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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Comparison consequence of violet and red laser irradiation on the optical properties of cobalt dioxide (CoO2) thin films prepared via (SCSPT)
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Publication Date
Fri Jan 01 2021
Journal Name
Aip Conference Proceedings
Comparison effect of violet and red laser irradiation on the structural properties of mawsonite Cu6Fe2SnS8 [CFTS] thin films deposited via (SCSPT)
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Publication Date
Mon Jul 01 2019
Journal Name
Journal Of Engineering
The Characters of the Form in the Vernacular Architecture A comparative study of the form's characters of facades of individual houses and commercial buildings in the City of Baghdad after 2003–Zayoona district as a case study
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The characters of facades' form of the Iraqi building after 2003 have been changed, it has been described by many names. The problem of the research is that what are the features of the characters of the form in the façades of the buildings in Baghdad city after 2003? Are the façade of the individual houses or the commercial buildings is the heaviest in the visual weight? The research aims to answer those questions by choosing the vernacular architecture as a measurement tool. It is the informal image of the architecture, which is built by people informally and spontaneously, without official control and legislation to be organized. This is smellier to what has happened in Baghdad, after 2003 according to previous stud

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Publication Date
Wed Sep 01 2021
Journal Name
Journal Of Ecological Engineering
Study of The Fermentation Conditions of the Bacillus Cereus Strain ARY73 to Produce Polyhydroxyalkanoate from Glucose
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Polyhydroxyalkanoates (PHAs) have gained much attention as biodegradable polymers, many efforts are being made to minimize the cost of PHAs by finding cheap carbon source depending on the type of microorganism and fermentation conditions. The aims of this study were to evaluate the effects of different glucose concentrations and other important conditions on the PHA production by Bacillus cereus isolated from soil. Polyhydroxyalkanoates PHAs accumulated by soil microorganisms were examined by screening the isolated bacteria using Sudan B Black and Nile Blue staining process. A Gram positive strain was identified using the 16s rRNA gene, deposited in the NCBI GenBank sequence database. Different growth conditions (favorite glucose concentrat

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Publication Date
Thu Apr 05 2018
Journal Name
Acs Applied Nano Materials
Direct Formation of 2D-MnO<sub><i>x</i></sub> under Conditions of Water Oxidation Catalysis
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We describe the synthesis and characterization of a novel 2D-MnOx material using a combination of HR-TEM, XAS, XRD, and reactivity measurements. The ease with which the 2D material can be made and the conditions under which it can be made implies that water oxidation catalysts previously described as “birnessite-like” (3D) may be better thought of as 2D materials with very limited layer stacking. The distinction between the materials as being “birnessite-like” and “2D” is important because it impacts on our understanding of the function of these materials in the environment and as catalysts. The 2D-MnOx material is noted to be a substantially stronger chemical oxidant than previously noted for other birnessite-like manganese oxi

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Publication Date
Thu Jun 15 2023
Journal Name
Jornal Of Al-muthanna For Agricultural Sciences
Effect of different levels of Adrenocorticotropic hormone (ACTH) on physiological performance of broiler under heat stress conditions.
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This experiment was holdup in A-Faris poultry farms from 1st March to 11 of Aprile 2019. (ACTH) hormone infusion was tested in this experiment on acid-base regulation in broiler chickens. For 7 days, osmotic pumps dispensed 8 IU of ACTH in saline/kg of BW/d, or the same volume of saline as in ACTH at 1 l/h. On days 0 and 14, after the beginning of the infusions, blood samples were obtained to establish a baseline. The plasma concentrations of Na+, K+, and Cl- were decreased, whereas the partial pressure of CO2, anion gap, corticosterone, mean corpuscular hemoglobin concentration, and blood concentrations of hemoglobin and HCO - were all elevated due to the ACTH administration. When given ACTH, neither blood pH nor plasma Ca2+ levels changed

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Publication Date
Sat Oct 01 2022
Journal Name
Baghdad Science Journal
Toxicity of Nanomulsion of Castor Oil on the Fourth larval stage of Culex quinquefsciatus under Laboratory Conditions
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Mosquitoes like Culex quinquefasciatus are the primary vector that transmits many causes of diseases such as filariasis, Japanese encephalitis, and West Nile virus, in many countries around the world. The development in the scientific fields, such as nanotechnology, leads to use this technique in control programs of insects including mosquitoes through the use of green synthesis of nanoemulsions based on plant products such as castor oil.  Castor oil nanoemulsion was formulated in various ratios comprising of castor oil, ethanol, tween 80, and deionized water by ultrasonication. Thermodynamic assay improved that the formula of (10 ml) of castor oil, ethanol (5ml), tween 80 (14 ml) and deionized water (71ml)   was mor

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Publication Date
Fri Jan 24 2025
Journal Name
Plos One
Assessment of the bypass of obturation materials beyond fractured instruments after using different obturation techniques in simulated curved canals (An in-vitro study)
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This study evaluated the extent to which obturation materials bypass fractured endodontic instruments positioned in the middle and apical thirds of severely curved simulated root canals using different obturation techniques. Sixty resin blocks with simulated root canals were used, each with a 50° curvature, a 6.5 mm radius of curvature, and a length of 16.5 mm, prepared to an ISO #15 diameter and taper. Canals were shaped using ProTaper Universal files (Dentsply Maillefer) attached to an X-smart Plus endo motor (Dentsply), set at 3.5 Ncm torque and 250 rpm, up to size S2 at working length. To simulate fractures, F2 and F3 files were weakened 3 mm from the tip, then twisted to break in the apical and middle sections of the canal, re

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Publication Date
Fri Aug 05 2022
Journal Name
Spectroscopy Europe
Raman spectroscopy analysis for monitoring of chemical composition of aspirin after exposure to plasma flame
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A Raman spectroscopy method was optimised to examine the chemical changes of aspirin tablets after interaction with helium temperatures. Several aspirin tablets were exposed to plasma-assisted desorption ionisation flame for different times (10, 30, 50, 60, 180 and 300s) and then analysed by Raman spectroscopy using optimal conditions. The changes in chemistry between exposed and fresh (without exposure to plasma) tablets were compared. The vibrational peaks of the aspirin molecule in the Raman spectrum were identified by checking the peak position. The results showed clear spectra with increases in intensity of vibrational peaks until 30s, whereas no spectra were measured for the exposed tablets to plasma flame after 50s. It can, the

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Publication Date
Sun Jan 01 2023
Journal Name
Ibero- American Journal Of Exercise And Sports Psychology
THE EFFECT OF SPECIAL EXERCISES USING TWO DESIGNED DEVICES IN DEVELOPING SOME DEFENSIVE HANDBALL SKILLS
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