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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Apr 01 2023
Journal Name
Iop Conference Series: Earth And Environmental Science
Effect of Blue and Red LED Light and some Plant Extract on Lettuce Growth and Yield in NFT Technique
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Abstract<p>This experiment was carried out in the College of Agricultural Engineering Sciences, Univ. of Baghdad, during autumn 2021 growing season to investigate possibility study of increase lettuce antioxidant and biological yield, growing and producing lettuce hydroponically under film technique (NFT) using a globally approved standard solution (Cooper solution), Nested design with three replications adopted in the experiment, each of them included in main plot the first factor, which is LED light (B and R), Then levels of second factor were randomly distributed within each replicate, which included spraying with organic nutrients which was Cymbopogon citratus and Hibiscus sabdariffa at two </p> ... Show More
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Publication Date
Fri Mar 01 2024
Journal Name
Results In Engineering
Experimental and analytical study of the energy and exergy performance for different evaporative pads in hot and dry climate
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In this work, effects of using different evaporative cooling pads (ECPs) on the energetic and exergetic efficiency of a direct evaporative air cooler (DEAC) have been theoretically and experimentally investigated. Three types of ECPs were used, i.e., honeycomb cellulose cooler pad (HCCP), shading-cloth cooler pad (SCCP), and aspen wood wool cooler pad (AWWCP). For SCCP and AWWCP, a 3-cm pad thickness was used, while for the HCCP, three different values of pad thickness were used, i.e., 3, 5, and 7 cm. Tests were carried out using air velocities of 8, 14, and 19 m/s, measured at the DEAC outlet. Engineering equation solver (EES) used for performing the required calculations of the various parameters affecting the thermal performance of the D

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Publication Date
Fri Apr 22 2022
Journal Name
Neuroquantology
Effect of Using Avocado and Chia Oil and their Mixture in Meat Broiler Diets on Some Physiological and Microbial Characteristics of Blood Plasma
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This study was conducted in the field of the Poultry Research Station of the Department of Animal Production / Department of Agricultural Research / Ministry of Agriculture for the period 4/4/2021 to 16/5/2021, in which 300 one-day-old Ross308 chicks that fed on diets used avocado oil and Chia with percentages 0, 0.2, 0.4, 0.6% respectively, and their mixture consisting of 0.0, 0.1, 0.2, 0.3 each of avocado and Chia oil (50% avocado + 50% Chia oil). The experiment included 4 treatments with 3 replicates for each treatment (10 birds/replicates), in order to study the effect of using avocado and chia oil and their mixture in meat broiler diets on some physiological and microbial characteristics of blood plasma. The results indicate a

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Publication Date
Tue Sep 06 2016
Journal Name
Al-qadisiyah Journal For Administrative And Economic Sciences
Awareness of the regulatory and administrative leadership and its role in achieving the effectiveness of the internal control system and achieve fair accountability
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The research aims to achieve a set of the most important objectives of the review of the role of creative administrative leadership in achieving aspects of economic reform in various government institutions and indicate the role of supervisory awareness of administrative leadership in the revitalization of the role of the internal control system to achieve the best use of available resources. This paper deals with three problems is the loss of financial resources of the state as a result of the growing phenomenon of administrative and financial corruption in the majority of government institutions, and the weakness of the role of the internal control system in the province on the resources available and to achieve the best use of these reso

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Publication Date
Mon Nov 01 2021
Journal Name
Iop Conference Series: Earth And Environmental Science
Study of Seed Soaking and Foliar Application of Ascorbic Acid, Citric Acid and Humic Acid on Growth, Yield and Active Components In Maize
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Foliar application and seed soaking has been used as a means of supplying supplemental doses of nutrients, plant hormones, stimulants, and organic components. the effects of these applications have included yield increases, and improved drought tolerance, and enhanced crop quality, so A field experiment was carried out during spring seasons in 2019 and 2020 for styding Seed soaking and Foliar Application of Ascorbic acid, Citric acid and Humic acid on Growth, Yield and Active Components IN Maize. Randomized complete block design in split plots arrangement was used with three replicates. Main-plots were for seeds soaking with ascorbic, citric (100 mg l-1) frequently and humic at (1 ml l-1). Sub-plots were for vegetative parts nutrition with

