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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Jun 01 2019
Journal Name
Journal Of Accounting And Financial Studies ( Jafs )
Investigate the effectiveness of investment in the electricity sector And its role in achieving sustainable development
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The provision of electric power is necessary for the advancement of the country's economy. It is the main engine of the economy and its various activities. It is an indicator of social welfare and it is considered as the basic pillars for achieving sustainable development (economic, social, environmental and institutional) by raising the levels of performance and meeting local needs. The problem of research was the absence of a program to audit the performance of the electricity sector contributes to ensure the application of sustainable development. The research was based on the hypothesis that the preparation of a proposed program to audit the performance of the electricity sector contributes to the achievement of The researchers sough

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Publication Date
Wed May 10 2023
Journal Name
Journal Of Planner And Development
Relationship of LST, NDVI, and NDBI using Landsat-8 data in Duhok city in 2019-2022
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One of the most significant elements influencing weather, climate, and the environment is vegetation cover. Normalized Difference Vegetation Index (NDVI) and Normalized Difference Built-up Index (NDBI) over the years 2019–2022 were estimated based on four Landsat 8 TIRS’s images covering Duhok City. Using the radiative transfer model, the city's land surface temperature (LST) during the next four years was calculated. The aim of this study is to compute the temperature at the land's surface (LST) from the years 2019-2022 and understand the link, between LST, NDVI, and NDBI and the capability for mapping by LANDSAT-8 TIRS's. The findings revealed that the NDBI and the NDVI had the strongest correlation with the

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Publication Date
Sun Jun 30 2019
Journal Name
Iraqi Journal Of Chemical And Petroleum Engineering
Effect of Microwave Treatment in Graphite Anode for Microbial Fuel Cell and Its Application in Biosensor
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The electrode in the microbial fuel cell has a significant effect on cell performance. The treatment of the electrode is a crucial step to make the electrode surface more habitable for bacteria growth, thus, increases the power production as well as waste treatment. In the current study, two graphite electrodes were treated by a microwave. The first electrode was treated with 100W microwave energy, while the second one was treated with 600W microwave energy. There is a significant enhancement in the surface of the graphite anode after the pretreatment process. The results show an increase in the power density from 10 mW/m2 to 15 mW/m2 with 100w treatment and to 13.47 mW/m2 with 600w treatment. An organic

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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)
Effects of Allopurinol on Ketone Body Metabolism and Tissue Lipid Peroxidation in Alloxan Diabetes in Rats
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The aim of the present study is to investigate whether or not xanthine oxidase (XO)–derived reactive oxygen species (ROS) may play a role in the pathogenesis of alloxan (ALX)–induced diabetes in rats using the specific XO inhibitor and hydroxyl radical scavenger, allopurinol

The involvement of oxidative stress in ALX – diabetes was assessed by the measurement of plasma and various tissues lipid peroxides levels ( using thiobarbituric acid ( TBA ) reactive substances ). Furthermore, the ability of allopurinol to influence these and other biochemical parameters, including plasma and urine ketones levels were also investigated in diabetic rats.

Rats were divided into four groups: control, untreated diabe

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Publication Date
Sun Jan 01 2023
Journal Name
8th Engineering And 2nd International Conference For College Of Engineering – University Of Baghdad: Coec8-2021 Proceedings
Prediction of pore and fracture pressure using well logs in Mishrif reservoir in an Iraqi oilfield
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Publication Date
Fri Dec 07 2018
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Phytochemical Investigation of Corchorus olitorius L. Leaves Cultivated in Iraq and it’s In Vitro Antiviral Activity
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The aim of our study was to investigate the antiviral activity of the Corchorus olitorius family Tiliaceae cultivated in Iraq against measles virus, and to demonstrate an overview about chemical constituents and pharmacological activity of Corchorus olitorius L.

About150 gm Leaves of Corchorus. olitorius were defatted by maceration in hexane for 24 hrs. The defatted plant materials were subjected for extraction after filtration using Soxhlet apparatus, with aqueous methanol 85% as a solvent extraction for 24 hours, the extract was filtered, and the solvent was evaporated under reduced pressure using a rotary evaporator to get a dry extract of about 12 gm. About 4 gm from the residue was suspended in 100

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Publication Date
Sun Dec 31 2023
Journal Name
College Of Islamic Sciences
Variation in general formulas in the strength of its foundation and the reasons for the discrepancy
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A legal discourse in the Qur’an and Sunnah is almost devoid of the use of one of the general formulas, and due to its frequent rotation in the tongue of the legislator, the formulas may overlap their members in apparently contradictory provisions, which makes the individual from the general members appear to the beholder to be covered by two contradictory provisions, and this research came to present what might happen to him The legal text interpreter of weighting between the two opposing texts is the strength of the generality that is established by the generality formula, so the two strongest formulas in the inclusion of its members outweigh the weaker of them and precede them, and the research decided that the formulas vary

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Publication Date
Mon Jun 19 2023
Journal Name
Journal Of Engineering
Detection and Removal of Polycyclic Aromatic Hydrocarbon from Selected Areas in Tigris River in Baghdad City
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Aromatic hydrocarbons present in Iraqi national surface water were believed to be raised principally from combustion of various petroleum products, industrial processes and transport output and their precipitation on surface water.
Polycyclic aromatic hydrocarbons (PAHs) were included in the priority pollutant list due to their toxic and carcinogenic nature. The concern about water contamination and the consequent human exposure have encouraged the development of new methods for
PAHs detection and removal.
PAHs, the real contaminants of petroleum matter, were detected in selected sites along Tigris River within Baghdad City in summer and winter time, using Shimadzu high performance liquid chromatography (HPLC) system.
Analysi

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Publication Date
Thu Jul 04 2024
Journal Name
Pharmaceutics
Formulation Development of Meloxicam Binary Ethosomal Hydrogel for Topical Delivery: In Vitro and In Vivo Assessment
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Abstract: The article aimed to formulate an MLX binary ethosome hydrogel for topical delivery to escalate MLX solubility, facilitate dermal permeation, avoid systemic adverse events, and compare the permeation flux and efficacy with the classical type. MLX ethosomes were prepared using the hot method according to the Box–Behnken experimental design. The formulation was implemented according to 16 design formulas with four center points. Independent variables were (soya lecithin, ethanol, and propylene glycol concentrations) and dependent variables (vesicle size, dispersity index, encapsulation efficiency, and zeta potential). The design suggested the optimized formula (MLX−Ethos−OF) with the highest desirability to perform the

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Publication Date
Tue Mar 01 2011
Journal Name
Journal Of Economics And Administrative Sciences
The impact of cognitive processes in the areas of organizational changeApplied Study in the Directorate General of Training and Development / Ministry of Electricity
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Centric study on the interest of the Directorate General of Training and Development / Ministry of Electricity to consolidate the concept of process and enhancement of knowledge in the areas of organizational change، it reached a sample of the study (44) people who are highly heads of departments، technicians and administrators in different sections of the Directorate and by using the correlation coefficient (Spearman) & coefficient of simple regression been tested correlations between variables and the impact of the study، as has been reached to integrate the role of cognitive processes with the areas of organizational change and relationships that were significant at the level of overall dimensions and subsidiary organs.

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