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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Sep 27 2022
Journal Name
Al–bahith Al–a'alami
THE MOST IMPORTANT PHENOMENA OF THE ARABIC LANGUAGE IN THE MEDIA BETWEEN (warning and development)
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Summary of the research : Our research tagged (Arabic language in the media between warning and development) attempts to follow the most prominent phenomena that accompanied the evolution of the use of Arabic language in the media with the development of these means and spread technically globally, and how divided researchers and linguists and intellectuals Arabs into two teams, each demanding what contradicts the other, in the matter The use of the Arabic language in the media, and the arguments of each team in the need to deal with the media as one of the pillars of the nation culturally, historically and civilized, in order to enhance its position and maintain unity, continued the research highlighted the positions of hard-lin

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Publication Date
Wed Feb 22 2023
Journal Name
Iraqi Journal Of Science
Facies, Depositional Environment and Cyclicity of the Fatha Formation in East Baghdad Oil Field, Iraq.
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This study deals with establishing the depositional environment of the Fatha Formation through facies analysis. It also deals with dividing the formation into units based on the rhythmic nature. Data from selected shallow wells near Hit area and deep wells at East Baghdad Oil field are used. Five major lithofacies are recognized in this study, namely, greenish grey marl, limestone, gypsum (and/or anhydrite), halite and reddish brown mudstone (with occasional sandstone).The limestone lithofacies is divided into three microfacies: Gastropods bioclastic wackestone microfacies, Gastropods peloidal bioclastic packstone, and Foraminiferal packstone microfacies.The lithofacies of the Fatha are nested in a rhythmic pattern or what is known as sh

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Publication Date
Thu Jan 30 2020
Journal Name
Neuroquantology
Studying Effect of Temperature on Electron Transport Parameter and Coefficients in CF3I Mixture with N2O
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Publication Date
Thu Jun 01 2023
Journal Name
Baghdad Science Journal
Mesenchymal and stemness transdifferentiation via in-vitro infection of T24 cell line with Klebsiella pneumoniae
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Klebsiella pneumoniae has been found in the urinary tract of some bladder cancer patients. Bacterial presence within tumor tissue may affect the tumor-microenvironment and consequently influence cancer behavior, development, and treatment response. This study investigated mesenchymal and stemness transdifferentiation of bladder cancer cell line due to environmental stress of K. pneumoniae. Cultures of urothelial bladder cancer cell line (T24) were infected with K. pneumoniae with different multiplicity of infection (MOI) for two and four days. Transdifferentiation-associated features were morphologically assessed.

Moreover, transdifferentiation markers were estimated using Q-PCR and immunohistoc

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Publication Date
Thu Jun 30 2011
Journal Name
Al-kindy College Medical Journal
THE PREVALENCE AND CLINICAL SIGNIFICANCE OF PERINUCLEAR ANTINEUTROPHIL CYTOPLASMIC ANTIBODY IN PATIENTS WITH INDETERMINATE COLITIS
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Background: Indeterminate colitis (IC), a term
originated by pathologists to characterize confounding
histopathlogic appearance of resected mucosa, has
become catch phrase for cases in which diagnostic
criteria at all levels elude classification as Crohn's
disease (CD) or ulcerative colitis (UC).
OBJECTIVES: evaluate the prevalence of pANCA
expression in the sera and its isotypes.
Patients and methods: PATIENTS GROUP
consisted of 60 patients (40 males and 20 females)
with indeterminate colitis and their age range was (19-
84 years). CONTROL GROUP consisted of 30 (15
males and 15 females) healthy volunteers and their
age range was (20- 66 years).
Antineutrophil cytoplasmic ( pANCA and cANCA)
te

