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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Wed Jan 01 2020
Journal Name
Research Journal Of Pharmacy And Technology
Structural, Spectral and Thermal studies of new bidentate Schiff base ligand type (NO) derived from Mebendazol and 4-Aminoantipyrine and it's metal complexes and evaluation of their biological activity
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Publication Date
Wed Apr 30 2025
Journal Name
International Journal Of Environmental Impacts
Analysis of the Effect of Heavy Elements in Polluted Industrial Water and its Environmental Treatment: An Applied Study on the Gas Power Plant/ 1 (Central Region) in Southern Baghdad and its Discharge into the Tigris River
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Water produced from power plants is one of the most important sources of water pollution, especially for areas like Baghdad, Contaminated industrial wastewater is a major environmental challenge due to the rapid growth of industries, leading to increased accumulation of harmful pollutants in water resources, the work is intended to study the impact of water generated from a power plant in the south on the level of heavy metals before and after the treatment process and after its discharge to the Tigris River. Objective is to determine the extent of heavy metals such as iron, copper, chromium, and zinc concentration in water extracted from various points and subsequently study the monthly variations of these elements with a view to assessmen

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Publication Date
Sat Jan 02 2021
Journal Name
Journal Of The College Of Languages (jcl)
Determining situational dimensions as a method of Equivalence in the source and target language in the translation of Russian and Arab: ( Понимание реальности ) средство полной эквивалентности текста оргинала и текста перевода на русском и арабском языках
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The present paper stresses the direct effect of the situational dimension termed as “reality” on the authors’ thoughts and attitudes. Every text is placed within a particular situation which has to be correctly identified by the translator as the first and the most important step for a good translation. Hence, the content of any word production reflects some part of reality. Comprehending any text includes comprehending the reality’s different dimensions as reflected in the text and, thus illuminating the connection of reality features.

Аннотация 

Исследование под названием  ((«Понимание реальности» средство полно

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Publication Date
Wed Mar 30 2022
Journal Name
College Of Islamic Sciences
The Image of the man in the series "The Cart and the Rain" by the storyteller (Badia Amin): The Image of the man in the series "The Cart and the Rain" by the storyteller (Badia Amin)
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Abstract:

The research aims to monitor the image of the man in the group (The Cart and the Rain) by the storyteller (Badiaa Amin); With the aim of highlighting an aspect of feminist writing, especially with regard to the relationship of women to men, and determining the form adopted by the storyteller in drawing the features of men.

The research used the descriptive-analytical method in the space of its textual formation, which aims to stand on the text and deconstruct its narrative significance. To provide a comprehensive picture of it.

Three images of the man appeared in the group's stories, represented by (the authoritarian, the negative, and the positive), and the image of the authoritarian ma

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Publication Date
Thu Dec 29 2016
Journal Name
International Journal Of English And Literature
THE FORMS AND FUNCTIONS OF APOLOGIES WITH INDICATIVE REFERENCES TO THE LETTERS OF KEATS AND BYRON
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11-22 Description An apology may be defined as “the act of declaring one’s regret, remorse or sorrow for having insulted, failed, injured, harmed or wronged another (Internet Encyclopedia of Philosophy IEP). A definition quite interested in the function suggests that “an apology is a speech act addressed to B’s face–needs and intended to remedy an offence for which A. takes responsibility.”(Holmes, 1990: 159). Apologies are also" speech acts" that are hard to identify, define or categorize, a difficulty that arises directly out of the functions they perform (Lakoff, 2001: 201) and the forms they take. In function, they range from selfabasement for wrongdoing to the formal display of appropriate feeling. In form, they range from

