnostics of prostate cancer. However, there is no commercial kit approved for the preparation of [99mTc]Tc-PSMA-I&S on the market. This work presents an automated process for the synthesis of [99mTc]Tc-PSMA-I&S concerning good manufacturing practice (GMP). We used a Scintomics GRP 4 V module, with the SCC software package for programming sequences for this development. The optimum reaction conditions were evaluated in preliminary experiments. The pH of the reaction solution was found to be crucial for the radiochemical yield and radiochemical purity. The validation of [99mTc]Tc-PSMA-I&S (n = 3) achieved a stable radiochemical yield of 58.7 ± 1.5% and stable radiochemical purities of 93.0 ± 0.3%. The amount of free [99mTc]TcO4− in the solution and reduced hydrolysed [99mTc]TcO2 was <2%. Our automated preparation of [99mTc]Tc-PSMA-I&S has shown reliability and applicability in the clinical setting.
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فهرسة مساهمة: Keywords: [99mTc]Tc-PSMA-I&S; automated preparation; technetium-99m
المشرفين على المادة: 7440-26-8 (Technetium)
0 (Radiopharmaceuticals)
تواريخ الأحداث: Date Created: 20230121 Date Completed: 20230124 Latest Revision: 20230308
رمز التحديث: 20240628
مُعرف محوري في PubMed: PMC9864623
DOI: 10.3390/molecules28020577
PMID: 36677636
قاعدة البيانات: MEDLINE
الوصف
تدمد:1420-3049
DOI:10.3390/molecules28020577