Pub Date : 2023-01-01DOI: 10.4236/jbm.2023.1111003
Evelyn Pena, Alfredo Inatti, Xenón Serrano Martin
Objectives: Evaluate the bioequivalence (BE) of two oral tablets formulations of diclofenac 150 mg in healthy male subjects under fasting condition. This was a phase I, randomized, open label, balanced, two period, two sequences, single oral dose, crossover, analyst blind study. Methods: Twenty four (24) healthy subjects were randomly assigned to one of two sequences protocol: 150 mg XR of reference formulation (R), diclofenac sodium in the first period or the test formulation (T), diclofenac potassium in the second or vice versa. The plasma concentrations were determined using a validated LC-MS/MS method. Pharmacokinetic (PK) parameters included: maximum plasma concentration (Cmax), area under the plasma concentration—time curve from time 0 to the last measurable concentration (AUC0-t), and area under the plasma concentration—time from time 0 to infinity (AUC0-∞), were evaluated for BE. Results: The results showed that 90% confidence intervals for the test/reference geometric mean ratios (GMR) of Cmax (90.43 - 107.17), AUC0-t (93.08 - 116.46) and AUC0-∞ (92.52 - 117.39) were within the BE (80% - 125%) acceptance range. Conclusions: Two formulations, reference product (R) Voltaren® (diclofenac sodium) of Novartis and test product (T), Diklason Bi (diclofenac potassium) of Laboratorios Leti S.A.V., with a single dose of 150 mg XR, under fasting conditions were bioequivalent. No severe, serious or unexpected adverse events (AEs) were reported in this study.
{"title":"Bioequivalence Study of Diclofenac 150 mg XR: A Single-Dose, Randomized, Open Label, 2-Period Crossover Study in Healthy Adult Volunteers","authors":"Evelyn Pena, Alfredo Inatti, Xenón Serrano Martin","doi":"10.4236/jbm.2023.1111003","DOIUrl":"https://doi.org/10.4236/jbm.2023.1111003","url":null,"abstract":"Objectives: Evaluate the bioequivalence (BE) of two oral tablets formulations of diclofenac 150 mg in healthy male subjects under fasting condition. This was a phase I, randomized, open label, balanced, two period, two sequences, single oral dose, crossover, analyst blind study. Methods: Twenty four (24) healthy subjects were randomly assigned to one of two sequences protocol: 150 mg XR of reference formulation (R), diclofenac sodium in the first period or the test formulation (T), diclofenac potassium in the second or vice versa. The plasma concentrations were determined using a validated LC-MS/MS method. Pharmacokinetic (PK) parameters included: maximum plasma concentration (Cmax), area under the plasma concentration—time curve from time 0 to the last measurable concentration (AUC0-t), and area under the plasma concentration—time from time 0 to infinity (AUC0-∞), were evaluated for BE. Results: The results showed that 90% confidence intervals for the test/reference geometric mean ratios (GMR) of Cmax (90.43 - 107.17), AUC0-t (93.08 - 116.46) and AUC0-∞ (92.52 - 117.39) were within the BE (80% - 125%) acceptance range. Conclusions: Two formulations, reference product (R) Voltaren® (diclofenac sodium) of Novartis and test product (T), Diklason Bi (diclofenac potassium) of Laboratorios Leti S.A.V., with a single dose of 150 mg XR, under fasting conditions were bioequivalent. No severe, serious or unexpected adverse events (AEs) were reported in this study.","PeriodicalId":15067,"journal":{"name":"Journal of Biosciences and Medicines","volume":"102 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135448174","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease deadly. In Africa, little data exists on this condition and the form familial is the most common with a younger age of onset. Our observations relate to three brothers, born from a consanguineous marriage. The diagnosis of amyotrophic lateral sclerosis was certain placed in all patients according to the criteria of Awaji. The average age of patients was 16.66 years, and the average age of onset of symptoms was 10.33 years old. The female gender was the most represented with a sex ratio of 0.5. Our patients benefited from rilusole, vitamin D and physiotherapy. A only patient presented with dysphagia. However, no cases have been observed at this day.
