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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Tue Feb 28 2023
Journal Name
Iraqi Journal Of Science
Applications of the Finite Operator〖 〗_3 E_2 (■(q^(-N),a,b@c,d);q,-fθ) for the Polynomials B_n (a,b,c,d,f,x,y|q)
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     In this work,   polynomials  and the finite q-exponential operator  are constructed. The operator  is used to combine an operator proof of the generating function with its extension, Mehler's formula with its extension and Roger's formula for the polynomials . The generating function with its extension,  Mehler's formula with its extension and Rogers formula for Al-Salam-Carlitz polynomials  are deduced by giving special values to polynomials .

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Publication Date
Sun Jun 02 2019
Journal Name
Journal Of The College Of Languages (jcl)
Artistic Features Of Re-Writing The Novel "On The Eve, on The Eve" By YevgueniBobov: As an Example: Жанровые Особенности Ремейка (На Материале Романа Е. Попова «Накануне Накануне»)
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 The paper tackles two topics. The first is about the term "Ремейк" which is very common in contemporary Russian literature; it has counterparts such as " Обработка" and " Переделка", where these two may indicate any of the following meanings (remake, reformulate, rewrite, treatment, modification, change). It has been shown that this term does not have a stable definition. Also, the role of this term in literary studies has been mentioned along with how it has come to its peak of use in post-modern literature.

The second is that I have taken a sample of well-known works in Russian literature " On the Eve, On the Eve " by the contemporary Russian writer YevgueniBobov, and shown the effort of the writer

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Publication Date
Tue Jan 01 2013
Journal Name
Advances In Physics Theories And Applications
Adsorption Study of Symmetrical Schiff Base Ligand 4,4’-[hydrazine-1,2-diylidenebis(methan-1-yl-1-ylidene) bis (2-methoxyphenol)] on Granulated Initiated Calcined Iraqi Montmorillonite via Columnar Method.
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The adsorption ability of Iraqi initiated calcined granulated montmorillonite to adsorb Symmetrical Schiff Base Ligand 4,4’-[hydrazine-1, 2-diylidenebis (methan-1-yl-1-ylidene)) bis (2-methoxyphenol)] derived from condensation reaction of hydrazine hydrate and 4-hydroxy-3-methoxybenzaldehyde, from aqueous solutions has been investigated through columnar method.The ligand (H2L) adsorption found to be dependent on adsorbent dosage, initial concentration and contact time.All columnar experiments were carried out at three different pH values (5.5, 7and 8) using buffer solutions at flow rate of (3 drops/ min.),at room temperature (25±2)°C. The experimental isotherm data were analyzed using Langmuir, Freundlich and Temkin equations. The monol

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Publication Date
Mon Jan 13 2020
Journal Name
Journal Of Accounting And Financial Studies ( Jafs )
Analyzing the net profitability of total investments using a constructed mathematical model: An applied research at Iraqi Middle East Bank for investment for the financial years 2008-2010
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The trading banks in Iraq invest their funds according to regulations imposed by the Central Bank in Iraq in different financial fields like stock exchanges, acquire stocks as assets that could be sold at any time as well as make loans and contributing in corporations establishment also magnitude foreign capital through direct contacts with foreign exchange markets.

We can summarize the problem of this paper as shortage in mathematical models that used in studying and analyzing these investments and according to this problem we used (a constructed mathematical model ) consists of three major indicators: profitability of total investment assets which is divided into three sub-indicators: owners equity risk indicator, debits risk i

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Publication Date
Wed Jul 05 2017
Journal Name
Chemical Engineering Communications
Microwave-assisted preparation of mesoporous-activated carbon from coconut (<i>Cocos nucifera</i>) leaf by H<sub>3</sub>PO<sub>4</sub>activation for methylene blue adsorption
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Publication Date
Sun Mar 01 2020
Journal Name
Journal Of Accounting And Financial Studies ( Jafs )
Implement some basic health accreditation standards Issued by the Health Care Accreditation Council (HCAC) for auditing the Performance of Hospitals: Applied research at the Education Children Protection Hospital
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The health care provided by health institutions and all kinds suffers from many problems, and since the health services provided are related to human life, it is necessary to shed light on this activity and identify the causes of these problems. This research aims to Definition of health institutions (hospitals) Performance audit of these institutions according to the latest indicators, which are the standards of health accreditation for hospitals, specifically the basic standards issued by the Health Care Accreditation Council (HCAC) to reach the level of performance and Knowledge of Constraints that lead to in an acceptable manner consistent with the approved standards. In theoretical and practical study, a number of conclusions were r

