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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Jun 04 2008
Journal Name
Ibn Al-haitham Journal For Pure And Applied Science
Synthesis and characterization of new ligand c
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In the present paper we report the synthesis of a new ligand [HL][(2-1-[(2-hydroxy-benzylidene)-hydrazono]-ethyl) benzene-1, 3, 5-triol and its complexes with (Mn", Fe", Cd", and Hg") The ligand was prepared in two steps. In the first step a solution of salicylaldehyed in methanol reacted under reflux with hydrazinemonohydrate to give an intermediate compound which reacted in the second step with 2, 4, 6-trihydroxidernonohydrate giving the tientioned ligand. The complexes were synthesis by direct reaction of the corresponding metal chloride with ligand. The ligand and the complexes have been characterized by spectroscopic methods [" H NMR, IR, UV-Vis,, atomic absorption], HPLC microanalysis along with conductivity measurements. From the abo

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Publication Date
Thu Feb 01 2024
Journal Name
Baghdad Science Journal
Forgotten Index and Forgotten Coindex of Graphs
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F index is a connected graph, sum of the cubes of the vertex degrees. The forgotten topological index has been designed to be employed in the examination of drug molecular structures, which is extremely useful for pharmaceutical and medical experts in understanding the biological activities. Among all the topological indices, the forgotten index is based on degree connectivity on bonds. This paper characterized the forgotten index of union of graphs, join graphs, limits on trees and its complements, and accuracy is measured. Co-index values are analyzed for the various molecular structure of chemical compounds

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Publication Date
Wed Sep 12 2012
Journal Name
Journal Of Engineering
Design and Implementation of a Vlsm Simulator
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Variable-Length Subnet Masks (VLSM), often referred to as "subnetting a subnet", is used to maximize addressing efficiency. The network administrator is able to use a long mask on networks with few hosts, and a short mask on subnets with many hosts. This addressing scheme allows growth and does not involve wasting addresses. VLSM gives a way of subnetting a network with minimal loses of IP addresses for a specific range. Unfortunately, the network administrator has to perform several mathematical steps (or use charts) to get the required results from VLSM. In this paper, a simple graph simulator is proposed (using Visual Basic 6.0 Language) to perform all the required mathematical steps and to display the obtained required information (the

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Publication Date
Sat Mar 30 2002
Journal Name
Iraqi Journal Of Chemical And Petroleum Engineering
Preparation, Characterization, and Properties of Barium Titanate
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Publication Date
Sun Dec 05 2010
Journal Name
Baghdad Science Journal
Jordan ?-Centralizers of Prime and Semiprime Rings
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The purpose of this paper is to prove the following result: Let R be a 2-torsion free ring and T: R?R an additive mapping such that T is left (right) Jordan ?-centralizers on R. Then T is a left (right) ?-centralizer of R, if one of the following conditions hold (i) R is a semiprime ring has a commutator which is not a zero divisor . (ii) R is a non commutative prime ring . (iii) R is a commutative semiprime ring, where ? be surjective endomorphism of R . It is also proved that if T(x?y)=T(x)??(y)=?(x)?T(y) for all x, y ? R and ?-centralizers of R coincide under same condition and ?(Z(R)) = Z(R) .

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Publication Date
Tue Mar 28 2017
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Formulation and Evaluation of Flurbiprofen Oral Film
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Fast dissolving film can be defined as a dosage form, which when placed in the oral cavity. It will rapidly disintegrate and dissolves to release the medication for oral mucosal absorption or allow for the gastrointestinal absorption to be achieved when swallowed.

Flurbiprofen is non-steroidal anti-inflammatory agent with antipyretic and analgesic properties and can be used   in low doses 8.75 mg as analgesic and anti inflammatory agent in sore throat infection. This study aims to   formulate flurbiprofen as oral dissolving films,   to improve the effective relief of pain with severe sore throats with little or no adverse effect.

Nine formulas were prepared using solvent-casting method, and t

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Publication Date
Sun Mar 01 2009
Journal Name
Al-khwarizmi Engineering Journal
Monitoring and Quality Control of Stud Welding
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This study is conducted to carry out a straightforward way appropriate for quality monitoring and stability of arc stud welding process, followed by a number of procedures to control the quality of welded samples, namely torque destructive testing and visual inspection context.  Those procedures were being performed to support the monitoring system and verify its validity. Thus, continuous on-line monitoring guarantees earlier discovering stud welding defects and avoiding weld repeatability. On-line welding electronic monitoring system is for non destructive determining if a just completed weld is satisfactory or unsatisfactory, depending on welding current peak value detected by the system. Also, it has been observed significant ha

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Publication Date
Tue Jul 01 2014
Journal Name
Bulletin Of The Iraq Natural History Museum (p-issn: 1017-8678 , E-issn: 2311-9799)
MORPHOLOGICAL AND ANATOMICAL STUDY OF ASPHODELUS MICROCARPUS
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    The genera and species of Liliaceae show a considerable structural diversity of leaves and especially stems. This paper presents a morphological and anatomical study of the leaves and stems of Asphodelus microcarpus. The results showed that the investigated species had typical morphological characters. and also that it could be distinguished from another plant not only by its morphological but anatomical characters as well.

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Publication Date
Sun Dec 01 2002
Journal Name
Iraqi Journal Of Physics
FLUORESCENCE LIFETIME MEASUREMENT OF C5H6 AND C6D6
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Absorption and lifetime measurements were made for C6H6. and C6D6 molecules in pure solid phase and in solid matrices of Ar, N2, CO, and CO2. All measurement are made at low temperatures ranging between 12-50 K. A modified least square fitting deconvolution was utilized to measure the fluorescence lifetime with an error less than 1%. The results show that the use of matrix isolation technique offer a unique environment that minimize the perturbation of the molecular or atomic system and hence facilitate spectral analysis.

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Publication Date
Thu Feb 23 2023
Journal Name
Chalcogenide Letters
Fabrication and evaluation of CuAlSe2/Si photodetector
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In this work, we have examined the spectral response of (p-CuAlSe2/n-Si) detector, (CAS) thin films deposited by thermal evaporation at RT with a thickness (450) nm, and annealing temperature at (473K) for 2 h. Optical transmission measurements displayed reasonably slight transmission besides higher absorbance trendy the visible region, energy gaps were observed by annealing, were found to be direct, and decreased with the effect of annealing. The extreme responsivity value arises at wavelength 459 nm, with improvement value of specific detectivity and quantum efficiency the annealing films be situated originate as greatest suitable aimed at numerous device application.

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