Preferred Language
Articles
/
bijps-367
Bioequivalence and Pharmacokinetics Comparison of Two Formulations of Extended-Release Pentoxifylline Tablets in Healthy Subjects after Fasting and Fed Conditions
...Show More Authors

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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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.

Crossref
View Publication Preview PDF
Quick Preview PDF
Publication Date
Thu Mar 30 2017
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Phytochemical Study of some Flavonoids Present in the Fruits of Two Ammi L. Species Wildly Grown in Iraq
...Show More Authors

Ammi species belong to the family Umbellifereae that provide a host of bioactive compounds (mainly coumarins and flavonoids) of important biological activities, like prevention and treatment of heart and vascular disease and some types of cancer. Literature survey revealed that there was no study concerning Ammi flavonoids in Iraq. Ammi majus and Ammi visnaga, which are wildly grown in Iraq, were chosen for this study. This study concerned with extraction, identification, isolation, and purification of some biologically important flavonols quercetin and kaempferol from the fruits of Ammi majus and Ammi visnaga. Extraction of these flavonols was carried out using 85% methanol and 90% e

... Show More
View Publication Preview PDF
Crossref (9)
Crossref
Publication Date
Sun Aug 18 2019
Journal Name
Political Sciences Journal
The challenges of precision axes for futuristic regional relations in the middle east (Iraq after post triumph's period)
...Show More Authors

The research has tackled about an important transformation within the whole region of middle east, especially there were more challenges which revealed under the huge pivotal interests of global powers that ruled the new world order by United states of America ; being very affected over the international and regional relations than any situations appeared previously within political realities. So that, many of variables inside the international scene which happened during of this period of contradicting strategic policies by the process of reforming and restructuring of difficult equations that imposed by international and regional allies and blocs . This article had concentrated over various strategic and political studies which reflect

... Show More
View Publication Preview PDF
Crossref
Publication Date
Sun Mar 07 2010
Journal Name
Baghdad Science Journal
Implementation of Optical Coherent Communication System between Two Computers
...Show More Authors

This work represents implementation and investigation of optical coherent communication system between two computers. A single mode optical fiber is selected as transmission medium. The data are sent via the RS-232 standard interface with a bit rate of 9.6 kbps from personal computer (PC1) by line receive to convert the data from electrical levels (-12/+12 V) into TTL level (0/5 V). The modulation of this data was accomplished by internal modulation using laser diode type (HFCT-5208M) 1310 nm wavelength. The optical D-coupler was used to combine the optical signal that come from laser source with optical signal of laser local oscillator (OTS-304XI) at 1310/1550 nm wavelength to obtain coherent (homodyne and heterodyne) detection respective

... Show More
View Publication Preview PDF
Crossref
Publication Date
Sat May 23 2026
Journal Name
Journal Of Engineering
Computational Method for Unsteady Motion of Two-Dimensional Airfoil
...Show More Authors

A numerical method is developed for calculation of the wake geometry and aerodynamic forces on two-dimensional airfoil under going an arbitrary unsteady motion in an inviscid incompressible flow (panel method). The method is applied to sudden change in airfoil incidence angle and airfoil oscillations at high reduced frequency. The effect of non-linear wake on the unsteady aerodynamic properties and oscillatory amplitude on wake rollup and aerodynamic forces has been studied. The results of the present method shows good accuracy as compared with flat plate and for unsteady motion with heaving and pitching oscillation the present method also shows good trend with the experimental results taken from published data. The method shows good result