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Publication Date
Wed Sep 30 2015
Journal Name
College Of Islamic Sciences
Issam al-Din al-Asfrani's footnote On the interpretation of the oval Imam Issam al-Din Ibrahim Arbashah al-Asfrani (Th 159 e)   Surah Al-Baqarah (verse 55-911)
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Issam al-Din al-Asfrani's footnote
On the interpretation of the oval
Imam
Issam al-Din Ibrahim Arbashah al-Asfrani
(Th 159 e)
  Surah Al-Baqarah (verse 55-911)

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Publication Date
Sun Mar 04 2018
Journal Name
Iraqi Journal Of Science
Assessment of ISNAG fluorimeter (Total fluorescence measurements at+ 90° & - 90° using four solar cell on each side for 100mm distance at 2mm path length) with well-known fluorescent molecules via CFIA
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Two well-known fluorescent molecules: fluorescein sodium salt (FSS) and 2,7-dichloro fluorescein (DCF) were tried to prove the efficiency, trustability and repeatability of ISNAG fluorimeter by using discrete and continuous flow injection analysis modes.A linear range of 0.002-1 mmol/L for FSS and 0.003-0.7 mmol/L was for DCF, with LOD 0.0018 mmol/L and 0.002 mmol/L for FSS and DCF respectively, were obtained for discrete mode of analysis. While the continuous mode gave a linear range of 0.002-0.7 mmol/L and 0.003-0.5 mmol/L for FSS and DCF respectively, the LOD were 0.0016mmol/L and 0.0018 mmol/L for FSS and DCF respectively. The results were compared with classical method at variable λex for both fluorescent molecules at 95

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Publication Date
Sat Jun 03 2023
Journal Name
Iraqi Journal Of Science
Effect Effect Effect Effect Effect Effect Effect of Thickness on Some Physical PropertiesThickness on Some Physical PropertiesThickness on Some Physical PropertiesThickness on Some Physical PropertiesThickness on Some Physical Properties Thickness on Some
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The effect of thickness variation on some physical properties of hematite α-Fe2O3 thin films was investigated. An Fe2O3 bulk in the form of pellet was prepared by cold pressing of Fe2O3 powder with subsequent sintering at 800 . Thin films with various thicknesses were obtained on glass substrates by pulsed laser deposition technique. The films properties were characterized by XRD, and FT-IR. The deposited iron oxide thin films showed a single hematite phase with polycrystalline rhombohedral crystal structure .The thickness of films were estimated by using spectrometer to be (185-232) nm. Using Debye Scherrerś formula, the average grain size for the samples was found to be (18-32) nm. Atomic force microscopy indicated that the films had

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Publication Date
Sun Jan 26 2020
Journal Name
Journal Of Global Pharma Technology
Synthesis, Characterization of 2-azido-4-(azido (2-azido-2-( azido carbonyl)-1,3-dioxoian-4-yl)methyl)– 5-((R-azido (hydroxyl) methyl- 1,3-dioxole-2-carbonyl azide. ethanol. hydrate (L-AZD) with Some Metal Complexes
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The reaction oisolated and characterized by elemental analysis (C,H,N) , 1H-NMR, mass spectra and Fourier transform (Ft-IR). The reaction of the (L-AZD) with: [VO(II), Cr(III), Mn(II), Co(II), Ni(II), Cu(II), Zn(II), Cd(II) and Hg(II)], has been investigated and was isolated as tri nuclear cluster and characterized by: Ft-IR, U. v- Visible, electrical conductivity, magnetic susceptibilities at 25 Co, atomic absorption and molar ratio. Spectroscopic evidence showed that the binding of metal ions were through azide and carbonyl moieties resulting in a six- coordinating metal ions in [Cr (III), Mn (II), Co (II) and Ni (II)]. The Vo (II), Cu (II), Zn (II), Cd (II) and Hg (II) were coordinated through azide group only forming square pyramidal

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