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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Aug 01 2020
Journal Name
Heat Transfer
A parametric study of a photovoltaic panel with cylindrical fins under still and moving air conditions in Iraq
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Publication Date
Fri Oct 20 2023
Journal Name
Bmc Endocrine Disorders
Dietary caffeine intake is associated with favorable metabolic profile among apparently healthy overweight and obese individuals
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Abstract<sec> <title>Background

Recent studies have revealed some conflicting results about the health effects of caffeine. These studies are inconsistent in terms of design and population and source of consumed caffeine. In the current study, we aimed to evaluate the possible health effects of dietary caffeine intake among overweight and obese individuals.

Methods

In this cross-sectional study, 488 apparently healthy individuals with overweight and obesity were participated. Dietary intake was assessed by a Food Frequency Questionnaire (FFQ) and

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Publication Date
Sat Mar 30 2002
Journal Name
Iraqi Journal Of Chemical And Petroleum Engineering
Potential and Current Distribution in Flow Through Porous Electrochemical Reactor Working under Limiting Current Conditions
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Publication Date
Sat Mar 25 2023
Journal Name
International Journal Of Drug Delivery Technology
Improvement of Entrapment and Ocular Permeability of Ganciclovir Nanostructured Lipid Carriers Using Various Conditions of Preparations
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Ganciclovir (GCV) is a drug included in BCS-Class III, having high solubility and low permeability. It is a synthetic acyclic nucleoside analog of 2′-deoxyguanosine, considered a potent inhibitor of herpes viruses and cytomegalovirus (CMV) infection. Herpes simplex virus (HSV) infections are very common and are also considered a major cause of corneal blindness. This study intended to advance a pioneering nanostructured lipid carriers (NLCs) system for improving the ocular permeability of GCV. Several procedures were used for the preparation. Cold homogenization, solvent injection, and emulsifi cationultrasonication methods. A mixture of palmitic acid (PA) and oleic acid (OA) as a lipid matrix, cremophore EL, and transcutol HP wer

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Publication Date
Sun Jun 03 2012
Journal Name
Al-kindy College Medical Journal
Ultrasound of the Rotator Cuff: A Comparison of Ultrasonographic and Physical Examination Finding in SeventyCases
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Background : Shoulder pain is a common problem that can pose difficult diagnostic and therapeutic challenges for the family physician It is the third most common musculoskeletal complaint in the general population, and account for 5% of all general practitioners musculoskeletal consults Objective: To determine the diagnostic performance of ultrasonography compared with the physical examination for detection of rotator cuff tears in painful shoulder syndrome. Method: Prospective study was done on seventy patients (48 male, 22 female), age ranged between 30-70 years (mean age 50 years), From February 2007 to July 2011, were subjected to comparative study in Al-Kindy teaching hospital with rotator cuff tears, including physical and ultrasonogr

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Publication Date
Sun Aug 30 2020
Journal Name
Journal Of Economics And Administrative Sciences
Assessing the Iraqi general budget in light of corruption and fluctuations in oil prices, and their repercussions on unemployment rates after 2003
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The researcher highlighted the general budget in Iraq for the period (2003-2018) facing the challenges of administrative and financial corruption, in addition to the fluctuations in oil prices, the repercussions and many problems suffered and will suffer the Iraqi government in the process of preparing the general budget of the state and weak contribution of the agricultural and industrial sectors and other economic sectors and neglect altogether, oil has become the main supplier in funding Iraq's budget after 2003, and the impact on the unemployment rates in Iraq, which recorded fluctuating rates and then increased during the period (2012-2018) to achieve this, an inductive method was adopted, using theoretical and descriptive a

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Publication Date
Wed Apr 01 2015
Journal Name
Al–bahith Al–a'alami
Methods of US propaganda in Iraq- A Study of Coalition Provisional Authority and US Army Data after 2003
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with an organized propaganda campaign. This military campaign was helped to formulate its speech by many institutions, research centers, and knowledge and intelligence circles in order to mobilize public opinion gain supporters and face the opponents by different means depending on a variety of styles to achieve its required effects. 
          After the US occupation of Iraq, US media fighters sought to influence the Iraqi public opinion and making them convinced them of the important presence of US military forces in Iraq which necessitated finding its justification through the use of persuasive techniques in its intensive propaganda campaigns. 
  This research discusses the most important

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Publication Date
Wed Jul 01 2015
Journal Name
Al–bahith Al–a'alami
Photos of Women in Iraqi Feature Films after 2003
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The research seeks to examine the image of women in Iraqi films produced after 2003 over the answer to questions such as “ level of the representation of women and appearing in films and features that are attributable to them and their relationships with men and their interests and tendencies , activities and ways and methods pursued to achieve their goals , or what appeared to be trying to achieve and whether made movies vivid and varied models for women, or confined to a rigid model and duplicate Is films raised issues concerning women? The research seeks to examine the image of women in Iraqi films produced after 2003 over the answer to questions such as “ level of the representation of women and appearing in films and features th

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Publication Date
Sat Jan 01 2022
Journal Name
Chemical Methodologies
Determination of the Quantity of Losartan Active Ingredient in the Medication Formulations via Turbidimetric-Flow Injection Technique
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Publication Date
Thu Jan 30 2025
Journal Name
Iraqi Journal Of Science
Development of A New Colorimetric-Flow System Approach for The Determination of Cefotaxime Sodium in Pharmaceutical Formulations
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     A new colorimetric-flow injection method has been developed and validated for the detection of Cefotaxime sodium in pharmaceutical formulations. This method stands out for its rapid and sensitive nature. The formation of a brown-colored complex between Cefotaxime sodium and the Biuret reagent in a highly alkaline environment serves as the basis for the detection. The intensity of this colored complex is measured using a custom-built Continuous Flow Injection Analyzer, enabling accurate quantification of Cefotaxime sodium. Optimization studies of the chemical and physical parameters such as dilution of Biuret reagent, effect of the medium basicity, flow rate, sample loop and others have been investigated. The calibration gra

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