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development of a Ready-to-Use PSMA-11 Kit Formulation and Biological Evaluation of Binding Affinity

Advances in Molecular Imaging 2024年第2期13卷 7-22页

作者： Maria Renata Valente Brandão Freire Natália Marchesan Bexiga Marco Antonio Stephano joão Ezequiel Oliveira Carlos Roberto jorge Soares Ana Cláudia Camargo Miranda Anna Carolina de Alcântara Barbosa Marycel Figols de Barboza Laura Fernanda Garcia Luiz Felipe S. Teixeira Maria Helena Marumo Bellini Natanael Gomes da Silva Luiza Mascarenhas Balieiro joel mendes.elaine bortoleti de araújo Centro de Radiofarmcia Instituto de Pesquisas Energticas e Nucleares (IPEN) Cidade Universitria So Paulo Brasil departamento de Tecnologia Farmacutica Faculdade de Cincias Farmacuticas (USP) Cidade Universitria So Paulo Brasil Centro de Biotecnologia Instituto de Pesquisas Energticas e Nucleares (IPEN) Cidade Universitria So Paulo Brasil departamento de Medicina Nuclear do Hospital Israelita Albert Einstein So Paulo/SP Brasil

Introduction: 68Ga-PSMA-11 is considered the gold standard in detection of micro and oligometastases in advanced prostate cancer, being used for therapeutic planning, as well as, potentially, for evaluating response to treatment. The development of ready-to-use lyophilized kit of PSMA-11 adds quality and safety to the routine use of this radiopharmaceutical and represents a pharmacotechnical challenge as it must preserve the integrity and specificity of the ligand. Methods: PSMA-11 kit formulation was proposed, considering radiolabeling parameters and the preservation of the peptide during the lyophilization process, using mannitol as an excipient. Critical temperature characterization studies were carried out using DSC equipment and the freeze-drying process was developed. The direct radiolabeling conditions were evaluated and standardized using 68Ge/68Ga generator eluate from two different manufacturers (ITG and Eckert & Ziegler). The radiochemical purity was evaluated by TLC and HPLC. Biological evaluation was carried out with lyophilized PSMA-11 to demonstrate the integrity of the peptide and preservation of biological activity after the lyophilization process. Results: Based on critical temperature characterization studies, the freeze-drying cycle was designed to reach a freezing temperature of around −40˚C and primary drying at 2˚C. Using 20 mg of mannitol, an intact and elegant lyophilized cake was obtained. PSMA-11 lyophilized kit was directly labeled with 68Ga eluate from 68Ge/68Ga GMP generators (ITG and Eckert & Ziegler) resulting in % RP > 95% at pH 4.0 to 4.5. The results obtained from in vitro and in vivo biological competition studies confirmed the preservation of PSMA-11 affinity for the receptor after lyophilization. Conclusion: A lyophilized formulation (Kit) of PSMA-11 was successfully obtained, which preserved the integrity and biological activity of the peptide and guaranteed radiolabeling efficiency.

关键词： 68Ga-PSMA-11 Prostate-Specific Membrane Antigen (PSMA) Ready-to-Use Kit GMP-Grade Generators Metastatic Prostate Cancer PET Imaging

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development of a Ready-to-Use PSMA-11 Kit Formulation and Biological Evaluation of Binding Affinity

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Advances in Molecular Imaging（分子影像学） 2024年第2期 7页

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Serum vitamin D content is associated with semen|parameters and serum testosterone levels in men

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Asian journal of Andrology 2021年第1期23卷 52-58页

作者： Inari M Ciccone elaine MF Costa Juliana R Pariz Thiago A Teixeira joel R Drevet Parviz Gharagozloo Robert J Aitken jorge Hallak Androscience Science and Innovation Center in Andrology and High-Complex Clinical and Andrology LaboratorySao Paulo 04534-011Brazil Division of Urology University of Sao PauloSao Paulo 05403-000Brazil Men's Health Study Group Institute for Advanced StudiesUniversity of Sao PauloSao Paulo 05508-060Brazil Division of Endocrinology University of Sao PauloSao Paulo 05403-000Brazil School of Medicine Urology DepartmentFederal University of AmapaMacapa 68903-419Brazil Faculty of Medicine GReD LaboratoryUniversity Clermont Auvergne49Bd Frangois-Mitterrand-CS 6003263001 Clermont-Ferrand CedexFrance Cell0xess LLC EwingNJ 08628USA School of Environmental and Life Sciences Priority Research Centre for Reproductive SciencesUniversity of NewcastleCallaghanNSW 2308Australia Reproductive Toxicology Unit Department of PathologyUniversity of Sao PauloSao Paulo 05403-000Brazil

