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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Dec 28 2017
Journal Name
Ibn Al-haitham Journal For Pure And Applied Sciences
Evaluating the Efficiency of the Entomopathogenic Fungus Beauveria bassiana to Control the Brown Banded Cockroach Supella longipalpa F.
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      Entomopathogenic fungi can be ideal for the biocontrol of cockroaches since it is environment-friendly microbial pesticide. Susceptibility of second and fourth instar of nymphs and adults of the brown banded cockroach, Supella longipalpa (F.) (Blattodea: Blattellidae) to the entomopathogenic fungi Beauveria bassiana (Bals.) Vuill. at two concentrations 1x 107 and 1x 108 spore/ml was evaluated. Fungus was tested by using two different methods: bait and direct contact. Mortality was monitored after 3, 5 and 7 days’ post exposure. Direct contact of B. bassiana at concentration 1x 107 spore/ml produced mortality on adults 82.76% and for fourth and second instar of nymphs 82.76 and 93.10% after 7 daysâ

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Publication Date
Mon Jul 01 2013
Journal Name
Political Sciences Journal
Towards Promoting Political Participation of Female - University Students - Field Study on Al-Quds Open University Female - Students - Rafah
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نحو تعزيز المشاركة السياسية للطالبات الجامعيات الفلسطينيات

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Publication Date
Tue Jan 01 2019
Journal Name
Chemical Industry And Chemical Engineering Quarterly
Optimization of dye adsorption process for Albizia lebbeck pods as a biomass using central composite rotatable design model
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Albizia lebbeck biomass was used as an adsorbent material in the present study to remove methyl red dye from an aqueous solution. A central composite rotatable design model was used to predict the dye removal efficiency. The optimization was accomplished under a temperature and mixing control system (37?C) with different particle size of 300 and 600 ?m. Highest adsorption efficiencies were obtained at lower dye concentrations and lower weight of adsorbent. The adsorption time, more than 48 h, was found to have a negative effect on the removal efficiency due to secondary metabolites compounds. However, the adsorption time was found to have a positive effect at high dye concentrations and high adsorbent weight. The colour removal effi

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Publication Date
Mon Jun 01 2020
Journal Name
Iop Conference Series: Materials Science And Engineering
The possibility of Using the Low-Cost External Antenna with Smartphone for Accurate Surveying Applications by RTX Technology
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Abstract<p>Real Time Extended (RTX) technology works to take advantage of real-time data comes from the global network of tracking stations together with inventor locating and compression algorithms to calculate and relaying the orbit of satellite, satellite atomic clock, and any other systems corrections to the receivers, which lead to real-time correction with high accuracy. These corrections will be transferred to the receiver antenna by satellite (where coverage is available) and by IP (Internet Protocol) for the rest of world to provide the accurate location on the screen of smartphone or tablet by using specific software. The purpose of this study was to assess the accuracy of Global Navig</p> ... Show More
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Publication Date
Sun Jul 31 2022
Journal Name
Iraqi Journal Of Science
Reservoir Characterization of Lower Qamchuqa (Shu'aiba) Formation from the Well BH-86, Bai- Hassan Oil field, Northern Iraq
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      The reservoir characterization of Lower Qamchuqa (Shu'aiba) Formation (Aptian) is studied at the well BH-86 of Bai- Hassan Oilfield in Kirkuk area, Northern Iraq. The lithological study (of 91 thin sections) revealed that the formation consists of shaly limestone, a thin bed of marl within the limestone, and dolomitic limestone. Four petrographic microfacies were noticed Lime mudstone microfacies, Dolomudstone microfacies, Lime wackestone microfacies, subdivided into benthonic foraminifera lime wackestone submicrofacies and bioclasts lime wackestone submicrofacies, and the last microfacies is the Lime packstone microfacies, which is subdivided into pelloidal lime packstone submicrofacies and Orbitolina lime packstone microfaci

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Publication Date
Thu Dec 01 2022
Journal Name
Chemical Data Collections
Removal of an anionic Eosin dye from aqueous solution using modified activated carbon prepared from date palm fronds
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Publication Date
Tue Aug 27 2024
Journal Name
Tem Journal
Preparing the Electrical Signal Data of the Heart by Performing Segmentation Based on the Neural Network U-Net
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Research on the automated extraction of essential data from an electrocardiography (ECG) recording has been a significant topic for a long time. The main focus of digital processing processes is to measure fiducial points that determine the beginning and end of the P, QRS, and T waves based on their waveform properties. The presence of unavoidable noise during ECG data collection and inherent physiological differences among individuals make it challenging to accurately identify these reference points, resulting in suboptimal performance. This is done through several primary stages that rely on the idea of preliminary processing of the ECG electrical signal through a set of steps (preparing raw data and converting them into files tha

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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
Sat Oct 01 2011
Journal Name
Journal Of Engineering
THE EFFECT OF SPACE VOLUME ON FREE CONVECTION HEAT TRANSFER FOR ONGITUDINAL FINNED CYLINDER WITH DIFFERENT SLOPE NGLES
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This study deals with free convection heat transfer for the outer surface of two
cylinders of the shape of (Triangular & Rectangular fined cylinders with 8-fins),
putted into two different spaces; small one with dimension of (Length=1.2m,
height=1m, width=0.9m) and large one with dimension of (Length=3.6m, height =3m,
width=2.7m). The experimental work was conducted with air as a heat transport
medium. These cylinders were fixed at different slope angles (0o, 30o, 60o and 90o)
.The heat fluxes were (279, 1012, 1958, 3005, 4419) W/m2, where heat transferred by
convection and radiation. In large space, the results show that the heat transfer from
the triangular finned cylinder is maximum at a slope angle equals

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Publication Date
Sun Jul 25 2021
Journal Name
Natural Resources Research
Effect of Water Flooding on Oil Reservoir Permeability: Saturation Index Prediction Model for Giant Oil Reservoirs, Southern Iraq
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