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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 2019
Journal Name
Microbial Pathogenesis
Comparison of adhesin genes expression among Klebsiella oxytoca ESBL-non-producers in planktonic and biofilm mode of growth, and imipenem sublethal exposure
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Publication Date
Wed Jul 31 2019
Journal Name
Journal Of Engineering
Comparison Study of Adsorption of Lead and Methylene Blue on Zeolite, Activated Carbon and Their Composite Materials
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In this study, composite materials consisting of Activated Carbon (AC) and Zeolite were prepared for application in the removal of methylene blue and lead from an aqueous solution. The optimum synthesis method involves the use of metakaolinization and zeolitization, in the presence of activated carbon from kaolin, to form Zeolite. First, Kaolin was thermally activated into amorphous kaolin (metakaolinization); then the resultant metakaolin was attacked by alkaline, transforming it into crystalline zeolite (zeolitization). Using nitrogen adsorption and SEM techniques, the examination and characterization of composite materials confirmed the presence of a homogenous distribution of Zeolite throughout the activated carbon.

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Publication Date
Thu Jun 15 2017
Journal Name
Journal Of Baghdad College Of Dentistry
Comparison Of Oral Health Status And Behavior between First And Fifth Years Of Al-Mustansiriyah Dental Students
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Background:Periodontal diseases and dental caries are the most common oral diseases, but they can be adequately prevented by adopting a specific health behavior and plaque control.The study was carried out to determine and compare oral health status; it included both caries experience, gingival health and oral hygiene behavior betweenfirst and fifth yearsof Al-Mustansiriyahdental students. Materials and methods: Total sample of the study consisted of 50 students at first year (25 males, 25 females)and 60 students at fifth year (30 males, 30 females). Plaque andgingival indices,dental caries indices (DMFS and DMFT) wererecorded to evaluateoral health status for each student. Further questionnaires were given to evaluate different oral hyg

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Publication Date
Sun Mar 25 2018
Journal Name
Biomedical And Pharmacology Journal
Apical Extrusion of Debris and Irrigants After using Different Irrigation Needles and Systems With Different Depth of Penetration (A Comparative Study)
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Publication Date
Thu Jan 20 2022
Journal Name
Journal Of Clinical Medicine
Comparison of the Safety and Efficacy of Laser Versus Pneumatic Intracorporeal Lithotripsy for Treatment of Bladder Stones in Children
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This study aimed to compare the safety and efficacy of laser lithotripsy and pneumatic lithotripsy, the two most commonly used transurethral lithotripsy methods for treating bladder stones in children in Iraq. Between January 2013 and December 2016, 64 children with bladder stones were included in this prospective randomized study, after ethical committee approval and written consent from the children’s parents or caregivers were obtained. Patients were assigned randomly by computer software to two groups treated with either pneumatic cystolithotripsy or laser lithotripsy. A 9 Fr. semirigid ureteroscope was used to pass the lithotripter through and fragment the stone. A catheter of 8–12 Fr. was then introduced and kept in place

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Publication Date
Mon Jan 01 2018
Journal Name
World Journal Of Dentistry
In vitro Remineralization of Caries-affected Dentin after Selective Carious Tissue Removal
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Publication Date
Mon Jul 01 2024
Journal Name
Iop Conference Series: Earth And Environmental Science
Assessment of Two Extraction Methods LLE and QUEChERS to Determine Pesticides Residues in Vegetables by Gas Chromatography
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Abstract<p>The extraction of pesticides is a critical and urgent issue in the preparation for and determination of pesticide residues. The lack of a quick, easy, and successful extraction process is the most critical and challenging problem, even if diagnostic tools have improved and pesticide residues have been better understood. This study contrasted the QuEChERS method, which uses gas chromatography with a flame ionization detector, with the LLE method, which uses liquid-liquid extraction, in order to extract pyridaben from cucumbers and spiromesifen from tomatoes. The GC-FID device was employed to ascertain the spiromesifen LOD and LOQ, which were 0.002 μg mL<sup>-1</sup> and 0.00</p> ... Show More
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Publication Date
Sat Jul 08 2017
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Estimation of Superoxide Dismutase, Matrix-metalloprotinase-9, and Interleukin -18 in Patients with Type Two Diabetes Mellitus
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Antioxidant status imbalance and inflammatory process are cooperative events involved in type 2 diabetes mellitus. This study aimed to investigate     superoxide dismutase as a potential biomarkers of antioxidant imbalance, matrix-metaloprotinase-9,   and interleukin -18  as biomarkers of inflammation in serum and to estimate  the effects of other confounding factors  gender, age and finally measuring the relation among the interested biomarkers.

This case - control study included 50 patients,   and   45 of  healthy subjects matched age –gender were also enrolled  in this study as a control group.    The   focused &nbsp

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Publication Date
Sat Aug 01 2015
Journal Name
Euphrates Journal Of Agricultural Science
MEASURES OF SPECIFIC PRODUCTIVITY, ACTUAL TIME, APPEARANCE AND TILLAGE DEVIATION FOR TWO PLOWS MOSTLY USED IN IRAQ
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Experiment was conducted in Baghdad, three factor were used in this research included Two types of Plows included moldboard and disk plows which represented the main plot, Three forward speeds of the tillage was the second factor included 1.85, 3.75 and 5.62 km / h which represented sup plot , and Three levels of Soil Moisture was third factor included 21, 18 and 14 % in all of Vertical and Lateral Plowing Deviation, Practical and specific productivity, actual time for plowing one donam and appearance (goodness) of Tillage represented by the number of clods > 10 cm in silt clay loam soil with depth 22 cm were studied. the experiment was used Split – split plot design under randomized complete block design with three replications and Le

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Publication Date
Tue Dec 24 2024
Journal Name
Malaysian Journal Of Mathematical Sciences
Exploring the Role of Hunting Cooperation, and Fear in a Prey-Predator Model with Two Age Stages
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The aim of this study is to utilize the behavior of a mathematical model consisting of three-species with Lotka Volterra functional response with incorporating of fear and hunting cooperation factors with both juvenile and adult predators. The existence of equilibrium points of the system was discussed the conditions with variables. The behavior of model referred by local stability in nearness of any an equilibrium point and the conditions for the method of approximating the solution has been studied locally. We define a suitable Lyapunov function that covers every element of the nonlinear system and illustrate that it works. The effect of the death factor was observed in some periods, leading to non-stability. To confirm the theore

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