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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Jun 07 2023
Journal Name
Journal Of Educational And Psychological Researches
The Difficulties Facing the Schools of Challenge and Resilience and their Relationship to Motivation towards School Work for Its Workers in Hebron Governorate
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The current study aims to examine the level of problems faced by university students in distance learning, in addition to identify the differences in these problems in terms of the availability of internet services, gender, college, GPA, interactions, academic cohort, and family economic status. The study sample consisted of (3172) students (57.3% females). The researchers developed a questionnaire with (32) items to measure distance learning problems in four areas: Psychological (9 items), academic (10 items), technological (7 items), and study environment (6 items). The responses are scored on a (5) point Likert Scale ranging from 1 (strongly disagree) to 5 (strongly agree). Means, standard deviations, and Multivariate Analysis of Vari

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Publication Date
Fri Dec 05 2025
Journal Name
مجلة اللغة الروسية في الخارج
Types of Comparisons and Their Use in Russian and Arabic: A Comparative Analysis-انواع التشبيه وطرق استخدامه في اللغتين الروسية والعربية :تحليل مقارن
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The article provides a comparative analysis of comparisons in Russian and Arabic, aimed at identifying their structural, typological, and functional-pragmatic features. The study is based on a systematic approach to the analysis of linguistic means of expressing comparisons in two differ- ent linguistic cultures. The article analyzes the main structural components of comparisons, their classification, and their cognitive and aesthetic functions. The results of the study demonstrate the deep cultural conditioning of comparative constructions and their important role in representing the specific features of the respective linguistic cultures.

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Publication Date
Fri Jun 30 2023
Journal Name
The International Tinnitus Journal
Adenoidectomy and Endoscopic Myringotomy with and without ventilation tube insertion for Treatment of Otitis Media with Effusion in 6-12 years old Children
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Publication Date
Fri May 01 2015
Journal Name
Journal Of Engineering
Numerical Analysis of Fluid Flow and Heat Transfer by Forced Convection in Channel with one-sided Semicircular Sections and Filled with Porous Media
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This research presents a numerical study to simulate the heat transfer by forced convection as a result of fluid flow inside channel’s with one-sided semicircular sections and fully filled with porous media. The study assumes that the fluid were Laminar , Steady , Incompressible and inlet Temperature was less than Isotherm temperature of a Semicircular sections .Finite difference techniques were used to present the governing equations (Momentum, Energy and Continuity). Elliptical Grid is Generated using Poisson’s equations . The Algebraic equations were solved numerically by using (LSOR (.This research studied the effect of changing the channel shapes on fluid flow and heat transfer  in two cases ,the first: cha

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Publication Date
Fri Jan 01 2021
Journal Name
Artificial Intelligence For Covid-19
An Efficient Mixture of Deep and Machine Learning Models for COVID-19 and Tuberculosis Detection Using X-Ray Images in Resource Limited Settings
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Publication Date
Tue Dec 01 2009
Journal Name
Journal Of Economics And Administrative Sciences
Evaluation of the efficiency and effectiveness of the accounting system of the Department of Missions and Cultural Relations (*) at the Office of the Ministry of Higher Education and Scientific Research
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The evaluation and efficiency and effectiveness of account system for the department of delegation and cultural Relationships in the center of ministry of higher Education and Scientific research Considered as a very important and active subjects in the modification of accounting system in this department and to develop it and make it able to make available important and accurate information for the planning requirements and monetary and evaluation performance and to make decisions, besides to develop the performance of Iraqi Cultural departments working abroad and to render its role effective to serve the students of higher education in the progressive Countries to facility its growing in scientific and professional and technica

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Publication Date
Wed Mar 22 2017
Journal Name
Iraqi Journal Of Market Research And Consumer Protection
STRATEGIC DECISION MAKING APPROACHES AND ITS INFLUENCE AT EFFICIENCY OF SERIVICE MARKETING: AN APPLIED STUDY IN GENERAL DIRECTORATE OF TRAFFIC.: STRATEGIC DECISION MAKING APPROACHES AND ITS INFLUENCE AT EFFICIENCY OF SERIVICE MARKETING: AN APPLIED STUDY IN GENERAL DIRECTORATE OF TRAFFIC.
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Strategic decision making is considered one of the important processes for senior management in contemporary business organizations and service organizations due to the properties of the service such as intangibility, concomitance and mortality. Decision-making has three approaches according to the opinions of most of the writers and researchers in the administrative area: an analytical approach, intuitive approach and behavioral approach. This research is trying to discover the nature of the relationship in terms of the link between the impact of each of these approaches and efficiency of marketing services by selecting an intentional sample of 58 researches from the Directorate General of Traffic, one of the Iraqi Interior Ministry ins

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Publication Date
Fri Aug 02 2024
Journal Name
Farmacia
SOLUPLUS AND SOLUTOL HS-15 OLMESARTAN MEDOXOMIL NANOMICELLE BASED ORAL FAST DISSOLVING FILM: IN VITRO AND IN VIVO CHARACTERIZATION
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Olmesartan medoxomil (OM) has low bioavailability and limited solubility. To enhance bioavailability, fast dissolving films (FDF) with mixed micelles of soluplus (SPL) and solutol HS15 (STL H15) were developed using solvent casting. The optimised formula, FM2, used polyvinyl alcohol (PVA) and showed high entrapment efficiency, rapid disintegration, and significant improvement in OM bioavailability compared to the market tablet (Olmetec®). FM2 also demonstrated stability and potential for enhanced drug delivery.

Publication Date
Sat Dec 01 2018
Journal Name
Political Sciences Journal
A study in Tunisian - Iraqi Relations and its role in determining strategies for dealing with conflict and peace situations
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If the State attaches great importance to its foreign relations and intends to strengthen them in order to ensure the achievement of the highest national goals and interests. External relations between countries are one of the most prominent features of foreign policy, which depends on a combination of internal and external factors, the modern relations between Tunisia and Tunisia, which goes back to the pre-independence of Tunisia, when Iraq was a supporter of Tunisia's independence from France in the 1940s, Although these relations did not cause any disturbance by the two countries, but they remained weak relations did not develop in all areas except the sports and cultural field, which we will determine the reasons and the pos

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Publication Date
Fri May 10 2019
Journal Name
International Journal Of Research In Pharmaceutical Sciences
Interleukin-1β, interleukin-6 and tumour necrosis factor-alpha levels in blood and saliva in hypothyroidism accompanied with periodontitis
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Relationship between thyroid dysfunction and periodontal disease has been mediated through an immune response. Cytokines are implicated in the initiation, consequences of immune response and a crucial role in the pathogenesis of thyroid disease, directly target thyroid follicular cells; and in the development and progression of periodontitis. This study aimed to detect cytokines levels which known to be associated with periodontitis in serum and saliva, to test the hypothesis that hypothyroidism influences the levels of biomarkers of periodontitis. Samples were collected from sixty patients with hypothyroid age ranged (20-64) years, thirty of patients were without periodontitis (group I) and 30 with periodontal disease (II); moreover, 30 su

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