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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Wed May 29 2019
Journal Name
Iraqi Journal Of Physics
Impact strength behaviour of PMMA denture base through addition of different nanoparticles after immersion in some nutrition liquids
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Poly methyl methacrylate PMMA polymer could be considered the main material that used mostly in the recent years in denture base fabrication. It commonly known by it is poor strength properties such as low impact strength. The aim of the present research was to enhance the performance of PMMA denture base through the addition of two kind of nanoparticles (nano particles that selected from artificial and natural sources). Nano -particles from both Al2O3 and crushed peanut Peel were used for comparing purposes.Various weight fraction used in this study for both kinds of the additive (1%, 2% and 3%). Moreover, in this work a study and evaluation in impact strength (I.S.) value were done before and after immersion. The new prepared nanocompo

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Publication Date
Thu Jan 02 2025
Journal Name
مجلة كلية القانون للعلوم القانونية والسياسية
Employment of Chinese Cyber Power in Regional Conflict Management Strategies The Case of Conflict with Japan After 2014
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Abstract:- Cyberspace is a new arena for conflict between international powers, especially since the cost of cyber-conflict is less than its traditional warfare counterparts regardless of the nature of the weapons used, whether traditional or non-traditional. Cyber conflict is necessarily based on strategies to deter, attack, and defend. The aim of the cybercrime conflict is to ensure the defensive sufficiency of the state, ensuring its national security and safeguarding its supreme interests. Despite Japan-China relations characterized by convergence and cooperation in post-Cold War economic spheres, Japan continues to retain the growing Chinese influence in East Asia. These variables prompted Japan to announce a hedging strategy due to un

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Publication Date
Mon Aug 18 2025
Journal Name
Journal Of Baghdad College Of Dentistry
Oral health status, salivary physical properties and salivary Mutans Streptococci among a group of mouth breathing patients in comparison to nose breathing
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Background: Mouth breathing can lead to introduce cold, dry unprepared air that insults the tissue of oral cavity, nasopharynx and lung, leading in turn to pathological changes in oronasal cavity, nasopharyngeal and other respiratory tissue, mouth breathing associated with nasal obstruction may lead to many health problems, in particular oral health problems such as inflammation of gingiva, oral dryness, change in oral environment that may decrease pH, salivary flow rate and increase bacteria and dental caries.Aims of the present study were to assess the oral health condition among mouth breather associated with nasal obstruction, including dental caries, oral cleanliness and gingival health condition as well as to evaluate the changes in s

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Publication Date
Sat Dec 01 2018
Journal Name
Al-khwarizmi Engineering Journal
Design and Implementation of an Automatic Control for Two Axis Tracking System for Applications of Concentrated Solar Thermal Power
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The present work presents design and implementation of an automated two-axis solar tracking system using local materials with minimum cost, light weight and reliable structure. The tracking system consists of two parts, mechanical units (fixed and moving parts) and control units (four LDR sensors and Arduino UNO microcontroller to control two DC servomotors). The tracking system was fitted and assembled together with a parabolic trough solar concentrator (PTSC) system to move it according to information come from the sensors so as to keep the PTSC always perpendicular to sun rays. The experimental tests have been done on the PTSC system to investigate its thermal performance in two cases, with tracking system (case 1) and without trackin

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Publication Date
Mon Jan 01 2018
Journal Name
Euphrates Journal Of Agriculture Science
Effect of Interaction Between Dietary Two Levels of Cumin (Cuminum cyminum) and Ginger (Zingiber officinale) on Japanese Quail performance
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The study was conducted to determine the effect of of cumin (Cuminum cyminum) and ginger (Zingiber officinale) powder on performance in Japanese quails. 630 bird (7 birds for each treatment) nine weeks of age were used. Experiment was continued for 12 weeks divided to six periods and the birds distributed randomly on nine combinations of cumin and ginger, three levels of each plant powder namely, 0, 0.5 and 1%. T1 (Control) contain the slandered diet (0% of cumin and 0% of ginger), T2: (0% of cumin and 0.5% of ginger), T3: (0% of cumin and 1% of ginger), T4: (0.5% of cumin and 0% of ginger), T5: (0.5% of cumin and 0.5% of ginger), T6: (0.5% of cumin and 1% of ginger), T7: (1% of cumin and 0% of ginger), T8: (1% of cumin and 0.5% of ginger),

