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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Thu Jan 02 2020
Journal Name
Journal Of The College Of Languages (jcl)
The newspaper is a field for the use of phraseologism: Газета как сфера использованиея фразеологических единиц
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Idiomatic expressions in Russian journalism make one important borrowed means for making a dialogue with the receiver's intellect in so far as it has the distinct feature of  having clarity and exactness of meaning. The meaning is seen as a shortcut for covering a series of concepts and details so as to arrive at the intended meaning. This is done by stimulating the reader by the use of certain clear idioms. The use of such idioms in a journalistic text is not for a linguistic purpose only, but it is a cultural and social phenomenon reflecting the type of current changes in the society and it aims at discoursing with the reader's mind. This paper is a practi

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Publication Date
Sat Feb 15 2025
Journal Name
Iraqi Journal Of Science
Effect of Aluminum Dust Particles on Plasma Parameters at Different Gas Pressure with Different Dust Contents
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In this work, the effect of aluminum (Al) dust particles on the DC discharge plasma properties in argon was investigated. A magnetron is placed behind the cathode at different pressures and with varying amounts of Al. The plasma temperature (Te) and density (ne) were calculated using the Boltzmann equation and Stark broadening phenomena, which are considered the most important plasma variables through which the other plasma parameters were calculated. The measurements showed that the emission intensity decreases with increasing pressure from 0.06 to 0.4 Torr, and it slightly decreases with the addition of the NPs. The calculations showed that the ne increased and Te decreased with pressure. Both Te and ne were reduced by increasing

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Publication Date
Sat Jan 01 2022
Journal Name
Journal Of Engineering
Efficient Energy Management for a Proposed Integrated Internet of Things-Electric Smart Meter (2IOT-ESM) System
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In this work, an efficient energy management (EEM) approach is proposed to merge IoT technology to enhance electric smart meters by working together to satisfy the best result of the electricity customer's consumption. This proposed system is called an integrated Internet of things for electrical smart meter (2IOT-ESM) architecture. The electric smart meter (ESM) is the first and most important technique used to measure the active power, current, and energy consumption for the house’s loads. At the same time, the effectiveness of this work includes equipping ESM with an additional storage capacity that ensures that the measurements are not lost in the event of a failure or sudden outage in WiFi network. Then then these

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Publication Date
Thu Dec 26 2019
Journal Name
Bulletin Of The Iraq Natural History Museum (p-issn: 1017-8678 , E-issn: 2311-9799)
FIRST RECORD OF THE CELLAR SPIDER GENUS NITA HUBER & EL-HENNAWY, 2007 (ARANEAE, PHOLCIDAE) FROM IRAQ
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    The current study presents the cellar spiders genus Nita Huber & El-Hennawy, 2007 (Araneae, Pholcidae) as the first record for Iraq spider fauna, this genus represented by the species Nita elsaff Huber & El-Hennawy, 2007 were identified based on morphological characteristics and DNA sequence data. A short morphological description is also presented for cellar spiders listed in Iraq; including this species in addition to Artema Atlanta Walckenaer, 1837.

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Publication Date
Wed Dec 01 2021
Journal Name
Bioresource Technology Reports
Biosynthesis of polyhydroxyalkanoate (PHA) by a newly isolated strain Bacillus tequilensis ARY86 using inexpensive carbon source
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Publication Date
Wed Mar 01 2023
Journal Name
Journal Of Engineering
Stiffness Characteristics of Pile Models for Cement Improving Sandy Soil by Low-Pressure Injection Laboratory Setup
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Soil improvement has developed as a realistic solution for enhancing soil properties so that structures can be constructed to meet project engineering requirements due to the limited availability of construction land in urban centers. The jet grouting method for soil improvement is a novel geotechnical alternative for problematic soils for which conventional foundation designs cannot provide acceptable and lasting solutions. The paper's methodology was based on constructing pile models using a low-pressure injection laboratory setup built and made locally to simulate the operation of field equipment. The setup design was based on previous research that systematically conducted unconfined compression testing (U.C.Ts.). Th

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Publication Date
Wed Jun 21 2023
Journal Name
Bionanoscience
Evaluation the Antimicrobial Action of Kiwifruit Zinc Oxide Nanoparticles Against Staphylococcus aureus Isolated from Cosmetics Tools
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Publication Date
Wed Apr 01 2020
Journal Name
Isa Transactions
Design of a Complex fractional Order PID controller for a First Order Plus Time Delay system
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Publication Date
Wed Dec 09 2020
Journal Name
Civil Engineering Journal
Torsional Strengthening of Reinforced Concrete Beams with Externally-Bonded Fibre Reinforced Polymer: An Energy Absorption Evaluation
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The impacts of numerous important factors on the Energy Absorption (EA) of torsional Reinforced Concrete (RC) beams strengthened with external FRP is the main purpose and innovation of the current research. A total of 81 datasets were collected from previous studies, focused on the investigation of EA behaviour. The impact of nine different parameters on the Torsional EA of RC-beams was examined and evaluated, namely the concrete compressive strength (f’c), steel yield strength (fy), FRP thickness (tFRP), width-to-depth of the beam section (b/h), horizontal (ρh) and vertical (ρv) steel ratio, angle of twist (θu), ultimate torque (Tu), and FRP ultimate strength (fy-FRP). For the evaluation of the energy absorption capacity at di

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Publication Date
Mon Mar 23 2020
Journal Name
Journal Of Engineering
Performance Analyses of 15 kW Grid-Tied Photo Voltaic Solar System Type under Baghdad city climate
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The performance analyses of 15 kWp (kW peak) Grid -Tied solar PV system (that considered first of its type) implemented at the Training and Energy Research Center Subsidiary of Iraqi Ministry of Electricity in Baghdad city has been achieved. The system consists of 72 modules arranged in 6 strings were each string contains 12 modules connected in series to increase the voltage output while these strings connected in parallel to increase the current output. According to the observed duration, the reference daily yields, array daily yields and final daily yields of this system were (5.9, 4.56, 4.4) kWh/kWp/day respectively. The energy yield was 1585 kWh/kWp/year while the annual total solar irradiation received by solar array system was 198

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