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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Nov 18 2021
Journal Name
Thesis
Phytochemical investigation of some active constituents and evaluation of antimicrobial activity of Conyza canadensis (F: Asteraceae) grown naturally in Iraq
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The plant Conyza canadensis, which belongs to Asteraceae (Compositae) family and known as Canadian horseweed. It was used as traditional medicine in China, Pakistan, India, and Africa for the treatment of various diseases causing by bacteria, fungi, or viruses. The plant has antimicrobial, antioxidant, anticoagulant, anti-inflammatory, and anticancer pharmacological activity. This study provides the first phytochemical investigation of the plant in Iraq and is concerned with extraction, fractionation, isolation, and purification of some of the important phytochemicals detected in the plant-like phenolic acids, flavonoids, and alkaloids. Also, the literature survey has revealed that the plant has a substantial antimicrobial activity, so it w

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Publication Date
Sun Jan 01 2023
Journal Name
The Egyptian Journal Of Hospital Medicine
Association of Interleukin-12B Polymorphism and Serum Level of Interleukin-12 in a Sample of Iraqi Patients with Rheumatoid Arthritis
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Background In rheumatoid arthritis, your immune system attacks the tissue lining the joints on both sides of your body. Other parts of the body may also be affected. Unsure of the exact cause. Two separate genes termed IL12A (p35) and IL12 encode the heterodimeric cytokine known as IL12 (p40). Several different hematopoietic cell types can have several different hematopoietic cell types that can generate antigen-presenting cells (APCs), including DCs and macrophages. Objectives This study aimed to investigate if the interleukin IL-12B gene's common polymorphisms in an Iraqi population were associated with RA. Material and methods Blood samples were taken from 70 Iraqi patients with RA illnesses and 30 Iraqi controls during the periods from

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Publication Date
Wed Jul 01 2020
Journal Name
Plant Archives
Effect of sedimentation source on the nature occurrence and distribution of the feldspar in some soil of Alluvial plain Iraq
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The current study was conducted to find out the effect of the sediment source (sedimentary of Iraqi-Iranian borderline and Tigris River) on the content and distribution of feldspar minerals and their effect on the optical properties of these minerals in some soils of Wasit and Maysan province. Eight pedons were chosen to represent the study area, five of them represented sediments coming from the borderline, which included pedons of (Badra, Taj Al-Din, Al-Shihabi, Jassan, and Galat), while two of them represent the sediments of the Tigris River (Essaouira, Al-Dabouni). Finally, the pedon of Ali Al-Gharbi represented the mixing area of sediments of all the torrents coming from borderline and the sediments of the Tigris River. The diagnostic

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Publication Date
Mon Dec 25 2017
Journal Name
Al-khwarizmi Engineering Journal
Comparisons of Mechanical Properties of sub-mm Lead Based and Lead Free Based Solder Using in Manufacturing of Printed Circuits
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Abstract

This study investigates the mechanical compression properties of tin-lead and lead-free alloy spherical balls, using more than 500 samples to identify statistical variability in the properties in each alloy. Isothermal aging was done to study and compare the aging effect on the microstructure and properties.

The results showed significant elastic and plastic anisotropy of tin phase in lead-free tin based solder and that was compared with simulation using a Crystal Plasticity Finite Element (CPEF) method that has the anisotropy of Sn installed. The results and experiments were in good agreement, indicating the range of values expected with anisotropic properties.

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Publication Date
Wed Sep 27 2023
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Evaluation of the Genotoxicity of the Aerial Parts of Iraqi Euphorbia cyathophora on Bone Marrow and Spleen Cells in Mice
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The aim of the study was extraction of arial part of Euphorbia cyathophora constituents with methanol and evaluate its effect on mitotic index and total chromosomal aberration bone marrow cell and spleen cell in mice  200 gm of E. cyathophora fine powder was defatted then extracted by cold maceration 80% ethanol for seven days. The extract was filtered and dried in a rotary evaporator then the dried extract was suspended with water and consecutively extracted using chloroform, ethyl acetate for each. The aqueous layer was then mixed with 100ml methanol. These fractions are dried under reduced pressure to obtain the dry extract. Twenty-four Albino mice were used for the experiment. The animals were divided into four groups: Gr

