Methylphenidate is a central nervous system stimulant indicated for attention deficit hyperactivity disorder (ADHD) and narcolepsy. Methylphenidate GPO ® had been developed as a generic alternative to Ritalin ® 10 for Thai people. The aims of this study were to characterize pharmacokinetics in Thai population, and to evaluate bioequivalence of Methylphenidate GPO ® to Ritalin ® 10 to support product registration. A comparative dissolution test was performed in four dissolution media, followed by an open-label, randomized, two-way crossover bioequivalence study under fasting conditions. A single dose of the test or reference product was administered in period I and switched over to another product in period II after 7-day washout period. Blood samples were collected at predefined time points over 24 hours after dosing. Plasma concentrations of methylphenidate were quantified using a validated liquid chromatography-mass spectrometry method. The pharmacokinetics was characterized from plasma concentration-time profile following administration of the test and reference formulations. The pharmacokinetic parameters were in agreement with the previously published data. The AUC 0-t , AUC 0−∞ and C max of two methylphenidate 10 mg tablet formulations were statistically compared in 23 healthy Thai volunteers. The analysis of variance (ANOVA) did not show any significant difference between the formulations. The ratios for geometric least-square means and 90% confidence intervals of log-transformed parameters were within the acceptance range of 80.00–125.00%. Both products were generally well tolerated by healthy Thai subjects. Methylphenidate GPO ® and Ritalin ® 10 were bioequivalent in terms of rate and extent of absorption, and could be used interchangeably.
{"title":"Pharmacokinetics and Bioequivalence of Methylphenidate Hydrochloride 10 mg Immediate-Released Tablets in Healthy Thai Volunteers under Fasting Conditions","authors":"K. V","doi":"10.23880/beba-16000141","DOIUrl":"https://doi.org/10.23880/beba-16000141","url":null,"abstract":"Methylphenidate is a central nervous system stimulant indicated for attention deficit hyperactivity disorder (ADHD) and narcolepsy. Methylphenidate GPO ® had been developed as a generic alternative to Ritalin ® 10 for Thai people. The aims of this study were to characterize pharmacokinetics in Thai population, and to evaluate bioequivalence of Methylphenidate GPO ® to Ritalin ® 10 to support product registration. A comparative dissolution test was performed in four dissolution media, followed by an open-label, randomized, two-way crossover bioequivalence study under fasting conditions. A single dose of the test or reference product was administered in period I and switched over to another product in period II after 7-day washout period. Blood samples were collected at predefined time points over 24 hours after dosing. Plasma concentrations of methylphenidate were quantified using a validated liquid chromatography-mass spectrometry method. The pharmacokinetics was characterized from plasma concentration-time profile following administration of the test and reference formulations. The pharmacokinetic parameters were in agreement with the previously published data. The AUC 0-t , AUC 0−∞ and C max of two methylphenidate 10 mg tablet formulations were statistically compared in 23 healthy Thai volunteers. The analysis of variance (ANOVA) did not show any significant difference between the formulations. The ratios for geometric least-square means and 90% confidence intervals of log-transformed parameters were within the acceptance range of 80.00–125.00%. Both products were generally well tolerated by healthy Thai subjects. Methylphenidate GPO ® and Ritalin ® 10 were bioequivalent in terms of rate and extent of absorption, and could be used interchangeably.","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":"140 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77778460","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":"Nutrition, Bioavailability and Food Safety Covid-19 Corona Crisis, Immunity and Novel Food Processing Technologies: A Review","authors":"Borse Bb","doi":"10.23880/beba-16000142","DOIUrl":"https://doi.org/10.23880/beba-16000142","url":null,"abstract":"","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":"42 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76580765","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}
Detarium senegalense Gmelin. is a leguminous tree widely used in Nigeria for food and medicine. It produces fruits that are nutritious. The seeds have been applied to control blood-glucose levels in diabetic individuals. Report showed that the seeds are used for the treatment of mosquito bites and as an antidote against arrow poison and snake bite. Despite its rich pharmacological potential, the plant has not been scientifically evaluated. Thus the Chemical investigation of the bioactive constituents of the seed of Detarium senegalense resulted in the isolation of a new compound, 2l , 2l ,-dimethyl 11,11 7, 7- tetrahydroxy- 6 – methoxy –1- propoxy 3,4 –dimethylene 1,2, 5 –triamine. The structure was elucidated using NMR spectroscopy in combination with IR and MS spectral data. Antibacterial studies showed that the isolated compound successfully inhibited Escherichia coli, Pseudomonas aeruginosa and Proteus mirabilis. This result authenticates the use of the plant in phytomedicine for the treatment of infections and for prevention of diseases.