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Publication Date
Fri Jun 01 2012
Journal Name
Journal Of Economics And Administrative Sciences
Dumping and Its Challenges in Extent of World Trade Organization "Models for selected Agricultural Goods"
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The subject of dumping is considering today one of the subjects in which form an obstruction arise in front of the cycle of growth for some countries , such as the study of dumping is capturing a large attention by the competent because either a big  role and effect in growing the economies of nations then the subject of dumping became a field turn around its sides many measures and laws … and may be done resorting to by many states of the world to anti-dumping as approach of determent weapon delimit  the impact of dumping and gives the national agriculture sector the opportunity for rising and growing so this section of international economics is capturing a special importance and represent in same time an important

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Publication Date
Sun Dec 02 2012
Journal Name
Baghdad Science Journal
Estimation Activity And Partial Purification Of Leucine Amino Peptidase (Lap) In Patients Wiith Diabetic Nephropathy
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Leucine aminopepotidase (LAP)[EC:3.4.11.1] activity has been assayed in (50) serum samples of patients with diabeties naphrophathy D.N (non-insulin dependent diabetic (NIDD) , and (50)serum sample of healthy individuals without any clinically detectable diseases have been as control group. The aim of this study is to measure leucine aminopeptidase activity and partially purifying the enzyme from sera of patients with diabetes nephropathy The results of this study revealed that Leucine aminopeptidase (LAP) activity of nephropathy patient’s serum shows a high signifiacant increase (p < 0.001) compared to that of the healthy subjects.LAP was purified from the serum of patients with diabetes nephropathy by dialysis and gel filtration (Se

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Publication Date
Sun Sep 01 2013
Journal Name
Baghdad Science Journal
Spectrophotometric Determination of Bismuth(III) with Arsenazo(III) Reagent in Water samples and Veterinary Preparation
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A simple , sensitive and accurate spectrophotometric method for the trace determination of bismuth (III) has been developed .This method is based on the reaction of bismuth (III) with arsenazo(III) in acid solution (pH=1.9) to form a blue water soluble complex which exhibits maximum absorption at 612nm .Beer's law is obeyed over the concentration range of 2-85 ?g bismuth (III) in a final volume of 20 mL( i.e. 0.1 – 4.25?g.mL-1) with a correlation coefficient of (0.9981) and molar absorptivity 1.9×104 L.mol-1.cm-1 . The limit of detection (LOD) and the limit of quantification (LOQ) are 0.0633 and 0.0847 ?g.mL-1 , respectively . Under optimum conditions,the stoichiometry of the reaction between bismuth (III) and arsenazo(III) r

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Publication Date
Wed Sep 01 2021
Journal Name
Baghdad Science Journal
Concentrations and Radiation Hazard Indices of Naturally Radioactive Materials for Flour Samples in Baghdad Markets
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In the present work, Uranium (238U), Thorium (232Th) and Potassium (40K) specific activity concentration in (Bq/kg) was measured in five different types for wheat flours that are available in the Iraqi markets. The gamma spectrometry method with an NaI (Tl) detector has been used for radiometric measurements. Calculations of radium equivalent activity, annual effective dose equivalent, external hazard index (Hex), internal hazard index (Hin), representing gamma index and gamma dose rate in all  flour samples were 17.98132 Bq/kg, 0.0100334, 0.04502, 0.04857, 0.06872, 0.125883 and 8.181244 respectively. It is found that the average of specific activity concentration of wheat flour sam

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Publication Date
Mon Mar 31 2014
Journal Name
Al-khwarizmi Engineering Journal
Corrosion Behavior of V2AlC and Cr2AlC Compared with SS 316L in NaOH at Four Temperatures
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Abstract

      This work involves the manufacturing of MAX phase materials include V2AlC and Cr2AlC using powder metallurgy as a new class of materials which characterized by regular crystals in lattice. Corrosion behavior of these materials was investigated by Potentiostat to estimate corrosion resistance and compared with the most resistant material represented by SS 316L. The experiments were carried out in 0.01N of NaOH solution at four temperatures in the range of 30–60oC. Polarization resistance values which calculated by Stern-Geary equation indicated that the MAX phase materials more resistant than SS 316L. Also cyclic polarization tests confirme

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