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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Jul 09 2023
Journal Name
Journal Of Engineering
Dynamic Behavior of Pb(II) and Cr(III) Biosorption onto Dead Anaerobic Biomass in Fixed-Bed Column, Single and Binary Systems
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The biosorption of lead (II) and chromium (III) onto dead anaerobic biomass (DAB) in single and binary systems has been studied using fixed bed adsorber. A general rate multi- component model (GRM) has been utilized to predict the fixed bed breakthrough curves for single and dual- component system. This model considers both external and internal mass transfer resistances as well as axial dispersion with non-liner multi-component isotherm (Langmuir model). The effects of important parameters, such as flow rate, initial concentration and bed height on the behavior of breakthrough curves have been studied. The equilibrium isotherm model parameters such as maximum uptake capacities for lead (II) and chromium (III) were found to be 35.12 and

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Publication Date
Sun Dec 07 2014
Journal Name
Baghdad Science Journal
The Effect of Sodium Selenite and Vitamin A on FSH and LH Level in Albino Male Mice treated with Hexavalent Chromium
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The present expermint was designed to determine the effect of Sodium Selenite (0.5 mg/kg) and Vitamin A (10 mg/kg) in FSH and LH level in Albino Male Mice treated with Hexavalent Chromium (1000 ppm). `This study included 48 mice divided into six groups (1st group treated with distilled water and the 2nd group treated with Sesame Oil were considered as control group, 3th group exposed to Hexavalent chromium , 4th group treated with Sodium Selenite and exposed to Hexavalent Chromium , 5th group treated with Vitamin A and exposed to Hexavalent Chromium and 6th group treated with Sodium Selenite and Vitamin A and exposed to Hexavalent Chromium ) . The treatment lasted for 35 days. The results showed a significant (P ? 0.05) decrease in FSH an

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Publication Date
Sun Jun 05 2016
Journal Name
Baghdad Science Journal
Level and Statistical Distribution of Thyroid Peroxidase and Thyroid Hormones in Iraqi patients with Type1 Diabetes Mellitus at Al-Karkh Side
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Type 1 diabetes mellitus (T1DM) is an autoimmune disease frequently associated with autoimmune thyroid disease (AITD). The study is conducted at the Specialized Center for Endocrinology and Diabetes-Baghdad at Al-karkh side, during December 2013 up to April 2014. In this study, we investigate the prevalence of anti-thyroid peroxidase (anti-TPO) antibody in(80) type1 diabetic patients with (AITD) and (30) healthy controls .Blood samples are taken for investigation of thyroid tests by using Vitek Immunodiagnstic Assay System (VIDAS).Enzeme Linked Immunosorbent Assay (ELISA) is used to detect anti-thyroid antibody(anti-TPO). The results show that age, gender and BMI (body mass index) are similar in both groups, p>0.05. Among 80 type1 diabetic

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Publication Date
Fri Jan 01 2021
Journal Name
Brazilian Dental Science
Assessing the level and diagnostic accuracy of osteopontin and oral health status in periodontitis patients with/without Type-2 Diabetes Mellitus
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Publication Date
Sat Jul 04 2020
Journal Name
College Of Islamic Sciences
The Scientific Trips Set Out by Scholars of Marrouzzeen and Baihaq Between each Other in the 5th and 6th Hijrah Centuries
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The present paper aims at finding out the Variance Ratio of Trips Set Out by Scholars of Both Marrouzzeen and Baihaq  .The researcher has come up with conclusion including certain findings ,one of which is that the trip is considered an essential base with high effectiveness since  the old times and has been evolved .This means that the trip has been the main source of  knowledge and sciences from the scholars directly .This had driven the scholars of both Baihaq and Marrouz cities .It has been noticed , though this paper, that the number of the Marrouz scholars who visited was less than those of Baihaq . The researcher has focused on their meetings or conferences and investigated what has been going on in such meetin