{"title":"Isolation and Characterization of Methoxy, Propoxy Dimethylamine from Detarium Senegalense Seed","authors":"U. Ri","doi":"10.23880/beba-16000136","DOIUrl":"https://doi.org/10.23880/beba-16000136","url":null,"abstract":"Detarium senegalense Gmelin. is a leguminous tree widely used in Nigeria for food and medicine. It produces fruits that are nutritious. The seeds have been applied to control blood-glucose levels in diabetic individuals. Report showed that the seeds are used for the treatment of mosquito bites and as an antidote against arrow poison and snake bite. Despite its rich pharmacological potential, the plant has not been scientifically evaluated. Thus the Chemical investigation of the bioactive constituents of the seed of Detarium senegalense resulted in the isolation of a new compound, 2l , 2l ,-dimethyl 11,11 7, 7- tetrahydroxy- 6 – methoxy –1- propoxy 3,4 –dimethylene 1,2, 5 –triamine. The structure was elucidated using NMR spectroscopy in combination with IR and MS spectral data. Antibacterial studies showed that the isolated compound successfully inhibited Escherichia coli, Pseudomonas aeruginosa and Proteus mirabilis. This result authenticates the use of the plant in phytomedicine for the treatment of infections and for prevention of diseases.","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":"59 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-01-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74611227","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":"Bioavailability of Natural Products","authors":"S. Anb","doi":"10.23880/beba-16000137","DOIUrl":"https://doi.org/10.23880/beba-16000137","url":null,"abstract":"","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":"27 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-01-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86527413","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}
Terminalia chebula, traditionally regarded as universal panacea, is known for its pleiotropic effects, including the effects on oxidative stress, malignant tumor growth, wound healing, and insulin sensitivity in Type 2 diabetes. In India and Southeast Asia the fruit is used as a popular folk medicine for antitussive, diuretic, homeostatic, laxative and cardiotonic treatments. In the fruits of T. chebula three hydrolyzable tannins chebulinic acid, chebulagic acid and 1, 3, 6-tri-O-galloylß-D-glucose could be determined by RP-HPLC. The contents of the first two substances were interrelated with the varieties. Experimental studies presented by different article show important action of substance present in fruit pulp Terminalia chebula, Antibacterial activity Test showed a broad spectrum of antibacterial activity with an inhibition zone size of 11 to 27 mm, against all the test bacteria. There was a synergistic action of the crude extracts with broad spectrum antibiotic like tetracycline and other pulp extract also act on viral disease In vitro they may inhibited the replication of human cytomegalovirus growth. Antioxidant activity of T. chebula fruit pulp well established, The aqueous extract of T. chebula fruit pulp was tested for its cytoprotective activity. Show, the cultured rat primary hepatocytes and rat whole livers the extract reversed an oxidative injury; caused by tert-butyl hydroperoxide and lactate dehydrogenase leakage significantly. Pharmacological effects, includes against anaphylactic shock, Antispasmodic activity, Gastrointestinal activity, Cardiotonic activity etc
传统上被认为是万能的灵丹妙药，以其多效性而闻名，包括对氧化应激、恶性肿瘤生长、伤口愈合和2型糖尿病的胰岛素敏感性的影响。在印度和东南亚，这种水果被用作一种流行的民间药物，用于止咳、利尿、体内平衡、通便和强心治疗。用反相高效液相色谱法测定了chebula果实中三种可水解单宁酸chebullic acid, chebullic acid和1,3,6 -三- o -没食子酸ß- d -葡萄糖。前两种物质的含量与品种有关。不同文献的实验研究表明，该物质对所有试验菌均有抑菌活性，抑菌范围为11 ~ 27 mm。粗提物与四环素等广谱抗生素及其它果肉提取物有协同作用，对病毒性疾病也有抑制作用，在体外可抑制人巨细胞病毒的复制生长。研究了板栗果肉的抗氧化活性，并对板栗果肉水提物的细胞保护活性进行了测试。结果表明，提取物对培养大鼠原代肝细胞和大鼠全肝具有逆转氧化损伤的作用;造成过氧化叔丁基和乳酸脱氢酶明显渗漏。药理作用，包括抗过敏性休克、抗痉挛活性、胃肠活性、强心活性等
{"title":"Ethnopharmacological Review of Terminalia chebula","authors":"C. R","doi":"10.23880/beba-16000135","DOIUrl":"https://doi.org/10.23880/beba-16000135","url":null,"abstract":"Terminalia chebula, traditionally regarded as universal panacea, is known for its pleiotropic effects, including the effects on oxidative stress, malignant tumor growth, wound healing, and insulin sensitivity in Type 2 diabetes. In India and Southeast Asia the fruit is used as a popular folk medicine for antitussive, diuretic, homeostatic, laxative and cardiotonic treatments. In the fruits of T. chebula three hydrolyzable tannins chebulinic acid, chebulagic acid and 1, 3, 6-tri-O-galloylß-D-glucose could be determined by RP-HPLC. The contents of the first two substances were interrelated with the varieties. Experimental studies presented by different article show important action of substance present in fruit pulp Terminalia chebula, Antibacterial activity Test showed a broad spectrum of antibacterial activity with an inhibition zone size of 11 to 27 mm, against all the test bacteria. There was a synergistic action of the crude extracts with broad spectrum antibiotic like tetracycline and other pulp extract also act on viral disease In vitro they may inhibited the replication of human cytomegalovirus growth. Antioxidant activity of T. chebula fruit pulp well established, The aqueous extract of T. chebula fruit pulp was tested for its cytoprotective activity. Show, the cultured rat primary hepatocytes and rat whole livers the extract reversed an oxidative injury; caused by tert-butyl hydroperoxide and lactate dehydrogenase leakage significantly. Pharmacological effects, includes against anaphylactic shock, Antispasmodic activity, Gastrointestinal activity, Cardiotonic activity etc","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":"5 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2019-01-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89081349","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}
京公网安备 11010802042870号
京ICP备2023020795号-1
扫码关注我们
求助内容：
应助结果提醒方式：