Journal of Bioequivalence & Bioavailability最新文献_第8页

Circumventing Polysorbate Induced Unwanted Immunogenicity and Anaphylaxis 规避聚山梨酯诱导的不良免疫原性和过敏反应

Journal of Bioequivalence & Bioavailability Pub Date : 2017-09-01 DOI: 10.4172/JBB.1000352

Maggio Et

引用次数: 0

Lipid Fluidity as an Essential Therapeutic Tool for Cell Pathology 脂质流动性是细胞病理学的基本治疗工具

Journal of Bioequivalence & Bioavailability Pub Date : 2017-08-24 DOI: 10.4172/JBB.10000E80

S. Ayrapetyan

引用次数: 0

Formulation and Pharmacokinetics of Ketorolac Tromethamine Floating Compression Coated Mini-Tablets 酮咯酸三甲胺漂浮压缩包衣迷你片的处方及药动学研究

Journal of Bioequivalence & Bioavailability Pub Date : 2017-08-08 DOI: 10.4172/JBB.1000351

Vemula Sk, Venisetty Rk, Veerareddy Pr

{"title":"Formulation and Pharmacokinetics of Ketorolac Tromethamine Floating Compression Coated Mini-Tablets","authors":"Vemula Sk, Venisetty Rk, Veerareddy Pr","doi":"10.4172/JBB.1000351","DOIUrl":"https://doi.org/10.4172/JBB.1000351","url":null,"abstract":"Present research is intended to develop the Ketorolac Tromethamine (KTM) effervescent floating mini-tablets using compression coating method. Mini-tablets have the advantages of both tablets and multiparticulate formulations such as pellets. The main principle of floating mini-tablets can be applied to decrease the irritant effect of KTM on the stomach by avoiding the direct contact with the gastric mucosa and obtaining a low dosage for prolonged periods. KTM mini-tablets were prepared using 4 mm round flat punches and compression coated with hydroxypropyl methylcellulose and effervescent mixture. The prepared tablets were evaluated for weight variation, thickness, friability, hardness, drug content, in vitro buoyancy and in vitro release and the best formulation was subjected to further in vivo examination. The prepared mini-tablets exhibited satisfactory physicochemical characteristics. Formulation F3 offered the best controlled drug release (99.46 ± 0.93% in 12 h and T80%=9.4 h) along with floating lag time 12 h. Pharmacokinetic studies of F3 formulation in male albino rabbits showed 2.25-fold higher bioavailability and 1.35-fold higher Cmax compared to immediate release core mini-tablets. Hence development of KTM effervescent compression-coated floating mini-tablets is the best way to give through oral route to maximize the therapy.","PeriodicalId":15184,"journal":{"name":"Journal of Bioequivalence & Bioavailability","volume":"60 1","pages":"493-498"},"PeriodicalIF":0.0,"publicationDate":"2017-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89404028","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: 4

600 mg Oxcarbazepine Tablets Bioequivalence Study 600 mg奥卡西平片生物等效性研究

Journal of Bioequivalence & Bioavailability Pub Date : 2017-08-04 DOI: 10.4172/JBB.1000350

M. Vargas, Villarraga Ea

{"title":"600 mg Oxcarbazepine Tablets Bioequivalence Study","authors":"M. Vargas, Villarraga Ea","doi":"10.4172/JBB.1000350","DOIUrl":"https://doi.org/10.4172/JBB.1000350","url":null,"abstract":"Bioequivalence studies are evidence of generic drugs quality, demonstrating that the rate and quantity of effective substance absorbed from each of the studied formulations, showed no significant differences. The aim of the pharmacokinetic study of the two formulations, containing 600 mg of Oxcarbazepine, is to analyse bioavailability between the Test Product (Oxicodal® from Synthesis Laboratory S.A.S, Colombia) and the Reference Product (Trileptal® from Novartis Laboratory) and to affirm the Bioequivalence. Therefore, a study was developed in 24 healthy volunteers; an open, four periods and four randomized sequences, with one dose of 600 mg during fasting and postprandial conditions, and 7-day wash time between each period study. Conducting the study in 4 periods obeys the need to know if there are differences in relation to the presence or not of food during the bioavailability of the formulations studied. The benefits sought in this study are to offer public health a guarantee of quality, safety and inter-changeability of the drugs studied to increase the population's access to generic medicines. \u0000 \u0000The analytical method used was HPLC chromatography UV detector. The 90% confidence interval for the parameters Cmax, AUC0-t and AUC0-∞, according to European guidelines and the FDA is within the permitted ranges for the declaration of bioequivalence and compatibility of the Synthesis S.A.S (Colombia) product Oxicodal®, with the Novartis Laboratories Reference Product Trileptal®, for both feeding conditions, fasting and postprandial.","PeriodicalId":15184,"journal":{"name":"Journal of Bioequivalence & Bioavailability","volume":"77 1","pages":"489-492"},"PeriodicalIF":0.0,"publicationDate":"2017-08-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76776206","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: 1