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Publication Date
Fri Dec 01 2017
Journal Name
Ibn Al-haitham Jour. For Pure & Appl. Sci.
Synthesis, Characterization and Study of Mesomorphic Behavior of New Bent and Liner Core Compounds Containing Heterocyclic
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We described herein the synthesized and characterized of new bent and liner core compounds containing thiazolidin-4-one ring[XI-XIII] and [XIV-XVI] respectively. These compounds synthesized by sequence reactions starting from reaction resorcinol or hydroquinone with chloracetyl chloride to yield compounds [I] and [II] ,then the later compounds reactant with 4-hydroxybenzylaldehyde to product dialdehyde compounds [III] and [IV] .The Schiff bases compounds[V-VII] and [VIII-X] synthesized from reaction the compound [III] or [IV] with different aromatic amines, while the bent and liner core mesogens containing thiazolidin-4-one ring [XI-XIII] and [XIV-XVI] synthesized from reaction Schiff bases compounds[V-VII] or [VIII-X] with thioglycolic aci

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Publication Date
Sun Sep 01 2024
Journal Name
Kufa Journal For Agricultural Sciences
Effect of feed forms, mash and pellets on productive performance and carcass weights of broiler chicken
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This study has aimed to investigate the effect of feed forms, mash and pellet on productive performance and carcass yields of broilers. 225 unsexed birds of the hybrid Ross 308 broiler were used, with a starting weight of 45.4 g one day old. The experiment lasted up to 35 days. The birds were randomly distributed into five treatments; each treatment contained 45 chicks according to three replicates (15 birds/ replicate). The experiment’s treatments included: (T1) Control mash 100% (pellet 0%), (T2) mash 75% (pellet 25%), (T3) mash 50% (pellet 50%), (T4) mash 25% (pellet 75%) and (T5) mash 0% (pellet 100%). Results were recorded a significant superior of T4 compared with other treatments (P≤0.05) in live body weight, weight gain,

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Publication Date
Thu Sep 01 2022
Journal Name
Prepodavatel Xxi Vek
Metaphor and Genre of Family Chronicle (On the Example of L. Ulickaya’s "Medea and Her Children”)
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The article deals with the role of metaphors in forming the plot of L. Ulitskaya’s family chronicle “Medea and Her Children”. The author of the article describes the results of the next stage of research related to the works of Lyudmila Evgenievna Ulitskaya, a representative of modern Russian prose. The analysis of tropes and figures in the works written at the turn of the XXth – XXIth centuries is of importance for the study of the modern state of Russian language as an independent system. “Medea and Her Children” is one of the works by L. Ulitskaya (written in 1996), which, like her other works, is characterized by a unique style of narration, rich in vocabulary, lexical, semantic and stylistic diversity of the author’s word

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Publication Date
Thu May 02 2013
Journal Name
Diyala Journal For Pure Sciences
Synthesis and Characterization of Mixed Ligands of Dithizone and Schiff Base Complexes with Selected Metal Ions.
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Salicylaldehyde was react with 4-amino-2,3-dimethyl-1-phenyl-3-pyrazoline-5-on to produce the Schiff base ligand 2,3-dimethyl-1-phenyl-4-salicylidene-3-pyrazoline-5-on (L). The prepared ligand was identified by Microelemental Analysis, and FT.IR, UV-Vis spectroscopic techniques. A new complexes of Fe(III),Co(II),Ni(II),Cu(II),Ce(III) and Pb(II) with mixed ligands of dithizone (DTZ) and Schiff base were prepared in aqueous ethanol with a 2:2:1 M:L:DTZ. The prepared complexes were characterized using flame atomic absorption, (C.H.N) Analysis, FT.IR and UV-Vis spectroscopic methods as well as magnetic susceptibility and conductivity measurements. In addition biological activity of the ligands and complexes against two selected type of bacteria

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Publication Date
Sun Nov 26 2017
Journal Name
Journal Of Engineering
Experimental Investigation of Nano Alumina and Nano Silica on Strength and Consistency of Oil Well Cement
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In oil and gas well cementing, a strong cement sheath is wanted to insure long-term safety of the wells. Successful completion of cementing job has become more complex, as drilling is being done in highly deviated and high pressure-high temperature wells. Use of nano materials in enhanced oil recovery, drilling fluid, oil well cementing and other applications is being investigated. This study is an attempt to investigate the effect of nano materials on oil well cement properties. Two types of nano materials were investigated, which are Nano silica (>40 nm) and Nano Alumina (80 nm) and high sulfate-resistant glass G cement is used. The investigated properties of oil well cement included compressive strength, thickening

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