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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Oct 01 2023
Journal Name
Journal Of Advanced Pharmaceutical Technology & Research
Factors affecting on in vitro release of miconazole from in situ ocular gel
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The reason for conducting this study is to prolong release of miconazole in the ocular site of action by ocular-based gels (OBGs) formulations. The formulation factors affecting on the release from OBG should be studied using various gelling agents in various concentrations to achieve the improvement in retention and residence time in response to prolonged release. In this study, the formulations were prepared using carbopol 940, pectin, sodium alginate, poloxamer 407, and poly(methacrylic acid) at 0.5%, 1%, and 1.5% w/v, respectively. Hydroxypropyl methylcellulose E5 (HPMC E5) 1% was added as thickening agent/viscosity builder. The formulation containing carbopol 940, pectin and sodium alginate at 1.5% w/v, displayed a noticable im

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Publication Date
Wed Jun 20 2018
Journal Name
Al-academy
Style in contemporary Iraqi painting before and after the war
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What happened on the Iraq war in 2003 put the problematic about what can happen from a shift in the style of individual or collective in contemporary Iraqi art similar to what is known in the history of the modern art world.

It wanted the researcher to identify this dilemma in academic study looking for an explanation of this Alastfhamat from the entrance of the definitions shows laparoscopic destination, as it determines the address (b style in painting contemporary Aeraa before and after the war) was a comparative analysis, through a choice of two Iraqi artists who have production style known sets since before the war, in order to read the transformation that took place in art before and after their tactics, and in order to off

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Publication Date
Fri Sep 12 2025
Journal Name
Journal Of Baghdad College Of Dentistry
An in vitro evaluation of fit of the crowns fabricated by zirconium oxide-based ceramic CAD/CAM systems, before and after porcelain firing cycles and after glaze cycles
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Background: The objective of this in vitro study was to evaluate the vertical marginal fit of crowns fabricated with ZrO2 CAD/CAM, before and after porcelain firing cycles and after glaze cycles. Materials and Methods: An acrylic resin model of a left maxillary first molar was prepared and duplicated to have Nickel-Chromium master die. Ten die stone dies were sent to the CAD/CAM (Amann Girrbach) for crowns fabrication. Marginal gaps along vertical planes were measured at four indentations at the (mid mesial, mid distal, mid buccal, mid palatal) before (Time 0) and after porcelain firing cycles (Time 1) and after glaze cycles (Time 2) using a light microscope at a magnification of ×100. One way ANOVA LSD tests were performed to determine wh

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Publication Date
Tue Jul 01 2014
Journal Name
Political Sciences Journal
Political events in Iraq after 2003 and the impact of belonging and awareness in contemporary Iraqi composition
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الاحداث السياسية في العراق بعد 2003 وأثر الانتماء والوعي في التشكيل العراقي المعاصر

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Publication Date
Fri Jan 17 2025
Journal Name
African Journal Of Biomedical Research
Digital Evaluation of Cuspal Deflection of Endodontically Treated Teeth Restored with Resin Composite and Different Fiber Formulations
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Background: This study evaluated the influence of different fiber formulations incorporation in resin composite on cuspal deflection (CD) of endodontically-treated teeth with mesio-occluso-distal (MOD) cavities. Materials and Methods: Thirty-two freshly extracted maxillary premolar teeth received MOD cavity preparation followed by endodontic treatment using single cone obturation technique, and divided into: Group I: direct composite resin only using a centripetal technique, Group II: direct composite resin with short fiber-reinforced composite (everX Flow), Group III: direct composite resin with leno wave ultra-high molecular weight polyethylene (LWUHMWPE) fibers placed on the cavity floor, and Group IV: direct composite resin with LWUHMWP

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Publication Date
Fri Jul 14 2017
Journal Name
Tenside Surfactant
Oil-Water Interfacial Tensions of Silica Nanoparticle-Surfactant Formulations
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The implementation of nanotechnology in all industries is one of most significant research fields. Nanoparticles have shown a promising application in subsurface fields. On the other hand, various surfactants have been used in the oil industry to reduce oil/water interfacial tension and also widely used to stabilize the nano-suspensions. The primary objective of this study was to investigate the improvements of surfactants ability in term of interfacial tension (γ) reduction utilizing addition of silicon dioxide nanoparticles at different temperatures and salinity. The pendant drop technique has been used to measure γ and electrical conductivity has been used to measure the critical micelle concentration (CMC). The synergistic effects of

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Publication Date
Sun Jan 01 2023
Journal Name
Revista Brasileira De Enfermagem
Healthy lifestyle behaviors and risk of cardiovascular diseases among nursing faculty during COVID-19 Pandemic
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ABSTRACT Objective: Cardiovascular diseases are the first ranked cause of death worldwide. Adhering to health promoting lifestyle behaviors will maintain an individual’s cardiovascular health and decrease the risk of cardiovascular diseases. Methods: In this descriptive study, 150 nursing faculty were surveyed via a non-probability (purposive) sampling method to assess their adherence to health promoting lifestyle in order to know the risk of cardiovascular diseases. The Arabic version of Health-Promoting Lifestyle Profile II (HPLP-II) was used to achieve this goal. Results: Seventy-two nursing faculty completed the survey. The results indicated that the study sample had moderate level of health promotion based on Health-Promot

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Publication Date
Wed Dec 13 2023
Journal Name
Drug And Chemical Toxicology
Single and repeat-dose toxicity and local tolerance assessment of newly developed oil emulsion adjuvant formulations for veterinary purposes
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Publication Date
Thu Aug 31 2017
Journal Name
Journal Of Engineering
The Phenomenon of Division and Modification of The Individual Houses in Baghdad after 2003
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The Research deals with the negative phenomena which appeared in the urban scenes of the  Iraqi cities after 2003, particularly trespassing the architectural design of the urban Individual houses.  Many academic researchers , critics, and cultural circles, drawn attention to the impact of  political and cultural variable change on such phenomena  without detailed  analysis . The research problem  is set according to central questions : If the phenomena is the trespass , what
are the sides which are being trespassed  in the division of the individual house? , If the diagnosis of the phenomena denotes perceived repetition of the cases , So what's size of this transposes on the architectural design of t

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Publication Date
Mon Oct 01 2018
Journal Name
Journal Of Economics And Administrative Sciences
Comparison of the statistical methods used to Forecast the size of the Iraqi GDP for the two sectors (public and private) for the period (2025-2016)
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Gross domestic product (GDP) is an important measure of the size of the economy's production. Economists use this term to determine the extent of decline and growth in the economies of countries. It is also used to determine the order of countries and compare them to each other. The research aims at describing and analyzing the GDP during the period from 1980 to 2015 and for the public and private sectors and then forecasting GDP in subsequent years until 2025. To achieve this goal, two methods were used: linear and nonlinear regression. The second method in the time series analysis of the Box-Jenkins models and the using of statistical package (Minitab17), (GRETLW32)) to extract the results, and then comparing the two methods, T

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