Bioequivalence Study of Imatinib Formulations that Contain 400 mg in Healthy Colombians 含400mg伊马替尼制剂在健康哥伦比亚人体内的生物等效性研究

Journal of Bioequivalence & Bioavailability Pub Date : 2017-07-31 DOI: 10.4172/JBB.1000349

M. Vargas, E. Villarraga

引用次数: 2

Comparative Bioavailability Study of Two 81 mg Coated Tablet Formulations of Acetylsalicylic Acid in Fasting Healthy Volunteers 两种81 mg乙酰水杨酸包衣片在空腹健康志愿者体内的生物利用度比较研究

Journal of Bioequivalence & Bioavailability Pub Date : 2017-07-31 DOI: 10.4172/JBB.1000348

Dolores Rc, Antunes Nj, Moreno R, Di Vaio P, Magli E, De Nucci G

{"title":"Comparative Bioavailability Study of Two 81 mg Coated Tablet Formulations of Acetylsalicylic Acid in Fasting Healthy Volunteers","authors":"Dolores Rc, Antunes Nj, Moreno R, Di Vaio P, Magli E, De Nucci G","doi":"10.4172/JBB.1000348","DOIUrl":"https://doi.org/10.4172/JBB.1000348","url":null,"abstract":"Introduction: Low-dose acetylsalicylic acid is used as antithrombotic agent and the enteric-coated formulations are widely used to minimize the gastrointestinal side effects. \u0000Aim: To compare the bioavailability of two acetylsalicylic acid formulations (Ecasil-81®, 81 mg coated tablet) in fasting healthy volunteers. \u0000Methods: Healthy volunteers (n=16) were recruited to a monocentric, open label, randomized, two-way crossover pharmacokinetic study, with seven days washout period between the treatments. They received a single 81 mg oral dose of a test (new formulation) or a standard reference formulation of acetylsalicylic acid (Ecasil-81®) after about 8 h fasting. Blood samples were collected over a period of 36 h. The salicylic acid plasma concentration was evaluated by high-performance liquid chromatography coupled to tandem mass spectrometry (HPLC-MS/MS). Noncompartmental pharmacokinetic analysis was performed using the WinNonlin program. \u0000Results: The maximum plasma concentration (Cmax) of salicylic acid was 5433 and 5719 ng/mL reached in 3.66 and 4.02 h (tmax) for the test and the reference formulation, respectively. The 90% confidence interval of the ratios of geometric means of Cmax and area under curve of plasma concentration until the last concentration observed (AUC0- last) were within the interval 80-125%. \u0000Conclusion: The new acetylsalicylic acid formulation has a bioavailability equivalent to the reference formulation for the rate and the extent of absorption.","PeriodicalId":15184,"journal":{"name":"Journal of Bioequivalence & Bioavailability","volume":"45 1","pages":"477-483"},"PeriodicalIF":0.0,"publicationDate":"2017-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86973244","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: 3

Dengue Fever in Pakistan, Episodes of Epidemic to Endemic: Treatment Challenges, Prevention and Current Facts 巴基斯坦的登革热，从流行到地方病:治疗挑战、预防和当前事实

Journal of Bioequivalence & Bioavailability Pub Date : 2017-07-28 DOI: 10.4172/JBB.1000347

Ali H, Alvi A, Fatima S, Zafar F, Naveed S, Khan K, Ali U, Tariq A, Naqvi Gr, Mallick N

