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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Aug 01 2021
Journal Name
Sensors And Actuators B: Chemical
Sensitive and simple colorimetric methods for visual detection and quantitative determination of semicarbazide in flour products using colorimetric reagents
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After baking the flour, azodicarbonamide, an approved food additive, can be converted into carcinogenic semicarbazide hydrochloride (SEM) and biurea in flour products. Thus, determine SEM in commercial bread products is become mandatory and need to be performed. Therefore, two accurate, precision, simple and economics colorimetric methods have been developed for the visual detection and quantitative determination of SEM in commercial flour products. The 1st method is based on the formation of a blue-coloured product with λmax at 690 nm as a result of a reaction between the SEM and potassium ferrocyanide in an acidic medium (pH 6.0). In the 2nd method, a brownish-green colored product is formed due to the reaction between the SEM and phosph

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Publication Date
Thu Jul 11 2024
Journal Name
الموئتمخر الدولي للعلم والتعليم
SUFFIXAL METHOD FOR FORMING NEW VOCABULARY IN RUSSIAN AND ARARBIAN LANGUAGES AND ITS INFLUENCE ON ACHIEVEMENT OF TRANSLATION ADEQUACY
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Abstract. In this scientific work, we investigate the problem of the practical necessity of achieving the adequacy of translation activities with active translation from Russian into Arabic in various fields of translation. Based on the material of the latest suffix vocabulary, a serious attempt is made to clarify and specify the rules for the development of translator's intuition when translating from Russian into Arabic and vice versa. Based on the material collected by the latest suffix vocabulary, we try to make an attempt to reveal the role of suffix word creation in highlighting the general rules for achieving translation equivalence. The paper examines the process of creating words in multi-family languages, the difference between th

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Publication Date
Sun Mar 13 2011
Journal Name
Baghdad Science Journal
Effects of Organic Pollution on some Fish and Benthic Macroinvertebrate Groups in Rivers Tigris and Diyala at Baghdad Area.
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Various activities taking place within the city of Baghdad have significantly contributed to organic pollution in Rivers Tigris and Diyala. The present study aimed to assess some physical, chemical and biological aspects of six sites on Rivers Tigris and Diyala as they flow through the city of Baghdad. Monthly samples were collected for the period January to December, 2005. Marked differences in the physical and chemical characteristics of water were noted between the two rivers’ sites. Average values during the study period of dissolved oxygen, biochemical oxygen demand, particulate organic matter, nitrate, phosphate and total dissolved solids for Tigris and Diyala were 7.8,4.7; 2.4,10.4; 350.1,921.4;7.8,13.9;1.2,4.8;814,2176 mg / l re

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Publication Date
Thu Mar 30 2017
Journal Name
Journal Of Biotechnology Research Center
Study the Effects of Methotrexate with and without Vitamin A on Some Biochemical and Histological Parameters in Male Rabbits
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The present study aims to evaluate the effects of methotrexate (MTX) with and without vitamin A (Vit. A) on some biochemical parameters and histological structure in male rabbits liver. Twenty male rabbits weighing 1250-1480 gm were divided into four equal number groups. The first group was given 2 ml distilled water as control group. The second group was given MTX (20 mg/kg), the third group was given Vit. A (5000 IU), while the fourth group was given MTX (20 mg/kg) +Vit. A (5000 IU) in alternative days. Following four weeks of treatment, lipid profile total cholesterol (TC), triglycerides (TG), high-density lipoprotein (HDL), [low-density lipoprotein (LDL) and very low-density lipoprotein (VLDL)]; in addition to thyroid hormones tr

