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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Thu Jun 01 2017
Journal Name
The Journal Of Immunology
Definition of the Nature and Hapten Threshold of the β-Lactam Antigen Required for T Cell Activation In Vitro and in Patients
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Abstract<p>Covalent modification of protein by drugs may disrupt self-tolerance, leading to lymphocyte activation. Until now, determination of the threshold required for this process has not been possible. Therefore, we performed quantitative mass spectrometric analyses to define the epitopes formed in tolerant and hypersensitive patients taking the β-lactam antibiotic piperacillin and the threshold required for T cell activation. A hydrolyzed piperacillin hapten was detected on four lysine residues of human serum albumin (HSA) isolated from tolerant patients. The level of modified Lys541 ranged from 2.6 to 4.8%. Analysis of plasma from hypersensitive patients revealed the same pattern and leve</p> ... Show More
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Publication Date
Wed Jun 29 2016
Journal Name
Iraqi Journal Of Market Research And Consumer Protection
EFFECT OF USE MICROWAVE RADIATION IN SOM FOODS AND IABORATORY APPLICATIONS.: EFFECT OF USE MICROWAVE RADIATION IN SOM FOODS AND IABORATORY APPLICATIONS.
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study the effect of radiation microwave (MW) in inhibition the growth of some types of bacteria in a minced meat and barker were exposed to MW for different times included (0, 10, 20, 30 and 40) sec.The results showed a high inhibition rate for 40 sec, reached to 100%. It is the other side studied the effect of microwave radiation against four types of bacteria included (Staphylococcus aureus, Escherichia coli, Proteus mirabilis and Klebsiella spp), when were exposed to for (0, 5, 10, 20, 30 and 40) sec the inhibition ratio reached to 100% in each of the Proteus mirabilis and Klebsiella spp at 30 sec and Staphylococcus aureus and Escherichia coli at 40sec. using MW in the sterilization media, such as Nutrient agar, Macconkey agar and Man

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Publication Date
Wed Jun 03 2020
Journal Name
Political Sciences Journal
The Muslim Arab Self and the image of the other, religiously and culturally different: a critical analytical study of the causes and forms of political and social intolerance in Iraq
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This research aims to analyze the intellectual and civilizational regression that afflicted Iraqi and Arab society due to political and religious tyranny and internal conflicts, which was reflected in the deterioration of human rights values and the absence of equality and justice in dealing with the other religiously, which affected the reluctance of members of religious groups to interact with their national societies and then migrate to Outside, which contributed to a double loss, in terms of the loss of these societies by productive and effective national competencies, and in terms of distorting the image of Islam. The research stressed that the first treatments of this phenomenon are the consolidation of the values of citize

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Publication Date
Tue May 14 2024
Journal Name
Iranian Journal Of Catalysis
Feasible and simple preparation of Pd (II), Ni (II), and Pt (IV) complexes: Their biological and industrial applications and investigation of Pd (II) complex in Suzuki reaction
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A novel ligand, (E)-5-((2-hydroxy-4,6-dimethylphenyl)diazenyl)-2,3-dihydrophthalazine-1,4- dione, was synthesized through the reaction of 3,5-dimethylphenol with the diazonium salt of 5-amino-2,3-dihydrophthalazine-1,4-dione. The ligand underwent characterization through the utilization of diverse spectroscopic methods, including UV-Vis, FT-IR, 13C, and 1H-NMR, alongside Mass spectroscopy and micro elemental analysis (Carbon, Hydrogen, Nitrogen, and Oxygen). Metal chelates of transition metals were prepared and analyzed using elemental analysis, mass spectra, atomic absorption, UV-Vis, FT-IR spectral analysis, as well as conductivity and magnetic measurements. The investigation into the compounds’ nature was conducted by utilizing mole r

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Publication Date
Thu Dec 31 2020
Journal Name
College Of Islamic Sciences
: Islamic law; perfection The rule of perfection in Islamic law and its impact on the creative construction of the individual and society: The rule of perfection in Islamic law and its impact on the creative construction of the individual and society
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This research explains to us the role of the Islamic religion in the issue of accuracy in speech and work, and how it is closely related to human production in his life, and Islam affirms that his idea is mainly reflected in his production, and how it affects the perception of the meaning of creativity. Therefore, our Islam affirmed the accuracy in every word or work we do to build a society in which people enjoy high quality in ethics and dedication in their work so that the Islamic system depends on humanity to preserve our rights on the other hand the research discusses the deliberate default and how it reflects on our production and how it makes it less good.

