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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Mon Jul 24 2023
Journal Name
Research Journal Of Pharmacy And Technology
Comparison of the effects of Methotrexate and Etanercept on RANKL and OPG as Bone Metabolism Biomarkers in patients with Rheumatoid Arthritis
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Rheumatoid arthritis is an autoimmune diseasecharacterized by chronic inflammationthat affects joints and cartilage. Bone complications such asRA-relatedosteoporosis are one of the most extra-articular manifestations. Many inflammatory mediators are released during RA disease pathophysiology; these mediators stimulate osteoclast genesis of bone by direct effects on RANKL and OPG. The study aimedto measure RANKL, OPG in RA patients treated with Etanercept only and other groups treated with Methotrexate onlyat baseline and after three months to evaluate bone state. An observational case-control prospective study was done on 30 RA patients who received MTX, 30 RA patients who received ETN, and 30 healthy,age-matched control groups. The

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Publication Date
Mon Nov 07 2022
Journal Name
Environmental Monitoring And Assessment
Comparison of Climate Change Impact upon Water Productivity of Winter Wheat in Northern and Southern Regions of Iraq 
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Abstract<p>Maximizing the water productivity for any agricultural system is considered an adaptation to the potential climate change crisis. It is required, especially in arid and semi-arid environments in Iraq. Therefore, this study assessed the potential impact of climate change on the different environments in the Qadissiya and Nineveh provinces. The ensemble of six GCM models employed for the regional climate model of the HCLIM-ALADIN in high-resolution 10*10 km<sup>2</sup> and Aqua-Crop was used to examine the response of water productivity and yield of winter wheat. With and without CO<sub>2 </sub>concentration changing under different water regimes in the near term (2020-2040</p> ... Show More
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Publication Date
Wed Jun 30 2010
Journal Name
Al-kindy College Medical Journal
Effect of Very Early Atorvastatin Initiation for Acute Myocardial Infarction on Creatine Kinase release
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Background : It has been suggested that pretreatment with a statin agent prior to
myocardial infarction limits myocardial
creatine kinase release, and thus may act to
limit myocardial infarct size in humans.
Objective : To examine the effect of very
early statin initiation for acute myocardial
infarction (AMI), to the extent of
myonecrosis as manifested by peak serum
creatine kinase levels.
Methods : Patients with AMI admitted to AlKindy teaching hospital cardiac care unit
from 1st February 2007 to 28th February
2008, who fulfilled the inclusion criteria
cited in the present study, were randomly
assigned into two study groups. The statin
group patients have received a single oral
dose of 40 mg

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Publication Date
Mon Jan 01 2018
Journal Name
Jordan Journal Of Biological Sciences
Expression of biotransformation and antioxidant genes in the liver of albino mice after exposure to aflatoxin B1 and an antioxidant sourced from turmeric (Curcuma longa)
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The present investigation aims to determine the effects of aflatoxin B1 (AFB1) on biotransformation and antioxidant genes and the protective effects of curcumin, present in turmeric (Curcuma longa) powder (TMP). Specifically, the study included four groups of albino mice were fed for 30 days on diet Group I: Control, Group II: animals fed on the conventional basal diet supplemented with 0.5% food grade TMP that supplied 74 mg/kg total curcuminoids. Group III contained animals reared on conventional basal diet supplemented with 1.0 ppm AFB1 supplied by ground aflatoxin culture material (760 ppm AFB1). Finally, Group IV comprised of albino mice fed with basal diet supplemented with 1.0 ppm AFB1 and 0.5% TMP that supplied 74 mg/kg of the

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Publication Date
Thu Aug 07 2025
Journal Name
Journal Of Baghdad College Of Dentistry
Effects of time delay and tension system application after final flask closure on the vertical displacement of acrylic and porcelain teeth in maxillary complete dentures
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Background: The displacement of artificial teeth during complete denture construction presents major processing errors in the occlusal vertical dimension which were verified at the previous trial denture stage. The aim of this study was to assess the effect of delay in processing after final flask closure and tension application on the vertical acrylic and porcelain teeth displacement of complete dentures constructed from heat cured acrylic and the results were compared with the conventional processing method. Materials and methods: forty samples of identical maxillary complete dentures were constructed from heat polymerized acrylic resin. These samples were subdivided into the following experimental subgroups in which each subgroup contai

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Publication Date
Tue Dec 15 2020
Journal Name
Journal Of Baghdad College Of Dentistry
Impact of two non-nutritive sucking patterns on the development of anterior open bite in children of two kindergartens in Baghdad city
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Background: Non-nutritive sucking habit (NNSH) is the main environmental causative factor that disturbs normal orofacial development. In spite of the harmful effect of pacifier as a NNSH, mothers aware from the other types of NNSH like thumb sucking far more than pacifier use. Open bite is one of the most challenging malocclusions in orthodontics due to the high prevalence of relapse after treatment, so preventing the causative factor of its occurrence is essential at early age of child life. This study aims to assess the impact of two non-nutritive patterns on the development of anterior open bite in primary dentition and to compare which of these habits mostly affect open bite development. Materials and Methods: The sample consisted of

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Publication Date
Thu Jun 30 2011
Journal Name
Iraqi Journal Of Chemical And Petroleum Engineering
A PARTICULAR SOLUTION OF THE TWO AND THREE DIMENSIONAL TRANSIENT DIFFUSION EQUATIONS
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A particular solution of the two and three dimensional unsteady state thermal or mass diffusion equation is obtained by introducing a combination of variables of the form,
η = (x+y) / √ct , and η = (x+y+z) / √ct, for two and three dimensional equations
respectively. And the corresponding solutions are,
θ (t,x,y) = θ0 erfc (x+y)/√8ct and θ( t,x,y,z) =θ0 erfc (x+y+z/√12ct)

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Publication Date
Sun Dec 07 2014
Journal Name
Baghdad Science Journal
Baysian and NonBaysian Methods to Estimate the two parameters of Logistic Distribution
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In this paper ,the problem of point estimation for the two parameters of logistic distribution has been investigated using simulation technique. The rank sampling set estimator method which is one of the Non_Baysian procedure and Lindley approximation estimator method which is one of the Baysian method were used to estimate the parameters of logistic distribution. Comparing between these two mentioned methods by employing mean square error measure and mean absolute percentage error measure .At last simulation technique used to generate many number of samples sizes to compare between these methods.

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Publication Date
Sun Apr 07 2013
Journal Name
Journal Of Educational And Psychological Researches
Two Types of Personality and Achievement Motivation among University Teaching Staff Members
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    Research aimed to:1- Be acquainted to the two types of personality A,B with the members of the teaching staff of Anbar university 2- The level of the motivational achievement among the teaching staff  3- The level of motivational achievement  of the teaching staff  of( A,B). 4- Differences of the abstract implications of A,B type  5- The relationship between A and B and the motivational achievement.

  Research Tools: the researchers  followed  measure  A, B type of  Howard Glaser  1978,and   measure  of Achievement Motivation for Mansoorm1986.

   The Result showed: 1. A tendency of the t

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Publication Date
Fri Oct 02 2020
Journal Name
International Journal Of Pharmaceutical Research
A turbidimetric method for the quantitative determination of cyproheptadine hydrochloride in tablets using an optoelectronic detector based on the LEDs array
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