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Publication Date
Tue Oct 04 2022
Journal Name
Azerbaijan Medical Journal
Ultrasonic fetal Doppler and growth indices and their relation to immediate neonatal outcomes in different severities of maternal anemia
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Doppler assessment may lead to intervention that reduces the risk of fetal brain damage. Aim of thestudy: to assess the relation between ultrasonic hemodynamic Doppler indices of middle cerebral and umbilical arteries (PI, RI), growth indices to immediate neonatal outcomes (weight, head & abdominal circumference, APGAR scores at 1 and 5 minutes and neonatal unit admission) in women with mild, moderate and severe anemia during pregnancy. Present study is a clinical prospective study carried out in Al-Elwiya Maternity Teaching Hospital during (January-Jun) 2019, all anemic pregnant women presented to Obstetrical wards in hospitals for emergency cesarean section were the study population. The final sample selected was 120 pregnant women. Ultra

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Publication Date
Tue Jan 01 2019
Journal Name
Asian Journal Of Chemistry
Oxidative Stress Status in Sera and Saliva of Type 2 Diabetic Iraqi Patients with and without Proliferative Diabetic Retinopathy
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The present study aimed to look for the differences in the oxidative stress status in sera and saliva samples of type 2 diabetic Iraqi patients with and without proliferative diabetic retinopathy. As well as to look for the possibility whether this status can be measured in saliva as an alternative sample to that of serum, hence to achieve that total oxidant status, total antioxidant status and oxidative stress index were measured in both sera and saliva samples of two groups of patients with type 2 diabetes mellitus and the healthy individuals. Upon the comparison between patients without proliferative diabetic retinopathy and the control sample the results showed presence of a significant increase (p < 0.05) of total oxidant st

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Publication Date
Sat Dec 01 2018
Journal Name
Political Sciences Journal
The Patterns of the Strategic Environment and its Role in Determining Strategies for Dealing with Conflict and Peace Situations
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Abstract

The decision maker needs to understand the strategic environment to be addressed through different means and methods. It is obvious that there is a difference between the three strategic environments (conflict environment, peace environment, post- peace environment) in terms of inputs and strategies to deal with each one of them. There is an urgent need to understand each pattern separately, analyze its inputs, and identify the factors and variables that affect the continuity of this situation (conflict, peace, post-peace). It is not appropriate to identify treatment without diagnosis of the condition, so it is very important to understand the type of strategic environment to be dealt with it.

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Publication Date
Fri Jul 07 2023
Journal Name
Journal Of Obstetrics, Gynecology And Cancer Research
Evaluation of Maternal and Fetal Complications in Pregnant Women with Polycystic Ovary Syndrome (PCOS) with Severe and Mild Phenotype
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An essential issue in obstetrics is the prevalence of maternal and fetal complications in pregnant women with polycystic ovary syndrome (PCOS). The purpose of the present study was to investigate the prevalence of pregnancy complications among various phenotypes of pregnant women with PCOS.

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Publication Date
Fri Jul 01 2022
Journal Name
Nternational Journal Of Special Education
Comparative Study between a Combination of Plants Extracts and Drugs on Thyroid Hormones and Lipid Profile in Experimental Animals
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The thyroid gland is a vital part of the overall endocrine system, which is regulated some of body function as oxygen use, basal metabolic rate, growth, cellular metabolism and development This study shed light on a number of extracts that have been shown to have beneficial effects on the thyroid and its function, as well as the various factors linked to thyroid dysfunction. The experiment was conducted to determine the effect of a mixture of two extracts of "Fucus vesiculosus (150 mg/ kg) with Coleus forskohlii (1000 mg/ kg) and Rosmarinus officinalis (220 mg/ kg) with Camellia sinensis (1.25 mg/ kg)" on thyroid hormones as well as lipids profile and tested the effectiveness of two drugs one of them stimulates the hormones of the thyroid (

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Publication Date
Sat Apr 01 2017
Journal Name
Journal Of Physical Education
Body Image and Its Relationship With Self&#8211;Confidence In Female College of Physical Education and Sport Sciences Students
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سها علي حسين, هويدة إسماعيل إبراهيم, Journal of Physical Education, 2017 - Cited by 1

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