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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Jan 01 2019
Journal Name
Indian Journal Of Public Health Research & Development
Comparison of the Cyclic Fatigue of Protaper Next, 2Shape and Hyflex EDM Using Glyde
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Publication Date
Wed Aug 26 2020
Journal Name
Iraqi Journal Of Agricultural Sciences
COMPARISON THE ACCURACY OF COMPUTING POINT COORDINATS BETWEEN DIFFERENT INSTRUMENTS AND APPLICATIONS OF GPS
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The study was aimed to determine the coordinates of  the points were measured by different ways and different instruments, the most precise way using the differential global positioning system (DGPS) that will be the reference measurements in comparison, less precise way using navigator GPS. Google earth (pro.), and the other applications of GPS mobile ( Samsung and I-phone). In this research (8 points) were chosen that are occasional in location. The comparison of the different observations can give us an idea of ​​the extent to which the accuracy of the observations differs from the different devices used in the observing, as well as through the knowledge of the best device and the best way to measure coordinates accurately t

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Publication Date
Tue May 01 2018
Journal Name
Journal Of Physics: Conference Series
Application of Weyl Module In The Case Of Two Rows
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Publication Date
Thu Mar 30 2017
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Synthesis and Biological Evaluation of Two New Analogues of Gonadotropin Releasing Hormone (GnRH)D-alanine8 and D-alanine
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So far synthesis of Gonadotropin Releasing Hormone (GnRH) analogues reported in the literature has clarified some aspects of structural activity of the naturally released GnRH. As a part of continuing efforts for further understanding of this relationship, the present investigation was undertaken which involved synthesis and biological evaluation of two GnRH analogues, firstly, by replacement of the amino acid L-Argenine in the 8th position at the backbone structure of the natural hormone by the amino acid D-Alanine; and secondly, by replacement of the amino acid L-Glycine in the 10th position by D-Alanine also at the backbone structure of the nature hormone, to obtain the following analogues respectively:

P

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Publication Date
Sun Apr 30 2023
Journal Name
Al-kindy College Medical Journal
Persistent Intraocular Pressure Elevation after Silicon Oil Removal in Patients with Post-Pars Plana Vitrectomy: IOP Level After SO Removal
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Background: It is well-known that silicon oil (SO) injection into the vitreous cavity after pars plana vitrectomy is usually associated with high intraocular pressure.

Objectives: To determine the influence of silicon oil (SO) removal on IOP level after pars plana vitrectomy for spontaneous rhegmatogenous retinal detachment (RRD)

Subjects and Methods: A prospective study was conducted at Ibn Al-Haitham eye teaching hospital, Baghdad- Iraq. Intraocular pressure (IOP) was measured pre and post SO removal in patients who have underwent retinal detachment surgery with SO injection of 1000 centistokes (cSt) viscosity. Baseline IOP was measured for all the patient before the SO

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Publication Date
Mon Nov 19 2018
Journal Name
Ibn Al-haitham Journal For Pure And Applied Science
Study of Two Types Finite Graphs in KU-Semigroups
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In this ˑwork, we present theˑ notion of the ˑgraph for a KU-semigroup as theˑundirected simple graphˑ with the vertices are the elementsˑ of and weˑˑstudy the ˑgraph ofˑ equivalence classesˑofˑ which is determinedˑ by theˑ definition equivalenceˑ relation ofˑ these verticesˑ, andˑ then some related ˑproperties areˑ given. Several examples are presented and some theorems are proved. Byˑ usingˑ the definitionˑ ofˑ isomorphicˑ graph, ˑwe showˑ thatˑ the graphˑ of equivalence ˑclasses ˑand the ˑgraphˑof ˑa KU-semigroup ˑ areˑ theˑ sameˑ, in special cases.

Publication Date
Mon Jan 01 2018
Journal Name
Int. J. Agricult. Stat. Sci. V
The role of irrigation management processes and micronutrient fertilization on parameter of growth and yield of two wheat varieties
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The experiment was conducted in Al- Mahaweel Research Station in Babel Governorate, Ministry of Agriculture during autumn season 2016-2017 to determine the role of irrigation management processes and micronutrient fertilization in growth and productivity of two varieties of wheat IPA 99 and Al-Rasheed 22 in clay loam soil classified as Typic Torriflovent. The experiment included four irrigation treatments and six fertilization treatments. The experiment was designed under randomized complete block design (RCBD) with three replications. Wheat grain IPA 99 and Al-Rasheed 22 varieties were planted in 23/11/2016 and harvested in 13/5/2017. The amount and periods of irrigation depended on sensors reading of volumetric water content was measured

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Publication Date
Fri Oct 01 2021
Monitoring and controlling the speed and direction of a DC motor through FPGA and comparison of FPGA for speed and performance optimization
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<span lang="EN-US">We are living in the 21<sup>st</sup> century, an era of acquiring necessity in one click. As we, all know that technology is continuously reviving to stay ahead of advancements taking place in this world of making things easier for mankind. Technology has been putting his part in introducing different projects as we have used the field programmable gate arrays (FPGAs) development board of low cost and programmable logic done by the new evolvable cyclone software is optimized for specific energy based on Altera Cyclone II (EP2C5T144) through which we can control the speed of any electronic device or any Motor Control IP product targeted for the fan and pump. Altera Cyclone FPGAs’ is a board thro

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Publication Date
Wed Feb 20 2019
Journal Name
Political Sciences Journal
Iraqi Woman Political situation in Quota Framework after 2003
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Abstract Since 2003. Iraq has begun a new phase in its modern history, which was after a long period of tyranny, repression of freedom of expression, and women were no better off than men; they suffered marginalization and exclusion, but after the fall of the former regime and the adoption of a parliamentary system of government, The level of participation in the government; where it approved the share of women in the legislative authority called "quota" which reflects the legislative level of a certain proportion of the seats in Parliament, amounting to 25%, and this is approved by the Iraqi constitution for 2005. But it is noticeable that women in parliament did not work within the quota; in other words they belonged to the pol

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Publication Date
Sun Mar 13 2011
Journal Name
Baghdad Science Journal
Phytoplankton primary production in southern Iraqi marshes after restoration
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Primary productivity and chlorophyll-a were used in this study to monitor the restoration process of southern Iraqi marshes (Al-Hewaizeh, central marshes, and Al-Hammar). The phytoplankton primary productivity was based on oxygen light/dark bottle method. Two different depths samples were taken monthly from six studied marshes stations (two stations for each marsh) during November 2005 to October 2006, while chlorophyll-a samples taken from surface water. The phytoplankton primary productivity values ranged 9.38 – 249.79 mg C/m3.hr for all marshes, its values for surface water sample ranged 11.71 – 256.24 mg C/m3.hr, while for 1m depth ranged 9.38 – 142.5 mg C/m3.hr. Chlorophyll-a values ranged between (1.1 – 21.26) µg/l indicating

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