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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Sat Nov 04 2017
Journal Name
Silicon
Optimization of Preparation Conditions to Control Structural Characteristics of Silicon Dioxide Nanostructures Prepared by Magnetron Plasma Sputtering
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Publication Date
Fri Nov 01 2019
Journal Name
Renewable Energy
Test of solar adsorption air-conditioning powered by evacuated tube collectors under the climatic conditions of Iraq
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Publication Date
Mon May 11 2020
Journal Name
Baghdad Science Journal
On the Growth of Solutions of Second Order Linear Complex Differential Equations whose Coefficients Satisfy Certain Conditions
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In this paper, we study the growth of solutions of the second order linear complex differential equations  insuring that any nontrivial solutions are of infinite order. It is assumed that the coefficients satisfy the extremal condition for Yang’s inequality and the extremal condition for Denjoy’s conjecture. The other condition is that one of the coefficients itself is a solution of the differential equation .

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Publication Date
Thu Jun 18 2026
Journal Name
Mustansiriya University
Effects Of Some Environmental Growth Conditions On Autoaggregation Of Lactobacillus spp. Isolated From Bacterial Vaginitis Infected Females
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المستودع الرقمي العراقي. مركز المعلومات الرقمية التابع لمكتبة العتبة العباسية المقدسة

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Publication Date
Thu Sep 12 2019
Journal Name
Al-kindy College Medical Journal
Minimal sternotomy surgery in comparison to standard sternotomy in the coronary bypass Surgery
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Background Median sternotomy is the gold standard incision for most cardiac operations. However, with the advent of minimal invasive surgery, a new approach emerged in cardiac surgery named mini-sternotomy and has been successfully used to perform a variety of operations.

 The aim of this paper is to present our experience of using mini-sternotomy to harvest the left internal mammary artery (LIMA) for off-pump revascularization of the left anterior descending artery (LAD)

 Methodology Over a 2-year period (October 2012-October 2014), 100 patients underwent coronary artery bypass grafting (CABG) via conventional median sternotomy (CMS) (n=80) and mini-sternotomy (MS) (n=20). The

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Publication Date
Thu Aug 13 2020
Journal Name
Periodicals Of Engineering And Natural Sciences
A comparison of some forecasting models to forecast the number of old people in Iraqi retirement homes
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Statistical methods of forecasting have applied with the intention of constructing a model to predict the number of the old aged people in retirement homes in Iraq. They were based on the monthly data of old aged people in Baghdad and the governorates except for the Kurdistan region from 2016 to 2019. Using Box-Jenkins methodology, the stationarity of the series was examined. The appropriate model order was determined, the parameters were estimated, the significance was tested, adequacy of the model was checked, and then the best model of prediction was used. The best model for forecasting according to criteria of (Normalized BIC, MAPE, RMSE) is ARIMA (0, 1, 2).

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Publication Date
Thu Jun 30 2016
Journal Name
Al-kindy College Medical Journal
Power Versus Conventional Color Doppler Sonographic Diagnosis Of Acute Cholecystitis: Comparison In The Depiction Of Mural Flow
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Background: Gray-scale sonography is generally
considered as a first-line diagnostic tool for patient with
suspected acute cholecystitis. It is suggested by gallstones,
Murphy's sign, thickening of the gallbladder wall and bile
sludging, but the specificity of these sonographic findings
are not as high as their sensitivity. Blood flow of the
gallbladder wall is increased in acute inflammation.
Objective: To evaluate the sensitivity and specificity of
power Doppler sonography and compared with conventional
color Doppler and gray-scale sonography in diagnosing
patients with acute cholecystitis.
Type of the study: This was a cross sectional study.
Patients and methods: The study was conducted t

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Publication Date
Sat Aug 01 2020
Journal Name
Periodicals Of Engineering And Natural Sciences
A comparison of some forecasting models to forecast the number of old people in Iraqi retirement homes
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Statistical methods of forecasting have applied with the intention of constructing a model to predict the number of the old aged people in retirement homes in Iraq. They were based on the monthly data of old aged people in Baghdad and the governorates except for the Kurdistan region from 2016 to 2019. Using BoxJenkins methodology, the stationarity of the series was examined. The appropriate model order was determined, the parameters were estimated, the significance was tested, adequacy of the model was checked, and then the best model of prediction was used. The best model for forecasting according to criteria of (Normalized BIC, MAPE, RMSE) is ARIMA (0, 1, 2)

Publication Date
Tue Mar 01 2016
Journal Name
Journal Of Baghdad College Of Dentistry
A Comparison of the Effectiveness of Reciprocating System with Continuous Rotary Systems in Non-Surgical Endodontic Retreatment
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Background: Optimal root canal retreatment was required safe and efficient removal of filling material from root canal. The aim of this in vitro study was to compare the efficacy of reciprocating and continuous motion of four retreatment systems in removal of root canal filling material. Materials and Methods: Forty distal roots of the mandibular first molars teeth were used in this study, these roots were embedded in cold clear acrylic,roots were instrumented using crown down technique and rotary ProTaper systemize Sx to size F2 ,instrumentation were done with copiousirrigation of 2.5% sodium hypochlorite and 17% buffered solution of EDTA was used as final irrigant followed by distilledwater, roots were obturated with AH26 sealer and Prota

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Publication Date
Wed Nov 01 2023
Journal Name
Al-rafidain Journal Of Medical Sciences ( Issn 2789-3219 )
After Introducing Artificial Intelligence, can Pharmacists Still Find a Job?
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