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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Jun 11 2021
Journal Name
Journal Of Baghdad College Of Dentistry
Management of trauma to the anterior segment of the maxilla: alveolar fracture and primary incisors crown and root fracture
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Background: An injury to both the primary and permanent teeth and the supporting structures is one of the most common dental problems seen in children. Splinting is usually difficult or impossible to perform in the primary dentition (due to diminutive room size and lack of patient cooperation). Healing must, therefore, occur despite mobility at the fracture line, usually resulting in interposition of connective tissue. In some instances, infection will occur in the coronal pulp. The present study reported a case of trauma to the anterior primary teeth and alveolar bone in a four year old child. The trauma has caused fracture to the crowns and roots of the primary anterior teeth. The following case was managed in a procedure that may

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Publication Date
Wed Dec 01 2021
Journal Name
Int. J. Agricult. Stat. Sci
THE EFFECT OF PUTRESCINE AND SPERMIDINE ON SOMATIC EMBRYOGENESIS AND REGENERATION OF DATE PALM (PHOENIX DACTYLIFERA L.) CV. BARHEE
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The present study was conducted to determine the effect of different concentrations of putrescine and spermidine at all stages of regeneration (callogenesis, somatic embryos multiplication, germination and rooting)) of date palm cultivar Barhee. Shoot tips were eradicated from 2-3 years old offshoots, surface sterilized and inoculated onto Murashiege and Skoog, 1962 (MS) medium supplemented with 20 mg/L 2,4-D and 3 mg/L N6-2-isopentyl adenine (2ip). Primary callus was obtained after 24 weeks on the nutrient medium. Calli were then transferred onto fresh MS medium containing 0.0, 50, 100 or 150 mg/L of putrescine or spermidine individually. Results were recorded after 12 weeks. A significant increase in embryonic callus fresh weights reached

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Publication Date
Thu Jun 01 2023
Journal Name
Baghdad Science Journal
Design and study the effect of inner bore diameter on the magnetic and optical properties of the unipolar lens
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    Many designs have been suggested for unipolar magnetic lenses based on changing the width of the inner bore and fixing the other geometrical parameters of the lens to improve the performance of unipolar magnetic lenses. The investigation of a study of each design included the calculation of its axial magnetic field the magnetization of the lens in addition to the magnetic flux density using the Finite Element Method (FEM) the Magnetic Electron Lenses Operation (MELOP) program version 1 at three different values of current density (6,4,2 A/mm2). As a result, the clearest values and behaviors were obtained at current density (2 A/mm2). it was found that the best magnetizing properties, the high

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Publication Date
Wed Dec 01 2021
Journal Name
Iraqi Journal Of Veterinary Sciences
Isolation and antimicrobial resistance of Staphylococcus spp., enteric bacteria and Pseudomonas spp. associated with respiratory tract infections of sheep
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Sheep are considered as an important part of livestock in the worldwide, particularly in Iraq, as they provide meat, milk, leather, wool, and manure. The present study aim is isolation and identification of staphylococci, enteric bacteria and Pseudomonas spp. Totally, 115 samples were collected from sheep (100 samples were collected from the nasal cavity of local sheep suffering from respiratory infections, and 15 samples were collected from apparently healthy local sheep). All the samples were collected from seven flocks located in Abu Ghraib and Al-Radwaniyah, Baghdad governorate, Iraq. The samples were taken during the period from October 2020 to February 2021. Staphylococcus spp., Pseudomonas spp., and enteric bacteria were detected fi

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Publication Date
Mon Oct 22 2018
Journal Name
Journal Of Economics And Administrative Sciences
Measuring and analyzing the relationship between the volatility of US stock market indices and the volatility of oil prices
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The volatility of the financial markets and the oil market plays a major role in influencing macroeconomic activity, as well as the high interaction between the both markets and the remarkable sensitivity to their each other fluctuations which cause the undesirable impact on other economic sectors as an expected result due the mentioned interaction.

