Journal of Bioequivalence & Bioavailability最新文献

{"title":"How Pitfalls during Drug Quantitation by Mass Spectrometry May Affect the Variability of Pharmacokinetic Data during a Bioequivalence Trial","authors":"G. Marcelín-Jiménez","doi":"10.4172/JBB.1000337","DOIUrl":"https://doi.org/10.4172/JBB.1000337","url":null,"abstract":"The majority of the time, during the performance of a bioequivalence trial, clinicians exercise extreme care in the selection of volunteers in order to obtain a homogeneous population, and control several sources of variation, such as diet, fasting period, hydration, and drug administration (among others), to the extent possible, to limit interand intra-individual variability and to achieve the statistical power required for the assay. In addition, monitoring staffs is charged with guaranteeing compliance with good clinical practices [1].","PeriodicalId":15184,"journal":{"name":"Journal of Bioequivalence & Bioavailability","volume":"1 1","pages":"430-431"},"PeriodicalIF":0.0,"publicationDate":"2017-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89454780","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 α-mangostin on Enhanced Transdermal Bioavailability of Gartanin via Efflux Transporters","authors":"P. Rukthong, N. Sereesongsang, T. Kulsirirat, B. Nimprayoon, K. Sathirakul","doi":"10.4172/JBB.1000344","DOIUrl":"https://doi.org/10.4172/JBB.1000344","url":null,"abstract":"Mangosteen (Garcinia mangostana L) is a tropical evergreen tree growing in Southeast Asia and has been used as traditional medicine treatment for skin wounds and infection. The pericarp crude extract can be isolated to fifty xanthone compounds, α-, β and γ-mangostins, gartanin etc. This study aimed to characterize and compare the transdermal transport of α-mangostin and gartanin when used alone and co-administered in human epidermal keratinocyte cells, neonatal (HEKn cells). The concentrations of the compounds were determined of by LC-MS/MS. In the absorptive direction, gartanin could not be detected during the entire 8 hour. Moreover, apparent permeability coefficient in secretory direction (Papp, B-A) was significantly higher than that of absorptive direction (Papp, A-B) but not found in α-mangostin. The results showed that after incubating the HEKn cells with rotenone, Papp, A-B of gartanin was significantly increased. In contrast, Papp, A-B of α-mangostin with and without rotenone was unchanged. For the mixture of gartanin and α-mangostin, α-mangostin had the similar inhibitory effect to the uptake and secretion of gartanin to the effect of rotenone. These indicated that the effect of efflux transporter of gartanin could be inhibited by α-mangostin and the permeability of gartanin in absorptive direction was achieved with co-administration of α-mangostin at high concentration. It is postulated that alpha-mangostin may act as a natural enhancer to improve the bioavailability of gartanin. The synergistic effect of the co-existing of the compounds in the natural extract may be important for therapy.","PeriodicalId":15184,"journal":{"name":"Journal of Bioequivalence & Bioavailability","volume":"15 10 1","pages":"455-462"},"PeriodicalIF":0.0,"publicationDate":"2017-06-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86661974","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":"Improving Treatment Outcomes for Tuberculosis","authors":"Z. Zwolska","doi":"10.4172/JBB.1000341","DOIUrl":"https://doi.org/10.4172/JBB.1000341","url":null,"abstract":"Major issues are currently associated with Tuberculosis (TB) treatment, particularly in patients infected by Multi-drug Resistant Tuberculosis/Extensively Drug Resistant Tuberculosis (mdr-TB/XDR-TB) resistant mycobacteria. A new threat recently reported in various Asian countries is totally Drug Resistant Tuberculosis (TDR). The presence of such Mycobacterium tuberculosis strains is disturbing also for the reasons they spread beyond the continent of Asia. \u0000The currently recommended tuberculosis treatment regimen is not well received by patients due to its minimum six-month, complexity, and common adverse events. The prevalence of MDR-TB and XDR-TB are inversely correlated with the quality of TB control and the proper use of second-line anti-TB drugs. Moreover, cost is extraordinary high. Since the mid-1960s only two new anti-TB drugs, bedaquiline and delamandine, have come to market; however, these drugs are not available in many regions and are limited to severely resistant cases. Currently, new derivatives such as spectinoamide are of interest in tuberculosis treatment. In vitro results and animal studies are used to aid in drug development. \u0000There is an urgent need for treatment improvement through enhancement of existing agents. Namely, individual differences in absorption and excretion of the primary anti-TB drugs, isoniazid and rifampin, require consideration. Recently, several studies attempted to evaluate the effect of anti-TB drug concentrations on treatment outcomes. Authors showed that 50-76% of the tested patients had low concentrations of INH (Isoniazid) and RMP (Rifampin). Because Therapeutic Drug Monitoring (TMD) was performed in small numbers of selected patients with comorbidities or slow treatment responses, the studies did not clearly demonstrate the effect of low drug levels on treatment outcomes. Future coordinated research is required. \u0000New molecular tests allow for research using