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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 14 2014
Journal Name
Molecular Crystals And Liquid Crysta
Synthesis and Mesomorphic Behavior of Two New Homologous Series Containing Azobenzene and 1,3,4-Oxadiazole Units
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Two new nonsymmetrical mesogenic homologous series of terminal substituent ether (series [Vn]) and carboxy (series [VIn]) incorporating azobenzene and 1,3,4-oxadiazole group were synthesized. Both series have been All compounds thus isolated were purified and characterized by elemental analysis, Fourier Transform Infrared Spectroscopy, 1H NMR, along with thermal analysis and texture observation using Differential Scanning Calorimetry (DSC) and Polarizing Optical Microscopy (POM), respectively. All compounds of the first series exhibited liquid crystalline properties. The homologues [V1]-[V3] display a nematic mesophase, the compounds [V4]-[V7] exhibit a dimorphism behavior, nematic (N) and smectic A (SmA) mesophases, the compounds [V8] and

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Publication Date
Thu Feb 07 2019
Journal Name
Iraqi Journal Of Laser
Design and Comparative Study of a one and Two Stage Blumlein Circuit TEA Nitrogen Laser
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Two Prototypes of Transversely Excited at atmospheric pressure (TEA) Nitrogen laser systems (One Stage Blumlein Circuit and Two Stage Blumlein Circuit) were fabricated and operated. High voltage power supply with variable operating voltage (0-20 kv) and operating current (1-3A) was built and tested successfully. The gas flow rate of 15 L/ min and 10 L/ min for OSBC and TSBC was used. The performance of the fabricated systems was studied extensively reaching to the optimum operating conditions. The obtained laser output energy for the first system has linear relationship with the applied voltage. The maximum output energy was about (1.14 mJ) with (10.40) ns pulse duration and the half-wave divergence angle was about (0.1455 m rad). In the

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Publication Date
Wed Jan 01 2020
Journal Name
International Journal Of Medical Sciences
Comparison of ABGAR Score among Gestational, Pregestational Diabetes and Normal Pregnant Women
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Background: The Apgar score is calculated based on the five features: heart rate, reflexes, color, muscle tone, and respiratory effort. Each element is scored from 0 to 2, with a total probable score of 10 at 1 minute and 5 minute. Aim: To study the influence of gestational diabetes mellitus (GDM) and diabetes mellitus on APGAR score in neonate. Materials and methods: The samples were studied from Department of Obstetrics and Gynaecology in Al-Imamain Al-Kadhimiyain (AS) Medical city, Baghdad Teaching Hospital and Al-Karkh Maternity Hospital in the period between 1 December 2016 and 1 may 2017, after obtaining the approval from Iraqi Ministry of Health. A total of 102 neonates were included in this study which includes 34 neonates of mother

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Publication Date
Wed Mar 10 2021
Journal Name
Baghdad Science Journal
Comparison of HF and HCl Chemical Laser Parameters by using Mathematical Model
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A simplified theoretical comparison of the hydrogen chloride (HCl) and hydrogen fluoride (HF) chemical lasers is presented by using computer program. The program is able to predict quantitative variations of the laser characteristics as a function of rotational and vibrational quantum number. Lasing is assumed to occur in a Fabry-Perot cavity on vibration-rotation transitions between two vibrational levels of hypothetical diatomic molecule. This study include a comprehensive parametric analysis that indicates that the large rotational constant of HF laser in comparison with HCl laser makes it relatively easy to satisfy the partial inversion criterion. The results of this computer program proved their credibility when compared with th

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Publication Date
Fri Dec 29 2017
Journal Name
Ibn Al-haitham Journal For Pure And Applied Sciences
Efficacy of Some Formulations of the Insecticide Chlorpyrifos against Microcerotermies diversus Silv. On Citrus Tree Orchards
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The eflicacy  of six formula from chloropyrifos against tem1ite

Microterotermes - diversus on citrus tree orchards has been

tested years .

