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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Fri Dec 15 2017
Journal Name
Journal Of Baghdad College Of Dentistry
Comparison of periodontal health status in relation to IQ in right- and left handed individuals
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Background: Periodontal disease (PD) is a chronic inflammatory condition characterized by destruction of supporting structures of the teeth. Intelligence quotient (IQ) was potentially reported to significantly associated with prevalence of gingivitis. Mild gingivitis was obtained in high IQ levels while moderate gingivitis may be attributed to poor oral hygiene seen among the subjects having low IQ levels. Method: One hundred volunteers aged between 20-45 years old were enrolled in this study, patients were equally divided into right- and left-handed (50 patients each)and each group then subdivided into patients with healthy gingiva(10), patients with gingivitis (20), and patients suffering from periodontitis (20).An IQ questionnaire was p

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Publication Date
Sat Dec 01 2018
Journal Name
Agricultural Engineering
Evaluation of Flat Fan Nozzles Operating Parameters Under Conditions of Accelerated Boundary and Destructive Wear
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Abstract<p>Two tests were carried out to measure the standard flat fan nozzles wear during a specific period of an accelerated wear procedure. The first test aimed at getting 10% increase in the flow rate compared to the nominal flow rate, which is the threshold to replace the nozzles according to the nozzles testing standards. The second test was to wear the nozzles intensively (100 hours of accelerated wear), which represents the use of nozzles beyond the allowed threshold. The results showed that the flow rate reached 1.31 l·min<sup>−1</sup> (equal to 10% increase) for the tested nozzles after 35 hours of the wear test. For the second test, the 10% increase of the flow rate was r</p> ... Show More
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Publication Date
Tue Dec 01 2020
Journal Name
Ieee Transactions On Industrial Electronics
Cascaded-Extended-State-Observer-Based Sliding-Mode Control for Underactuated Flexible Joint Robot
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This article presents a new cascaded extended state observer (CESO)-based sliding-mode control (SMC) for an underactuated flexible joint robot (FJR). The control of the FJR has many challenges, including coupling, underactuation, nonlinearity, uncertainties and external disturbances, and the noise amplification especially in the high-order systems. The proposed control integrates the CESO and SMC, in which the CESO estimates the states and disturbances, and the SMC provides the system robustness to the uncertainty and disturbance estimation errors. First, a dynamic model of the FJR is derived and converted from an underactuated form to a canonical form via the Olfati transformation and a flatness approach, which reduces the complexity of th

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Publication Date
Wed Jun 29 2022
Journal Name
Iraqi Journal Of Chemical And Petroleum Engineering
Studying and Analyzing Operating Conditions of Hollow Fiber Membrane Preparation Process: A Review Paper
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Polymeric hollow fiber membrane is produced by a physical process called wet or dry/wet phase inversion; a technique includes many steps and depends on different factors (starting from selecting materials, end with post-treatment of hollow fiber membrane locally manufactured). This review highlights the most significant factors that affect and control the characterization and structure of ultrafiltration hollow fiber membranes used in different applications.    

   Three different types of polymers (polysulfone PSF, polyethersulfone PES or polyvinyl chloride PVC) were considered to study morphology change and structure of hollow fiber membranes in this review. These hollow fiber membranes were manufactured with different pro

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Publication Date
Tue Apr 05 2022
Journal Name
Nano Hybrids And Composites
Structural and Optical Properties of ZnO Nanostructures Synthesized by Hydrothermal Method at Different Conditions
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ZnO nanostructures were synthesized by hydrothermal method at different temperatures and growth times. The effect of increasing the temperature on structural and optical properties of ZnO were analyzed and discussed. The prepared ZnO nanostructures were characterized by X-ray diffraction (XRD), UV–Vis. absorption spectroscopy (UV–Vis.), Photoluminescence (PL), and scanning electron microscopy (SEM). In this work, hexagonal crystal structure prepared ZnO nanostructures was observed using X-ray diffraction (XRD) and the average crystallite size equal 14.7 and 23.8 nm for samples synthesized at growth time 7 and 8 hours respectively. A nanotubes-shaped surface morphology was found using scanning electron microscopy (SEM). The optic

