Preferred Language
Articles
/
bijps-367
Bioequivalence and Pharmacokinetics Comparison of Two Formulations of Extended-Release Pentoxifylline Tablets in Healthy Subjects after Fasting and Fed Conditions
...Show More Authors

The pharmacokinetics and bioequivalence of a newly developed extended-released (ER) tablet containing 400 mg pentoxifylline as a test product was compared with the reference brand product Trental® 400 mg ER tablet produced by Sanofi-Aventis. Two separate studies were conducted simultaneously. The first study was conducted under fasting condition, whereas, the second study was conducted under fed condition; using the same batches of the test and reference products in both studies. In each study, both products were administered to 32 healthy male adult volunteers applying a single-dose, two-treatment, two-period, two-sequence, randomized crossover design with one-week washout period between dosing. Twenty two blood samples were withdrawn from each volunteer over 24 hours period.  Pentoxifylline concentrations were determined in plasma by a validated HPLC method according to FDA Bioanalytical Method Validation Guidance using UV detection and chloramphenicol as internal standard. The lower limit of quantitation of the drug in plasma was 5 ng/ml and the upper limit of quantitation was 500 ng/ml. From the plasma concentration-time data of each individual, the pharmacokinetic parameters; Cmax,  AUC0-t, AUC0-Â¥, Cmax/AUC0-Â¥, Tmax, lZ & T0.5; were calculated applying non-compartmental analysis. Data of the test and reference products were statistically analyzed to test for bioequivalence of the two products, using criteria of FDA and EMEA Guidance.  The pharmacokinetic parameters mentioned above were statistically analyzed by descriptive statistics, ANOVA test and 90% Confidence Interval (CI). ANOVA test involved the calculation of the effects of: treatment, period, sequence and subjects nested in sequence. According to the above guidance, the primary pharmacokinetic parameters used for bioequivalence testing, namely Cmax, AUC0-t and AUC0-Â¥ were also statistically analyzed by ANOVA & CI tests using the corresponding Ln-transformed values. The mean values  Cmax,  AUC0-t , AUC0-Â¥ , Cmax/AUC0-Â¥ , Tmax, lZ & T0.5 for the test formula obtained from the fasting study  were; 144.4 ng/ml,  845.4 ng.hr/ml, 868.4 ng.hr/ml, 0.186 hr-1, 3.29 hr, 0.561 hr-1 and 1.65 hr, respectively; and the mean values of these parameters for the reference formula were; 150.0 ng/ml,  871.1 ng.hr/ml, 893.7 ng.hr/ml, 0.177 hr-1, 3.70 hr, 0.558 hr-1 and 1.59 hr,  respectively.  The mean values of the above mentioned parameters for the test formula obtained from the fed study were; 157.8 ng/ml, 826.5 ng.hr/ml, 853.8 ng.hr/ml, 0.198 hr-1, 5.4 hr, 0.458 hr-1 and 2.06 hr, respectively; and the mean values of these parameters for the reference formula were; 162.1 ng/ml, 869.7 ng.hr/ml, 894.8 ng.hr/ml, 0.196 hr-1, 4.1 hr, 0.525 hr-1 and 1.80 hr, respectively.  Based on criteria of FDA and   EMEA Guidance on Bioavailability and Bioequivalence, the results of the fasting and fed studies demonstrated bioequivalence of the two products under either condition. Accordingly, it is concluded that the newly developed ER tablet containing 400 mg pentoxifylline is bioequivalent to Trental® 400 mg ER tablet produced by Sanofi-Aventis.

Keywords: Pentoxifylline, Pharmacokinetics, Bioequivalence.

Crossref
View Publication Preview PDF
Quick Preview PDF
Publication Date
Tue Aug 24 2021
Journal Name
Agronomy
Impact of Nitrogen Rate in Conventional and Organic Production Systems on Yield and Bread Baking Quality of Soft Red Winter Wheat
...Show More Authors

Soft red winter wheat (SRW) is characterized by high yield and relatively low protein content. In Kentucky, there is growing demand from local artisan bread bakers for regionally produced flour, requiring production of grain with increased protein content and/or strength. The objective of this two-year field experiment was to evaluate the effect of nitrogen (N) management on five cultivars of winter wheat on yield and bread baking quality traits of modern and landrace SRW cultivars (Triticum aestivum L.). All five cultivars were evaluated using two N application rates in conventional and organic production systems. All traits measured were significantly affected by the agricultural production system and N rate, although plant height

... Show More
View Publication
Scopus (5)
Crossref (6)
Scopus Clarivate Crossref
Publication Date
Thu Jul 20 2023
Journal Name
Polymers In Medicine
Effect of subinhibitory doses of rifaximin on in vitro Pseudomonas aeruginosa adherence and biofilm formation to biotic and abiotic surface models
...Show More Authors

View Publication Preview PDF
Scopus (4)
Crossref (1)
Scopus Crossref
Publication Date
Sun Jun 23 2019
Journal Name
Journal Of The College Of Basic Education
Viscometric and Activation energy study of PEG 6000 in water, and solution of DMSO with water at 298.15 k, 308.15, 318.‏
...Show More Authors

Publication Date
Sun Feb 01 2026
Journal Name
Al–bahith Al–a'alami
THE RESPONSIBILITY OF INDEPENDENT IRAQI NEWSPAPERS IN PROMOTING THE VALUES OF CITIZENSHIP AND NATIONAL BELONGING IN THE SOCIETY: (An Analytical Study in the Opinion Articles in the Newspapers of Al-Sabah Al-Jadeed and Al-Mada)
...Show More Authors

