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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Jun 27 2021
Journal Name
Iraqi National Journal Of Nursing Specialties
Detection of Depression among Nurses Providing Care for Patients with COVID-19 at Baqubah Teaching Hospital
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Objectives: The present study aims at detecting the depression among nurses who provide care for infected patients with corona virus phenomenon and to find out relationships between the depression and their demographic characteristics of age, gender, marital status, type of family, education, and years of experience of nurses in heath institutions, infection by corona virus, and their participation in training courses.
Methodology: A descriptive study is established for a period from October 10th, 2020 to April 15th, 2021. The study is conducted on a purposive (non-probability) sample of (100) nurse who are providing care for patients with COVID-19 and they are selected from the isolation wards. The instrument of the study is develope

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Publication Date
Fri Jun 01 2018
Journal Name
Journal Of The College Of Languages (jcl)
Проблемы преподавания русской литературы в иракской аудитории Problems of Teaching Russian Literature to Iraqi College Students
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Аннотация

    в статье рассматриваются проблемы преподавания русской литературы в иракской аудитории.. Использование литературы в преподавании иностранного языка, как правило, имеет две цели. Первая-чисто лингвистическая .. Вторая цель, однако, ассоциируется больше с экстралингвистикой  и представляет собой ознакомление студентов с различными аспектами русской жизни, культуры,

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Publication Date
Fri Sep 30 2016
Journal Name
Al-khwarizmi Engineering Journal
Modeling the removal of Cadmium Ions from Aqueous Solutions onto Olive Pips Using Neural Network Technique
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The uptake of Cd(II) ions from simulated wastewater onto olive pips was modeled using artificial neural network (ANN) which consisted of three layers. Based on 112 batch experiments, the effect of contact time (10-240 min), initial pH (2-6), initial concentration (25-250 mg/l), biosorbent dosage (0.05-2 g/100 ml), agitation speed (0-250 rpm) and temperature (20-60ºC) were studied. The maximum uptake (=92 %) of Cd(II) was achieved at optimum parameters of 60 min, 6, 50 mg/l, 1 g/100 ml, 250 rpm and 25ºC respectively.

Tangent sigmoid and linear transfer functions of ANN for hidden and output layers respectively with 7 neurons were sufficient to present good predictions for cadmium removal efficiency with coefficient of correlatio

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Publication Date
Wed Dec 01 2021
Journal Name
Baghdad Science Journal
Studying the Photodegradation of Congo Red Dye from Aqueous Solutions Using Bimetallic Au–Pd/TiO2 Photocatalyst
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In this study, the photodegradation of Congo red dye (CR) in aqueous solution was investigated using Au-Pd/TiO2 as photocatalyst. The concentration of dye, dosage of photocatalyst, amount of H2O2, pH of the medium and temperature were examined to find the optimum values of these parameters. It has been found that 28 ppm was the best dye concentration. The optimum amount of photocatalyst was 0.09 g/75 mL of dye solution when the degradation percent was ~ 96 % after irradiation time of 12 hours, while the best amount of hydrogen peroxide was 7μl/75 mL of dye solution at degradation percent ~97 % after irradiation time of 10 hours, whereas pH 5 was the best value to carry out the reaction at the highest degradation percent. In additio

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Publication Date
Sun Jun 30 2024
Journal Name
Iraqi Journal Of Science
Detection of Zn Water Pollution by a Biosensor Based on Alkaloids Derived from Iraqi Catharanthus Roseus
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     In this work, the detection of zinc (Zn) ions that cause water pollution is studied using the CSNPs- Linker-alkaloids compound that was prepared by linking extracted alkaloids from Iraqi Catharanthus roseus plant with Chitosan nanoparticles (CSNPs) using maleic anhydride. This compound is characterized by an X-ray diffractometer (XRD) which shows that it has an orthorhombic structure with crystallite size in the nano dimension. Zeta Potential results show that the CSNPs-Linker-alkaloids carried a positive charge of 54.4 mV, which means it possesses high stability.  The Fourier transform infrared spectroscopy (FTIR) shows a new distinct band at 1708.93 cm-1 due to C=O esterification. Scanning electron microscope (SEM) image

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Publication Date
Mon Jun 19 2023
Journal Name
Journal Of Engineering
Study the Impact Behavior of the Prosthetic Lower Limb Lamination Materials Due to Low Velocity Impactor
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This work involves three parts ,  first part  is manufacturing different types of laminated below knee prosthetic socket materials with different classical laminated materials used in Baghdad center for prosthetic and orthotic (4perlon layers+2carbon fiber layer+4 perlon layers) , two suggested laminated materials(3perlon layers+2carbon fiber layer+3 perlon layers) and (3perlon layers+1carbon fiber layer+3 perlon layers) ) in order to choose perfect laminated socket . The second part tests (Impact test) the laminated materials specimens used in socket manufacturing in order to get the impact properties for each socket materials groups using an experimental rig designed especially for this purpose. The interface pressure between

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Publication Date
Wed Jul 17 2019
Journal Name
Aip Conference Proceedings
The correction of the line profiles for x-ray diffraction peaks by using three analysis methods
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In this study used three methods such as Williamson-hall, size-strain Plot, and Halder-Wagner to analysis x-ray diffraction lines to determine the crystallite size and the lattice strain of the nickel oxide nanoparticles and then compare the results of these methods with two other methods. The results were calculated for each of these methods to the crystallite size are (0.42554) nm, (1.04462) nm, and (3.60880) nm, and lattice strain are (0.56603), (1.11978), and (0.64606) respectively were compared with the result of Scherrer method (0.29598) nm,(0.34245),and the Modified Scherrer (0.97497). The difference in calculated results Observed for each of these methods in this study.

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Publication Date
Sun Jul 01 2012
Journal Name
Ieee Transactions On Geoscience And Remote Sensing
Echo Amplitude Normalization of Full-Waveform Airborne Laser Scanning Data Based on Robust Incidence Angle Estimation
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Publication Date
Mon Mar 23 2020
Journal Name
Baghdad Science Journal
Surfactant Cloud Point Extraction as a Procedure of Preconcentrating for Metoclopramide Determination Using Spectro Analytical Technique
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In current article an easy and selective method is proposed for spectrophotometric estimation of metoclopramide (MCP) in pharmaceutical preparations using cloud point extraction (CPE) procedure. The method involved reaction between MCP with 1-Naphthol in alkali conditions using Triton X-114 to form a stable dark purple dye. The Beer’s law limit in the range 0.34-9 μg mL-1 of MCP with r =0.9959 (n=3) after optimization. The relative standard deviation (RSD) and percentage recoveries were 0.89 %, and (96.99–104.11%) respectively. As well, using surfactant cloud point extraction as a method to extract MCP was reinforced the extinction coefficient(ε) to 1.7333×105L/mol.cm in surfactant-rich phase. The small volume of organi

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Publication Date
Mon Apr 19 2021
Journal Name
Bridge Maintenance, Safety, Management, Life-cycle Sustainability And Innovations
Flexure strengthening of concrete bridge girders with concavely curved soffit using near-surface-mounted CFRP bars
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