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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Mon Sep 15 2025
Journal Name
Alustath Journal For Human And Social Sciences
Searching for Meaning in a Chaotic World: An Analysis of Tina Howe’s Birth and After Birth
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Publication Date
Wed Dec 14 2016
Journal Name
Journal Of Baghdad College Of Dentistry
Comparison of Bolton’s Ratios in a Sample of Iraqi and Egyptian Populations
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Background: The objective of this study was to investigate the possibility of standardizing the Bolton ratio analysis as a diagnostic measure for both Iraqi and Egyptian orthodontic populations within three Angle' classification groups. Materials and methods: Two hundred forty pretreatment study casts (one hundred twenty of each population) were included in this study and divided into three Angle' classification groups. The mesiodistal crown diameters of all teeth were measured for computing the anterior and total Bolton ratios. Analysis of variance was performed to compare the mean ratios of Bolton analysis as a function of the Angle classification.HSD test was used to specify the classes of malocclusion that have significant differences.

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Publication Date
Tue Dec 01 2020
Journal Name
Ieee Transactions On Industrial Electronics
Cascaded-Extended-State-Observer-Based Sliding-Mode Control for Underactuated Flexible Joint Robot
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This article presents a new cascaded extended state observer (CESO)-based sliding-mode control (SMC) for an underactuated flexible joint robot (FJR). The control of the FJR has many challenges, including coupling, underactuation, nonlinearity, uncertainties and external disturbances, and the noise amplification especially in the high-order systems. The proposed control integrates the CESO and SMC, in which the CESO estimates the states and disturbances, and the SMC provides the system robustness to the uncertainty and disturbance estimation errors. First, a dynamic model of the FJR is derived and converted from an underactuated form to a canonical form via the Olfati transformation and a flatness approach, which reduces the complexity of th

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Publication Date
Thu May 01 2025
Journal Name
Egyptian Journal Of Histology
Comparative morphological and histological study of liver in two Iraqi mammals (Felis catus) and (Sciurus anomalus)
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Introduction: The mammals digestive system demonstrates various structural and functional adaptations to their diverse offeeding habits, and the digestive system representing a function link between food-seeking activities and energy conservationby allocating energy to different events.Aim of the Work: This study was aimed to compare the histological structure of the liver in the domestic cat ( F. catus) andCaucasian squirrel (S. anomalus), which differ in their feeding pattern.Materials and Methods: In the present study, ten adult animals were used including five of F. catus and five of S. Caucasian,Samples were obtained from local market in Baghdad . Samples fixed using formalin (10%) to prepare all specimens for thehistological study. Th

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Publication Date
Thu Jan 12 2023
Journal Name
مجلة السياسية والدولية /
Iraq’s Societal Security after 2003: Challenges and Countering Strategies
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Societal security is regarded as a basic need for human society through which the stability, progress and prosperity of the nation is measured. It is the guarantor of the safety of individuals and groups from various internal and external dangers, based on the protection of the three pillars: the individual, the family, and society. For decades, Iraq has witnessed the phenomenon of political instability, represented by its entry into several wars, starting with the 1948 war, leading up to the American war on Iraq in 2003. Then, those wars were followed by an era in which corruption and terrorism spread, and this, in turn, led to the fragmentation of the national will and the division of Iraqi public opinion regarding many regional and inte

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Publication Date
Sun Jun 03 2012
Journal Name
Baghdad Science Journal
Influence of chemical and physical conditions on the production of bacteriocin by Aeromonas hydrophila
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Aeromonas hydrophila have been isolated as a cause of a cute gastroenteritis in 23 (5.6%) of 410 patients. Other bacterial enteropathogens have been isolated from 387 patients with diarrhea, were 19 different strains. A. hydrophila occurred more commonly in children with acute diarrhea, the results showed that 18(78.26%) isolates of A. hydrophila found in children under 10 years old ,distributed to 10(43.47%) in male and 8(34.78%) in female ,and in adults with diarrhea 5 (21.73%). In the other hand, we noticed frequency of isolation was higher in male 14(60.86%) when compared with 9(39.14%) in female. Six strains of A. hydrophila have been observed to have bacteriocin activity against 12 of 23 different A. hydrophila ,as well as Staphy

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Publication Date
Sun Dec 02 2012
Journal Name
Baghdad Science Journal
The Dissolution Study For Sodium Selenite Tablets Using Atomic Absorption Spectrophotometer
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The development of a meaningful dissolution procedure for drug products with limited water solubility has been a challenge to both the pharmaceutical industry and the agencies that regulate them. Natural surfactants aid in the dissolution and subsequent absorption of drugs with limited aqueous solubility. In vitro, various techniques have been used to achieve adequate dissolution of the sparingly water – soluble or water insoluble drug products such as the use of mechanical methods (i.e., increased agitation and the disintegration method) or hydro alcoholic medium or large volumes of medium. The necessity of assuring the quality of drugs , especially those with low aqueous solubility and in vivo absorption , has led to the development and

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Publication Date
Sun Sep 27 2020
Journal Name
Iraqi National Journal Of Nursing Specialties
Parents' Efficacy for Child Healthy Weight Behavior in Elementary Schools in Hilla City
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Objectives: The study aims to (1) Assess the parents' efficacy for child healthy weight behavior. (2) Identify the difference in parents’ efficacy for child healthy weight behavior between the groups of parent’s gender, family’s socioeconomic status, child’s gender, and child’s birth order, (3) Find out the relationship between parents’ age, child’s age, child’s body mass index, family’s socioeconomic status, the number of children in the family and parents’ efficacy for child healthy weight behavior.
Methodology: A descriptive correlational study is conducted for the period from November 11th, 2018 to March 25th, 2019 to assess the parents' efficacy for child healthy weight behavior. The study was carried-out in (

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Publication Date
Thu Nov 17 2022
Journal Name
مجلة الدراسات الدولية
Iraq's strategic performance in achieving sustainable development after 2005: challenges and coping strategies
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The research discusses the obstacles that faced the Iraqi strategic performance in achieving sustainable development after the election of the first Iraqi government in 2005 and the most important strategies to overcome these obstacles.

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Publication Date
Tue Mar 19 2024
Journal Name
Baghdad Science Journal
Comparison of physical characteristics of mass and luminosity function of disk systems in barred and unbarred spiral galaxies
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إحدى أهم الطرق لتقصي توزيع المجرات عبر الزمن الكوني هي دالة اللمعان LF بدلالة كتلة القرص الباريوني ψS(Mb)، القدر . لقد درسنا تقديرًا لكثافة كتلة الباريون في عينة من المجرات الحلزونية القضيبية وغير القضيبية من الادبيات السابقة، والتي تتضمن فعليًا، لكل صنف من الاجرام السماوية ذات المحتوى الباريون المرئي، جزءًا لا يتجزأ من ناتج دالة الضيائية (LF) ونسبة الكتلة إلى الضوء. استخدمت تقنية الانحدار المتعدد لحزمة الب

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