The research problem stems from a chief question: “What is the nature of the responsibility that «Al-Sabah Al-Jadeed» and «Al-Mada» Newspapers have undertaken in promoting the values of citizenship and national belonging in the society? The research aims to achieve a number of goals, including: Determining the most prominent themes that were emphasized in the opinion articles in these two newspapers within the framework of the responsibility of promoting the values ​​of citizenship and national belonging in society, and revealing the most prominent topics that were discussed in opinion articles in the two sample newspapers regarding the promotion of the mentioned values. This research is a desc

... Show More
View Publication Preview PDF
Crossref
Publication Date
Sat Feb 09 2019
Journal Name
Journal Of The College Of Education For Women
Employment and Societal Changes in Iraq Challenges and Policies
...Show More Authors

This study attempts to focus on there lation ship between employment policies andsocietal changesinIraq.Theconstruction ofoperational policyincommunitiesin crisis remains fraught with challenges and risks, especially in countries that have longoutstanding conflict sand crises, it is important in this context to achieve those policy and build the foundations of human security and poverty alleviation, unemployment, to find effective ways to help the community to achieve stability and reduce the risk of renew edorrepeat the cycleofviolence-butthatwouldrequirearadicalrethinking, including rethinking the way evaluating therisksandchallengesand management.And thatsuchaprojectshouldbe based ona clear roadmap, andthevisionsofdevelopmentanda clea

... Show More
View Publication Preview PDF
Publication Date
Thu Jun 30 2016
Journal Name
Al-kindy College Medical Journal
Obesity and its co morbidities in children and adolescents
...Show More Authors

Background: Obesity has become one of the most important public heath problems all over the world.An epidemic of obesity is affecting children and adolescents across the developed and developing countries in recent years. As the prevalence of obesity increased, so did the prevalence of co morbidities like metabolic and endocrine diseases.Objectives: To overview obesity clinical features and the prevalence of associated co morbidities in children and adolescents attended the obesity researches and therapy center in Alkindy medical collage.Type of study: This is a cohort observational studyMethods : Obese child and adolescents aged 4-15year attended the obesity research and therapy unit in AL Kindy medical collage from the 1st of September

... Show More
View Publication Preview PDF
Publication Date
Sat Aug 01 2015
Journal Name
Journal Of Engineering
Values and technology in architecture - the impact and vulnerability
...Show More Authors

Technology is an important factor for achieving architecture as an impact and vulnerability. It represents one of the significant elements in creating the intellectual framework, as well as having its own intellectual breakdown, while values constitute the most important and obviously factor of the community's intellectual. Research aims was determined accordingly by: investigating the role and impact of values and their relationship to technology in architecture.

In this context, the research investigated values and technology in architecture, through discussing their aspects and dimensions in architecture. In the context of values, the research discussed their concept and the related ones to have a concrete def

... Show More
View Publication Preview PDF
Publication Date
Wed Dec 07 2011
Journal Name
Journal Of Planner And Development
centralization and decentralization in Iraq and its future prospects
...Show More Authors

Centralization and decentralization, planning and development, and community participation in the management of its affairs and to activate all the abilities that multiple methods aimed at creating the proper environment for the growth and development of society in the place where he lives. As long as the overall trend in Iraq, represented by the Permanent Constitution of decentralization to regions and provinces, the solutions to the obstacles that may face this transition in some respects presents ways of coordination and integration between multiple levels of planning which can be exercised by the schematic in the future the organization. In this paper some of the visions and ideas that can  contribute to the organization

... Show More
View Publication Preview PDF
Publication Date
Sun Dec 06 2015
Journal Name
Baghdad Science Journal
The effect of aqueous crude extract of ginger on the histology of corpus luteum and the concentration of hormones estrogen and progesterone in pregnant mice
...Show More Authors

This study was designed to investigate the effect of aqueous extract of ginger Zingiber officinale Roscoe on the histology of corpus luteum and the concentration of the hormones progesterone and estrogen during the first trimester of pregnancy (0 - 7) days from fertilization. 30 pregnant mice were divided into five experimental groups: control group (administrated with distilled water), and four groups treated at doses (284, 568, 1136,1420 mg / kg), orally administrated , daily with (0.1 ml). Microscopic examination results have shown histopathological changes in corpus luteum included: Pyknosis in some nuclei of granulosa cells, Karyorrhexis, Karyolysis in some granulosa cells, and necrosis in corpus luteum, with additional significant dec

... Show More
View Publication Preview PDF
Crossref
Publication Date
Sun Dec 07 2008
Journal Name
Baghdad Science Journal
Measurements of Radon-222 and its Daughters Concentrations in Buildings of Department Physics in College of Sciences of Baghdad University
...Show More Authors

The present work aims to investigate approaches, measures and detection of indoor radon level in buildings of the department of physics in college of science of Baghdad University. CR-39 solid state nuclear track detectors were used to measure the radon concentrations inside the rooms, including five laboratories and five workplace rooms in ground and first storey of the department. The average radon concentration at first storey was found to be 43.1±13.2 Bq/m3 and 40.1±13.4 Bq/m3 at the ground storey. The highest level of radon concentration at the first storey in the radioactive sources store was 87.5±29 Bq/m3 while at the ground storey in room(2) was 70.2±24 Bq/m3 which is due to the existence radioactive sources in some selected

... Show More
View Publication Preview PDF
Crossref