Bioequivalence & Bioavailability International Journal最新文献

{"title":"Covid-19 Vaccine Efficacy on Omicron Variant","authors":"Hussain S","doi":"10.23880/beba-16000162","DOIUrl":"https://doi.org/10.23880/beba-16000162","url":null,"abstract":"","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":"42 3 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72763629","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":"Concept of Therapeutic Action: Vaccine and Homeopathic Remedies","authors":"Sharma P","doi":"10.23880/beba-16000165","DOIUrl":"https://doi.org/10.23880/beba-16000165","url":null,"abstract":"","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":"9 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72814695","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":"Bioequivalence of a Preparation of Tulathromycin in Cattle","authors":"Suman Lh","doi":"10.23880/beba-16000158","DOIUrl":"https://doi.org/10.23880/beba-16000158","url":null,"abstract":"Testing the quality of antibacterial pharmaceutical preparations that can be regarded as generic is of utmost importance to ensure sustainable medical practices. Hence, comparative pharmacokinetics studies become necessary. In this trial, a new pharmaceutical preparation of tulathromycin (TTM) was submitted to a bioequivalence test, taking the reference preparation of this macrolide derivative as control i.e., the commercial preparation of TTM containing 100 mg of the drug Pisadrax ® , manufactured by PiSA Agropacuaria S.A. de C.V. and the reference brand of TTM Draxxin ® (Zoetis, Mexico). Twenty-four young steers Charolais/Brahman randomly divided into two groups of twelve animals each, received a single injection of 2.5 mg/kg subcutaneously of either preparation. A validated HPLC-masses analytical technique of plasma concentrations of tulathromycin was used to determine TTM plasma concentrations at fixed intervals for 240 h. The key pharmacokinetic parameters were obtained by compartmental and non-compartmental analysis. Results show that the experimental preparation of tulathromycin (Pisadrax ® ) can be regarded as bioequivalent to the reference one (Draxxin ® ) in steers, given that AUC0-240, MRT, and K½el values from both preparations resulted statistically indistinguishable and with confidence interval > 95%.","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":"33 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86857636","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":"Is Omicron, the New Variant, Deadlier than the Previous Strains?","authors":"Gul W","doi":"10.23880/beba-16000157","DOIUrl":"https://doi.org/10.23880/beba-16000157","url":null,"abstract":"","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":"83 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82391664","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":"Assessment of Oral Bioavailability of Vitamin D 3 and Its Metabolite, 25-hydroxy (OH) Vitamin D 3 in Male Sprague Dawley Rats Following a Single Oral Dose of Biofield Energy Treated Vitamin D 3","authors":"Jana S","doi":"10.23880/beba-16000147","DOIUrl":"https://doi.org/10.23880/beba-16000147","url":null,"abstract":"The present study was performed to determine the effects of The Trivedi Effect ® -Energy of Consciousness Healing Treatment on vitamin D 3 and rats through the pharmacokinetic parameters measurement of both plasma level of vitamin D 3 and 25-hydroxy (OH)-vitamin D 3 after the oral administration of vitamin D 3 in rats. The test item, vitamin D 3 was divided into two parts. One part was denoted as the control (without Biofield Energy Healing Treatment), while the other part was defined as the Biofield Energy Treated sample, which received the Biofield Energy Healing Treatment by renowned Biofield Energy Healer, Mahendra Kumar Trivedi. Additionally, one group of animals also received Consciousness Energy Healing Treatment per se by the Healer under similar conditions. Vitamin D 3 oral formulations were administrated by oral gavage at a dose of 500 μg per kg in groups viz. G1 (untreated Vitamin D 3 ), G2 (Biofield Energy Treated Vitamin D 3 ) and G3 (Biofield Energy Treated animals received untreated Vitamin D 3 ) group. The results showed that the relative oral exposure (AUC 0 –t) of vitamin D 3 was significantly increased by 155.62% and 111.73% in G2 and G3 groups, respectively as compared to the control group. Biofield Energy Treatment also significantly improved the plasma peak concentration (C max ) of vitamin D 3 by 223.84% and 187.5% in G2 and G3 groups, respectively as compared to the control group. This study results also showed that the relative oral exposure (AUC 0 –t) of 25-hydroxy (OH)-vitamin D 3 (metabolite) was significantly increased by 161.28% and 113.96% in G2 and G3 groups, respectively as compared to the control group (G1). Biofield Energy Treatment also significantly improved the plasma peak concentration (C max ) of 25-hydroxy (OH)-vitamin D 3 by 174.25% and 111.77% in G2 and G3 groups, respectively as compared to the control group. After oral administration, plasma concentrations of active metabolite, 25-hydroxy (OH)-vitamin D 3 in all three groups were declined slowly. The mean residence time (MRT last ) and elimination rate constant (K el ) for this metabolite were unaltered in all three groups. These data suggest that Biofield Energy Treated vitamin D 3 might be influenced in vivo biological activity of vitamin D 3 due to