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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Fri Mar 19 2021
Journal Name
Annals Of The Romanian Society For Cell Biology
Immunological Value of Periostin, Amphiregulin, IL-33 and sST2 Markers in Rhinosinusitis Patients
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Background: Rhinosinusitis is an inflammatory disorder that refers to inflammation of the nose and paranasal sinuses. Recent studies show that serum IL-33, periostin, ARGE and sST2 had the role in the pathogenesis of chronic rhinosinusitis as an easy, non-invasive and readily available (biomarker) for diagnosis of chronic rhinosinusitis. We tested for correlations of IL-33, periostin, ARGE and sST2 between acute and chronic rhinosinusitis in compare to healthy people. This study aimed to Measure serum levels of periostin, IL-33, sST2, and ARGE biomarkers in patients ARS and CRS. Materials and Methods: We collected serum of 30 patients with acute rhinosinusitis, 30 with chronic rhinosinusitis, and 30 controls to examine serum levels of IL-3

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Publication Date
Wed Mar 15 2023
Journal Name
Al-academy
Kinetic diversity and its effectiveness in the formal variables of industrial product design
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The formal diversity in designs is achieved by creating shapes and lines with a distinct movement pattern, which are preceded by mental processes. The greatest source of diversity in design in general and industrial design in particular is the creation of multiple directions for the completion of designs and the diversification of intellectual proposals for the design idea. The human activity that takes place around us in various fields of life takes place due to the diversity of movement in the form of the design product and its effectiveness through the dynamic diversity in the form, which differs in the methods of designing and showing it. He invents material value as a distinct artistic product that he owns A specific form or system

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Publication Date
Fri Oct 14 2022
Journal Name
المجلة العراقية لعلوم التربة
REVIEW: USING MACHINE VISION AND DEEP LEARINING IN AUTOMATED SORTING OF LOCAL LEMONS
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Sorting and grading agricultural crops using manual sorting is a cumbersome and arduous process, in addition to the high costs and increased labor, as well as the low quality of sorting and grading compared to automatic sorting. the importance of deep learning, which includes the artificial neural network in prediction, also shows the importance of automated sorting in terms of efficiency, quality, and accuracy of sorting and grading. artificial neural network in predicting values and choosing what is good and suitable for agricultural crops, especially local lemons.

Publication Date
Fri Feb 01 2013
Journal Name
Ijbpas
ALTERATION OF IMMUNE MEDIATORS IN PATIENTS WITH HEPATITIS B AND C VIRUS INFECTION
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HBV and HCV are the major causes of chronic liver diseases throughout the world, and constitute a major global health risk. There is accumulated evidence that the imbalance of proinflammatory and anti-inflammatory cytokine production may play an important role in the pathogenesis of viral hepatic infections and may influence the clinical outcome and disease progression. This study was undertaken to analyze the circulating levels of Tumor Necrotic Factor (TNF-α) and Th2 cytokine IL-10 in patients infected with Hepatitis B and C virus. The study population consisted of 30 patients with chronic HBV, in addition to other 30 patients with chronic HCV infection were recruited on their first examination at the Al-Kindy General Hospital in Baghdad

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Publication Date
Wed Jul 21 2010
Journal Name
Veterinary Medical Journal Giza
Efficacy of some drugs and pathological studies on Toxoplasma gondii infection in mice.
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The study was conducted to determine the effect Toxoplasma gondii and the efficacy of azithromycin and garlic tablets on the treatment of acute murine toxoplasmosis and observe the histopathological changes due to infection. 60 Albino mice were divided into six groups, and their survival rate, pathology, bioassay trial and immunofluorescence were observed. Results revealed that azithromycin (250 mg/kg/day) given to infected mice increased the survival rate (90% on day 7 PI) and decreased the histopathological changes when compared with the control groups. Garlic tablets (500 mg/kg/day) had lesser effect on infected mice, and the survival rate (40% at days 6 and 7 PI) was lower than the groups treated with azithromycin. The group treated wit

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Publication Date
Thu Jun 29 2023
Journal Name
Iraqi Journal Of Chemical And Petroleum Engineering
Synthesis of Novel Porphyrin Derivatives and Investigate their Application in Sensitized Solar Cells
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Solar energy has significant advantages compared to conventional sources such as coal and natural gas, including no emissions, no need for fuel, and the potential for installation in a wide range of locations with access to sunlight. In this investigation, heterocyclic derivatives were synthesized from several porphyrin derivatives (4,4',4",4"'-(porphyrin-5,10,15,20-tetrayl) tetra benzoic acid) compound (3), obtained by reaction Pyrrole with 4-formyl benzoic acid. Subsequently, porphyrin derivative-component amides 5a, 5b, and 5c were produced by reacting compound (3) with amine derivatives at a 1:4 molar ratio. These derivatives exhibited varying sensitivities for utilization in solar cells, with compound 5a displaying the highest power

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Publication Date
Wed Jan 30 2019
Journal Name
Journal Of The College Of Education For Women
The General Principles of The Curriculum In Some Manuscripts Arab And Muslim Scholars
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Our scientists Arabs old efforts in achieving texts that led to the foundations of general
rules they have set for this work in accordance with the systematic context is based on the
study, analysis and precision in dealing with this work, which became the basis for each
investigator to the present day, which was to them careful consideration manuscripts and
work to be closer to the image by its author, so produced their efforts in this area several
books provided the technical wizards of this science, which did not leave a gap in which only
gave her treatments and suggestions each and every one of the point made by and gave her
what produced the expertise in this direction in accordance with the formulations
meth

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Publication Date
Wed Mar 30 2011
Journal Name
Iraqi Journal Of Chemical And Petroleum Engineering
PARAMETRIC STUDY OF NATURAL CONVECTIVE AND RADIATIVE HEAT TRANSFER IN INCLINED CYLINDRICAL ANNULI
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The unsteady state laminar mixed convection and radiation through inclined
cylindrical annulus is investigated numerically. The two heat transfer mechanisms of
convection and radiation are treated independently and simultaneously. The outer
cylinder was kept at a constant temperature while the inner cylinder was heated with
constant heat flux. The study involved numerical solution of the governing equations
which are continuity, momentum and energy equations using finite difference method
(FDM), where the body fitted coordinate system (BFC) was used to generate the grid
mesh for computational plane. A computer program (Fortran 90) was built to calculate
the bulk Nusselt number (Nub) after reaching steady state con

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Publication Date
Thu Sep 26 2013
Journal Name
Astronomy & Astrophysics
High-resolution observations of SDSS J080800.99+483807.7 in the optical and radio domains
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Publication Date
Tue Apr 19 2022
Journal Name
Ishraqat Tanmawia
The reality of the divorce problem in Iraqi society Reasons, solutions and results
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Praise be to God, who created people from one soul, and made her husband, and prayers and peace be upon His Messenger, Mercy given and the grace given, and on a machine and companions pure. Divorce cases have increased in recent years in a worrying manner, especially since divorce has unforeseen consequences at the individual and social levels. The source of concern stems from the fact that the cohesion and integrity of society starts from a family as it is the cornerstone of the social structure, which is the foundation upon which the large society is based. Marital life may suffer from problems and obstacles that are difficult to solve, so the man presents the divorce of his wife and that the phenomenon of divorce is not a result of it, b

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