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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Sat Jun 30 2007
Journal Name
Iraqi Journal Of Chemical And Petroleum Engineering
Corrosion Inhibition of Carbon Steel under Two Phase Flow (Water-Petroleum) Simulated by Turbulently Agitated System
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The corrosion of carbon steel in single phase (water with 0.1N NaCl ) and two immiscible phases (kerosene-water) using turbulently agitated system is investigated. The experiments are carried out for Reynolds number (Re) range of 38000 to 95000 corresponding  to rotational velocities from 600 to 1400 rpm using circular disk turbine agitator at 40 0C. In two-phase system test runs are carried out in aqueous phase (water) concentrations of 1 % vol., 5 % vol., 8% vol., and 16% vol. mixed with kerosene at various Re. The effect of Reynolds number (Re), percent of dispersed phase, dispersed drops diameter, and number of drops per unit volume on the corrosion rate is investigated and discussed. Test runs are carried out using two types of

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Publication Date
Mon Dec 31 2012
Journal Name
Al-khwarizmi Engineering Journal
Genetic Algorithm Based PID Controller Design for a Precise Tracking of Two-Axis Piezoelectric Micropositioning Stage
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 In this paper, an intelligent tracking control system of both single- and double-axis Piezoelectric Micropositioner stage is designed using Genetic Algorithms (GAs) method for the optimal Proportional-Integral-Derivative (PID) controller tuning parameters. The (GA)-based PID control design approach is a methodology to tune a (PID) controller in an optimal control sense with respect to specified objective function. By using the (GA)-based PID control approach, the high-performance trajectory tracking responses of the Piezoelectric Micropositioner stage can be obtained. The (GA) code was built and the simulation results were obtained using MATLAB environment. The Piezoelectric Micropositioner simulation model with th

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Publication Date
Sun Dec 09 2018
Journal Name
Baghdad Science Journal
A Comparative Efficiency Study of Two Adsorbent Materials to Remove Eosin Y Dye from Aqueous Solutions
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This study was done to find a cheap, available and ecofriendly materials that can remove eosin y dye from aqueous solutions by adsorption in this study, two adsorbent materials were used, the shells of fresh water clam (Cabicula fluminea) and walnut shells. To make a comparison between the two adsorbents, five experiments were conducted. First, the effects of the contact time, here the nut shell removed the dye quickly, while the C. flumina need more contact time to remove the dye. Second, the effects of adsorbent weight were examined. The nut shell was very promising and for all used adsorbent weight, the R% ranged from 94.87 to 99.29. However C. fluminea was less effective in removing the dye with R% ranged from 47.59 to 55.39. The thi

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Publication Date
Fri Apr 01 2022
Journal Name
Baghdad Science Journal
Study the Efficiency of Two Concentrations from Algae Cladophora glomerata Extract on the Giardia lamblia parasite
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Giardia lamblia parasite was isolated from the diarrhea samples of patients with Giardiasis dysentery and was developed in HSP media, four mice groups have been used to find in vivo efficacy of two concentrations (128,256) mg/ml of chlorophorm extracts from Cladophora glomerata algae against Giardia lamblia parasite  as compared with (Flagyl) by measuring several biochemical markers as ( GPT and GOT) enzymes ,sodium ,potassium and iron concentration as well as counting the number of parasitic cysts in each mice groups. The results demonstrate that levels of GPTA GOT enzymes have been decreased in mice treated with algal extract. As for the concentration of the Sodium, Potassium and Iron increased in mice treat

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Publication Date
Wed Jan 15 2020
Journal Name
Iraqi Journal Of Laser
Optimizing the Secure Key Rate of a Single Sequential Quantum Repeater with Two Different Quantum Memories
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Quantum channels enable the achievement of communication tasks inaccessible to their
classical counterparts. The most famous example is the distribution of secret keys. Unfortunately, the rate
of generation of the secret key by direct transmission is fundamentally limited by the distance. This limit
can be overcome by the implementation of a quantum repeater. In order to boost the performance of the
repeater, a quantum repeater based on cut-off with two different types of quantum memories is suggestd,
which reduces the effect of decoherence during the storage of a quantum state.

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Publication Date
Fri Jan 01 2016
Journal Name
Aip Conference Proceedings
Analysis of performance measures with single channel fuzzy queues under two class by using ranking method
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Publication Date
Fri Aug 30 2024
Journal Name
Iraqi Journal Of Science
The Dissipation of the Kinetic Energy for 2D Bounded Flow by Using Moment-Based Boundary Conditions with Burnett Order Stress for LBM
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     In this article, the lattice Boltzmann method with two relaxation time  (TRT)  for the  D2Q9 model is used to investigate numerical results for 2D flow. The problem is performed to show the dissipation of the kinetic energy rate and its relationship with the enstrophy growth for 2D dipole wall collision. The investigation is carried out for normal collision and oblique incidents at an angle of . We prove the accuracy of moment -based boundary conditions with slip and Navier-Maxwell slip conditions to simulate this flow. These conditions are under the effect of Burnett-order stress conditions that are consistent with the discrete Boltzmann equation. Stable results are found by using this kind of boundary condition where d

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Publication Date
Sat Jul 01 2006
Journal Name
Saudi Medical Journal
Treatment of alopecia areata by topical diclofenac sodium gel in comparison to benzoyl peroxide gel. A novel single blind therapeutic clinical trial
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KE Sharquie, AA Al-Nuaimy, WJ Kadhum, Saudi medical journal, 2006 - Cited by 3

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Publication Date
Tue Dec 01 2015
Journal Name
Journal Of Economics And Administrative Sciences
A Comparison Between Some Estimator Methods of Linear Regression Model With Auto-Correlated Errors With Application Data for the Wheat in Iraq
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This research a study model of linear regression problem of autocorrelation of random error is spread when a normal distribution as used in linear regression analysis for relationship between variables and through this relationship can predict the value of a variable with the values of other variables, and was comparing methods (method of least squares, method of the average un-weighted, Thiel method and Laplace method) using the mean square error (MSE) boxes and simulation and the study included fore sizes of samples (15, 30, 60, 100). The results showed that the least-squares method is best, applying the fore methods of buckwheat production data and the cultivated area of the provinces of Iraq for years (2010), (2011), (2012),

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Publication Date
Thu Oct 31 2024
Journal Name
Mathematical Modelling Of Engineering Problems
Investigating the Effects of Canard Dihedral Angle on the Wing Span Loading in a Forward-Swept Wing Aircraft at Transonic Speeds at Steady State Conditions Using Computational Fluid Dynamics
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Forward-swept wings were researched and introduced to improve maneuverability, control, and fuel efficiency while reducing drag and they are often used alongside canards, to further enhance their characteristics. In this research, the effects of canard dihedral angles on the wing loading of a forward-swept wing in transonic flow conditions were studied, as the wing loading provides a measure of wing’s efficiency (lift/drag). A generic aircraft model from literatures was selected, simulated, and compared to, using CFD software ANSYS/Fluent where the flow equations were solved to calculate the aerodynamic characteristics. The research was carried at two different Mach numbers, 0.6 and 0.9, for five different canard dihedral angles which tra

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