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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Tue Mar 20 2018
Journal Name
Offshore Technology Conference Asia
Prediction of Hydrate Phase Equilibrium Conditions for Different Gas Mixtures
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Abstract<p>Gas hydrate formation poses a significant threat to the production, processing, and transportation of natural gas. Accurate predictions of gas hydrate equilibrium conditions are essential for designing the gas production systems at safe operating conditions and mitigating the problems caused by hydrates formation. A new hydrate correlation for predicting gas hydrate equilibrium conditions was obtained for different gas mixtures containing methane, nitrogen and carbon dioxide. The new correlation is proposed for a pressure range of 1.7-330 MPa, a temperature range of 273-320 K, and for gas mixtures with specific gravity range of 0.553 to 1. The nonlinear regression technique was applie</p> ... Show More
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Publication Date
Sat Aug 01 2015
Journal Name
Journal Of Engineering
Determination of the Optimum Conditions in Evaluation of Kiwi Juice as Green Corrosion Inhibitor of Steel in Hydrochloric Acid
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The corrosion protection of low carbon steel in 2.5 M HCl solution by kiwi juice was studied at different temperatures and immersion times by weight loss technique. To study the determination of the optimum conditions from statistical design in evaluation of a corrosion inhibitor, three variables, were considered as the most dominant variables. These variables are: temperature, inhibitor concentration (extracted kiwi juice) and immersion time at static conditions.

These three variables are manipulated through the experimental work using central composite rotatable Box – Wilson Experimental Design (BWED) where second order polynomial model was proposed to correlate the studied variables with the corrosion rate o

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Publication Date
Thu Sep 01 2016
Journal Name
Journal Of Engineering
Demulsification of Remaining Waste (Water In Oil Emulsions) After Removal Of Phenol In Emulsion Liquid Membrane Process
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The aim of present work is to study the removal of phenol present in aqueous feed solution by the emulsion liquid membrane technique using kerosene as a diluent, sodium hydroxide as a stripping agent, and sorbitan monooleate (Span 80) as a surfactant. The parameters studied were: surfactant concentration, volume ratio of membrane phase to internal phase, and stirring speed. It was found that more than 98% of phenol can be removed at the conditions were surfactant concentration 2% (v/v), volume ratio of membrane phase to internal phase 5:1 and stirring speed 400 rpm. Maximum phenol extraction efficiency at 7 minutes of process time was observed. It was found that there was a good agreement between the standard kerosene an

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Publication Date
Thu Mar 31 2022
Journal Name
Journal Of The College Of Education For Women
News of Zubarah Family- Unionists in Nishapur and their Scientific Contributions in the two Centuries (4-6 AH/10-12 AD)
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This research is concerned with qualitatively studying the history of an ancient family, one of the most prominent noble, Alawite families, that assumed the position of the Student Union for the Alawite Supervision in the city of Nishapur in Khorasan during the centries (4-6 H./ 10-12 A.H.). Thus, the research aims to investgate the historical news, and the outstanding Zubarah figures who experience the supereme the religious, historical and scientific position in Khorasan generally and Nishapur particularily. It further aims at arriving at the true meaning of the name Zubarah, and to whom it was called, and the extent of this family’s affiliation to the noble Alawi House, and how they moved to live and settle in the cities of the East

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Publication Date
Sat Mar 23 2024
Journal Name
Irish Journal Of Medical Science (1971 -)
Validity of galactin-3 in acromegaly: comparison with traditional markers
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Publication Date
Mon Jan 01 2024
Journal Name
E3s Web Of Conferences
Analytical Comparison of Leading Sustainability Systems in the Iraqi Environment
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Over the last two decades, several sustainability assessment methods have developed as key accelerators for the development and improvement of sustainable industrial buildings. Some of these systems, like as LEED or BREEAM, are considered international, whereas others, such as Pearl Rating Systems (PRS), are local. Although they all share similar goals, they can lead to the construction of green buildings or the improvement of the efficiency of existing conventional buildings. Each technique has its structure, certification process, and weighting norms. The inequalities have prompted various questions about whether global assessment systems appropriately consider the country’s national settings. This study aims to compare the Pear

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Publication Date
Sun Sep 01 2024
Journal Name
Baghdad Science Journal
Isolation and Identification of Flavonoid Compounds from Euphorbia Milii Plant Cultivated in Iraq and Evaluation of its Genetic Effects on Two Types of Cancer Cell Line
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يعتبر "تاج الأشواك" أو نبات شوكة المسيح، وهو من نباتات الزينة الطبية ، ينتمي إلى جنس يوفوربيا. E. milii يحتوي كميات وفيرة من المركبات الفينولية ، التربينات، الستيرويدات والقلويدات. كانت الأهداف الرئيسية لهذه الدراسة هي فحص مستخلصات الفلافونويد والنانو فلافونويد ضد نوعين من خطوط الخلايا السرطانية. تم تصنيع مركبات الفلافونويد النانوية عن طريق تفاعل مركب الكيتوسان والماليك اسد. تم تحليل مركبات الفلافونويد ال

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Publication Date
Thu Dec 26 2019
Journal Name
Bulletin Of The Iraq Natural History Museum (p-issn: 1017-8678 , E-issn: 2311-9799)
COMPARATIVE ANATOMICAL AND HISTOLOGICAL STUDY OF SOME ORGANS IN TWO FISH SPECIES CYPRINUS CARPIO LINNAEUS, 1758 AND MESOPOTAMICHTHYS SHARPEYI (GÜNTHER, 1874)(CYPRINIFORMES, CYPRINIDAE)
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  The present study aims to give some details about the normal anatomical and histological structure of the liver, pancreas and gall bladder in Cyprinus carpio Linnaeus, 1758 and Mesopotamichthys sharpeyi (Günther, 1874). Anatomical results revealed that the liver of C. carpio is a reddish-brown in color, located in the anterior part of abdominal cavity and dispersed between most of the intestines, which is divided into two lobes; while in M. sharpeyi the liver is light brown in color located in the anterior part of abdominal cavity and extends to the end of the intestinal tract with two lobs. The gallbladder situated in the right side of the liver in both species. Histological results in both species showed that the liver consists

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Publication Date
Wed Jan 01 2020
Journal Name
Medico -legal Update
Histological changes in liver tissue resulting from Hydatid cyst infection: Comparison between sheep and cattle in iraq
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Publication Date
Wed Jun 10 2026
Journal Name
Journal Of Baghdad College Of Dentistry
An Assessment of Salivary Leptin and Resistin Levels in Type Two Diabetic Patients with Chronic Periodontitis (A Comparative Study)
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Background: Type 2 diabetes mellitusand chronic periodontitis hold a close relationship that has been the focus of many researches. Currently there is an appreciation to the role of adipose tissue-derived substances "the adipokines" in immune-inflammatory responses; also, there is an interest in using the simple non-invasive saliva in diagnosing and linking oral and general health problems. The current study aims to determine the periodontal health status in the chronic periodontitis patients with and without poorly or well controlled type 2 diabetes mellitus, measure the salivary levels of two adipokines "leptin and resistin", pH and flow rate and then correlate between these clinical periodontal, biochemical and physical parameters in eac

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