increased plasma exposure (AUC) of both vitamin D 3 and metabolite level, 25-hydroxy (OH)-vitamin D 3 in rats. There was significant improvement (>100%) of relative oral bioavailability of both vitamin D 3 and 25-hydroxy (OH)-vitamin D 3 that might be due to the alteration of physicochemical properties and thermal properties of vitamin D 3 by the Biofield Energy Treatment. Biofield Energy Healing Treatment could be an innovative strategy that opens new avenues to overcome poorly absorbed pharmaceuticals/nutraceuticals/herbal extracts and can also improve the therapeutic performance of orally active molecules.","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":"26 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88790725","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":"Bioequivalence and Pharmacokinetics of Carvedilol (6.25 and 12.5 Mg Tablets) in Healthy Thai Volunteers","authors":"K. V","doi":"10.23880/beba-16000156","DOIUrl":"https://doi.org/10.23880/beba-16000156","url":null,"abstract":"The Government Pharmaceutical Organization (GPO) had developed the generic products of carvedilol 12.5 and 6.25 mg tablets as low-cost alternatives for patients and physicians to enhance patient adherence and accessibility to long-term use medications. Two bioequivalence studies were conducted to evaluate the bioequivalence between the test and reference products of carvedilol 12.5 mg and 6.25 tablets. The design for both studies was comparative randomized, open-label, single- dose, two-way crossover. Carvedilol and 4′-hydroxyphenyl carvedilol (active metabolite) concentrations in plasma were simultaneously determined by a validated liquid chromatography tandem mass spectrometry method. The pharmacokinetic analysis was carried out for carvedilol and 4′-hydroxyphenyl carvedilol. The pharmacokinetic parameters describing the rate and extent of absorption of carvedilol (AUC 0-tlast , AUC 0-∞ and C max ) were used to conclude the bioequivalence between the test and reference products whereas the pharmacokinetic parameters of 4′-hydroxyphenyl carvedilol were presented as supportive information. The statistical analysis was calculated using an analysis of variance and did not show any significant difference between the two formulations. The 90% confidence intervals of the geometric least squares mean ratios (test/ reference) of ln-transformed AUC 0-tlast , AUC 0-∞ and C max were 98.54-106.94%, 98.54-106.56% and 90.70-104.84%, respectively for carvedilol 12.5 mg tablets, and 95.56-105.99%, 94.80-104.98% and 92.00-107.33%, respectively for carvedilol 6.25 mg tablets. The results were well within 80.00-125.00% corresponding to the bioequivalence criteria. Therefore, the generic carvedilol products (Carvolol) at both strengths are bioequivalent with the innovator products (Dilatrend) in terms of rate and extent of absorption. Similar findings were observed for 4′-hydroxyphenyl carvedilol, thus therapeutic equivalence between the test and reference formulations could also be anticipated. The products were well tolerated by the study subjects and no serious adverse events were reported in both studies.","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90949396","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":"Effect of Food on Bioavailability of Drug through Gastro-Retentive Drug Delivery System","authors":"S. S","doi":"10.23880/beba-16000148","DOIUrl":"https://doi.org/10.23880/beba-16000148","url":null,"abstract":"Gastro retentive drug delivery systems (GRDDS) have been explored for controlling the release of the drugs by oral administration. However, since these systems are intended to reside in the gastric region for longer period of time, several factors are expected to hamper the absorption rates of the drug in GRDDS. These systems are in contact with the gastric content for longer time and thus, “Food” is expected to interfere with the rate of absorption from these systems. This article focuses on various foods related factors responsible for affecting absorption from the GRDDS type of novel system.","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":"15 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88988929","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":"Bioequivalence of Oseltamivir Phosphate 6 mg/mL Powder for Oral Suspension Formulations in Healthy Thai Volunteers under Fasting Conditions","authors":"K. V","doi":"10.23880/beba-16000146","DOIUrl":"https://doi.org/10.23880/beba-16000146","url":null,"abstract":"Oseltamivir is an oral antiviral of choice indicated for treatment and prophylaxis of influenza A and B infections. Oseltamivir is an inactive prodrug of oseltamivir carboxylate, an active form exerting antiviral activity. Oseltamivir oral suspension is an alternative formulation for pediatric patients or adults with dysphagia. GPO-A-FLU ® , oseltamivir 6 mg/mL powder for oral suspension had been developed as a generic substitute for reference product, Tamiflu ® oral suspension. In this study, we investigated the pharmacokinetics and bioequivalence of the test oral suspension oseltamivir formulation with respect to the corresponding reference oral suspension formulation. A comparative open-label, randomized, single dose, two-way crossover study was conducted under fasting conditions. Blood samples were collected for 24 hours post-dose and the plasma was separated for oseltamivir assay using a validated liquid chromatography-mass spectrometry