... Show More
View Publication
Publication Date
Sat Jul 01 2023
Journal Name
Iop Conference Series: Earth And Environmental Science
Performance Evaluation of Two Date Palm Frond Cutting Saws
...Show More Authors
Abstract<p>Traditional tree management is laborious and costly, thus this work aimed to study the performance of two different types of frond cutting saws (reciprocating saw and vibrating saw) and examine the two saws on five date palm varieties. Four parameters were examined, including cutting time for a single frond, the power needed for cutting a single frond, frond cutting productivity expressed as tree/h, and vibration conveyed to the worker’s hand. A field experiment was designed according to the nested randomized complete block design, including five date palm varieties as the main plot and the type of saw as a sub-plot. Means were compared using the least significant differences (LSD 0</p> ... Show More
View Publication
Scopus Crossref
Publication Date
Sun May 01 2022
Journal Name
Journal Of Engineering
Parametric Study of a Two-Phase Closed Thermosyphon Loop
...Show More Authors

A theoretical and experimental investigation was carried out to study the behavior of a two-phase closed thermosyphon loop (TPCTL) during steady-state operation using different working fluids. Three working fluids were investigated, i.e., distilled water, methanol, and ethanol. The TPCTL was constructed from an evaporator, condenser, and two pipelines (riser and downcomer). The driving force is the difference in pressure between the evaporator and condenser sections and the fluid returns to the heating section by gravity. In this study, the significant parameters used in the experiments were filling ratios (FR%) of 50%, 75%, and 100% and heat-input range at the evaporator section of 215-860.2 W. When the loop reached to

... Show More
View Publication Preview PDF
Crossref (1)
Crossref
Publication Date
Wed Aug 23 1989
Journal Name
J. Agric. Water Reso. Res 8 (1), 11-25‏
Response Of Two Barley Mutants CV. Arivat To Salinity‏
...Show More Authors

Publication Date
Thu Mar 01 2018
Journal Name
Journal Of Engineering
Impact Response for Two Designs of Athletic Prosthetic Feet
...Show More Authors

The present work evaluated the differences in mechanical properties of two athletic prosthetic feet samples when subjected to impact while running. Two feet samples designated as design A and B were manufactured using layers of different orientations of woven glass fiber reinforced with unsaturated polyester resin as bonding epoxy. The samples’ layers were fabricated with hand lay-up method. A theoretical study was carried out to calculate the mechanical properties of the composite material used in feet manufacturing, then experimental load-deflection  test was applied at 0 degree position and 25 degree dorsiflexion feet position  and impact test were applied for both feet designs to observe the behavior

... Show More
View Publication Preview PDF
Crossref (2)
Crossref
Publication Date
Wed Jun 30 2021
Journal Name
Journal Of Economics And Administrative Sciences
comparison Bennett's inequality and regression in determining the optimum sample size for estimating the Net Reclassification Index (NRI) using simulation
...Show More Authors

 Researchers have increased interest in recent years in determining the optimum sample size to obtain sufficient accuracy and estimation and to obtain high-precision parameters in order to evaluate a large number of tests in the field of diagnosis at the same time. In this research, two methods were used to determine the optimum sample size to estimate the parameters of high-dimensional data. These methods are the Bennett inequality method and the regression method. The nonlinear logistic regression model is estimated by the size of each sampling method in high-dimensional data using artificial intelligence, which is the method of artificial neural network (ANN) as it gives a high-precision estimate commensurate with the dat

... Show More
View Publication Preview PDF
Crossref
Publication Date
Sun Mar 02 2008
Journal Name
Baghdad Science Journal
He-Ne Laser Irradiation Encourages reparative processes After cartilage loss in New Zealand rabbits
...Show More Authors

Many therapeutic methods used to encourage reparative processes of cartilage and accelerate their healing such as drugs, magneto-laser and so on. Twenty four adult New Zealand rabbits used in this study. They were divided in to two groups; control and treaded with He –Ne laser. A square skin flap done on the medial aspect of both auricles followed by pealing a square piece of cartilage from the auricle then the flaps sutured .The site of the operation in the rabbits of the treated group were irradiated with He –Ne laser 5mw power for seven days began after the operation directly. 3 rabbits from each group used for collection of specimens for histopathological examination at the 1, 2, 4 & 6 weeks post the operation. Significant

... Show More
View Publication Preview PDF
Crossref (1)
Crossref