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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Jun 01 2014
Journal Name
Baghdad Science Journal
A study of the physical and chemical characteristics of the waters of the central marshes in southern Iraq after restoration
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some ecological (physical and chemical varible) of water samples were studies monthly from December 2008 to May 2009 at two stations( St.1) Al - Chibayesh marsh and (St.2) Abu – Zirik marsh which are located in the south of Iraq . These variables included : Temperature, pH, EC, Dissolved oxygen , Total alkalinity, Nitrate, Sulphate, and phosphate, Si-SiO2 and Ca ,Mg, Cl, The marsh Considered as fresh water and alkaline. Abu-Zirik less than Al-Chibayesh.

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Publication Date
Mon Oct 01 2018
Journal Name
Journal Of Educational And Psychological Researches
The Effectiveness of Two Educational Models in Acquiring Historical Concepts and Orientation of Fourth Grade Students in History
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The study focuses on Kamez model and the Claus Meyer model of instructional design, which are models that provide the learner with educational experiences to suit the logical information of the learner and the variety of instructional models. Research Objective: The present research aims to identify Limitations of the study. The current research is determined by ((fourth grade preparatory students, the book of the date of the fourth preparatory course)) Chapter II includes Arabic and foreign studies on the model of Kemp and Claus Mayer in the acquisition of concepts and direction towards the material. Chapter III Experimental Design: The researcher adopted an experimental design with two experimental groups and a control group. The resea

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Publication Date
Sat Jun 30 2007
Journal Name
Iraqi Journal Of Chemical And Petroleum Engineering
Rise Velocity and Drag Coefficient of Collapsing Two-Phase Bubble Condensing in an Immiscible Liquid
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Collapse of the vapor  bubble condensing  in an immiscible  is investigated for  n-pentane and n-hexane vapors condensing in cold water and n-pentane in two different compositions of glycerin- water mixture. The rise velocity and the drag coefficient of the two-phase bubble are measured.

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Publication Date
Wed Oct 16 2013
Journal Name
International Journal Of Pharmacy And Pharmaceutical Sciences
Effects of mucoadhesive polymers combination on the properties of lisinpril buccal tablets prepared by wet granulation method
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Publication Date
Fri Mar 31 2017
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
The Effect of some Variables on the Formulation of Captopril as Tablets Shaymaa Nazar Al – Sammarrai
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Captopril is an angiotensin converting enzyme inhibitor (ACEI) used to treat hypertension,
congestive heart failure, and myocardial infraction.
The only dosage form available for captopril is the plain tablet in strength of 12.5,25,50 and 100mg
tablet.
This investigation is concerned with factors affecting the formulation of captopril as a plain
tablet dosage form of 50mg. Many trials were made to prepare satisfactory tablets for the drug by
using wet – granulation methods with various additives. It was found that poly vinyl pyrrolidone
(P.V.P.) as binder gave the most satisfactory tablets. At the same time a shorter disintegrantion time
and slower dissolution rate were obtained with the addition of starch

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Publication Date
Sun Sep 07 2008
Journal Name
Baghdad Science Journal
Mutagenic Effect of Crucifers Lepidium sativum and Eruca sativa in Comparison to Carrot Daucus carota
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The mutagenic effect of some crucifers widely consumed Lepiduim sativum (Garden cress) and Arugula (Eruca sativa) was studied in comparison to carrot (Daucus carota), using bacterial mutagenic system composed of three bacterial isolates; (Bacillus spp)G3 (Arthrobacter spp)G12, and (Brevibacterium spp)G27 ,. Treatment of isolates with plant extracts led to reduction in survival fraction (Sx)at different levels except that Aurgula extract did not show any inhibitory effect in isolates G12 and G27. Crucifers extracts induced streptomycin resistant mutants in G12 at higher level than G3 , but not in G27. No resistance to rifimpacin was detected in all isolates.

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Publication Date
Fri Feb 01 2019
Journal Name
Journal Of Economics And Administrative Sciences
Comparison of classical method and optimization methods for estimating parameters in nonlinear ordinary differential equation
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 ABSTRICT:

  This study is concerned with the estimation of constant  and time-varying parameters in non-linear ordinary differential equations, which do not have analytical solutions. The estimation is done in a multi-stage method where constant and time-varying parameters are estimated in a straight sequential way from several stages. In the first stage, the model of the differential equations is converted to a regression model that includes the state variables with their derivatives and then the estimation of the state variables and their derivatives in a penalized splines method and compensating the estimations in the regression model. In the second stage, the pseudo- least squares method was used to es

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Publication Date
Thu Nov 13 2025
Journal Name
Journal Of Baghdad College Of Dentistry
The surface roughness of new fluoride releasing material after using three polishing protocols and storage in artificial saliva
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Background: Prophylaxis methods are used to mechanically remove plaque and stain from tooth surfaces; such methods give rise to loss of superficial structure and roughen the surface of composites as a result of their abrasive action. This study was done to assess the effect of three polishing systems on surface texture of new anterior composites after storage in artificial saliva. Materials and methods: A total of 40 Giomer and Tetric®N-Ceram composite discs of 12 mm internal diameter and 3mm height were prepared using a specially designed cylindrical mold and were stored in artificial saliva for one month and then samples were divided into four groups according to surface treatment: Group A (control group):10 specimens received no surfa

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Publication Date
Mon Aug 26 2024
Journal Name
Jbpml
Studying The Changes in Motility and Morphology on Human sperm after exposure to low doses of x-rays
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the energy that a radiation source emits as light (photons), electromagnetic waves, or particles is known as radiation. X-ray is one type of ionizing radiation that falls within the electromagnetic wave category of short wavelengths. Because of their short wavelength. X-ray is a type of ionizing radiation that is used in a constantly growing number of diagnostic procedures. X-ray diagnostic imaging has been employed in the medical field for more than a century(Hariyoto et al., 2020). Radiation has advantages for human health, but there is also a risk. the impacts of Radiation on Fertility it is an oligospermia, or a reduction in the number of sperm cells, which is already possible after radiation exposure of 0.15 mGy. It Leads to impede

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Publication Date
Thu Apr 18 2019
Journal Name
Al-kindy College Medical Journal
Comparative study of anterior knee pain after patelloplasty with and without circumferential denervation in a total knee arthroplasty
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Background: The anterior knee pain is an important chief complaint of the patients with knee osteoarthritis due to patellofemoral pathology. The pain receptors denervation can be achieved by circumferential denervation of the patellar area by a process of electrocautery.

Objectives: The aim of current study is to assess the pain after total knee arthroplasty (TKA) by patelloplastywith and without circumferential denervation via electrocautery at a minimum follow up with 1 year separately for each patient.

Type of the study:Cross- sectional study.

Methods: Thirty five patients,with mean age of about (62.8) years, were enrolled in this pros

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