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Publication Date
Mon Mar 07 2022
Journal Name
Journal Of Educational And Psychological Researches
The Effect of Renzulli Model on Achievement and Holistic Thinking among Fifth Grade Students in the Holy Quran and Islamic Education
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The present study aims at identifying the effect of Renzulli model on achievement and holistic thinking among the fifth grade students in the Holy Quran and Islamic Education. The experimental method with partial control was used, and the sample was chosen randomly. The sample consisted of (62) students distributed into experimental and control groups. 164 behavioral goals were formulated based on Bloom's first three levels taxonomy (knowledge and comprehension, application, analysis and installation, and evaluation). The researchers designed a post-test to measure the achievement of students in the subject of Holy Quran and Islamic Education which consisted of (40) objective items and a measure of holistic thinking which consisted of (3

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Publication Date
Mon Jun 01 2009
Journal Name
Al-khwarizmi Engineering Journal
Effect of Adding Alcohols and Gas Velocity on Gas Hold up and Mass Transfer Coefficient in Bubble Columns with Draught Tube
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     The bubble columns are widely used as a two or three phase reactor in industrial chemical process such as absorption, biochemical reactions, coal liquefaction, etc. To design such a column, two main parameters should be taken in consideration, the gas hold-up (), and the liquid phase mass transfer coefficient KLa. The study includes the effect of gas velocity and the addition of alcohols on gas hold-up and mass transfer coefficient in bubble column with draught tube when the length of the column is 1.5m and the ratio of the draught tube diameter to the column diameter equals 0.5 and the air dispersion into the base of the draught tube using a multi hole tuyere is equivalent to a diameter of 0.15 mm and

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Publication Date
Thu Dec 11 2025
Journal Name
Journal Of The Faculty Of Medicine Baghdad
Circulating B-cell activating Factor in Multiple Myeloma Patients and Its Correlations with Serum Levels of β2-Microglobulin and Interleukin-6
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Background: Multiple myeloma (MM) is characterized by clonal proliferation of malignant plasma cells within the bone marrow. In most patients, monoclonal immunoglobulin heavy chains or light chains are produced and are associated with organ dysfunction. The growth factor B-cell activating factor (BAFF) plays an important role in the pathogenesis of multiple myeloma due to its ability to promote B-cell survival, expansion, and differentiation. Objective:  to measure the circulatory level of B-cell activating factor in multiple myeloma patients in relapsed and remission states and explore its possible correlations with the clinical staging, β2-microglobulin, and interleukin-6. Methods: This cross-sectional study was performed on 60

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Publication Date
Sat Sep 30 2023
Journal Name
College Of Islamic Sciences
Poetics and its functions In the book of "The Magic and Poetry" by Lisan Al-Din Ibn Al-Khatib (776 AH
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This study deals with a prominent critical term - poetics - in critical studies as an area related to uncovering the laws of creative and aesthetic discourses (Preaching)، and the various functions that accompany it in literary texts. So، the study employs the pioneers' works of this theory specially the eastern theorists in making a parallel comparing study of the text book of " the Magic and Poetry” by Al-Lisan Al-Din bin Al-Khatib (776 AH). It displays the utility of the concept of poetics in the referred book pointing to the illumination of various functions that، in turn، reflected the

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Publication Date
Tue Apr 03 2018
Journal Name
Journal Of Entomology And Zoology Studies
Histological effects of growth hormone (GH) and Insulin-like growth factor-1 (IGF-1) on heart, liner and gizzard in chickens
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In the present study, histological study was carried out on adult chickens to shed light on the effects of GH and IGF-1 on the heart, liver, and gizzard. The microscopic examination had shown that GH and IGF1 promote protein synthesis in the heart tissue. The herein work referred to the presence of a considerable amount of adipose tissue among the bundles of cardiac muscles, which is related to the metabolic process. The results also revealed that GH and IGF-1 promote both protein synthesis and Mitosis in the tissues of the liver and gizzard Moreover, the above hormones stimulate apoptosis, regeneration and secretory activity in gizzard secretory glands

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