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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Mon Dec 30 2019
Journal Name
College Of Islamic Sciences
The biography of the Prophet Muhammad () and his Sunnah between softness and distress
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The Prophet Muhammed () is distinguished in the history of mankind by the fact that he came with a law that combined these two opposing sides, reality and ideals, a wonderful and amazing collection, and he created a wonderful composition between them, and they used together a wise comprehension to ensure the treatment of its ills, and the reform of their delusions together, and uses both Both of them are in the necessary position of the needs of life, and the contradictions and separation of this collection and the wise harness in this research from his law, may God bless him and grant him peace, which shows us this balance in the system of Islam, the most sincere representation, where it is one of the honors of morality, good appreci

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Publication Date
Fri Apr 01 2005
Journal Name
Ibn Al-haitham Journal For Pure And Applied Science
Synthesis and Characterization of Schiff Base Folic Acid Based Ligand and Its Complexes
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D-mannose sugar was used to prepare [benzoic acid 6-formyl-2,2-dimethyl-tetrahydrofuro[3,4-d][1,3]dioxol-4-yl ester] (compound A). The condensation reaction of folic acid with (compound A) resulted in the formation of new ligand [L]. These compounds were characterized by elemental analysis CHN, atomic absorption A.A, (FT-I.R.), (U.V.-Vis), TLC, E.S. mass (for electrospray), molar conductance, and melting point. The new tetradentate ligand [L], reacted with two moles of some selected metal ions and two moles of (2-aminophenol), (metal : ligand : 2-aminophenol) at reflux in water medium to give a series of new complexes of the general formula K2[M2(L)(HA)2] where M= Co(II), Ni(II), Cu(II) and Cd(II). These complexes were characterized by elem

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Publication Date
Tue Nov 01 2022
Journal Name
Chemical Methodologies
Synthesis and Characterization of New Substituted Coumarin Derivatives and Study Their Biological Activity
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New substituted coumarins derivatives were synthesized by using nitration reaction to produce different nitro coumarin isomers which were separated from these isomers by using different solvent, and the reduction of nitro compounds was done to give corresponding amino coumarins. Temperature and reaction time of reaction were very important factors in determining the most productive nitro isotopes. A low temperature for three hours was sufficient to give a high product of a compound 6-nitro coumarin while increasing the temperature for a period of twenty-four hours that gave a high product of 8-nitro-coumarin. The synthesized compounds were confirmed by FT-IR,1 H-NMR, and13 C-NMR spectroscopy and all final compounds were tested for their ant

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Publication Date
Mon Jun 01 2015
Journal Name
Journal Of Engineering
Entransy dissipation of Shell and Double Concentric Tube Heat Exchanger Calculations and Analysis
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Shell-and-double concentric tube heat exchanger is one of the new designs that enhance the heat transfer process. Entransy dissipation is a recent development that incorporates thermodynamics in the design and optimization of heat exchangers. In this paper the concept of entransy dissipation is related to the shell-and-double concentric tube heat exchanger for the first time, where the experiments were conducted using hot oil with temperature of 80, 100 and 120°C, flow rate of cold water was 0.667, 1, and 1.334 kg/m3 respectively and the temperature of inlet cold water was 20°C. The entransy dissipation rate due to heat transfer and to fluid friction or pressure drop was studied.

 

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Publication Date
Wed Mar 10 2021
Journal Name
Baghdad Science Journal
Environment and lifestyle Fish Qattan in the Euphrates River in central Iraq
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Studied the environment and fish life Qattan in the Euphrates River in central Iraq for the period from September 2002 until 2003 recorded the lowest temperature of the water during the month of January during the month of August ranged salinity ranges between 068

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Publication Date
Mon Mar 12 2012
Journal Name
Iraqi Journal Of Science(the 1 St Scientific Conference Of Biology Department College Of Science University Of Baghdad March 2012)
Rotavirus Infection in Infants and Young Children with Acute Gastroenteritis in Baghdad.
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Publication Date
Mon Sep 30 2019
Journal Name
College Of Islamic Sciences
Scientific miracle in the verse walking and eating In Surat Al - Mulk
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The research includes the study of the scientific miracle in the verse: (It is the one who made you the earth humiliation and walked in their positions and eat from the living and to the publication of the human body and in the Qur'an) And mental and spiritual. The research also pointed to the tight link between the miracle of the precedent in the Holy Quran and the miracle of the divine power in the book of the Infinite Universe to give each miracle testimony of delivery and ratification of the other. The research included after the introduction, the first topic included four demands, which included basic concepts: - Definition of scientific miracle and its importance in the Koran, and the significance of the universal verses in the Kor

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Publication Date
Wed Oct 18 2023
Journal Name
Iraqi National Journal Of Nursing Specialties
Assessing the Nursing Knowledge and Practices in Premature Feeding in Premature Units
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Objectives: ٨ descriptive study has been conducted in the premature baby unit in Al-Khansaa' and Al-Batool
hospitals for maternity and children in Mosul city to assess knowledge and practice of the nursing staff in the
caring of premature infants. A descriptive study has been conducted in the premature baby unit in Al-Khansaa'
and Al-Batool hospitals for maternity and children in Mosul city to assess knowledge and practice of the nursing
staff in the caring of premature infants.
Methodology: the data were collected by using knowledge assessment and practice measurement tool.
Results: the results of the study show that high percentages (about 40%) of the staff who work in the premature
baby units are of the young age

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Publication Date
Wed Jan 10 2018
Journal Name
Al–bahith Al–a'alami
Quality standards and innovation in television production production processes in various fields
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And the necessity for the progress of modern societies Because the scientific and objective characteristics that characterize modern societies and distinguish them from traditional societies, Is represented by the extent of its innovative achievements in the theoretical, applied and material scientific and spiritual fields. It should be noted that quality and innovation in modern societies is based on two main pillars, Standard measures for measuring and evaluating innovations to achieve their high quality, And the dissemination of the culture of innovation to spread awareness of the importance and conditions of success, and this is done by the advanced industrial countries, However, despite the great disparity between developed industri

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Publication Date
Thu Jun 25 2020
Journal Name
Journal Of Nusantara Studies (jonus)
POWER AND SOLIDARITY IN POSITIVE FACEBOOK POSTINGS AMIDST COVID-19 IN MALAYSIA
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Background and Purpose: Coronavirus has posed an unfamiliar threat to the world. Despite such circumstances, Malaysians continue to stay optimistic by keeping abreast with updates and mostly by seeking refuge in hopeful and consoling messages shared by fellow citizens. This study identified Facebook postings with positive messages, posted by Malaysians during the Movement Control Order (MCO) implemented by the Malaysian government as a form of prosocial behaviour.   Methodology: Through an analytic framework consisting of Positive Discourse Analysis and Critical Discourse Analysis, 15 Facebook postings related to COVID-19 were selected and identified as positive discourse, which were coded and categorised using a thematic analysi

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