{"title":"Familial Lateral Sclerosis with Juvenile Onset: About 3 Cases and Review of the Literature","authors":"Camara Mamady, Barry Souleymane Djigué, Dore Male, Toure Mohamed Lamine, Diallo Mohamed Tafsir, Toure Laïla, Youla Seny, Konate Ibrahimasory, Barry Louceny Fatoumata, Camara Mohamed Salif, Camara Idrissa, Doumbouya Idrissa, Djibo Hamani Bachir, Conde Mohamed Lamine, Cisse Fodé Abass","doi":"10.4236/jbm.2023.1110006","DOIUrl":"https://doi.org/10.4236/jbm.2023.1110006","url":null,"abstract":"Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease deadly. In Africa, little data exists on this condition and the form familial is the most common with a younger age of onset. Our observations relate to three brothers, born from a consanguineous marriage. The diagnosis of amyotrophic lateral sclerosis was certain placed in all patients according to the criteria of Awaji. The average age of patients was 16.66 years, and the average age of onset of symptoms was 10.33 years old. The female gender was the most represented with a sex ratio of 0.5. Our patients benefited from rilusole, vitamin D and physiotherapy. A only patient presented with dysphagia. However, no cases have been observed at this day.","PeriodicalId":15067,"journal":{"name":"Journal of Biosciences and Medicines","volume":"87 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136208534","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Bridelia micrantha, commonly known as coastal golden leaf, is a member of the family Phyllanthaceae. In preliminary studies nine fractions, named F1 - F9, were obtained by fractionating the crude methanol extract of the stem bark of Bridelia micrantha using column chromatographic techniques. The fraction F6 was the most active when tested for antibacterial activity. Thus, toxicity of this fraction was investigated for further use. The present study evaluated the acute and sub-chronic toxicity of the crude methanolic bark extract of Bridelia micrantha and its fraction. The acute toxicity was carried out according to the experimental protocol of Organization for Economic Co-operation and Development (OECD). The plant extract or the fraction F6 was administered orally to female mice at a single dose of 2000 mg/kg and the animals were observed for any behavioral changes or mortality for 14 days. In the sub-chronic toxicity study, the extract and fraction were administered orally at 200, 400 and 800 mg/kg bw/day for 28 days to healthy Wistar rats. The general behavior and body weight of the rats were recorded daily. At the end of the experimental period, hematological and biochemical analyses, changes in vital organ weight (liver, lung, heart, spleen and kidney), and histopathological examination of the liver and kidney were performed. No mortality or adverse effects were noted at the 2000 mg/kg dose during the oral acute toxicity test. In the sub-chronic study, the crude methanolic bark extract of Bridelia micrantha and the fraction F6 induced no mortality or treatment-related adverse effects on body weight, general behavior, relative organ weights, hematological and biochemical parameters. Histopathological examination of the liver and kidney showed normal architecture suggesting no morphological alterations. In conclusion, the oral administration of the crude methanolic bark extract of Bridelia micrantha and the fraction F6 for 28 days at a dosage of up to 800 mg/kg did not induce toxicological damage in rats. From acute toxicity study, the median lethal dose (LD50) of the crude methanolic bark extract of Bridelia micrantha and the fraction F6 was estimated to be more than 2000 mg/kg.
{"title":"Acute and Sub-Chronic Toxicity Evaluation of the Crude Methanolic Bark Extract of <i>Bridelia micrantha</i> (Hochst.) Baill. (Phyllanthaceae) and Its Fraction","authors":"Colette Elysée Aboudi Etono, Landry Lienou Lienou, Fabrice Fabien Dongho Dongmo, Aristide Laurel Mokale Kognou, Raphael Tchientcheu, Rebecca Madeleine Ebelle Etame, Rosalie Anne Ngono Ngane","doi":"10.4236/jbm.2023.1110008","DOIUrl":"https://doi.org/10.4236/jbm.2023.1110008","url":null,"abstract":"Bridelia micrantha, commonly known as coastal golden leaf, is a member of the family Phyllanthaceae. In preliminary studies nine fractions, named F1 - F9, were obtained by fractionating the crude methanol extract of the stem bark of Bridelia micrantha using column chromatographic techniques. The fraction F6 was the most active when tested for antibacterial activity. Thus, toxicity of this fraction was investigated for further use. The present study evaluated the acute and sub-chronic toxicity of the crude methanolic bark extract of Bridelia micrantha and its fraction. The acute toxicity was carried out according to the experimental protocol of Organization for Economic Co-operation and Development (OECD). The plant extract