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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Jan 01 2022
Journal Name
Iranian Journal Of Ichthyology
Adsorption of Phosphorous and Zinc, and their interaction and processing power on Bentonite
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Publication Date
Tue Feb 28 2023
Journal Name
Iraqi Geological Journal
Development of 3D Geological Model and Analysis of the Uncertainty in a Tight Oil Reservoir in the Halfaya Oil Field
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A geological model was built for the Sadi reservoir, located at the Halfaya oil field. It is regarded as one of the most significant oilfields in Iraq. The study includes several steps, the most essential of which was importing well logs from six oil wells to the Interactive Petrophysics software for conducting interpretation and analysis to calculate the petrophysical properties such as permeability, porosity, shale volume, water saturation, and NTG and then importing maps and the well tops to the Petrel software to build the 3D-Geological model and to calculate the value of the original oil in place. Three geological surfaces were produced for all Sadi units based on well-top data and the top Sadi structural map. The reservoir has

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Publication Date
Wed Mar 28 2018
Journal Name
Indian Journal Of Natural Sciences
Detection of the Main Mycotoxins in Feed of Horses in Al-Zawra'a Park and Study their Effects on Hematological Feature
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Publication Date
Fri Feb 13 2026
Journal Name
Journal Of Baghdad College Of Dentistry
Assessment of serum levels of MMP-8 and hs CRP in chronic periodontitis patients in relation to atherosclerotic cardiovascular disease
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Background: Periodontitis and Atherosclerosis Cardiovascular disease are chronic inflammatory diseases which are highly prevalent. During the last two decades, there has been an increasing interest in the impact of oral health on atherosclerosis and subsequent cardiovascular disease.Aims of the study wereto evaluate the periodontal health status in study groups (Atherosclerotic cardiovascular disease patients with chronic periodontitis and patients having chronic periodontitis),to estimate the serum levels of Matrixmetalloproteinase-8(MMP-8) and high sensitive C-reactive protein(hs CRP) in study and control groups and compare between them. Also,test the correlation between the serum levels of MMP-8 and hs CRP with clinical periodontal par

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Publication Date
Sun Dec 04 2016
Journal Name
Baghdad Science Journal
The effect of nitrogen and sodium chloride stress in the productivity of some fatty acids in Chlorococcum humicola green alga
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Algae have been considered a sources task of biofuels, which is a future alternative to fossil fuels, and this lead the environmental studies concerned with the lifting of curves or growth rates and time of replication of different kinds of algae, as well as algae cells in response to different environmental conditions, whether chemical or physical, to assess their impact on the composition of these cells and the extent of affected components that make up the living, especially fatty acid ,total fats, proteins and carbohydrates, Gbrha. Green Chlorococcum humicola showed a different response when treated with an average of agriculture Chu-10 and Chu-13 which used as control media,Compared with the degree of its response when exposed to e

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Publication Date
Sun Jun 21 2020
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Evaluation the Incidence of Genotoxic Effects of Artificial Food Favoring Additives in Bone Marrow Cells and Spleen Cells in Mice
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Genetic material is the most important component of cells because it contains the genetic information; hence any disruption to the structure chromosome of cells could lead to very bad results. Genotoxicity use to evaluate the safety of any chemical compounds on genetic materials. Artificial food flavoring additive are chemical substances to produce specific placebo effects added to foods but impart specific flavor to it.

The present study evaluates the genotoxic effect of artificial food flavoring additive on structure of chromosomes at three different concentrations (50%, 100%and 150%) on both bone marrow cells and spleen cells in mice for fourteen successive days. It was found that artificial food flavoring addit

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Publication Date
Sun Dec 04 2011
Journal Name
Baghdad Science Journal
Determination of Uranium Concentration in child teeth by track detector CR-39 in same middle and south regions of Iraq
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The study of determing Uranium concentration in samples of teeth is the first of its kind in the Iraq . In this study Uranium concentration has been measured was (32) samples of child teeth distributed on the some of middle and south governorate of Iraq (Muthana – Dekar – Basrah – Najaf – Karbalah – Waset – Babel – Baghdad) . The Uranium concentration in teeth samples has been measured by using fission tracks registration in (CR-39) track detector that caused by the bombardment of (U235) with thermal neutrons falx from (24Am.Be) neutron source that has flux of (5x103n.cm-2S-1). The result obtained show that the Uranium concentrations in governorates were (0.18ppm), (0.172ppm), (0.160ppm), 0.150ppm) (0.89ppm), (0.07ppm) , (0.

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Publication Date
Fri Feb 13 2026
Journal Name
Journal Of Baghdad College Of Dentistry
The effect of in office bleaching on surface roughness and micro-hardness of newly developed composite materials (In vitro study)
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Background: Alterations in the microhardness and roughness are commonly used to analyze the possible negative effects of bleaching products on restorative materials. This in vitro study evaluated the effect of in-office bleaching (SDI pola office +) on the surface roughness and micro-hardness of four newly developed composite materials (Z350XT –nano-filled, Z250XT-nano-hybrid, Z250-mico-hybrid and Silorane-silorane based). Materials and methods: Eighty circular samples with A3 shading were prepared by using Teflon mold 2mm thickness and 10mm in diameter. 20 samples for each material, 10 samples for base line measurement (surface roughness by using portable profillometer, and micro-hardness by usingDigital Micro Vickers Hardness Test

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Publication Date
Thu Apr 30 2020
Journal Name
Journal Of Economics And Administrative Sciences
Banking liquidity and the possibility of invested it in enhancing the solvency For a number of commercial banks in Iraq
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The primary function of commercial banks is the process of converting liquid liabilities such as deposits to illiquid assets, (also known as a loan), liquid assets, (aka cash and cash equivalent) in a balanced manner between liquid and illiquid assets, that guaranteed the preservation of the rights of depositors and the bank and not by converting liquid liabilities into liquid assets in a very large percentage. This comes from its role as depository and intermediary institutions between supply and demand, therefore, we find that the high indicators of bank liquidity and solvency may reflect a misleading picture of the status of commercial banks, to some extent in terms of the strength of their balance sheets and

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Publication Date
Fri Nov 02 2018
Journal Name
Iraqi National Journal Of Nursing Specialties
Evaluation of Nursing Knowledge and Practices Concerning Nursing Care of Patient with Skin Traction in Orthopedic Units in Kurdistan Region
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Objective: The study aimed to evaluate knowledge and practices of nursing staff at the orthopedic units
regarding the existing care of patient with skin traction.
Methodology: The sample consists of (40) nurses, (20) of them from Emergency Teaching Hospital in Duhok
and the other (20) of them from Erbil Teaching Hospital in Erbil from 1st Dec. 2004 to the end of June 2005 in
Kurdistan Region.
Two instruments were constructed to evaluate knowledge and practices. Evaluation of knowledge was done by
using of multiple choice questions composed of (25) questions, and evaluation of practice was done by using the
observational check list which consist of four main category (pre skin traction, during skin traction, post skin

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