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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Dec 31 2023
Journal Name
College Of Islamic Sciences
The most prominent philosophical and rhetorical concepts in the perspective of philosophers and theologians
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     This research aims to clarify and define the most important philosophical and rhetorical concepts to which many philosophical and rhetorical issues refer، since they have an effective role in the diversity and difference of intellectual schools، which are indispensable in proving major dogmatic issues، such as the concept of (existence، being، essence، and authenticity). Existence or Essence in contrast to the consideration of the other concept)، because it is one of the complex concepts and common words that carry different connotations among thinkers.

   And from (the rule of judging something is a branch of its perception)، the researchers began to define these concepts، as evidence of the sincerity of perce

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Publication Date
Sun Sep 01 2013
Journal Name
Baghdad Science Journal
CMC Determination and Thermodynamic Micellisation Of NPE Surfactant In Aqueous And CH3OH – H2O Solvents
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The critical micelle concentration (CMC) of nonylphenolethoxylate (NPE) surfactant has been determined by measuring the surface tension as a function of the molar concentration of the surfactant in aqueous and binary mixture of water + methanol solutions at a temperature range from 20?C to 35?C. The interfacial parameters ?max, Amin, ?cmc and ?G?ads were calculated. The results indicate that the CMC increases as the temperature increases and that the addition of methanol the CMC decreases. The thermodynamic parameters such as standard Gibbs free energy (?G?), enthalpy (?H?), and entropy (?S?) of micellization were estimated using the change of CMC with temperature. The enthalpy – entropy compensation behavior of the surfactant was evaluat

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Publication Date
Fri Jul 11 2025
Journal Name
Scientific Reports
Molecular docking study and pharmacokinetic insights of rifampicin in pure and capsule dosage forms
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To detect the amount of rifampicin in bulk and medicinal dosage formulations, an accurate and costeffective UV spectrophotometric technique has been developed using the area under the peak to estimate the presence of rifampicin. This range of wavelengths (300–356 nm) was chosen. The method showed linearity in the 2–22 μg/mL range, with R2 being2 0.9996. The developed method’s linearity, detection limit, quantification limit, precision, repeatability, and accuracy were all statistically and experimentally validated. The suggested methodology can be used for routine quality control analysis of rifampicin in pure form and in capsule dosage form, as demonstrated by the satisfactory recovery percentage results. This study explores the str

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Publication Date
Sat Jan 05 2019
Journal Name
Iraqi Journal Of Physics
Antibacterial activity and mechanism of the silver nanoparticle in gram positive and negative bacteria
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Biomedical alloy 316L stainless steel enhancing to replace biological tissue or to help stabilize a biological structure, such as bone tissue, enhancing were coated with deposition a thin layer of silver nanoparticles as anti-bacterial materials by using DC- magnetron sputtering device. The morphology surface of The growth nanostructure under the influence of different working pressure were studied by atomic force microscope. The average grain size decrease but roughness of the silver thin layer was increased with‖ ―increasing the working pressure. The thickness of silver thin layer was increased from 107 nm at 0.08 mbar to 126 nm at 1.1 mbar. Antimicrobial activity of silver thin layers at different working pressure were studied. Th

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Publication Date
Tue Jun 01 2021
Journal Name
Political Sciences Journal
AL-Takfir in the thought of Islamic movements and organizations and its social repercussions
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This is an open access by CC Attribution-Noncommercial-NoDerivatives 4.0

https://creativecommons.org/licenses/by-nc-nd/4.0

Takfir is an ancient phenomenon that accompanied the emergence of Islam, and this phenomenon took its political dimension during the time of the fourth Rashidi Caliph with the emergence ofthe Kharijites sect that disbelieved many Muslims.

The study started from the hypothesis that "contemporary Islamicmovements and organizations have relied in their takfir on the ideas and fatwas presented by the predecessors which applied ontocontemporary rea

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Publication Date
Fri Jul 01 2016
Journal Name
Bulletin Of The Iraq Natural History Museum (p-issn: 1017-8678 , E-issn: 2311-9799)
IXODIOD TICK FAUNA INFESTING SHEEP AND GOATS IN THE MIDDLE AND SOUTH OF IRAQ
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    A total of 215 sheep and 87 goats were carefully searched for ixodid ticks from January to December 2015 at different regions of the middle and south of Iraq. The detached ticks count 1533 ticks from sheep with intensity of 8.4 and count 332 ticks from goats with intensity of 6.8. Tick species recovered from sheep and their incidence rates were: Rhipicephalus turanicus (39%), Hyalomma anatolicum (28%), R. (Boophilus) annulatus (11%), Hyalomma sp. (9%), H. turanicum (6%), H. excavatum (6%) and R. leporis (1%) while the tick species recovered from goats and their incidence rates were: R. turanicus (64%), H. anatolicum (24%)

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Publication Date
Tue Feb 28 2023
Journal Name
Iraqi Geological Journal
Depositional Architecture and Stratigraphic Framework of Albian Succession in Balad and Nasiyia Oil Fields
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The Albian Carbonate-clastic succession in the present study is represented by the Mauddud and Nahr Umr formations were deposited during the Albian stage within the Wasia Group More than 200 thin sections of cores and cuttings in addition to well logs data for Nahr Umr and Mauddud formations from 4 boreholes within two oil fields (Ba-4, Ba-8, Ns-2 and Ns-4) were used to interpret the different associations facies as well as the facies architectures to describe the sedimentary framework of the basin and development the petrophysical properties. Seven major microfacies were diagnosed in the carbonate succession of the Mauddud Formation, while the Nar Umr Formation includes five lithofacies; their grain types characteristic and deposit

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Publication Date
Wed Jun 01 2022
Journal Name
Iraqi Journal Of Physics
Statistical Analysis and Forecasting of Rainfall Patterns and Trends in Gombe North-Eastern Nigeria
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Rainfall in Nigeria is highly dynamic and variable on a temporal and spatial scale. This has taken a more pronounced dimension due to climate change. In this study, Standard Precipitation Index (SPI) and Mann-Kendall test statistical tools were employed to analyze rainfall trends and patterns in Gombe metropolis between 1990 and 2020 and the ARIMA model was used for making the forecast for ten (10) years. Daily rainfall data of 31 years obtained from Nigerian Meteorological Agency, (NIMET) was used for the study. The daily rainfall data was subjected to several analyses. Standard precipitation index showed that alternation of wet and dry period conditions had been witnessed in the study area. The result obtained showed that there is an u

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Publication Date
Tue Jan 27 2026
Journal Name
Journal Of Baghdad College Of Dentistry
Immunohistochemical expression of p53 and PCNA proteins in oral lichen planus and oral dysplasia
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Background: Oral lichen planus (OLP) is a relatively common chronic inflammatory muco-cutaneous disease classified among the potentially malignant lesions of oral mucosa. The aim of this study is to investigate and compare the expression of p53 and PCNA proteins in oral lichen planus and epithelial dysplasia cases. Materials and methods:Formalin-fixed and paraffin- embedded blocks of 21 lichen planusand 21 oral dysplasia cases were referred to immunohistochemical (IHC) analysis for anti p53 and anti PCNA monoclonal antibodies. Results: The results showed that positive nuclear staining for p53 was found in 11/21 (52.4%) cases of lichen planus and 17/21 (80.9%) cases of dysplasia. Positivity for PCNA was observed in 18/21(85.7%) of oral li

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Publication Date
Mon Sep 04 2017
Journal Name
Journal Of Chemical And Pharmaceutical Research
Lead, Cadmium and Nickel contamination of roadside soils and plant leaves in Baghdad City
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