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Publication Date
Tue Apr 05 2022
Journal Name
Nano Hybrids And Composites
Structural and Optical Properties of ZnO Nanostructures Synthesized by Hydrothermal Method at Different Conditions
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Zinc oxide (ZnO) nanoparticles were synthesized using a modified hydrothermal approach at different reaction temperatures and growth times. Moreover, a thorough morphological, structural and optical investigation was demonstrated using scanning electron microscopy (SEM), x-ray diffraction (XRD), ultra-violate visible light spectroscopy (UV-Vis.), and photoluminescence (PL) techniques. Notably, SEM analysis revealed the occurrence of nanorods-shaped surface morphology with a wide range of length and diameter. Meanwhile, a hexagonal crystal structure of the ZnO nanoparticles was perceived using XRD analysis and crystallite size ranging from 14.7 to 23.8 nm at 7 and 8 ℎ𝑟𝑠., respectively. The prepared ZnO samples showed good abso

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Publication Date
Tue Jan 18 2022
Journal Name
Special Care In Dentistry
Association between self‐reported oral disease/conditions and symptoms of depression among Iraqi individuals
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Abstract<sec><title>Aims

The negative impact of oral diseases on the function, economy, and general health of the population is well‐documented. In the last decades, evidence linking increased expression of depression and oral diseases/conditions has significantly increased. The aim of this study is to assess the association between oral disease/conditions and self‐reported symptoms of depression individuals.

Methods

A specially designed questionnaire was distributed via social media for 1 week. It consisted of two main sections; the first section was dedicated to collect demographic variables and self‐reported symptoms

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Publication Date
Fri Mar 01 2019
Journal Name
Al-khwarizmi Engineering Journal
Buckling and Pre Stressed Dynamics Analysis of Laminated Composite Plate with Different Boundary Conditions
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Critical buckling and natural frequencies behavior of laminated composite thin plates subjected to in-plane uniform load is obtained using classical laminated plate theory (CLPT). Analytical investigation is presented using Ritz- method for eigenvalue problems of buckling load solutions for laminated symmetric and anti-symmetric, angle and cross ply composite plate with different elastic supports along its edges. Equation of motion of the plate was derived using principle of virtual work and solved using modified Fourier displacement function that satisfies general edge conditions. Various numerical investigation were studied to exhibit a convergence and accuracy of the present solution for considering some design parameters such as edge

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Publication Date
Sat Dec 30 2023
Journal Name
Iraqi Journal Of Science
Using GPR Technique Assessment for Study the Sub-Grade of Asphalt and Concrete Conditions
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The Ground Penetrating Radar (GPR) is frequently used in pavement engineering
for road pavement inspection. The main objective of this work is to validate
nondestructive, quick and powerful measurements using GPR for assessment of subgrade
and asphalt /concrete conditions. In the present study, two different antennas
(250, 500 MHz) were used. The case studies are presented was carried in University
of Baghdad over about 100m of paved road. After data acquisition and radar grams
collection, they have been processed using RadExplorer V1.4 software
implementing different filters with the most effective ones (time zero adjustment and
DC removal) in addition to other interpretation tool parameters.
The interpretatio

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Publication Date
Wed May 29 2019
Journal Name
Iraqi Journal Of Physics
Analysis the effect of economic conditions on the vegetative change in Baghdad using GIS and remote sensing techniques
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The study of vegetative change of cities is one of the most important studies related to human life because of its direct correlation with the temporal conditions that occur. These include the economic problems that force people to move and look for job opportunities in the city, which leads to an increase in the population density of cities, especially for cities with an important economic and administrative location as in the capital city of Baghdad. In this study, the effect of the increasing in population density was analyzed on the urban planning of Baghdad city. The decreasing in vegetation was due to the increasing of urban areas on the outskirts of the city, which led to an increase in its area. Moreover, urban cities increased t

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