{"title":"Dengue Fever in Pakistan, Episodes of Epidemic to Endemic: Treatment Challenges, Prevention and Current Facts","authors":"Ali H, Alvi A, Fatima S, Zafar F, Naveed S, Khan K, Ali U, Tariq A, Naqvi Gr, Mallick N","doi":"10.4172/JBB.1000347","DOIUrl":"https://doi.org/10.4172/JBB.1000347","url":null,"abstract":"Dengue a majorly imperative arthropod-borne infection of viral origin has stroked the humans Worldwide. It has been estimated that about 2.5 billion inhabitants are at threatened by this infection around the globe. Dengue fever has become pandemic-prone viral disease prevailing all over subtropical and tropical regions. Majorly four characteristics of closely related serotypes of dengue are DENV-1, DENV-2, DENV-3 and DENV-4. Dengue fevers pass on by the bite of an infected female Aedes aegypti mosquito. The topmost ailments include; internal bleeding, Dengue Hemorrhagic Fever (DHF) which may lead to Circulatory Shock Syndrome (CSS), high temperature, cold like illness, urticaria, severe joint pain, thrombocytopenia and heme-concentration. From the recent years, this \"break-bone fever\" has become out breaking viral disease in Pakistan because Urbanization provided the ideal environment for these mosquitoes which includes presence of stagnant water in indoor drainage holes, contaminated water for drinking, poverty, immune compromised individuals and insufficient medical facilities. Such causative factors embrace viral disease that brings about high rate of mortality and morbidity. But nowadays, rational prescribing and the facilities provided by pharmaceutical care has become necessary element of health care for achieving definite outcomes that can improve a patient's quality of life.","PeriodicalId":15184,"journal":{"name":"Journal of Bioequivalence & Bioavailability","volume":"329 1","pages":"473-476"},"PeriodicalIF":0.0,"publicationDate":"2017-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74064479","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: 12

Fibrosis-Induced Abnormalities of the Cardiac Conduction System andMalignant Arrhythmias in Patients with Chagas Disease 恰加斯病患者纤维化诱导的心脏传导系统异常和恶性心律失常

Journal of Bioequivalence & Bioavailability Pub Date : 2017-07-24 DOI: 10.4172/JBB.10000E79

Centurión Oa, García Lb

引用次数: 0

Policy Practices to Maximise Social Benefit from Biosimilars 最大化生物仿制药社会效益的政策实践

Journal of Bioequivalence & Bioavailability Pub Date : 2017-07-17 DOI: 10.4172/JBB.1000346

A. Inotai, M. Csanádi, D. Vitezić, I. Francetic, T. Tesar, T. Bochenek, L. Lorenzovici, P. Dylst, Z. Kaló

{"title":"Policy Practices to Maximise Social Benefit from Biosimilars","authors":"A. Inotai, M. Csanádi, D. Vitezić, I. Francetic, T. Tesar, T. Bochenek, L. Lorenzovici, P. Dylst, Z. Kaló","doi":"10.4172/JBB.1000346","DOIUrl":"https://doi.org/10.4172/JBB.1000346","url":null,"abstract":"Biosimilar medicines can generate savings to the society. However, if patient access to original biologic medicines is limited, the main benefit of biosimilar medicines is to treat more patients from the same health care budget and hence generate more health gain. \u0000The aim of this policy paper is to provide recommendations on how to maximise the value proposition of biosimilar medicines in lower income countries with more limited health care resources. \u0000From the clinical perspective, first line use of multi-source, off-patent biologics should be considered for all treatment naive patients before prescribing any other patented biologic therapies without major added benefit. Systematic literature reviews indicate that significant and quantifiable economic benefits from switching patients on maintenance biologic to biosimilars should not be sacrificed for non-quantifiable and fairly low risks of immunogenicity, hence a single switch of patients from an original biologic to its biosimilar alternative under medical supervision should be mandated after patent expiry. \u0000From the health economic perspective authors advocate the use of cost-utility analysis to evaluate the full economic value of biosimilars. In sensitivity analyses decision-makers can explore the level of risk associated with immunogenicity, where switch of patients treated by original biologics is not the preferred policy approach anymore. However, authors still advocate the collection of real world pharmacovigilance data after switching patients to biosimilars, and reassessment of cost-effectiveness ratio after more real-world data becomes available. \u0000Appropriateness of biosimilar drug policies is equally important to market access of new biologic therapies in lower income countries.","PeriodicalId":15184,"journal":{"name":"Journal of Bioequivalence & Bioavailability","volume":"8 1","pages":"467-472"},"PeriodicalIF":0.0,"publicationDate":"2017-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89538332","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: 18

Anticancer Agents in Combination with Statins 抗癌药物与他汀类药物联合使用

Journal of Bioequivalence & Bioavailability Pub Date : 2017-07-12 DOI: 10.4172/JBB.1000345

Mohammad Adnan, K. Mohammad, Mohammad Emdad Hossain Manik

引用次数: 6