or the fraction F6 was administered orally to female mice at a single dose of 2000 mg/kg and the animals were observed for any behavioral changes or mortality for 14 days. In the sub-chronic toxicity study, the extract and fraction were administered orally at 200, 400 and 800 mg/kg bw/day for 28 days to healthy Wistar rats. The general behavior and body weight of the rats were recorded daily. At the end of the experimental period, hematological and biochemical analyses, changes in vital organ weight (liver, lung, heart, spleen and kidney), and histopathological examination of the liver and kidney were performed. No mortality or adverse effects were noted at the 2000 mg/kg dose during the oral acute toxicity test. In the sub-chronic study, the crude methanolic bark extract of Bridelia micrantha and the fraction F6 induced no mortality or treatment-related adverse effects on body weight, general behavior, relative organ weights, hematological and biochemical parameters. Histopathological examination of the liver and kidney showed normal architecture suggesting no morphological alterations. In conclusion, the oral administration of the crude methanolic bark extract of Bridelia micrantha and the fraction F6 for 28 days at a dosage of up to 800 mg/kg did not induce toxicological damage in rats. From acute toxicity study, the median lethal dose (LD50) of the crude methanolic bark extract of Bridelia micrantha and the fraction F6 was estimated to be more than 2000 mg/kg.","PeriodicalId":15067,"journal":{"name":"Journal of Biosciences and Medicines","volume":"155 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136256736","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-01-01DOI: 10.4236/jbm.2023.1110020
Yuan-Yuan Chen, Dong-Xu Ao, Chen-Yang Zuo, Jun Cai
{"title":"Biomarkers Associated with Radiation-Induced Lung Injury in Cancer Patients","authors":"Yuan-Yuan Chen, Dong-Xu Ao, Chen-Yang Zuo, Jun Cai","doi":"10.4236/jbm.2023.1110020","DOIUrl":"https://doi.org/10.4236/jbm.2023.1110020","url":null,"abstract":"","PeriodicalId":15067,"journal":{"name":"Journal of Biosciences and Medicines","volume":"263 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134884591","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Esther Perez-Torrero, Leticia Esmeralda Luna-Rodriguez, Gerardo Antonio Fonseca-Hernandez, Jose Santos-Cruz, Eric Mauricio Rivera-Muñoz, Maria Lucero Gomez-Herrera
A synthetizing material blended with two distinct proteins (collagen and casein) and mineral mixture, was developed in order to evaluate their properties suitable for possible applications in the biomedical such as inducing the regeneration of damaged bone, either due to an accident or illness. Samples were evaluated by 1) Mechanical properties tests under the bending, 2) Scanning electronic microscopy and 3) Infrared spectroscopy were carried out. The results showed that the developed material has breaking strength and structure characteristics associated with the protein used in their composition. This fact suggests that the used protein determines the resistance of the material, in such a way according to the required use, being able to choose appropriate strength and duration either short or long time. The material composition for specific use, in order to find the most suitable mixture for bone replacement, or induce bone recovery, according to the required properties similar to those of damaged living tissue.
{"title":"Synthesis and Characterization of a Polymeric Material Blended to Bone Forming Elements","authors":"Esther Perez-Torrero, Leticia Esmeralda Luna-Rodriguez, Gerardo Antonio Fonseca-Hernandez, Jose Santos-Cruz, Eric Mauricio Rivera-Muñoz, Maria Lucero Gomez-Herrera","doi":"10.4236/jbm.2023.119016","DOIUrl":"https://doi.org/10.4236/jbm.2023.119016","url":null,"abstract":"A synthetizing material blended with two distinct proteins (collagen and casein) and mineral mixture, was developed in order to evaluate their properties suitable for possible applications in the biomedical such as inducing the regeneration of damaged bone, either due to an accident or illness. Samples were evaluated by 1) Mechanical properties tests under the bending, 2) Scanning electronic microscopy and 3) Infrared spectroscopy were carried out. The results showed that the developed material has breaking strength and structure characteristics associated with the protein used in their composition. This fact suggests that the used protein determines the resistance of the material, in such a way according to the required use, being able to choose appropriate strength and duration either short or long time. The material composition for specific use, in order to find the most suitable mixture for bone replacement, or induce bone recovery, according to the required properties similar to those of damaged living tissue.","PeriodicalId":15067,"journal":{"name":"Journal of Biosciences and Medicines","volume":"6 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135701121","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ma. Guadalupe Calderón-Gallardo, L. Castillo-Martínez, S. Estrada-Soto, I. Gallardo-Ortíz, R. Villalobos-Molina