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Publication Date
Mon Dec 20 2021
Journal Name
Bulletin Of The Iraq Natural History Museum (p-issn: 1017-8678 , E-issn: 2311-9799)
MORPHOLOGY AND MOLECULAR IDENTIFICATION OF THE LARVAL STAGE OF TWO SPECIES FROM THE GENUS CHRYSOBOTHRIS ESCHSCHOLTZ, 1829 (COLEOPTERA, BUPRESTIDAE)
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The genus of Chrysobothris Eschscholtz, 1829 is one of the most diverse and widespread genera of the family Buprestidae of some 700 described species distributed throughout the world. In Iraq, particularly in the Kurdistan region, about 4 species had been recorded so far, many of these species are sympatric, share larval host plants, and are difficult to reliably separate morphologically. The current study investigates species limits and relationships among the recognized species occurring within the Erbil Province; mitochondrial cytochrome C oxidase (COX I) molecular analysis confirmed the monophyly of two Chrysobothris species, Ch. affinis (Fabricius, 1794) and Ch. chrysostigma (Linnaeus, 1758). Implications of the resultant larval mor

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Publication Date
Mon Dec 25 2017
Journal Name
Biomedical And Pharmacology Journal
Effect of the Addition of Polyamide (Nylon 6) Micro-Particles on Some Mechanical Properties of RTV Maxillofacial Silicone Elastomer Before and After Artificial Aging
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Publication Date
Fri Dec 01 2023
Journal Name
Iop Conference Series: Earth And Environmental Science
Relationship Study Between Total Length with Otolith Length and Thickness in Two Fish Species: Coptodon zillii (Gervais,1848) and Cyprinus carpio” (Linnaeus,1758)
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Abstract<p>This study aimed new indications that may clarify the relationships between the total and standard lengths, and the length of the otolith, as well as the thickness and weight of these bones compared to the body weights of two different species of invasive fish in the Iraqi aquatic environment, the common carp <italic>Cyprinus carpio</italic> of the Cyprinidae family, and the common Tilapia. <italic>Coptodon zillii</italic>, from the Cichlidae family. The results showed that the otolith were not related to some of the vital characteristics of the studied fish, and there were differences in the correlation coefficient between some vital measurements with high signifi</p> ... Show More
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Publication Date
Fri Nov 01 2019
Journal Name
Iop Conference Series: Earth And Environmental Science
The comparison of several methods for calculating the degree of heritability and calculating the number of genes in maize (Zea mays L.). I. Agronomic traits
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Abstract<p>The objective of present study was to compare of several methods for estimating the degree of heritability and calculating the number of genes using generation mean analysis of maize (<italic>Zea mays</italic>L.). The experiment was conducted at the field of Field Crop Dept. College of Agric / Univ. of Baghdad, for many seasons, spring and fall seasons 2009, 2010, spring 2011 and fall 2013.Six diverse inbred lines were crossed to produce F1,F2,BC1 and BC2 for four superior crosses.Broad-sense and narrow sense heritability estimates based on variance of different generations. The results showed that the four formulas used to estimate the heritability were different in estimating the values o</p> ... Show More
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Publication Date
Mon Aug 18 2025
Journal Name
Journal Of Baghdad College Of Dentistry
The Effect of Ceramic Thickness and Number of Firings on the Color of Two All-Ceramic Systems Measured by Spectrophotometer
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Background: This in vitro study was carried out to evaluate the effects of various veneering dentin ceramic thicknesses and repeated firings on the color of lithium disilicate glass-ceramic (IPS e.max Press) and zirconium-oxide (IPS ZirCAD) all-ceramic systems, measured by clinical spectrophotometers (Easyshade Advance 4.0) . Materials and methods: The 72specimens cube-shaped have the dimension of about 11 mm in width, 14 mm in length, 1mm in thickness, these cores divided into 3 groups according to the type of material each group have (24)core specimens. Each group had been divided into three sub-groups (each having 8 specimens) according to veneering with dentin ceramic thicknesses: as 0.5, 1, or 2 mm (n=8). IPS e.max press and ZirCAD c

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