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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Mon Jul 25 2022
Journal Name
2022 Ieee 20th International Conference On Industrial Informatics (indin)
Robust Continuous Sliding Mode Controller for Uncertain Canonical Brunovsky Systems Using Reduced Order Extended State Observer
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A reduced-order extended state observer (RESO) based a continuous sliding mode control (SMC) is proposed in this paper for the tracking problem of high order Brunovsky systems with the existence of external perturbations and system uncertainties. For this purpose, a composite control is constituted by two consecutive steps. First, the reduced-order ESO (RESO) technique is designed to estimate unknown system states and total disturbance without estimating an available state. Second, the continuous SMC law is designed based on the estimations supplied by the RESO estimator in order to govern the nominal system part. More importantly, the robustness performance is well achieved by compensating not only the lumped disturbance, but also its esti

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Publication Date
Sun Aug 01 2021
Journal Name
Eurasian Chemical Communications
New sensitive turbidimetric method for determination of losartan potassium in pharmaceutical formulations using flow injection combined with homemade turbidimeter
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Scopus
Publication Date
Thu Jun 15 2023
Journal Name
Romanian Neurosurgery
Similarities and differences between two coincidently gravitational bullet cases
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Many cases of gravitational bullets are reported in developed and non-developed countries. However, few papers highlighted these cases in the literature. In our study, we present two cases of gravitational bullets that have an unusual coincidence in the injury characteristics through their ages, and gender, the site of the inlet.

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Publication Date
Wed Feb 05 2020
Journal Name
Political Sciences Journal
“The constitutional- political structures in Iraq after 2003”
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It is obvious that the constitutional- political structures which has been emerged in Iraq after the occupation in 2003 frame worked by many sectarian, ethnic, tribal and political orientations, pushing forewords to escalating the contradictions between social- political powers, however, these changes unfortunately result not just destroy and taking apart the political regime and his authority, but the state and his institutions as well, although, did not stamped as wise and rational change for better future to new Iraq and its political, civil and military institutions. Finally, as quick as Iraq start to bisects to sectarian, ethnic and national components according to the new political – social components of Iraq. Indeed, what is req

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Publication Date
Sat Dec 01 2018
Journal Name
Political Sciences Journal
Affecting factors in Yemeni - Russian Relations after 2011
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Thethesis of theresearch is to deal with relations between Russia and Yemen after 2011.That relationwas significant in different fields, historic, economic, strategic and cultural ones. There are mutual interestsbetweenRussia and Yemen, especially with the economic development and growth in Russia as an important partner to Yemen.Their has to an a great deal of progress in different types of relations, where as they were only partner in military relations. The studywasclassifiedintoto three sections: the first section dealt with strategic importance of Yemen to Russia. And second section dealt withthe military factor between Russia and Yemen. While the third section dealt with the economic factor between Russia and Yemen. In addi

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Publication Date
Sun Dec 01 2024
Journal Name
Journal Of The Iraqi Translators Association Translation And Linguistics
COMPARISON OF THE IDEOLOGICAL DISCOURSE OF THE RUSSIAN-UKRAINIAN WAR IN REPORTS FROM NEWS CHANNELS CNN AND RT
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This study conducts a systematic comparative critical discourse analysis of news reports from prominent American (CNN) and Russian (RT) media sources covering the Russia-Ukraine conflict. Utilizing the theoretical frameworks of Norman Fairclough's multidimensional model and Teun van Dijk's socio-cognitive approach, the research examines the underlying ideological assumptions and discursive strategies employed by the two contrasting news channels. Quantitative analysis of discursive techniques and linguistic features provides insights into how each channel selectively utilizes language to convey distinct ideological positions. The findings demonstrate how media discourse constructs and normalizes particular ideological representations of pol

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Publication Date
Thu Nov 08 2018
Journal Name
Iraqi National Journal Of Nursing Specialties
Effect of using two packing Technic on Hardness of two dental acrylic resin
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Objective: the aim of this study is to invest age and determine the effect of using (2) packing
technique (conventional and new tension technique) on hardness of (2) types of heat cure acrylic
resin which are (Ivoclar and Qual dental type).
Methodology : this study was intended the using of two types of heat cure acrylic (IVoclar and
Qual dental type) which are used in construction of complete denture which packed in two different
packing technique (conventional and new tension technique) and accomplished by using a total of
(40) specimens in diameter of ( 2mm thickness, 2 cm length and 1 cm width) . This specimens were
sectioned and subdivide into (4) group each (10) specimens for one group , then signed as (A, Al B

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Publication Date
Sun Dec 30 2018
Journal Name
Baghdad Science Journal
Comparative morphological and histological study of the pecten oculi in two species of Iraqi birds (Falco tinnunculus L. and Streptopelia decaocto F.)
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Study showed structure of pecten oculi in the Kestrel Falco tinnunculus L.was
Pleated type and consisted of 17 folds which were thick. While in the Collared Dove
Streptopelia decaocto F. was Vaned type and consisted of 13 folds and it described
thin. The illustrated histological study of pecten oculi folds in the Kestrel and the
Collared Dove was composed of large number of capillaries, large blood vessels and
pigment cells which were few in Kestrel compare with the Collared Dove. The bridge
in the Kestrel and the Collared Dove pecten oculi was consisted of connective tissue,
many pigment cells, and contains on little capillaries and it linked the membrane to
the internal limiting membrane of the retina in the Kes

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Crossref
Publication Date
Wed Jul 31 2019
Journal Name
Journal Of Engineering
Comparison Study of Adsorption of Lead and Methylene Blue on Zeolite, Activated Carbon and Their Composite Materials
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In this study, composite materials consisting of Activated Carbon (AC) and Zeolite were prepared for application in the removal of methylene blue and lead from an aqueous solution. The optimum synthesis method involves the use of metakaolinization and zeolitization, in the presence of activated carbon from kaolin, to form Zeolite. First, Kaolin was thermally activated into amorphous kaolin (metakaolinization); then the resultant metakaolin was attacked by alkaline, transforming it into crystalline zeolite (zeolitization). Using nitrogen adsorption and SEM techniques, the examination and characterization of composite materials confirmed the presence of a homogenous distribution of Zeolite throughout the activated carbon.

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Publication Date
Thu Jun 15 2017
Journal Name
Journal Of Baghdad College Of Dentistry
Comparison Of Oral Health Status And Behavior between First And Fifth Years Of Al-Mustansiriyah Dental Students
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Background:Periodontal diseases and dental caries are the most common oral diseases, but they can be adequately prevented by adopting a specific health behavior and plaque control.The study was carried out to determine and compare oral health status; it included both caries experience, gingival health and oral hygiene behavior betweenfirst and fifth yearsof Al-Mustansiriyahdental students. Materials and methods: Total sample of the study consisted of 50 students at first year (25 males, 25 females)and 60 students at fifth year (30 males, 30 females). Plaque andgingival indices,dental caries indices (DMFS and DMFT) wererecorded to evaluateoral health status for each student. Further questionnaires were given to evaluate different oral hyg

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