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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Sun Jan 01 2023
Journal Name
Journal Of Engineering
State-of-the-Art in Data Integrity and Privacy-Preserving in Cloud Computing
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Cloud computing (CC) is a fast-growing technology that offers computers, networking, and storage services that can be accessed and used over the internet. Cloud services save users money because they are pay-per-use, and they save time because they are on-demand and elastic, a unique aspect of cloud computing. However, several security issues must be addressed before users store data in the cloud. Because the user will have no direct control over the data that has been outsourced to the cloud, particularly personal and sensitive data (health, finance, military, etc.), and will not know where the data is stored, the user must ensure that the cloud stores and maintains the outsourced data appropriately. The study's primary goals are to mak

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Publication Date
Sat Feb 27 2021
Journal Name
Journal Of Engineering
Assessment of Electromagnetic Pollution in Some Hospitals and Schools in Al-Najaf City
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The tremendous benefits of using cellular phones, which began to increase and unprecedented spread worldwide last decade, were accompanied by harmful effects on the environment due to the increase in electromagnetic radiation (EMR) which be emitted from mobile phone towers. This effect on humans, animals, and plants, which is considered a form of environmental pollution, was sensed by developed countries and Environmental protection organizations. These countries have established restrictions and enacted laws to reduce their negative impact on living beings. The field survey included six major hospitals and 38 schools were distributed over the central neighbourhoods in Al-Najaf city. The results showed that power density (PD) measurement

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Publication Date
Thu Jun 01 2023
Journal Name
جعفر الصادق
The Role of Criminal Policy in Iraq in Protecting and Improving the Environment
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Publication Date
Fri Jan 15 2021
Journal Name
Palarch's Journal Of Archaeology Of Egypt/egyptology
Belief and practice in the teaching of pronunciation in the Iraqi EFL context
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IH Abdul-Abbas, QJ Rashid, M RasimYounus, PalArch's Journal of Archaeology of Egypt/Egyptology, 2021 - Cited by 9

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Publication Date
Wed Jun 01 2011
Journal Name
Journal Of Economics And Administrative Sciences
The reality and dilemmas of higher education in IraqAnalytical vision in knowledge economies
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The subject of education, and since time immemorial, gripe the attention of the religious, intellectual, political, social and economic elites. This attention not only in Iraq, but in different countries in the world. There is a close correlation between the educational level of the societies and the edginess of its rising and advancement in all fields.

In order to achieve the research objectives, the research has   been divided into three sections: section I include the historical, scientific, humanitarian evolution of education, starting from the first economic revolution (The Agricultural revolution) through the second economic revolution (The Industrial Revolution) and till the Third Economi

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Publication Date
Thu Mar 30 2017
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Formulation and in vitro Evaluation of In-situ Gelling Liquid Suppositories for Naproxen
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In-situ gelation is a process of gel formation at the site of application, in which a drug product formulation that exists as a liquid has been transformed into a gel upon contact with body fluids. As a drug delivery agent, the in-situ gel has an advantage of providing sustained release of the drug agent.  In-situ gelling liquid suppositories using poloxamer 188 (26-30% W/W) as a suppository base with 10% W/W naproxen were prepared, the gelation temperature of these preparations were measured and they were all above the physiological temperature. Additives such as polyvinylpyrrolidin "PVP" ,hydroxylpropylmethylcellulose  "HPMC", sodium alginate and sodium chloride were used in concentration ranging from (0.25-1

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Publication Date
Sun Mar 14 2021
Journal Name
Aestimum
The role of fiscal and monetary policy in stimulating Circular Economy in Iraq
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The issue of the Circular Economy is not a new issue to several countries, especially the developed ones. Here in Iraq it is considered newly introduced, despite the few attempts to establish projects that concern recycling most of them were doomed to fail, due to two main reasons: the first one is the financial and administrative corruption widespread in all departments of the country, the second one is the priorities of public spending. It is well known that Iraq was subjected to two major attacks, the ISIS entry attack in 2014 to Iraq. ISIS occupied about a third of Iraqi lands which resulted in a collapse in oil prices, as Iraq depends almost entirely on oil revenues in its budget which is the second attack. This made the Iraqi governme

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Publication Date
Mon Apr 04 2022
Journal Name
Journal Of Educational And Psychological Researches
The Effect of Baska Style in Achievement and Creative Thinking among Students in the Fifth Grade Literary Material and Application Rhetoric
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The current research aims to identify the effect of Baska style on students’ achievement and the creative thinking in material rhetoric and the application of students for fifth grade literary. To achieve the study objectives, the researcher has designed an achievement test to measure group of students in the fifth grade literary in material application. The researcher chose a sample of 40 female students from Khansa School for Girls in Baghdad for the academic year (2014 - 2015), he applied the test on an exploratory sample consisted of 30 female students from the research community. The study resulted in being no statistically significant difference at the level of significance (0.05) between the mean scores of the experimental group

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Publication Date
Thu Dec 01 2022
Journal Name
Baghdad Science Journal
Determination of Nickel and Cobalt in Cosmetic Products Marketed in Iraq Using Spectrophotometric and Microfluidic Paper-based Analytical Device (µPADs) Platform
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Two quantitative, environment-friendly and easily monitored assays for Ni (II) and Co (III) ions analysis in different lipstick samples collected from 500-Iraqi dinars stores located in Baghdad were introduced. The study was based on the reaction of nickel (II) ions with dimethylglyoxime (DMG) reagent and the reaction of cobalt (III) ions with 1-nitroso-2-naphthol (NN) reagent to produce colored products. The color change was measured by spectrophotometric method at 565 nm and 430 nm for Ni and Co, respectively, with linear calibration graphs in the concentration range 0.25-100 mg L-1 (Ni) and 0.5-100 mg L-1 (Co) and LOD and LOQ of 0.11 mg L-1 and 0.36 mg L-1 (Ni), and 0.15 mg L-1 an

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Publication Date
Sat Aug 30 2025
Journal Name
Iraqi Journal Of Science
The role of Matrix metalloproteinase (MMP-9) and its tissue inhibitor (TIMP1) in Cutaneous Leishmaniasis patients and their role in prognosis
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Cutaneous leishmaniasis (CL) is a widespread, yet often overlooked, parasitic disease caused by the Leishmania protozoan, which is prevalent in numerous countries, including Iraq. This condition is marked by the appearance of skin lesions on various exposed areas of the body. In most old-world regions, sodium stibogluconate (SSG) is the classical widely used drug to treat CL. The progression of skin ulceration is controlled by different inflammatory modulators including cytokines and enzymes. In this study, the possible role of the enzyme Matrix metalloproteinase9 (MMP-9) and its inhibitor Metallopeptidase inhibitor-1 (TIMP-1) as immunological markers was evaluated in CL patients suffering from cutaneous leishmaniasis before and aft

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