Bioequivalence & Bioavailability International Journal最新文献_第9页

Pharmacokinetics and Bioequivalence of Methylphenidate Hydrochloride 10 mg Immediate-Released Tablets in Healthy Thai Volunteers under Fasting Conditions 盐酸哌甲酯10mg速释片在泰国健康志愿者禁食条件下的药代动力学和生物等效性

Bioequivalence & Bioavailability International Journal Pub Date : 2020-01-01 DOI: 10.23880/beba-16000141

K. V

{"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}

引用次数: 0

Nutrition, Bioavailability and Food Safety Covid-19 Corona Crisis, Immunity and Novel Food Processing Technologies: A Review 新冠肺炎危机、免疫和新型食品加工技术综述

Bioequivalence & Bioavailability International Journal Pub Date : 2020-01-01 DOI: 10.23880/beba-16000142

Borse Bb

引用次数: 0

Isolation and Characterization of Methoxy, Propoxy Dimethylamine from Detarium Senegalense Seed 塞内加尔苦参种子中甲氧基、丙氧基二甲胺的分离与表征

Bioequivalence & Bioavailability International Journal Pub Date : 2019-01-04 DOI: 10.23880/beba-16000136

U. Ri

引用次数: 0

Bioavailability of Natural Products 天然产物的生物利用度

Bioequivalence & Bioavailability International Journal Pub Date : 2019-01-04 DOI: 10.23880/beba-16000137

S. Anb

引用次数: 0

Ethnopharmacological Review of Terminalia chebula 诃子的民族药理学研究进展

Bioequivalence & Bioavailability International Journal Pub Date : 2019-01-04 DOI: 10.23880/beba-16000135

C. R

{"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}

引用次数: 2

Bioequivalence &amp; Bioavailability International Journal最新文献

Bioequivalence & Bioavailability International Journal最新文献