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Publication Date
Tue Jan 27 2026
Journal Name
Journal Of Baghdad College Of Dentistry
Oral signs and symptoms and hyperglycemic status of type II diabetic patients in relation to cytomorphometric findings of gingival and buccal cytobrush smears
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Background: Brush cytology is an accepted technique that gets renewed interest. It is now used as an aid for the diagnosis and observation of possible epithelial changes that could be associated with oral mucosal diseases. This study aimed to evaluate the cytomorphometric changes in gingiva and buccal mucosa of type II diabetics and to assess their relation to oral symptoms and glycemic status. Materials and methods: Cytological Papanicolaou stained smear were prepared from cheek and gingiva of 20 non treated cases, 20 treated diabetics and 20 healthy persons of both sex after measuring their HbA1c and recording their oral symptoms. Hundred unfolded epithelial cells were evaluated qualitatively using MCID software to measure nuclear and cy

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Publication Date
Wed Dec 30 2020
Journal Name
Modern Sport
An analytical study of the vitality of the conscience of the senior leaderships in the boards of colleges and departments of physical education and sports science in Baghdad
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The problem of research lies in answering some of the question: What is the reality of (vital conscience) in some colleges and departments of physical education and sports science in Baghdad from the viewpoint of the teachers? And The aim of the research is to prepare a scale (the vitality of the conscience) and learn about its reality in colleges and departments of physical education and sports science in Baghdad from the viewpoint of teachers and The researcher relied on the descriptive method in the survey method and the relationships related to the nature of the research problem and The sample of the research was senior administrators teaching some colleges and departments of physical education and sports science in Baghdad , Th

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Publication Date
Fri Dec 15 2023
Journal Name
Al-academy
The use of metal in ancient Syria in the manufacture of jewelry (ornamental tools in the third and second millennium BC and the molds used in their manufacture)
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 This research sheds light on the use of metal in the manufacture of jewelry, which is represented by ornamental tools in the period between the third and second millennium BC, in addition to the most important molds used in their manufacture. Man has been interested in metals since early ages, and was able to make tools that he uses in his daily life, especially jewelry. And the Syrian people got acquainted with the types of minerals, their characteristics, and how to deal with them. Minerals played an effective and prominent role in the economy of ancient Syria. Trade with those countries and secure their roads.

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Publication Date
Tue Dec 01 2020
Journal Name
Baghdad Science Journal
Seasonal variation and correlation between the physical, chemical and microbiological parameters of Nile water in selected area in Egypt (Case study): physical, chemical and microbiological parameters of Nile water
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Fresh water resources in terms of water quality is a crucial issue worldwide. In Egypt, the Nile River is the main source of fresh water in the country and monitoring its water quality is a major task on governments and research levels. In the present case study, the physical, chemical and algal distribution in Nile River was monitored over two seasons (winter and summer) in 2019. The aims of the study were to check the seasonal variation among the different water parameters and also to check the correlations between those parameters. Water samples were collected from the Nile in Cairo governorate in EGYPT. The different physiochemical and microbiological properties in water samples were assessed. The studied parameters were included: te

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Publication Date
Sat Dec 01 2018
Journal Name
Journal Of Accounting And Financial Studies ( Jafs )
Information and communication technology and its impact on the quality of service of the tourism sector and hotel: An analytical study in selected hotels in the Iraqi capital Baghdad
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   The research statement to the amount of the contribution of information and communication technology in the quality of tourism and hotel services, and determine the relationship between the impact of information and communication and the quality of tourism services technology, The importance of the research is to establish the philosophical thinking of the nature of variables, as a modern administrative terminology and employ them towards the quality of tourism and hotel services, the research dealt with a problem expressed by a number of intellectual and practical questions, Was formulated based on the current situation witnessed by the tourism sector and hotel in Iraq, and the real gap was the lack of awareness of the impo

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