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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Sun Jan 01 2023
Journal Name
Aip Conference Proceedings
Study of (Zn0.7 Mn0.3-x Ag0.3 Fe2O4) ferrite nanoparticles synthesized by auto combustion method for NO2 gas sensing
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Publication Date
Wed Oct 04 2023
Journal Name
Environmental Progress & Sustainable Energy
Removal of <scp>E133</scp> brilliant blue dye from artificial wastewater by electrocoagulation using cans waste as electrodes
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Abstract<p>Solid‐waste management, particularly of aluminum (Al), is a challenge that is being confronted around the world. Therefore, it is valuable to explore methods that can minimize the exploitation of natural assets, such as recycling. In this study, using hazardous Al waste as the main electrodes in the electrocoagulation (EC) process for dye removal from wastewater was discussed. The EC process is considered to be one of the most efficient, promising, and cost‐effective ways of handling various toxic effluents. The effect of current density (10, 20, and 30 mA/cm<sup>2</sup>), electrolyte concentration (1 and 2 g/L), and initial concentration of Brilliant Blue dye (15 and 30 mg/L) on </p> ... Show More
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Publication Date
Fri Mar 15 2024
Journal Name
Journal Of Baghdad College Of Dentistry
A clinicopathological analysis of 151 odontogenic tumors based on new WHO classification 2022: A retrospective cross-sectional study
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Background: Odontogenic tumors are a diverse group of lesions with a variety of clinical behavior and histopathologic subtypes, from hamartomatous and benign to malignant. The study aimed to examine the clinical and pathological features of odontogenic tumors in Baghdad over the last 11 years (2011–2021). Materials and Methods: The present retrospective study analyzed all formalin-fixed, paraffin-embedded tissue blocks of patients diagnosed with an odontogenic tumor that were retrieved from archives at a teaching hospital/College of Dentistry in Baghdad University, Iraq, between 2011 and 2021. The diagnosis of each case was confirmed by examining the hematoxylin and eosin stained sections by two expert pathologists. Data from pati

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Publication Date
Wed Dec 28 2016
Journal Name
Environmental Technology
Remediation of groundwater contaminated with the lead–phenol binary system by granular dead anaerobic sludge-permeable reactive barrier
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Publication Date
Thu Jun 01 2023
Journal Name
International Journal Of Artificial Intelligence (ij-ai)
Evaluation of massive multiple-input multiple-output communication performance under a proposed improved minimum mean squared error precoding
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<span lang="EN-US">The fundamental of a downlink massive multiple-input multiple-output (MIMO) energy- issue efficiency strategy is known as minimum mean squared error (MMSE) implementation degrades the performance of a downlink massive MIMO energy-efficiency scheme, so some improvements are adding for this precoding scheme to improve its workthat is called our proposal solution as a proposed improved MMSE precoder (PIMP). The energy efficiency (EE) study has also taken into mind drastically lowering radiated power while maintaining high throughput and minimizing interference issues. We further find the tradeoff between spectral efficiency (SE) and EE although they coincide at the beginning but later their interests become con

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Publication Date
Mon Mar 25 2019
Journal Name
Al-academy
Melodic Characteristics of Oud Instrument Compositions with the Iraqi Symphony Orchestra (Saleem Salim) A Model: رعد عدنان علوان
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The variety of ideas and freedom of expression among the authors who are looking for everything new that serves the goals of musical and aesthetic expression, which calls for the use of traditional musical instruments with the great composition of musical instruments known as the orchestra represents a great challenge in several aspects. The incompetence of some of these instruments or limited capabilities or its costly method of performance sometimes forbids its use permanently in this great composition. It was necessary to have some problems facing the composer and the player on the one hand and the recipient on the other hand, who must be looking for perfection. Among those instruments that are used regularly in the works of the orche

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Publication Date
Sun Oct 01 2023
Journal Name
Rawal Medical Journal
Fixation of unstable intertrochanteric fractures with proximal femoral nailing: Supine position with traction table versus lateral decubitus position
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Objective: To compare two positioning approaches in the surgical treatment of unstable intertrochanteric femoral fractures fixed by proximal femoral nailing, the supine versus lateral decubitus position Methodology: This randomized prospective comparative study on 26 patients with unstable intertrochanteric fractures was carried out from January 2020 and June 2022. We randomly divided patients into two groups: group A (13 patients) were operated using the traction table in the supine position for implant insertion, and group B (13 patients) were operated using the lateral decubitus position. We compared both groups regarding the setup time, operative time, tip-to-apex distance, collodiaphyseal angle, time for fluoroscopic time expo

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Publication Date
Fri Dec 31 2021
Journal Name
Iraqi Journal Of Laser
Parametric Optimization for Fatigue Life of 6061-T6 Aluminum Thin Sheets Processed with High-Speed Laser Shock Peening
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Abstract: Aluminum alloys grade 6061-T6 are characterized by their excellent properties and processing characteristics which make them ideal for varieties of industrial applications under cyclic loading, aluminum alloys show less fatigue life than steel alloys of similar strength. In the current study, a nanosecond fiber laser of maximum pulse energy up to 9.9 mJ was used to apply laser shock peening process (LSP) on aluminum thin sheets to introduce residual stresses in order to enhance fatigue life under cyclic loading Box-Behnken design (BBD) based on the design of experiments (DOE) was employed in this study for experimental design data analysis, model building and optimization The effect of working parameters spot size (ω), scannin

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Publication Date
Wed Jan 01 2020
Journal Name
Journal Of Biotech Research
Bacteriocin Production by Staphylococcus Epidermidis the Normal Flora of Outer Ear: A Potential Probiotic Against Outer Ear Infections
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Publication Date
Mon Oct 01 2018
Journal Name
Journal Of Terramechanics
Interaction of a rigid beam resting on a strong granular layer overlying weak granular soil: Multi-methodological investigations
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In the geotechnical and terramechanical engineering applications, precise understandings are yet to be established on the off-road structures interacting with complex soil profiles. Several theoretical and experimental approaches have been used to measure the ultimate bearing capacity of the layered soil, but with a significant level of differences depending on the failure mechanisms assumed. Furthermore, local displacement fields in layered soils are not yet studied well. Here, the bearing capacity of a dense sand layer overlying loose sand beneath a rigid beam is studied under the plain-strain condition. The study employs using digital particle image velocimetry (DPIV) and finite element method (FEM) simulations. In the FEM, an experiment

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