The present study aimed to evaluate the influence of serum vitamin D levels on semen quality and testosterone *** is a crosssectional study conducted at Androscience,Science and Innovation Center in Andrology and High-Complex Clinical and Andrology Laboratory in Sao Paulo,Brazil,with 508 male patients,aged 18-60 years,from 2007 to *** parameters and serum sexual hormones were correlated with serum vitamin D concentrations in 260 men selected by strict selection *** were divided into normozoospermic group(NZG,n=124)and a group with seminal abnormalities(SAG,n=136).Evaluation included complete physical examination,past medical history,habits and lifestyle factors,two complete seminal analysis with sperm functional tests,serum levels of 25-hydroxy-vitamin D_(3)(25(OH)VD_(3)),total and free testosterone,luteinizing hormone(LH),follicle-stimulating hormone(FSH),sex hormone-binding globulin(SHBG),total cholesterol,homeostatic model assessment of insulin resistance(HOMA-IR)index,and *** mean concentration of 25(OH)VD_(3)was significantly lower in the SAG(Parameters and total testosterone *** addition,serum vitamin D_(3)concentration was found to be positively correlated with sperm concentration(β=2.103;Parative study to address the issue of serum vitamin D_(3)content between normozoospermic patients and those with sperm *** clearly demonstrates a direct and positive relationship between serum vitamin D level and overall semen quality,male reproductive potential,and testosterone levels.

关键词： male infertility semen quality sexual hormones sperm motility testosterone vitamin D deficiency

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A dahlia flower extract has antidiabetic properties by improving insulin function in the brain

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Life Metabolism 2023年第4期2卷 39-50页

作者： Dominik Pretz Philip M.Heyward Jeremy Krebs joel Gruchot Charles Barter Pat Silcock Nerida Downes Mohammed Zubair Rizwan Alisa Boucsein Julia Bender elaine J.Burgess Geke Aline Boer Pramuk Keerthisinghe Nigel B.Perry Alexander Tups Centre for Neuroendocrinology School of Biomedical SciencesUniversity of OtagoDunedin 9054New Zealand department of Physiology School of Biomedical SciencesUniversity of OtagoDunedin 9054New Zealand Maurice Wilkins Centre for Molecular Biodiscovery University of AucklandAuckland 1010New Zealand department of Medicine University of OtagoWellingtonWellington South 6242New Zealand Centre for Endocrine Diabetes and Obesity Research Wellington Regional HospitalNewtownWellington 6021New Zealand Product development Research Centre University of OtagoDunedin 9054New Zealand department of Chemistry The New Zealand Institute for Plant and Food ResearchUniversity of OtagoDunedin 9054New Zealand

Butein,a rare chalcone found in the toxic plant Toxicodendron vernicifluum,has been shown to regulate glucose homeostasis via inhibition of the nuclear factor kappa-B kinase subunit beta(IKKβ)/nuclear factor kappa B(NF-κB)pathway in the ***,we investigated whether the nonpoisonous plant Dahlia pinnata could be a source of butein as a potential treatment for type 2 diabetes(T2D).In mice fed a high-fat diet(HFD)to induce glucose intolerance,an oral *** petal extract improved glucose tolerance at doses of 3.3 mg/kg body weight and 10 mg/kg body ***,this effect was not mediated by butein alone but by butein combined with the closely related flavonoids,sulfuretin and/or ***,the extract improved systemic insulin *** of phosphatidylinositol 3-kinase to block insulin signaling in the brain abrogated the glucoregulatory effect of the orally administered *** extract reinstated central insulin signaling and normalized astrogliosis in the hypothalamus of HFD-fed *** NF-κB reporter zebrafish to determine IKKβ/NF-κB activity,a potent anti-inflammatory action of the extract was found.A randomized controlled crossover clinical trial on participants with predia-betes or T2D confirmed the safety and efficacy of the extract in *** conclusion,we identified an extract from the flower petals of *** as a novel treatment option for T2D,potentially targeting the central regulation of glucose homeostasis as a root cause of the disease.

关键词： inflammation hypothalamus signal transduction neuroendocrine arcuate nucleus

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