method. The pharmacokinetic parameters were determined from plasma concentration-time profiles after administration of the test and reference formulations. The pharmacokinetic parameters were in agreement with the previously published data. The primary pharmacokinetic parameters: AUC 0−tlast , AUC 0−  and C max obtained from 47 subjects who completed the study were statistically compared. The 90% confidence intervals of geometric least squares mean ratio (test/reference) for log-transformed parameters were within 80.00-125.00% of bioequivalence criteria: 92.33-98.52% for AUC 0−tlast , 92.28- 98.43% for AUC 0−  , and 81.82-94.26% for C max . Both products were generally well tolerated by healthy Thai subjects. This study successfully demonstrated bioequivalence between GPO-A-FLU ® and Tamiflu ® , and supported product registration.","PeriodicalId":8995,"journal":{"name":"Bioequivalence & Bioavailability International Journal","volume":"79 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81234917","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":"The Biofield Energy Treatment and its Effect on the Relative Oral Bioavailability of Lovastatin Hydroxy Acid in Rats after a Single Oral Dose of Lovastatin","authors":"Jana S","doi":"10.23880/beba-16000150","DOIUrl":"https://doi.org/10.23880/beba-16000150","url":null,"abstract":"Lovastatin is a lipid-lowering drug used to reduce the risk of cardiovascular disease. Lovastatin shows poor oral bioavailability (<5%) because of its low water solubility and short half-life. Therefore, the present study was performed to determine the effects of the Trivedi Effect ® - Consciousness Energy Treatment (Blessing) on lovastatin and rats through the measurement of plasma lovastatin hydroxy acid concentrations after the oral administration of lovastatin in rats. The test item, lovastatin was divided into two parts. One part was denoted as the control, while the other part was defined as the Biofield Energy Treated sample, which received the Biofield Energy Treatment for about 3 minutes by renowned Biofield Energy Healer, Dahryn Trivedi. Additionally, one group of animals also received Biofield Energy Treatment under similar conditions. The Biofield Energy Healer who was located in the USA, while the test samples and animals were located in the research laboratory in India. Lovastatin oral formulations were administrated by oral gavage at a dose of 50 mg/kg in groups viz . G1 (untreated lovastatin), G2 (Biofield Treated lovastatin), and G3 (Biofield Treated animals received untreated lovastatin) group. The majority of lovastatin was rapidly converted to its metabolite, i.e. , lovastatin hydroxy acid following the oral administration. The pharmacokinetic parameter, the C max of lovastatin hydroxy acid was significantly altered by 155.76% and -24.82% in G2 and G3, respectively compared to G1. The T max of lovastatin hydroxy acid was significantly increased by 254.55% in G2 and 51.52% in G3 compared to G1. The mean residence time of lovastatin hydroxy acid was also altered in G2 (-30.46%) and G3 (3.96%), as compared to the G1. The relative oral bioavailability (Fr) of lovastatin was significantly increased by 281.87% in the group G2 and 15.71% in the group G3 compared to the G1. These data suggest that the Biofield Energy Treatment could be considered as an innovative strategy that opens new avenues to improve the bioavailability of nutraceuticals/pharmaceuticals and can also modulate the therapeutic performance of orally active molecules. The Biofield Energy Treated lovastatin could be beneficial for the treatment of cardiovascular disease, which includes heart attack, stroke, atherosclerosis, coronary revascularization, coronary death, myocardial infarction, unstable angina, peripheral artery disease, abdominal aortic aneurysm, chronic kidney disease, etc.","PeriodicalId":8995,"journal":{"name":"Bioequivalence &amp; Bioavailability International Journal","volume":"32 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87179259","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":"A Typical Properties of Nanomaterials for Applications in Drug Delivery: A Review","authors":"L. S.","doi":"10.23880/beba-16000155","DOIUrl":"https://doi.org/10.23880/beba-16000155","url":null,"abstract":"Developing a new drug molecule is an interdisciplinary research. A new drug molecule takes 10-14 years to develop with a 0.01% success rate. The developed new drug is administered as conventional or sustained release dosage forms. Among the conventional and sustained release dosage forms, sustained release form has many advantages. In the 21 st century, nanotechnology has become an innovative field and the nanomaterials/nanoparticles made by this technology had specific atypical properties. An extensive research interest among the researchers made a new revolution and its application almost in all the fields. This nanotechnology in medicinal profession especially in drug delivery has developed several products for the treatment and cure of many diseases. This article summarizes the different nanomaterials, its atypical properties and outlines the different methods of nanoparticle preparations for applications in drug delivery","PeriodicalId":8995,"journal":{"name":"Bioequivalence &amp; Bioavailability International Journal","volume":"47 18","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91436686","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}