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Publication Date
Thu Jan 01 2026
Journal Name
Lecture Notes In Networks And Systems
The Iraqi Judicial System in Light of the Activation of the Role of the Forensic Accountant: Proposed Strategies and Methods
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Forensic accounting (FA) is an important tool in exposing financial manipulation and corruption within institutions, making the role of FA essential in the Iraqi judicial system (IJS). This role suffers from limited implementation due to the lack of specialized legislation and insufficient awareness of its importance. The role of FA in the IJS can be enhanced by enhancing professional training, amending university curricula to include FA, and developing legislation regulating this field. Furthermore, cooperation between courts and the FA should be strengthened to ensure adequate financial evidence (FE) in judicial cases. For example, the experiences of developed countries, such as the United States and the United Kingdom, demonstrate how FA

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Publication Date
Sun Apr 01 2018
Journal Name
Research Journal Of Pharmaceutical, Biological And Chemical
Synthesis and characterization of azo dyes ligands complexes with Ni (II) and Cu (II) and studies their industrial and bacterial application
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1-[4-(4-Acetyl-2-hydroxy-phenylazo)-phenyl]-ethanone (L1) and 1-[3-Hydroxy-4(4-nitro-phenylazo)-phenyl]-ethanone (L2) were readied by combination the diazonium salts of amines with 3-hydroxyacetophenone. (C.H.N) analyses, infrared spectra, UV–vis electronic absorption spectra, 1H and 13CNMR spectral mechanisms are use to identified of the ligands. Complexes of Ni+2 and Cu+2 were performed as well depicted. The formation of complexes has been identified by using atomic absorption of flame, elemental analysis, infrared spectra and UV-Vis spectral process as well conductivity and magnetic quantifications. Nature of compounds produced have been studied obeyed the mole ratio and continuous contrast methods, Beer's law followed during a concent

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Publication Date
Sun Sep 01 2019
Journal Name
Journal Of Global Pharma Technology
Synthesis and Characterization of Azo Dyes Ligands Complexes with Rh (III) and La (III) and Studies Their Industrial and Bacterial Application
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1-[4-(2-Hydroxy-4, 6-dimethyl-phenylazo)-phenol]-ethanone (HL1) and 2-(4-methoxy-phenylazo)-3, 5-dimethyl-phenol (HL2) were produced by combination the diazonium salts of amines with 3, 5-dimethylphenol. The geometry of azo compounds was resolved on the basis of (C.H.N) analyses, 1H and 13CNMR, FT-IR and UV-Vis spectroscopic mechanisms. Complexes of La (III) and Rh (III) have been performed and depicted. The formation of complexes has been identified by using elemental analysis, FT-IR and UV-Vis spectroscopic process as well, conductivity molar quantifications. Nature of complexes produced have been studied obeyed mole ratio and continuous alteration ways, Beer's law followed through a concentration scope (1×10-4 - 3×10-4 M). H

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Publication Date
Fri Aug 19 2022
Journal Name
International Journal Of Health Sciences
A study of the mechanical and electrical activities of the heart and their relationship to the phosphagenic and lactic energy systems of young basketball players
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It was found that there was a significant correlation between all tests of the mechanical and electrical activity of the heart (systolic force FC, stroke volume SV, end-diastolic volume, EF volume, and left ventricular volume during diastole LVDD) with the test of the oxygen-phosphating energy system (Markaria). - As safe (Margaria-Kalamen( It was found that there is a significant correlation between all tests of the mechanical and electrical activity of the heart (myocardial systolic force FC, stroke volume SV, end-diastolic volume EDV, and the percentage of heart pumpingEF blood, and left ventricular volume during diastole (LVDD) with the Lactational Oxygen Energy System Test (Wingate Test 30 Second(

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Publication Date
Fri Mar 01 2013
Journal Name
Journal Of Economics And Administrative Sciences
Measure and evaluate the return and risk formulas of Islamic Finance: Empirical study of the state of Jordan Islamic Bank and Islamic Arab International Bank
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    The study aims to measure and evaluate the return and the risk formulas of Islamic finance of Jordan during the period (2000 – 2009) according of increasing  importance of these banks in recent and coming years to face challenges to maximize returns and minimize risks through financing with  Islamic formula to investigate of existence statistical significant  relationship between returns and risking Islamic bank , has been use of financial other statistical  measurement. Measuring return and risk of Islamic banks have not been widely considered ,except in few descriptive studies . The controversy among academic and professionals about hot to measure and evaluate a comprehe

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