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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Thu Aug 03 2023
Journal Name
Journal Of Legal Sciences
Subjective Objective Conditions for the Possibility of Punishment
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Objective conditions for the possibility of punishment are legal or material facts –positive or negative that depart from the activity of the offender. The legislator comments on their subsequent verification on the formation of some crimes the possibility of.The application of punishment to the offender , but although they are facts of an object nature that approach and overlap with many systems and cases , they are distinguished by a certain subjectivity that differentiates them from each case that may seem similar or approach them. To clarify the ambiguity that may surround these conditions , Which may lead to confusion between them and what be similar to other cases due to the common effect that they have in common , which is the f

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Publication Date
Sun Sep 04 2016
Journal Name
Baghdad Science Journal
Extraction conditions of polyphenol oxidase from banana peel
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Polyphenol oxidase (PPO) is an enzyme containing copper, presents in various fruits and vegetables. It is responsible for the browning reactions when the cells are damaged during handling. The best conditions for extraction of polyphenol oxidase from banana peel was by using an extraction buffer containing phosphate buffer (0.05 M, pH 7), 0.01 M ascorbic acid and 0.5% polyethylene glycol, with extraction ratio 1:4 (w:v) for one minute by using blender. The enzyme activity was measured spectrophotometrically at 425 nm. PPO was studied to prevent the browning of banana peel which results in the loss of their marketability. The aim of this study was to determine the optimum conditions for polyphenol oxidase extraction from banana peel.

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Publication Date
Thu May 31 2012
Journal Name
Al-khwarizmi Engineering Journal
The Stability Conditions of the Pump Structure Vibration
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 The general approach of this research is to assume that the small nonlinearity can be separated from the linear part of the equation of motion. The effect of the dynamic fluid force on the pump structure system is considered vibrates at its natural frequency but the amplitude is determined by the initial conditions. If the motion of the system tends to increase the energy of the pump structure system, the vibration amplitude will increase and the pump structure system is considered to be unstable. A suitable MATLAB program was used to predict the stability conditions of the pump structure vibration. The present research focuses on fluid pump problems, namely, the role played by damping coefficient C, damping factor

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Publication Date
Tue Aug 20 2019
Journal Name
Political Sciences Journal
The role of religious references in the reformation process in Iraq after 2003
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The Shiite religious authority in Iraq has played an active and vital role over its long history in promoting values of tolerance, rejecting extremism, advocating unity and confronting external challenges. This role has increased significantly after 2003 as a result of the great challenges that have passed in Iraq. Despite its clear policy of non-interference in political matters, except in cases of necessity, but the great role it played in maintaining national unity and advocating the rejection of extremism and sectarianism has made it a necessary need in Iraq to confront any deviations, dispersions or threats that affect society and the state. Therefore, its role in the process of reform was prominent on the political level by calling

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Publication Date
Fri Jun 01 2007
Journal Name
Journal Of The College Of Languages (jcl)
TECHNIQES OF SURREALISM: A STUDY IN TWO NOVELS BY THOMAS PYNCHON, V. AND THE CRYING OF LOT 49
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Surrealism is a twentieth-century literary and artistic movement oriented toward the liberation of the mind. Surrealism is a reaction to the philosophy of rationalism which was believed to be the cause of the disaster of World War I. It emphasizes the expression of the imagination as revealed in dreams and presented without conscious control, the unexpected juxtapositions of objects, the withdrawal of the self, and the exploitation of chance effects.
Surrealism began in Paris in the early 1920s, as Europe emerged from the devastation of World War I. A group of writers, artists, and filmmakers, led by the poet André Breton, adopted the word surréaliste (meaning, roughly, "super-real") as a label for their artistic activities. Influen

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Publication Date
Sun Mar 01 2020
Journal Name
International Journal Of Modern Physics E
Investigation of halo structure of neutron rich 14B, 15C, 19C and 22N nuclei in the two body model
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The two body model of (Core+n) within the radial wave functions of the cosh potential has been used to investigate the ground state features such as the proton, neutron and matter densities, the root mean square (RMS) nuclear proton, neutron, charge and mass radii of unstable neutron-rich 14B, 15C, 19C and 22N nuclei. The calculated results show that the two body model with the radial wave functions of the cosh potential succeeds in reproducing neutron halo in these nuclei.

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Publication Date
Sat Jul 01 2000
Journal Name
Bulletin Of The Iraq Natural History Museum (p-issn: 1017-8678 , E-issn: 2311-9799)
COMPARATIVE ECOLOY OF TWO SPECIES OF BIVALVE CORBICULA FL UMINEA AND CORBICULE FL UMINALIS IN SHATT AL-ARAB
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Some aspects of population dynamics of both corbicula species inhabiting intertidal zone of
shatt al-Arab are described. These informations are explained in accordance with the possible
occurrence of competition between the two related species.

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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
Wed Dec 24 2025
Journal Name
Baghdad Science Journal
Comparison of XRF and ICP-OES Methods to Determine Trace Element Concentrations of Kidney Stones in Iraqi Patients
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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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