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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
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
Sun Jan 01 2023
Journal Name
Dental Hypotheses
Assessment of Salivary Levels of the RANKL and RANK in Patients with Healthy Gingiva on Reduced Periodontium Versus Periodontitis: An Analytical Cross-Sectional Study
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Publication Date
Fri Dec 15 2017
Journal Name
Journal Of Baghdad College Of Dentistry
Comparison of periodontal health status in relation to IQ in right- and left handed individuals
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Background: Periodontal disease (PD) is a chronic inflammatory condition characterized by destruction of supporting structures of the teeth. Intelligence quotient (IQ) was potentially reported to significantly associated with prevalence of gingivitis. Mild gingivitis was obtained in high IQ levels while moderate gingivitis may be attributed to poor oral hygiene seen among the subjects having low IQ levels. Method: One hundred volunteers aged between 20-45 years old were enrolled in this study, patients were equally divided into right- and left-handed (50 patients each)and each group then subdivided into patients with healthy gingiva(10), patients with gingivitis (20), and patients suffering from periodontitis (20).An IQ questionnaire was p

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Publication Date
Mon Apr 23 2018
Journal Name
Ibn Al-haitham Journal For Pure And Applied Sciences
Comparison Between Procalcitonin and Traditional Blood Biomarkers in Diagnosis of Sepsis in Iraqi Wounded Soldiers
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      Early diagnosis of sepsis is a very critical matter especially for soldiers in battle field; on the other hand, Procalcitonin is a new promising biomarker for fast and accurate diagnosis of sepsis. The aim of this study is to investigate the ability of Procalcitonin (PCT) to indicate sepsis earlier than blood culture and other traditional biomarkers and then get use of this in early diagnosis of sepsis.Procalcitonin concentration was measured in 44 sera of Iraqi wounded soldiers who were admitted to GHAZI AL-HARIRI Hospital for surgery, using ELISA kit of BioRay/USA, along with blood culture and other infection biomarker like C-reactive protein, ESR, W.B.C. count. Six patients had elevated PCT and 3 of them

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Publication Date
Sun Sep 01 2013
Journal Name
Journal Of Economics And Administrative Sciences
The Economic Conditions of Living in the City of Mosul: Income and Labor Market during the Period 2004-2007
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Abstract

 

This study cares for the economic living conditions in Mosul City. Its importance lies in the critical period that has been covered
(2002-2007), which was dominated by far–reaching events at political economic and social levels.
Among the main results that have been revealed are the following: the rate of economic growth in the City has been the lowest among major urban centers in Iraq. Besides, real income per capita in the City has stayed stagnant during the period of the study. However, the inequality in distribution of income has decreased. The main bulk of the city's population rely on their income from wages and salari

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Publication Date
Sun Jan 01 2023
Journal Name
Sport Tk - Revista Euro Americana De Ciencias Del Deporte
Analysis of the amount of lost fluids, some blood components and mineral salts in volleyball under hot weather conditions
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Publication Date
Tue Jul 11 2023
Journal Name
Sport Tk-revista Euroamericana De Ciencias Del Deporte
Analysis of the amount of lost fluids, some blood components and mineral salts in volleyball under hot weather conditions
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The research objective was to study the amount of lost fluids, some blood components and mineral salts in volleyball players under hot weather conditions. The sample of the present study was composed of 12 volleyball players of Al-Sinaa Club (Baghdad, Iraq) in the 2022/2023 season. The variables analyzed in this study were: Heart rate before and after exercise, internal and external body temperature before and after exertion, potassium ion, sodium ion, calcium ion, and the amount of fluid lost (the player's weight) before and after the exercise. The tests were conducted at a temperature between 42-47 degrees Celsius. The maximum anaerobic exercise was performed with volleyball. The results showed that to play volleybal

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Publication Date
Tue Jul 11 2023
Journal Name
Sport Tk-revista Euroamericana De Ciencias Del Deporte
Analysis of the amount of lost fluids, some blood components and mineral salts in volleyball under hot weather conditions
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The research objective was to study the amount of lost fluids, some blood components and mineral salts in volleyball players under hot weather conditions. The sample of the present study was composed of 12 volleyball players of Al-Sinaa Club (Baghdad, Iraq) in the 2022/2023 season. The variables analyzed in this study were: Heart rate before and after exercise, internal and external body temperature before and after exertion, potassium ion, sodium ion, calcium ion, and the amount of fluid lost (the player's weight) before and after the exercise. The tests were conducted at a temperature between 42-47 degrees Celsius. The maximum anaerobic exercise was performed with volleyball. The results showed that to play volleybal

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Publication Date
Sun Dec 02 2012
Journal Name
Baghdad Science Journal
The Dissolution Study For Sodium Selenite Tablets Using Atomic Absorption Spectrophotometer
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The development of a meaningful dissolution procedure for drug products with limited water solubility has been a challenge to both the pharmaceutical industry and the agencies that regulate them. Natural surfactants aid in the dissolution and subsequent absorption of drugs with limited aqueous solubility. In vitro, various techniques have been used to achieve adequate dissolution of the sparingly water – soluble or water insoluble drug products such as the use of mechanical methods (i.e., increased agitation and the disintegration method) or hydro alcoholic medium or large volumes of medium. The necessity of assuring the quality of drugs , especially those with low aqueous solubility and in vivo absorption , has led to the development and

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Publication Date
Tue Feb 01 2022
Journal Name
Baghdad Science Journal
Flow Injection Analysis with Turbidity Detection for the Quantitative Determination of Mebeverine Hydrochloride in Pharmaceutical Formulations
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The main objective of this paper is to develop and validate flow injection method, a precise, accurate, simple, economic, low cost and specific turbidimetric method for the quantitative determination of mebeverine hydrochloride (MbH) in pharmaceutical preparations.  A homemade NAG Dual & Solo (0-180º) analyser which contains two identical detections units (cell 1 and 2) was applied for turbidity measurements. The developed method was optimized for different chemical and physical parameters such as perception reagent concentrations, aqueous salts solutions, flow rate, the intensity of the sources light, sample volume, mixing coil and purge time. The correlation coefficients (r) of the developed method were 0.9980 and 0.9986 for cell

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