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
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
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
文摘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.
文摘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.
文摘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.