Data!rom field trials confirmed that Dursbau 4TC, chlorpyrifos -

500 EC and Talaban 40,8 TC at rate 100 mL L protected citrus trees for two years.  While ch1orfate. 40.8 TC, Dormate 40,8TC, Yamasban

40,8 TC protected  them for 16,16 and 12 months respectively at the same concentration.

But the rate of 5m1/ L of Dursban, chropyfros 500 EC , Chlorfat,

Tafabun yamashan and Dormate protected the trees tor 24,16,4,4,2

and 4 months  , respectively .

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Publication Date
Sun Sep 02 2012
Journal Name
Baghdad Science Journal
Determination of optimal conditions for laccase production by Pleurotus ostreatus using sawdust as solid medium and its use in phenol degradation
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The ability of four local fungal isolates for extracellular laccase production has been tested with five grams 1:1(w/v) humidified sawdust as substrate in mineral salt medium. After 21 day of incubation at 25±1 ? C and using one mycelial plug (5mm), higher level of laccase activity (0.15U/ml) and specific activity (15U/mg) were observed by Pleurotus ostreatus in comparison with other fungal isolates. The results of optimum conditions for laccase production from selected isolate showed that, the maximum laccase activity (0.55U/ml) and specific activity (55U/mg) were obtained at moisture ratio 1:3 (w/v), using 3 mycelial plugs (5 mm), after 15 days incubation period at 25±1 ? C. The results of phenol degradation by crud laccase revealed th

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Publication Date
Thu Jan 01 2015
Journal Name
Journal Of Plant Interactions
Photosynthetic and biochemical characterization of in vitro-derived African violet (<i>Saintpaulia ionantha</i>H. Wendl) plants to ex vitro conditions
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Publication Date
Sat Sep 16 2023
Journal Name
مجلة الدراسات المستدامة
A Review Article: Use of fertilizers and their gradual release of mineral nutrients as a remedy to this problem have an adverse environmental impact.
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Throughout Agriculture has mostly relied on the use of natural fertilizers throughout human history, which are compounds that increase the nitrogen levels in the soil. Modern agriculture was made possible by the introduction of synthetic fertilizers at the end of the 19th centuryproduction of agriculture. Their application enhanced crop yields and sparked an agricultural revolution unlike anything the world had ever seen.In the near future, synthetic fertilizers are anticipated to continue to have a significant impa ct on human life, both positively and negatively. They are frequently utilized for producing all t ypes of crops and are essential to plant growth. The significance of synthetic fertilizers is their ability to provide the soil w

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Publication Date
Wed Mar 30 2016
Journal Name
College Of Islamic Sciences
Graphical significance To (if) and (if) the two cops in Surat al-Maidah
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Many writers and scientists hardly differentiate between the two instruments of use
(If) and (if) to convergence in the meaning, as they perform the meaning of the penalty and condition, as the answer relates to his condition, but when linguistic meditation we find a great difference in use in terms of meaning, so this research came to reveal these meanings and was extrapolated applied in Surat al-Maidah By counting the verses in which (if) and (if) the cops were given and looking at their contexts, the connotation of the cops in most places was within the context of probability, which is the origin of its use, given in twenty places of Surat al-Ma'idah, and it had multiple connotations according to the contexts of the verses received

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Publication Date
Mon Jun 19 2023
Journal Name
Journal Of Engineering
Effect of Design Parameters and Support Conditions on Natural Frequency of Pipe Excited by a Turbulent Internal Flow
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In this study, the effect of design parameters such as pipe diameter, pipe wall thickness, pipe material and the effect of fluid velocity on the natural frequency of fluid-structure interaction in straight pipe conveying fully developed turbulent flow were investigate numerically,analytically and experimentally. Also the effect of support conditions, simply-simply and clamped-clamped was investigated. Experimentally, pipe vibrations were characterized by accelerometer mounted on the pipe wall. The natural frequencies of vibration were analyzed by using Fast Fourier Transformer (FFT). Five test sections of two different pipe diameters of 76.2
mm and 50.8 mm with two pipe thicknesses of 3.7 mm and 2.4 mm and two pipe materials,stainles

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