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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Jan 01 2013
Journal Name
International Journal Of Contemporary Mathematical Sciences
Equivalent between the Criterion and the Three Open Set's Conditions in Disk-Cyclicity
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A vector in a separable infinite dimensional Hilbert space is called disk-cyclic for bounded operator if the orbit α : 0, α∈;|∝| 1is dense in. The useful tool used to discover codisk-cyclic operation is called the disk-cyclic Criterion. In this paper we will show that some equivalent conditions of the

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Publication Date
Wed Dec 01 2021
Journal Name
Journal Of Economics And Administrative Sciences
Expatriate Workers and Its Repercussions on the Economy and Labor Market in Iraq After 2003
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The demand for expatriate labor to Iraq increased after 2003 as a result of the openness that Iraq experienced, but this expatriate labor, which was requested at an increasing rate, has had economic, social, and political effects on the Iraqi economy in general, and the Iraqi labor market in particular. This is due to the high rates of unemployment, as most of these expatriate workers cause competition to local labor, and thus cause repercussions on the Iraqi economy as a whole, except for those expatriate workers coming with companies working in the oil sector. Iraq's GDP

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Publication Date
Thu Jan 01 2015
Journal Name
International Journal Of Astronomy And Astrophysics
Determination of Velocity and Radius of Supernova Remnant after 1000 yrs of Explosion
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Supernova explosions are described as very violent events which transfer a significant amount of energy to interstellar media and are responsible for a large variety of physical processes. This study does not discuss the actual explosion mechanisms but follows the behavior of the dynamical evolution of some selected type I and type II supernova remnant and particularly after a thousand years from their explosion and shows how the density of the medium affects the evolution and the lifetime of each remnant. By studying such behaviors, a simplified model has been proposed here for the velocity and radius of the remnant after thousand years of explosion that depends only on the density of the medium and age of the remnant. It has been found th

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Publication Date
Thu Feb 07 2019
Journal Name
Journal Of The College Of Education For Women
Healthy awareness Clothes associated with diseases symptoms
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The majority of used clothes represented a passion for brilliant
appearance and could be a reason for hiding body defects , as to avoid
criticism .
This may lead to purchase and wear un healthy or uncomfortable clothes
such as tide .As to appreciate the differences between wearing healthy clothes or
otherwise .
The study was carried out to assess healthy cloth awareness for university
girls as related to possibility of being subjected to harm caused by wearing tide
clothes .
The measurement items was determined and numbered ( 23 ). The answer
for these scale criteria was ( Always , Sometime ,Never ) for the weights (3,2,1)
. The scale was applied to a randomly selected sample of research community
that

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Publication Date
Sun Oct 01 2017
Journal Name
Al–bahith Al–a'alami
Issues of Media Trials in Iraqi after 2003
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The Supreme Judicial Council decided on July 3, 2003, to set up a court to deal with the issues of publication and media. This court tries to solve the problems of media and publishing in both its civil and penal aspects. The decision of establishing the court represents a new and important step to be taken by the Iraqi Judicial Council for the tremendous development witnessed by media sector in general and press in particular especially after 2003.
This study includes two main axes: the first one deals with the most important crimes of publication in the Iraqi legislations such as the crimes of defamation, libel, insult, indecency, and incitement; the second deals with an analytical survey of the completed cases i.e. the issues tha

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Publication Date
Wed Feb 20 2019
Journal Name
Political Sciences Journal
the circulation of power in Iraq after 2003
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The deliberation and exchanged of power is a matter of political importance For the Iraqi political system after 2003, The deliberation of power and its democratic transition and electoral integrity Is a good indicator of political stability and progress In the Iraqi parliamentary political system , The transfer of authority in terms of adopting the deliberative approach represents a structural and institutional dimension of the political process , it led the power to become Authority of the Foundation Exercised in accordance with the Constitution and the law not real power , And lead to the recognition of the existence of an official parliamentary opposition and its right to take political power later through the ballot box Makes the pr

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Publication Date
Mon Nov 01 2021
Journal Name
Journal Of Physics: Conference Series
Light scattering detector based on light-emitting diodes-Solar cells for a flow analysis of Warfarin in pure form and pharmaceutical formulations
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Abstract<p>Continuous turbidimetric analysis (CTA) for a distinctive analytical application by employing a homemade analyser (NAG Dual & Solo 0-180°) which contained two consecutive detection zones (measuring cells 1 & 2) is described. The analyser works based on light-emitting diodes as a light source and a set of solar cells as a light detector for turbidity measurements without needing further fibres or lenses. Formation of a turbid precipitated product with yellow colour due to the reaction between the warfarin and the precipitation reagent (Potassium dichromate) is what the developed method is based on. The CTA method was applied to determine the warfarin in pure form and pharmaceu</p> ... Show More
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Publication Date
Mon Nov 01 2021
Journal Name
Journal Of Physics: Conference Series
Light scattering detector based on light-emitting diodes-Solar cells for a flow analysis of Warfarin in pure form and pharmaceutical formulations
...Show More Authors
Abstract<p>Continuous turbidimetric analysis (CTA) for a distinctive analytical application by employing a homemade analyser (NAG Dual & Solo 0-180°) which contained two consecutive detection zones (measuring cells 1 & 2) is described. The analyser works based on light-emitting diodes as a light source and a set of solar cells as a light detector for turbidity measurements without needing further fibres or lenses. Formation of a turbid precipitated product with yellow colour due to the reaction between the warfarin and the precipitation reagent (Potassium dichromate) is what the developed method is based on. The CTA method was applied to determine the warfarin in pure form and pharmaceu</p> ... Show More
Scopus (16)
Crossref (6)
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Publication Date
Wed Mar 29 2017
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Development of Modified Release Nicotine Tablet Formulation for Treatment of Ulcerative Colitis
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One of the therapeutic effects of nicotine  is used as  a protective against developing ulcerative colitis . ulcerative colitis is an inflammatory disease of the bowel affecting the superficial lining mucosa in the rectum and large intestine. In this study nicotine tablets were formulated as modified release tablets targeted to the colon. All formulas were studied for drug release , effect of diluent, retardant concentration, avicel grade,and compression force, the selected formula was then further studied for drug release in 3 different pH ( coated tablets) .The kinetic study revealed acceptable shelf life  . Finally the selected formula was given to 6 patients in a pre-liminary clinical study which showed that nicotine c

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Publication Date
Mon Feb 04 2019
Journal Name
Journal Of The College Of Education For Women
The impact of cognitive incompatibility schemes on the development of creative thinking skills in history subjects among first grade students
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The aim of this research is to find out the impact of cognitive incompatibility schemes on the development of creative thinking skills among first grade students.
To prove the objective of the research, the researcher put the following hypothesis:
There is no statistically significant difference at the level of (0.05) between the average score of the experimental group who study the history of ancient civilizations according to the patterns of cognitive conflict and the average grades of the control group students who study the same subject in the usual way in the test of post-creative thinking skill

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