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Bioequivalence and Pharmacokinetics Comparison of Two Formulations of Extended-Release Pentoxifylline Tablets in Healthy Subjects after Fasting and Fed Conditions
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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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.

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Publication Date
Sat Feb 01 2020
Journal Name
Journal Of Economics And Administrative Sciences
The role of merger in creating differences in the profitability of companies Analytical research between a sample of subsidiaries to the Iraqi Ministry of Industry and Minerals
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The research aims to identify the impact of the merger of the companies affiliated to the Ministry of Industry and Minerals on their financial profitability since the companies before the merger suffered a rise in losses and the deficit reached very high levels that affected its overall performance and even on the morale of workers as losses are increasing and solutions Efficiency is absent. The problem stems from knowing the impact of the merger on the profitability ratios of the companies. The research field was represented by the companies affiliated to the Ministry of Industry and Minerals (21) companies, while the research sample reached (6) companies after the merger (14) companies before the merger, was based on data The f

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Publication Date
Wed Sep 01 2021
Journal Name
Baghdad Science Journal
Effects of Nitrogen and Sulfur Sprays on the Growth and Production of Broccoli Brassica Oleracea var. Italica L.: nitrogen and sulfur spray enhance broccoli growth and production
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In order to achieve optimal plant growth and production, essential nutrients must be readily available in adequate quantities and in a balanced proportion to give a good yield, especially broccoli which has health benefits that may not be found in many other plants. For this purpose, this experiment was carried out during the seasons 2019/2020 in the botanical garden of the Department of Biology, College of Science for Women, University of Baghdad, to study the effects of nitrogen and sulphur and their interaction on eight parameters reflecting the overall traits of vegetative growth, yield, and chlorophyll content of broccoli Brassica oleracea L. (var. italic JASSMINE F1 Hybrid). A factorial design with three replicates was use

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Publication Date
Thu Oct 25 2018
Journal Name
Al–bahith Al–a'alami
War Reporters In Iraqi Satellite Channels And Its Role In Increasing Understanding Of The Audience Of The News .: Field Study For The Reporters And The Audiences In Baghdad For The Period From 1/07/2014 Till – 1/11/2014
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The importance of media coverage in the war remains dependent on many indicators for its success, the most important is to have qualified reporters who carry the war news professionally. The idea of this research is to determine the role played by war correspondents working on Iraqi satellite channels during the war against ISIS.
The researcher has chosen ( 40 ) reporters those who was able to contact them and prepared a questionnaire for them to study their situations. Also, he chose an intentional sample from Baghdad audience on condition they should be informed by the performance of the reporters in the satellite channels applying the hypotheses of the theory of depending upon media.
The most important results reached by the re

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Publication Date
Mon Feb 01 2021
Journal Name
International Medical Journal
Use of immunohistochemistry and silver in situ hybridization (Sish) in evaluation of human epidermal growth factor receptor2 (HER2/neu) status in Iraqi patients with breast cancer
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Breast cancer is the commonest cause of cancer related death in women worldwide. Amplification or over-expression of the ERBB2 (HER/neu) gene occurs in approximately 15-30% of breast cancer cases and it is strongly associated with an increased disease recurrence and a poor prognosis. Determination of HER2/neu status is crucial in the treatment plan as that positive cases will respond to trastuzumab therapy. It has been used to test for HER2/neu by immunohistochemistry as a first step and then to study only the equivocal positive cases (score 2+) by in situ hybridization technique. The aim of our study is to compare between immunohistochemistry and silver in situ hybridization (SISH) in assessment of human epidermal growth factor (HER2/neu)

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Scopus
Publication Date
Sun Dec 31 2017
Journal Name
College Of Islamic Sciences
Sections of beliefs and area of endeavor
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Research summary

 


The researcher in theological sects finds that the controversial issues between the owners of the sects are many, filled with the books of the sects, articles and creeds, and when examining these books it became clear to us that the dispute is related, some of it is related to the meaning and some of it is related to the words and it is many, explained to us by rhetorical terminology such as guidance and delegation, Interpretation and others, and part of it is what is called the verbal disagreement, and sometimes it is by using common possible expressions of truth and falsehood, as in the saying of the Kharijites, “The judgment is only for God,” and some of it is related to something outside th

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Publication Date
Sat Oct 01 2016
Journal Name
Al–bahith Al–a'alami
Semiotics of Picture and News
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It has become familiar to see alchemy as a methodological approach that combines conscious, diverse, psychological, social, structural, and discrete approaches in the communications technology that Marshall McLuhan found to be able to extend our bodies and senses, The media discourse has a deep and superficial structure produced by the first, with its social, cultural and historical backgrounds, in a context that connects the image with the word, as the "meanings are made" - everywhere, as described by Jonathan ) In fashion, in the arts as a whole, and from its "signs" Our analysis of «meaning», in the media, and communication through advertising, magazines, newspapers, television, and the Internet. Therefore, alchemy is preoccupied wi

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Publication Date
Fri Apr 12 2019
Journal Name
Journal Of Economics And Administrative Sciences
The Role of Integration Between The Target Costing and Resource Consumption Accounting Techniques in Reducing Costs and Supporting Competitive Advantage - Analytical Study of The Opinions of a Sample of Employees of The Babylon Cement Factory.
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Abstract

The purpose of this research is to develop a proposed framework for achieving the Integration of the Target Cost and Resource Consumption Accounting Techniques and to show the role they play in reducing products costs and supporting the competitive advantage to cope with contemporary changes. To achieve this goal, the researchers followed the analytical method using the statistical questionnaire as a means of collecting data from the research sample include accounting, administrative, technical, engineering staffs and others. The research sample consists of (56) individuals and for the purpose of conducting statistical analysis of the data and testing hypotheses, the statistical program (SPSS) wa

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Publication Date
Wed Oct 02 2024
Journal Name
International Development Planning Review
A COMPARATIVE STUDY OF THE AMOUNT OF FORCE EXERTED ON THE GROUND AND THE TIME OF PROPULSION IN THE VERTICAL AND HORIZONTAL JUMPING TESTS FROM STABILITY USING A FOOT SCAN DEVICE
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Publication Date
Tue Nov 01 2016
Journal Name
Journal Of Economics And Administrative Sciences
Performance evaluation of policies and programs accordance with guide prepared by a dutch court of audit and the board of supreme audit (case study in wasit state company for textile industries)
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Abstract\

preparation process of performance evaluation in organizations is of extreme importance, and under development in organizations and the opening of markets and technological developments in the industry and heightened competition among industrial organizations imposed systems are built for performance give a clear picture about performance and competition,  And centered research problem in answering the following questions: Is performance evaluation system is available in Wasit State Company for Textile Industries(Research sample ), This research aims to assess the performance of policies and programs in the company, according to guide performance evaluation of programs and policies prepared by the Dutch Cou

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Publication Date
Sun Mar 19 2023
Journal Name
Journal Of Educational And Psychological Researches
The Extent of Fulfilling Total Quality Standards by Applied Sciences Colleges in the University of Technology and Applied Sciences in Light of the National Strategy of Education 2040 in the Sultanate Of Oman.
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Abstract

The study aims to identify the extent to which the applied colleges at the University of Technology and Applied Sciences meet the comprehensive quality standards in light of the national education strategy for the 2040 Vision in the Sultanate of Oman. To do this, the researchers used the descriptive approach. They used a questionnaire as a tool for data collection that was applied to (237) administrators, academics, and support functions. The study found that the extent to which the applied colleges at the University of Technology and Applied Sciences meet the comprehensive quality standards in the light of the National Education Strategy 2040 in the Sultanate of Oman recorded a high range. The study als

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