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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Dec 07 2008
Journal Name
Baghdad Science Journal
Optium Conditions for the Production of Neutral Protease from local strain Aspergillus niger var cabonarius
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The optimum conditions for the production of neutral protease from local strain Aspergillus niger var carbonarius by solid – state fermentation system (Wheat bran) moisted with 0.2 M phosphate buffer (PH7.0) . the hydration ratio was 1:5 (V:W) . the concentration of inoculum was 1×106 spores per 10 gram of solid materials , initial P H 6.5 and 96 hours of incubation period at 30? C .the enzyme activity was 1300 unit / ml and specific activity was 1550 unit / mg protein .

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Publication Date
Sat Oct 14 2023
Journal Name
Environmental Monitoring And Assessment
The technique of arsenic elimination from contaminated soil with enhanced conditions by electro-kinetic remediation
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Publication Date
Thu Oct 15 2015
Journal Name
International Journal Of Computer Applications
Experimental Investigation for Small Horizontal Portable Wind Turbine of Different Blades Profiles under Laboratory Conditions
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Experimental investigation for small horizontal portable wind turbine (SHPWT) of NACA-44, BP-44, and NACA-63, BP-63 profiles under laboratory conditions at different wind velocity range of (3.7-5.8 m/s) achieved in present work. Experimental data tabulated for 2, 3, 4, and 6- bladed rotor of both profiles within range of blade pitch angles . A mathematical model formulated and computer Code for MATLAB software developed. The least-squares regression is used to fit experimental data. As the majority of previous works have been presented for large scale wind turbines, the aims were to present the performance of (SHPWT) and also to make a comparisons between both profiles to conclude which is the best performance. The overall efficiency and el

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Publication Date
Wed Apr 01 2020
Journal Name
Plant Archives
Effect of soaking with bread yeast extract on sorghum seed germination under salt stress conditions
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Salt stress negatively affects germination and seedling growth. Sorghum cultivars (Bohuth70, Inqath and Rabeh), seed soaking in dry yeast extract (3, 6 and 9 g l-1) in addition to dry seeds and electrical conductivity (4, 10 and 16 dS m-1) were studied. Traits of germination ratio at first and final counts, lengths of radicle and plumule, seedling dry weight and seedling vigour index were studied. The cultivar of Bohuth70 and concentration of yeast extract (9 g l-1) were superior at all studied traits, while all traits values were reduced with increased saline stress. The combination (Bohuth70×9×4) was superior to most other treatments at first and final counts, radicle length and seedling dry weight, while superiority of plumule length a

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Publication Date
Thu Mar 01 2007
Journal Name
Al-khwarizmi Engineering Journal
An investigation into the performance of counter rotating floating ring journal under different working conditions
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The steady state performance of the counter rotating floating ring Journal bearing is analyzed with isothermal finite bearing theory. The effect of different parameters affecting the performance of the bearing (namely speed ratio, clearance ratio and radii ratio), have been investigated. The load carrying capacity of the bearing increasing with decreasing the radii ratio (R2/R1) of the ring and clearance ratio (c1/c2), in the other hand, the coefficient of friction increases with increasing the clearance and radii ratios, while decreases with incre4asing the bearing to journal speed ratio (γ). It is shown during this work that different operating conditions are greatly enhanced the performance

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Publication Date
Wed Oct 09 2024
Journal Name
Engineering, Technology & Applied Science Research
Experimental Investigation of Composite Circular Encased GFRP I-Section Concrete Columns under Different Load Conditions
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Pultruded materials made of Fiber-Reinforced Polymer (FRP) come in a broad range of shapes, such as bars, I-sections, C-sections, etc. FRP materials are starting to compete with steel as structural materials owing to their great resistance, low self-weight, and cheap maintenance costs, especially in corrosive conditions. This study aims to evaluate the effectiveness of a novel concrete Composite Column (CC) using Encased I-Section (EIS) as a reinforcement in contrast to traditional steel bars by using Glass Fiber-Reinforced Polymer (GFRP) as I-section (CC-EIS) to evaluate the effectiveness of the hybrid columns which have been built by combining GFRP profiles with concrete columns. To achieve the aims of this study, nine circular co

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Publication Date
Fri Mar 01 2024
Journal Name
Water, Air, & Soil Pollution
Decontamination of Cobalt-Polluted Soils Using an Enhanced Electro-kinetic Method, Employing Eco-friendly Conditions
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Publication Date
Sat Nov 01 2014
Journal Name
Journal Of Cosmetics, Dermatological Sciences And Applications
Therapeutic evaluation of 2% tea lotion in comparison with 5% zinc sulfate solution in the treatment of acne rosacea
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KE Sharquie, AA Noaimi, SA Al-Hashimy, MM Al-Salih, Journal of Cosmetics, Dermatological Sciences and Applications, 2014 - Cited by 12

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Publication Date
Sun Jan 01 2006
Journal Name
Smj
Treatment of alopecia areata by topical diclofenac sodium gel in comparison with benzoyl peroxide gel
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KE Sharqie, AA Al-Nuaimy, WJ Kadhum, SMJ, 2006 - Cited by 2

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Publication Date
Tue Sep 01 2020
Journal Name
Baghdad Science Journal
Diversity and Geographical Distribution of Sand Flies Phlebotomus papatasi (Diptera: Phlebotominae) by using Geometric Morphometric Technique from two Iraqi Provinces
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            The variation in wing morphological features was investigated using geometric morphometric technique of the Sand Fly from two Iraqi provinces Babylon and Diyala . We distributed eleven landmarks on the wings of Sand Fly species. By using the centroid size and shape together, all species were clearly distinguished.  It is clear from these results that the wing analysis is an essential method for future geometric morphometry studies to distinguish the species of Sand Flies in Iraq.

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