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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Sep 01 2013
Journal Name
Baghdad Science Journal
Flammability action of tires material after adding flame inhibitor
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Magnesium hydroxide was used as flame inhibitor to increased flame resistance for tires .Magnesium hydroxide was adding with (5%,10%) weight percents to rubber master batch of tire and then exposed the resulting material to a flame generated from gas torch with (10 mm) exposure distance . Method of measuring the surface temperature opposite to the flame was used to determine the heat transferred through tire material. The results were obtained shows enhanced flame resistance for tire by added magnesium hydroxide and this resistance increased by increasing hydroxide Percentage .

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Publication Date
Fri Dec 31 2021
Journal Name
مجلة العلوم السياسية
The Role of the Iraqi parliament in the adoption of the federal budget after 2005
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The approval of the federal general budget in Iraq is one of the most important competencies of the legislative authority , Being one of the important financial and monetary policy instruments on which the state depends for its economic growth , Hence, the obstruction of the approval of the federal budget due to sectarian quotas, the absence of national interest, and the emergence of bargaining processes between political parties belonging to the regions and sectarianism , As well as the absence of economic plans and programs as a result of non-cognition and understanding of the nature of its supposed political system applied in Iraq and the absence of specialists would le

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Publication Date
Fri Dec 31 2021
Journal Name
Political Sciences Journal
The Role of the Iraqi parliament in the adoption of the federal budget after 2005
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Receipt date: 2/2/2021 accepted date: 4/6/2021 Publication date: 12/31/2021

Creative Commons License This work is licensed under a Creative Commons Attribution 4.0 International License.

The approval of the federal general budget in Iraq is one of the most important competencies of the legislative authority , Being one of the important financial and monetary policy instruments on which the state depends for its economic growth , Hence, the obstruction of the approval of the federal b

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Publication Date
Wed Jun 30 2004
Journal Name
Iraqi Journal Of Chemical And Petroleum Engineering
Formulation of Multi-Purpose Grease for Use under Severe Conditions
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Publication Date
Sun Jul 09 2023
Journal Name
Journal Of Engineering
Effect of Operating Conditions on Reverse Osmosis (RO) Membrane Performance
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The aim of this research is to study the effect of high concentrations of salts, pressure and temperature on the performance of the RO membrane with time. Four different (Na2CO3) concentrations (5000, 15000, 25000 and 35000) ppm and various pressures such as (1, 3 and 5) bars at different temperatures of the feed solution (i.e., 25, 35 and 45) ◦C were used in this work. It was found that, as the concentration of salt and feed temperatures increase, the rejection of the salt decrease. While the salt rejection of the membranes increases with increase of transmembrane pressure.

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Publication Date
Tue Mar 20 2018
Journal Name
Offshore Technology Conference Asia
Prediction of Hydrate Phase Equilibrium Conditions for Different Gas Mixtures
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Abstract<p>Gas hydrate formation poses a significant threat to the production, processing, and transportation of natural gas. Accurate predictions of gas hydrate equilibrium conditions are essential for designing the gas production systems at safe operating conditions and mitigating the problems caused by hydrates formation. A new hydrate correlation for predicting gas hydrate equilibrium conditions was obtained for different gas mixtures containing methane, nitrogen and carbon dioxide. The new correlation is proposed for a pressure range of 1.7-330 MPa, a temperature range of 273-320 K, and for gas mixtures with specific gravity range of 0.553 to 1. The nonlinear regression technique was applie</p> ... Show More
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Publication Date
Mon Jan 01 2018
Journal Name
Fuel
Wettability of nanofluid-modified oil-wet calcite at reservoir conditions
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Nanofluids, liquid suspensions of nanoparticles (Np), are an effective agent to alter the wettability of oil-wet reservoirs to water-wet thus promoting hydrocarbon recovery. It can also have an application to more efficient carbon storage. We present a series of contact angle (θ) investigations on initially oil-wet calcite surfaces to quantify the performance of hydrophilic silica nanoparticles for wettability alteration. These tests are conducted at typical in-situ high pressure (CO2), temperature and salinity conditions. A high pressure–temperature (P/T) optical cell with a regulated tilted surface was used to measure the advancing and receding contact angles at the desired conditions. The results showed that silica nanofluids can alte

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Publication Date
Sun Oct 01 2017
Journal Name
Journal Of Engineering
Comparison the Physical and Mechanical Properties of Composite Materials (Al /SiC and Al/ B4C) Produced by Powder Technology
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In this investigation, metal matrix composites (MMCs) were manufactured by using powder technology. Aluminum 6061 is reinforced with two different ceramics particles (SiC and B4C) with different volume fractions as (3, 6, 9 and 12 wt. %). The most important applications of particulate reinforcement of aluminum matrix are: Pistons, Connecting rods etc. The specimens were prepared by using aluminum powder with 150 µm in particle size and SiC, B4C powder with 200 µm in particle size. The chosen powders were mixed by using planetary mixing setup at 250 rpm for 4hr.with zinc stearate as an activator material in steel ball milling. After mixing process the powders were compacted by hydraulic

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Publication Date
Thu Sep 01 2016
Journal Name
Journal Of Engineering
Demulsification of Remaining Waste (Water In Oil Emulsions) After Removal Of Phenol In Emulsion Liquid Membrane Process
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The aim of present work is to study the removal of phenol present in aqueous feed solution by the emulsion liquid membrane technique using kerosene as a diluent, sodium hydroxide as a stripping agent, and sorbitan monooleate (Span 80) as a surfactant. The parameters studied were: surfactant concentration, volume ratio of membrane phase to internal phase, and stirring speed. It was found that more than 98% of phenol can be removed at the conditions were surfactant concentration 2% (v/v), volume ratio of membrane phase to internal phase 5:1 and stirring speed 400 rpm. Maximum phenol extraction efficiency at 7 minutes of process time was observed. It was found that there was a good agreement between the standard kerosene an

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Publication Date
Sat Aug 01 2015
Journal Name
Journal Of Engineering
Determination of the Optimum Conditions in Evaluation of Kiwi Juice as Green Corrosion Inhibitor of Steel in Hydrochloric Acid
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The corrosion protection of low carbon steel in 2.5 M HCl solution by kiwi juice was studied at different temperatures and immersion times by weight loss technique. To study the determination of the optimum conditions from statistical design in evaluation of a corrosion inhibitor, three variables, were considered as the most dominant variables. These variables are: temperature, inhibitor concentration (extracted kiwi juice) and immersion time at static conditions.

These three variables are manipulated through the experimental work using central composite rotatable Box – Wilson Experimental Design (BWED) where second order polynomial model was proposed to correlate the studied variables with the corrosion rate o

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