The study aimed to analyze the relationship between the volatility of the major US market indices represented by the DJIA index, S & P500, due to their comprehensiveness of the financial market, as they summarize the performance of the entire US market which is the largest economy in the world, as well as the difference in the calculation mechanism, and oi

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Publication Date
Mon Dec 16 2024
Journal Name
Polimery
Synthesis and photochemical stability of polymeric derivatives formed by the reaction of acrylamide and succinic anhydride copolymer with dyes
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A new derivative of PAM, acrylamide was copolymerized with succinic anhydride, and the reaction product reacted with three dyes, anthocyanin, bromophenol, and thymol. The prepared polymers were characterized by X-ray diffraction, FT-IR and UV-visible spectroscopy, proton nuclear magnetic resonance spectrometry, and thermal analysis. FT-IR spectroscopy showed the disappearance of two bands near 3450 and 3380 cm-1 for the stretching vibrations of the primary amine which indicates for the formation of amides. The UV-photolysis of aqueous solutions of different concentrations of the polymers was studied. Polyacrylamide-g-succinic anhydride showed an increase in polymerization under light. An increase of ~ 50% was observed for a 200 mg/L

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Publication Date
Sun Apr 02 2017
Journal Name
Journal Of Educational And Psychological Researches
Self -affirmation and its relation of tendency toward perfection and the awareness of creativity among fine arts institutions students
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The study aimed to identify self –affirmation degree, tendency degree toward perfection, awareness degree of creativity among fine arts institutions students, and the significant correlation between self -affirmation and its tendency toward perfection, and the awareness of creativity among fine arts institutions students. To achieve these objectives, the author had constructed two scales: one to measure self –affirmation among the sample based on “Lang& Jakobowski theory” (Lang& Jakobowski, 1973) that consisted of (54) item divided into two parts: qualitative and situational. The other scale is to measure the tendency toward perfection depend on (flett & Hewitt, 1991) that composed of (46) item divided into two sectio

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Publication Date
Tue May 23 2023
Journal Name
Journal Of Engineering
Modeling and Simulation of Copper Removal from the Contaminated Soil by a Combination of Adsorption and Electro-kinetic Remediation
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Electro-kinetic remediation technology is one of the developing technologies that offer great promise for the cleanup of soils contaminated with heavy metals. A numerical model was formulated to simulate copper (Cu) transport under an electric field using one-dimensional diffusion-advection equations describing the contaminant transport driven by chemical and electrical gradients in soil during the electro-kinetic remediation as a function of time and space. This model included complex physicochemical factors affecting the transport phenomena, such as soil pH value, aqueous phase reaction, adsorption, and precipitation. One-dimensional finitedifference computer program successfully predicted meaningful values for soil pH profiles and Cu

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Publication Date
Tue Oct 02 2018
Journal Name
Iraqi Journal Of Physics
Measurement of indoor radon levels and assessment of radiological hazards at Al-Tuwaitha nuclear site and the surrounding area
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In the present study the radon concentration was measured in indoor places by the RAD7 (radon detector) was in some locations at Al-Tuwaitha nuclear site and some surrounding areas for the duration from 13/10/2016 to 2/1/2017 and the measurement of the indoor radon concentration ranged from (4.96±4.4 to 102±25) Bq/m3. The high value of radon has been found at decommissioning directorate /emergency room, which is lower than the action value recommended by the Environmental Protection Agency (EPA) which is (148 Bq/m3) while the lowest value has been founded in central laboratories directorate \ models room. These values were used to calculate the annual effective dose and the health risks for cells bronchial which caused by the inhalatio

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Publication Date
Thu Jul 31 2025
Journal Name
Indonesian Journal Of Chemistry
Evaluation of the Antioxidant and Anticancer Effectiveness of Some New Metal Ions Complexes with Azo Dye: Synthesis and Characterization
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This paper presents a new azo dye 3-[2-(1H-indol-2-yl)ethyldiazenyl]quinolin-2-ol] from the reaction of the diazonium salt derived from tryptamine and 2-hydroxyquinoline. Azo dye was used to prepare a series of complexes with the chlorides of Ni(II), Pt(IV), Pd(II), Cd(II), and Zn(II). Compounds were analyzed and characterized using elemental analysis, magnetic measurement, UV-vis, IR, MS, NMR, and conductivity. The findings demonstrated that the ligand acts as ionic in complex form, O-bidentate, supporting the proposed formula. The complexes generally exhibited tetrahedral and octahedral geometries, except the palladium complex, which adopted a square planar geometry. TGA was used to investigate the thermal characteristics of compo

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