High blood pressure is the main risk factor for cardiovascular diseases, it affects many people worldwide and is a public health problem. This study explored the acute and chronic actions of a mixture of turmeric (95% curcumin) plus black pepper (95% piperine) extracts, in the blood pressure pattern in spontaneously hypertensive rats (SHR) along they age. For the acute study male adult (4 - 7 months old) SHR and their control Wistar Kyoto rats (WKY) were used. A single oral dose of the mixture of turmeric/black pepper extracts (200 mg/2mg, respectively) suspension was administered. Tail-cuff was used to determine blood pressure during 180 min. For the chronic study, young (1-month-old) male SHR and their control WKY rats were fed with standard chow, or standard chow combined with cocoa, or combined with cocoa plus the mixture
{"title":"The Acute and Chronic Effects of Co-Administration of Turmeric and Black Pepper Extracts in Genetic Hypertension","authors":"Ma. Guadalupe Calderón-Gallardo, L. Castillo-Martínez, S. Estrada-Soto, I. Gallardo-Ortíz, R. Villalobos-Molina","doi":"10.4236/jbm.2023.118010","DOIUrl":"https://doi.org/10.4236/jbm.2023.118010","url":null,"abstract":"High blood pressure is the main risk factor for cardiovascular diseases, it affects many people worldwide and is a public health problem. This study explored the acute and chronic actions of a mixture of turmeric (95% curcumin) plus black pepper (95% piperine) extracts, in the blood pressure pattern in spontaneously hypertensive rats (SHR) along they age. For the acute study male adult (4 - 7 months old) SHR and their control Wistar Kyoto rats (WKY) were used. A single oral dose of the mixture of turmeric/black pepper extracts (200 mg/2mg, respectively) suspension was administered. Tail-cuff was used to determine blood pressure during 180 min. For the chronic study, young (1-month-old) male SHR and their control WKY rats were fed with standard chow, or standard chow combined with cocoa, or combined with cocoa plus the mixture","PeriodicalId":15067,"journal":{"name":"Journal of Biosciences and Medicines","volume":"45 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80594729","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Genomic Instability Is a Mechanism for Diminished Male Fertility Following Chronic Dichlorvos Exposure","authors":"R. Vhriterhire, S. Odeh, G. U. Egesie","doi":"10.4236/jbm.2023.117005","DOIUrl":"https://doi.org/10.4236/jbm.2023.117005","url":null,"abstract":"","PeriodicalId":15067,"journal":{"name":"Journal of Biosciences and Medicines","volume":"22 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86997771","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Research Progress of Anti-Angiogenic Drugs in First-Line Treatment of Small Cell Lung Cancer","authors":"Ying Wang, Xi Tang","doi":"10.4236/jbm.2023.111002","DOIUrl":"https://doi.org/10.4236/jbm.2023.111002","url":null,"abstract":"","PeriodicalId":15067,"journal":{"name":"Journal of Biosciences and Medicines","volume":"29 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73677047","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Zhenxu Lan, Zeduan Liu, Xiaolu Luo, Shao-jing Xi, Lida Mo
{"title":"The Influence of Integrated Chinese and Western Medicine Treatment on the Quality of Life and Laboratory Indicators of Patients with Novel Coronavirus Pneumonia","authors":"Zhenxu Lan, Zeduan Liu, Xiaolu Luo, Shao-jing Xi, Lida Mo","doi":"10.4236/jbm.2023.118002","DOIUrl":"https://doi.org/10.4236/jbm.2023.118002","url":null,"abstract":"","PeriodicalId":15067,"journal":{"name":"Journal of Biosciences and Medicines","volume":"102 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75800905","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Tambong Ako Ojongnkpot, D. D. Sofeu-Feugaing, Vanessa Tita Jugha, G. S. Taiwé, H. Kimbi
{"title":"Implication of Oxidative Stress and Antioxidant Defence Systems in Symptomatic and Asymptomatic <i>Plasmodium falciparum</i> Malaria Infection among Children Aged1 to 15 Years in the Mount Cameroon Area","authors":"Tambong Ako Ojongnkpot, D. D. Sofeu-Feugaing, Vanessa Tita Jugha, G. S. Taiwé, H. Kimbi","doi":"10.4236/jbm.2023.112009","DOIUrl":"https://doi.org/10.4236/jbm.2023.112009","url":null,"abstract":"","PeriodicalId":15067,"journal":{"name":"Journal of Biosciences and Medicines","volume":"12 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72643847","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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