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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Nov 01 2019
Journal Name
Global Journal Of Public Health Medicine
PURIFICATION OF INULINASE FROM KLEBSIELLA PNEUMONIAE AND STUDY THE ANTIBACTERIAL EFFECT OF COMBINATION OF INULINASE AND CEFTAZIDIME
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Klebsiella pneumoniae are Gram-negative which cause many diseases such as urinary tract infections, respiratory tract infections and septicemia. Inulinase is an enzyme used in food manufacture and pharmaceuticals. Inulinase is used in decreasing lipid ratio and, cholesterol in blood and considered as a prebiotic factor inside intestine. Many microorganisms can produce inulinase, such as yeast, fungi and bacteria; among such bacteria: Bacillus spp., Arthrobacter spp., and Pseudomonas spp. but there are no studies about inulinase production by K. pneumoniae have been reported. So the current study aims at investing the ability of producing and purification inulinase by K. pneumoniae. Method: K. pneumoniae were isolated from many hospitals and

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Publication Date
Thu Dec 01 2016
Journal Name
Journal Of Engineering
Numerical and Experimental Investigations of the Effect of PVD and Vacuum Pressure on the Degree of Saturation
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    Soft clays are generally characterized by low shear strength, low permeability and high compressibility. An effective method to accelerate consolidation of such soils is to use vertical drains along with vacuum preloading to encourage radial flow of water.  In this research numerical modeling of prefabricated vertical drains with vacuum pressure was done to investigate the effect of using vertical drains together with vacuum pressure on the degree of saturation of fully and saturated-unsaturated soft soils.  Laboratory experiments were conducted by using a specially-designed large consolidometer cell where a central drain was installed and vacuum pressure was applied. All tests were conducted

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Publication Date
Mon Aug 10 2009
Journal Name
European Journal Of Scientific Research
Synthesis and characterization and Fungicidal Activity of Triorganotin(IV) with Benzamidomethionine
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Publication Date
Wed May 02 2012
Journal Name
Journal Of Planner And Development
the planning and design characteristics of Iraqs mud building and settlement
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The Mesopotamian soil is muddy and fertile, and so from ancient eras Iraqis used mud in their building, settlements and architecture in different methodologies according to the nature and the function of the building that was either in its pure form or by mixing it with other materials such as straw . also as raw bricks in different ways either for the whale building or parts of it, or for the finishing parts such as roofing for instance. In this research these different forms and methodologies will permeate through out a chosen examples of historical building, rural buildings and settlements and ancient buildings as well as some current uses of mud in the structures and building in standing cities, this in order to conclude some

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Publication Date
Wed Jun 29 2022
Journal Name
College Of Islamic Sciences
Semitism and the allegations of the Jews Presentation, analysis and criticism
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he aim of the research is to clarify the meanings and connotations of (Semitic), and to identify the peoples that fell under this name according to historical data, biblical texts and Qur’anic news. International sympathy on the one hand and on the other hand controlling the land of Palestine and giving them international legitimacy to grow their entity according to global support and sympathy with their alleged slogan (anti-Semitism), which revolves around the oppression of the Jews.

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Publication Date
Fri Feb 20 2026
Journal Name
Journal Of Baghdad College Of Dentistry
The Clinical Approach and Treatment of Benign and Malignant Parotid Masses
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Background: Parotid gland tumors account for 80% of all salivary gland neoplasms, 20% of these are malignant, but in daily clinical practice most parotid masses are operated on before obtaining the final histological diagnosis. This clinical setting further complicates the critical point of parotid surgery, which is the management of the facial nerve. Materials and methods: 45 patients underwent parotidectomy for benign and malignant neoplasms. A complete history is collected from the patients with the duration and the site of the tumor, the facial nerve examined and its associations, a medical consultation done for opinion and management. Clinical examination with facial nerve was mandatory to avoid any mistakes that may occur. The most si

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Publication Date
Mon Oct 01 2012
Journal Name
Al–bahith Al–a'alami
The Arab Blogosphere and the Strategies of Self-Building and Diary
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Basically, media studies focused on the important role of the blogs in boosting the democratic process in the Arab States. Blogs also worked on creating an alternative media for the public that maintained freedom of expression. However, media studies ignored the status of the blogs in the social and cultural fields.
The current study tries to tackle the socio-cultural dimensions of the blogs by means of showing how the blogs construct the self. The researcher is going to conduct interviews with the bloggers. He will also carry out a semiotic analysis that may reveal the strategies used by the bloggers. Besides, he tries to identify the realistic and traditional frames in which the social relationships are buil

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Publication Date
Sun Jun 05 2016
Journal Name
Baghdad Science Journal
Synthesis and Characterization of Some Novel Oxazine, Thiazine and Pyrazol Derivatives
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In this paper, some chalcone derivatives (C1, C2) were synthesized based on the reaction of equal amount of substituted acetophenone and substituted banzaldehyde in basic medium. Oxazine and thiazine derivatives were prepared from the reaction of chalcones (C1-C2) with urea and thiourea respectively in a basic medium. Pyrazole derivatives were prepared based on the reaction of chalcones with hydrazine mono hydrate or phenyl hydrazine in the presence of glacial acetic acid as a catalyst. The new synthesized compounds were identified using various physical techniques like1 H-NMR and FT-IR spectra.

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Publication Date
Fri Jan 01 2016
Journal Name
The International Scientific Conference For Nanotechnology And Advance Research’s
Effect of the annealing and compositional on the Morphological and electrical
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Nanocrystalline TiO 2 and CuO doped TiO 2 thin films were successfully deposited on suitably cleaned glass substrate at constant room temperature and different concentrations of CuO (0.05,0.1,0.15,0.2) wt% using pulse laser deposition(PLD) technique at a constant deposition parameter such as : (pulse Nd:YAG laser with λ=1064 nm, constant energy 800 mJ, with repetition rate 6 Hz and No. of pulse (500). The films were annealed at different annealing temperatures 423K and 523 K. The effect of annealing on the morphological and electrical properties was studied. Surface morphology of the thin films has been studied by using atomic force microscopes which showed that the films have good crystalline and homogeneous surface. The Root M

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Publication Date
Mon Dec 01 2014
Journal Name
Aip Advances
Ab initio structural and vibrational properties of GaAs diamondoids and nanocrystals
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Gallium arsenide diamondoids structural and vibrational properties are investigated using density functional theory at the PBE/6-31(d) level and basis including polarization functions. Variation of energy gap as these diamondoids increase in size is seen to follow confinement theory for diamondoids having nearly equiaxed dimensions. Density of energy states transforms from nearly single levels to band structure as we reach larger diamondoids. Bonds of surface hydrogen with As atoms are relatively localized and shorter than that bonded to Ga atoms. Ga-As bonds have a distribution range of values due to surface reconstruction and effect of bonding to hydrogen atoms. Experimental bulk Ga-As bond length (2.45 Å) is within this distribu

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