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Publication Date
Thu Apr 07 2016
Journal Name
Iraqi Journal Of Market Research And Consumer Protection
Isolate and diagnose Mycotoxins associated with some producers of Indomie and Chips that available in local markets: Isolate and diagnose Mycotoxins associated with some producers of Indomie and Chips that available in local markets
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Abstract
This study aimed to survey fungi associated with the product Indomie and Chips being the trades Iargely by a very important segment of society who are the children, beside consumed by adults, but less so, as the survey results to accompany some fungui samples sterile showed proportions presence included various fungi like. Aspergillus flavus, Aspergillus niger, Penicillium Spp., Fusarium graminearum, F.moniliforme, Alternaria alternate and Rhizopus Spp., and other fungi sterile are not diagnosed. The results showed large dominion fungi A. niger by presence sterile samples of both producers, followed by infection in Fusarium Spp., Penicillium Spp., and A. alternata by infection percentage 55, 20 and 17% respectively for the pr

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Publication Date
Fri Jun 10 2022
Journal Name
Eurasian Chemical Communications
Detection of lead and cadmium in types of chips from local markets in Baghdad
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Publication Date
Tue Jun 03 2025
Journal Name
Journal Of Animal Health And Production
Prevalence of Toxocara spp. in Cats and Detection of Intestinal Helminth Infections in Humans
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This study aimed to investigate the prevalence of intestinal helminth infections in humans and detect Toxocara spp. in cats, with a focus on assessing the impact of age and gender on infection rates. Traditional diagnostic methods have historically limited the accurate identification of helminth infections in humans. Analysis of 450 human stool samples revealed an overall helminth infection rate of 5.7% using conventional techniques. The specific infection rates were 0.4% for Strongyloides stercoralis, 0.6% for Schistosoma mansoni, 1.7% for Hymenolepis nana, and 2.8% for Ascaris lumbricoides. Notably, no infections were recorded in the 30–39 and ≥40-year age groups, while the highest infection rate (16.3%, P≤0.01) was observed in indi

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Publication Date
Fri Jun 03 2022
Journal Name
Annals Of Parasitology
Genotyping and evaluation of interleukin-10 and soluble HLA-G in abortion due to toxoplasmosis and HSV-2 infections
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Abortion is a condition that occurs due to one of the pathological injuries, often one of the members of the TORCH is the real cause. The current study aimed to investigate the impact of toxoplasmosis, HSV-2 infections with abortion, and also, the identification of immunogenetics marker (interleukin-10) that may be associated with abortion. Anti-Toxoplasma IgG, IgM, Herpes simplex virus-2 IgM, human soluble leukocyte antigen class I–G and interleukin10 were estimated by ELISA technique, while the expression of IL-10 gene was investigated by using the real-time PCR. The results showed that among aborted women the rate of anti-Toxoplasma and HSV-2 IgM antibodies occurred within the age groups (21–30) years and (31–40) years 32(100.0%) a

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Scopus
Publication Date
Fri Oct 16 2020
Journal Name
Int J Energy Res
Structural, electronic and optoelectronic properties of AB5C8 (A = Cu/Ag; B = In and C = S, Se and Te) compounds
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Ternary semiconductors AB5C8 (A = Cu/Ag, B = In and C = S, Se or Te) have been investigated. The CuIn5S8 and AgIn5S8 have been synthesize in cubic spinel structure with space group (Fd3m), whereas CuIn5Se8, AgIn5Se8, CuIn5Te8 and AgIn5Te8 have tetragonal structures with space group P-42m. The relaxed crystal geometry, electrical properties such as electronic band structure and optoelectronic properties are predicted by using full potential method in this work. For the determination of relaxed crystal geometry, the gradient approximation (PBE-GGA) is used. All the studied compounds are semiconductors based on their band structures in agreement with the experimental results, and their bulk moduli are in the range 35 to 69 GPa. Wide absorption

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