supervised, individualized treatment of tuberculosis. In addition, effective tuberculosis outcomes require coordinated action multiple parameters for patient detection through implementation of rapid microbiological and clinical tests as well as reliable drug resistant tests of Mycobacterium tuberculosis. This leads to a break in the chain of transmission, and prevents the spread of disease in community. Education plays in important role for patients and families concerning the causes of disease and prevention methods. Additionally, medical staff should also themselves improve the level of diseases knowledge. Behaviour changes in tuberculosis infection control among medical personnel is also required. Keep in mind that one of the reasons for the relapse of tuberculosis is its disregard.","PeriodicalId":15184,"journal":{"name":"Journal of Bioequivalence & Bioavailability","volume":"270 1","pages":"442-446"},"PeriodicalIF":0.0,"publicationDate":"2017-06-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74939318","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":"An Overview on Stability of Extemporaneously Prepared Pharmaceutical Suspension","authors":"S. Naveed, F. Akhtar, S. Khan","doi":"10.4172/jbb.1000343","DOIUrl":"https://doi.org/10.4172/jbb.1000343","url":null,"abstract":"Aim: The aim of this study was to write review on stability studies of extemporaneous preparations. \u0000Materials and methods: Different methods are used for checking stability studies, depending on the nature of the preparations, like visual inspection, pH checking, different temperature storage, and HPLC. \u0000Results: It was found that the stability concern with the pharmaceutical suspensions includes the variation in both physical and chemical properties. Therefore, it is most important that formulator must ensure the efficacy of the formulation throughout the shelf life period. In this review article, method used for stability checking is valid and up to mark, so patient can use these extemporaneous preparations according to recommended period of time. \u0000Conclusion: We can conclude of our Stress studies that these suspensions cannot be stored over long period of time (average 90-120 days); but they are stable below 120 days (depending on the preparation) so we can have used these preparations because there is no stability issue if used in within recommended time-period, undeniably extemporaneously prepared suspensions can be a helpful for pediatric, geriatric and unconscious patients in drug dosing.","PeriodicalId":15184,"journal":{"name":"Journal of Bioequivalence & Bioavailability","volume":"70 1","pages":"452-454"},"PeriodicalIF":0.0,"publicationDate":"2017-06-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72729729","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":"Alpha-D-Galactosidase does not Interfere with Trimebutine OralPharmacokinetics in Mexican Healthy Volunteers","authors":"Penaloza Becerra CA, Ortega Escamilla E, Vasquez Vasquez JE, Marcelin Jimenez G, P Angeles Moreno AC, Garcia Gonzalez A, Laguna Leyte JS, Koretzky Sg, Batista Dieguez D, Lopez Sanchez P","doi":"10.4172/JBB.1000342","DOIUrl":"https://doi.org/10.4172/JBB.1000342","url":null,"abstract":"Gas production is a common symptom in bowel affections. There are different formulations to improve general symptoms, including motility regulators, such as trimebutine, and surfactants, such as simethicone, or both. These approaches, however, do not affect gas production. Methane, hydrogen, carbon dioxide, and water are generated in the intestines due to action of bacterial flora on non-digestible carbohydrates from the diet. The unfolding of these carbohydrates by specific enzymes promises greater improvement of symptomatology. Alpha-D-Galactosidase degrades these carbohydrates from diet. It is not known whether the addition of this enzyme modifies trimebutine pharmacokinetics. Thus, our aim was to assess whether the addition of Alpha-D-Galactosidase to a commercial formulation alters trimebutine oral pharmacokinetics. We conducted a controlled, cross-over, randomized, simpleblind, two-period, two-treatment, and two-sequence clinical trial on 30 healthy Mexican volunteers, receiving a single dose of reference product and test product. Pharmacokinetics and safety of usage were obtained. We measured N-desmethyl-trimebutine, the major metabolite of trimebutine. We showed that addition of galactosidase does not modify any pharmacokinetic parameter significantly. Safety of the subjects was not affected. We conclude that alpha-D-Galactosidase does not modify oral pharmacokinetics of trimebutine, rendering this approach suitable for commercial use in indicated bowel affections.","PeriodicalId":15184,"journal":{"name":"Journal of Bioequivalence & Bioavailability","volume":"17 1","pages":"447-451"},"PeriodicalIF":0.0,"publicationDate":"2017-06-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83217855","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 Decision-Theoretical Perspective on Bioequivalence","authors":"Long Nt","doi":"10.4172/JBB.1000339","DOIUrl":"https://doi.org/10.4172/JBB.1000339","url":null,"abstract":"Bioequivalence is a term used for the property of two treatments, formulations, or medical products (henceforth treatments) that their effects in a specified population are identical, or that the treatments can be interchanged without any differential therapeutic impact. In most contexts, ‘identical’ is qualified by ‘for all intents and purposes’, is acknowledged to mean ‘similar’, or is meant to be interpreted as such. In established approaches, providing evidence of bioequivalence amounts to rejecting the hypothesis that the difference of the average effects of the two treatments, Δ, is distant from zero-that the two-average treatment effects are dissimilar. A study to provide such evidence should start by defining the borderline between similar and dissimilar. It comprises a positive and a negative value, Δ+ > 0 and Δ< 0, or the interval they delimit, which contains zero. If we knew that the treatment effect is within this interval we would declare bioequivalence (B), and would declare dissimilarity (D) otherwise. Setting both δ and δ to zero corresponds to a dichotomy that is false because with such a degenerate borderline it would be safe to conclude that bioequivalence is absent. After all, there are uncountably many alternatives to the exact zero, and uncountably many of them are arbitrarily close to zero [1].","PeriodicalId":15184,"journal":{"name":"Journal of Bioequivalence & Bioavailability","volume":"9 1","pages":"437-438"},"PeriodicalIF":0.0,"publicationDate":"2017-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78547062","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":"Enhanced Bioavailability and Anticancer Activity of Vitamin Analogs","authors":"Kakullamarri Pr, R. Kln","doi":"10.4172/JBB.1000340","DOIUrl":"https://doi.org/10.4172/JBB.1000340","url":null,"abstract":"There is increased evidence to show that dietary supplementation of vitamins contributes to cancer prevention and also therapy. This paper explains the anticancer activity of few vitamins and the necessity of preparing their analogs to enhance their bioavailability. While the vitamin supplementation is needed in various health disorders, over supplementation of the same may not be effective due to failure to reach over maximal concentrations in the body. Vitamin mediated anticancer activities include cell cycle progression inhibition, targeting cell survival, inducing autophagy or apoptosis, inhibiting hypoxia, eradication of oxygen free radicals and immune modulation. As the in vitro data seems sufficient to support vitamin biological effects, advanced research is needed to support their in vivo activity and long-term treatment.","PeriodicalId":15184,"journal":{"name":"Journal of Bioequivalence & Bioavailability","volume":"31 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2017-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84312209","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":"Ventilator-Associated Pneumonia (VAP): Clinical Strategies, TreatmentChallenges and Economic Concerns","authors":"S. Zubair, H. Ali, F. Zafar, A. E. Beg, Ali Akbar Sial, S. Naveed, S. Saleem, A. Tariq","doi":"10.4172/JBB.1000338","DOIUrl":"https://doi.org/10.4172/JBB.1000338","url":null,"abstract":"The clinical and economic features of Ventilator-Associated Pneumonia (VAP) are quite unclear, with an extensive array of values and contradictory results. The real challenge in this connection is to present the real estimate of the clinical and associated economic consequences of VAP. In developing countries like Pakistan, it is important to formulate an optimal institutional antimicrobial policy that can be used as a guide for empirical/prophylactic and specific therapies of antibiotics in VAP with more rational approach to lessen the rates of mortality and morbidity, decline the length of treatment and hospitalization and the significant impact in prevention of development of multidrug resistant strains and cost reduction.","PeriodicalId":15184,"journal":{"name":"Journal of Bioequivalence & Bioavailability","volume":"94 1","pages":"432-436"},"PeriodicalIF":0.0,"publicationDate":"2017-06-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77010249","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 novel in vitro method to analyse the performance of subcutaneous formulations","authors":"Jesus B Alonso","doi":"10.4172/0975-0851-C1-030","DOIUrl":"https://doi.org/10.4172/0975-0851-C1-030","url":null,"abstract":"","PeriodicalId":15184,"journal":{"name":"Journal of Bioequivalence & Bioavailability","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2017-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76347153","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 Accepted “Clinical Interaction Model”: A Special Case of Reality","authors":"J. Kristiansen, S. Fey","doi":"10.4172/JBB.1000335","DOIUrl":"https://doi.org/10.4172/JBB.1000335","url":null,"abstract":"Pharmacology has focussed on the effects of compounds on tissues and organs with a view to promoting the well-being of a patient. This has been a special case of ‘reality’. With the dual realisation that these compounds can also have effects on microorganisms living in and on the patient and that these microorganisms play a vital role in maintaining the health of the patient it is essential that we modify our perspective to include the host, the microorganisms and compounds that affect either into a general theory for pharmacology.","PeriodicalId":15184,"journal":{"name":"Journal of Bioequivalence & Bioavailability","volume":"5 1","pages":"418-423"},"PeriodicalIF":0.0,"publicationDate":"2017-05-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88513680","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}