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Development of a Ready-to-Use PSMA-11 Kit Formulation and Biological Evaluation of Binding Affinity
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作者 Maria Renata Valente Brandão Freire Natália Marchesan Bexiga +12 位作者 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 《Advances in Molecular Imaging》 CAS 2024年第2期7-22,共16页
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 t... 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. 展开更多
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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Ready-to-Use型药物临床应用研究进展
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作者 杜茜 孙光春 +2 位作者 郑鹏翔 宋剑萍 解薇 《中国药业》 CAS 2022年第23期127-128,I0001-I0004,共6页
目的为药物剂型的研发和临床用药选择提供参考。方法检索Ready-to-Use(RTU)型药物的相关文献,总结其临床应用的优势。结果RTU型药物可与给药系统结合,无需配置即可使用。在疾病治疗方面,可缩短救治准备时间,减少延时给药风险,改善救治结... 目的为药物剂型的研发和临床用药选择提供参考。方法检索Ready-to-Use(RTU)型药物的相关文献,总结其临床应用的优势。结果RTU型药物可与给药系统结合,无需配置即可使用。在疾病治疗方面,可缩短救治准备时间,减少延时给药风险,改善救治结局,提高患者用药的自我管理能力。在用药安全方面,可降低相关血流感染、局部感染的发生率,减少医疗事故的发生,化学、生物、辐射、核(CBRN)事件发生时减少医务人员的职业暴露。结论随着研发技术的提升,药物种类的扩展,RTU型药物将来可能逐渐取代安瓿瓶等小针剂的使用,为临床患者和医务人员带来获益与便利。 展开更多
关键词 ready-to-use型药物 自我管理能力 救治时间 相关血流感染 临床应用
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Effective Therapeutic Feeding with Chickpea Sesame Based Ready-To-Use Therapeutic Food (CS-RUTF) in Wasted Adults with Confirmed or Suspected AIDS 被引量:1
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作者 Paluku Bahwere Hedwig Deconinck +1 位作者 Theresa Banda Steve Collins 《World Journal of AIDS》 2011年第4期169-181,共13页
Wasting has been observed as a common feature of the human immunodeficiency virus (HIV) disease since the first reports and its presence increases the risk of death. There is no consensus on how to manage wasting asso... Wasting has been observed as a common feature of the human immunodeficiency virus (HIV) disease since the first reports and its presence increases the risk of death. There is no consensus on how to manage wasting associated with HIV. The goal of this study was to assess the effectiveness of a locally made Chickpea Sesame Based RUTF (CS-RUTF) in treating wasting associated with HIV in developing countries. Chronically sick adults from Mangochi Health District (Malawi) with wasting and confirmed or presumptive clinical diagnosis of HIV were recruited for the study. Subjects received a daily ration of 500 grams of CS-RUTF for 3 to 5 months. Nutrition status changes and mortality were used to assess the effectiveness of the intervention. There were 3 patterns of anthropometric responses continuous weight gain (WG), static weight (SW) and continuation weight loss (WL). The distribution of the 3 patterns is 53.9% (82/154) for the WG pattern, 9.1% (14/154) for the SW pattern and 37.0% (57/154) for the WL pattern. For the WG pattern, the overall median weight gain was 4.6 (2.4 to 7.1) kg. It was 5.7 (3.5 to 7.8) kg for those who completed 3 months of sup-plementation. MUAC and BMI changes followed similar pattern than weight change. Not being on HAART, acute diarrhoea during follow up, episode of reduced appetite during follow up, missing at least one visit were identified as risk factors for intervention failure. Overall, 38.5% (72/187) of study participants died during the intervention. In conclusion, despite that the study confirms the limited impact of food based interventions on mortality among wasted HIV positive individuals, it also suggests that supplementation with CS-RUTF may be an effective intervention for reversing wasting associated with HIV if combined with HAART and specific treatment of severe opportunistic infection causing diarrhoea and reducing appetite. 展开更多
关键词 AIDS WASTING Nutrition Therapy ready-to-use THERAPEUTIC FOOD
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Effectiveness of Enriched Flour in the Recovery of Children Aged 6 to 59 Months with Moderate Acute Malnutrition
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作者 Oumalkher Youssouf Adam Imar Djibrine Soudy +2 位作者 Abdoullahi Hissein Ousman Mablahi Amina Kanika Mahamat Garba 《Food and Nutrition Sciences》 2023年第7期687-697,共11页
Introduction: In Chad, malnutrition is a silent emergency. Yet the use of local products in the fight against malnutrition is essential. The purpose of this study was to compare the efficacy of locally sourced enriche... Introduction: In Chad, malnutrition is a silent emergency. Yet the use of local products in the fight against malnutrition is essential. The purpose of this study was to compare the efficacy of locally sourced enriched flour in the recovery of children 6 to 59 months of moderate acute malnourishment compared to Ready-to-Use Therapeutic Foods (Plumpy’ Sup) in the city of Abéché-Chad. Methodology: This study took place from 1 October 2021 to 31 January 2022 in the city of Abéché, capital of the province of Ouaddaï. It was conducted in eight (8) urban health centers in the city of Abéché and concerned eighty (80) children with moderate acute malnutrition. It was based on a consumption assessment of two complementary foods by two groups of children. The assessment of nutritional status was made through anthropometric data such as weight, height and brachial perimeter. Results: All 80 children were tested for moderate acute malnutrition. Two complementary foods have been used which are locally produced flour and the Ready-to-Use Therapeutic Food. The study showed that the group 1 who consumed the locally produced flour had an average weight gain of 1100 g and the group 2 who consumed the Plumpy sup had an average weight gain of 400 g. Conclusion: The present study carried out in Abéché allowed us to compare the effectiveness of locally produced weaning flours with Ready-to-Use Therapeutic Foods on moderate malnourished child weight growth in the nutritional units of the town of Abéché. 展开更多
关键词 Moderate Acute Malnutrition Local Food ready-to-use Therapeutic Foods (Plumpy’ Sup)
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