Preferred Language
Articles
/
bijps-367
Bioequivalence and Pharmacokinetics Comparison of Two Formulations of Extended-Release Pentoxifylline Tablets in Healthy Subjects after Fasting and Fed Conditions
...Show More Authors

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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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.

Crossref
View Publication Preview PDF
Quick Preview PDF
Publication Date
Wed Aug 01 2018
Journal Name
Journal Of Economics And Administrative Sciences
Comparing parameters and Reliability of two-parameters exponential
...Show More Authors

One of the most important problems in the statistical inference is estimating parameters and Reliability parameter and also interval estimation , and testing hypothesis . estimating two parameters of exponential distribution and also reliability parameter in a stress-strength model.

This parameter deals with estimating the scale parameter and the Location parameter µ , of two exponential distribution   ,using moments estimator and maximum likelihood estimator , also we estimate the parameter R=pr(x>y), where x,y are two- parameter independent exponential random variables .

Statistical properties of this distribution and its properti

... Show More
View Publication Preview PDF
Crossref
Publication Date
Wed Mar 25 2020
Journal Name
Journal Of World's Poultry Research
Comparison of Weight, Components and Chemical Composition of Eggs in Guinea Fowl, Turkey, and Domestic Chicken.
...Show More Authors

The present study was carried out to compare the physicochemical characteristics of eggs of guinea fowl, turkeys and domestic chickens outdoor reared in traditional farms in Baghdad, Iraq. A total of 166 fresh eggs; 32 eggs from guinea fowls (Numida meleagris), 44 eggs from turkeys (Meleagris gallopavo) and 90 eggs from domestic chickens; were collected. Egg weight, percentage of egg components, chemical composition (protein, lipids, and ash), and lipid profile were determined. Results revealed the significant differences in egg weight among studied birds. The average egg weights for guinea fowl, turkey, and indigenous chicken were 48.51 ± 0.72, 52.15 ± 0.74 and 61.24 ± 0.22 g, respectively. No significant differences were found in egg c

... Show More
View Publication
Scopus Crossref
Publication Date
Fri Jan 01 2016
Journal Name
Al-qadisiyah Medical Journal
Comparison between dome and wedge osteotomy in management of hallux valgus deformity
...Show More Authors

Background: the condition of hallux valgus is considered as the most common deformities affecting females more than males, characteristically manifested as lateral deviation of the big toe and widening of first and second inter -metatarsal angle with a deformity of second toe in some severe cases. Objective: to make a radiological and clinical assessment of two surgical methods of osteotomy used in treatment of hallux valgu and to compare between them: first one is the distal dome osteotomy, and second one is a distal wedge metatarsal osteotomy. Patients and methods: a total of 36 feet of 28 patients suffer from hallux valgus, with mean age of 50.3 years were included in this study, followed for 6- 30 months ( mean follow-up of 8.8 months).

... Show More
Publication Date
Thu Jan 01 2015
Journal Name
International Journal Of Astronomy And Astrophysics
Determination of Velocity and Radius of Supernova Remnant after 1000 yrs of Explosion
...Show More Authors

Supernova explosions are described as very violent events which transfer a significant amount of energy to interstellar media and are responsible for a large variety of physical processes. This study does not discuss the actual explosion mechanisms but follows the behavior of the dynamical evolution of some selected type I and type II supernova remnant and particularly after a thousand years from their explosion and shows how the density of the medium affects the evolution and the lifetime of each remnant. By studying such behaviors, a simplified model has been proposed here for the velocity and radius of the remnant after thousand years of explosion that depends only on the density of the medium and age of the remnant. It has been found th

... Show More
View Publication Preview PDF
Crossref (3)
Crossref
Publication Date
Sun Apr 30 2017
Journal Name
Ibn Al-haitham Journal For Pure And Applied Sciences
Design of Electrostatic Unipotential Lens Accelerating And Decelerating Operated Under Finite And Infinite Magnification Conditions
...Show More Authors

  Theoretical study computerized has been carried out in field electron optics , to design electrostatic unipotential lens , the inverse problem is important method in the design of electrostatic lenses by suggesting an axial electrostatic potential distribution using polynomial function. The paraxial –ray equation is solved to obtain the trajectory particles that satisfy the suggested potential function. In this research , design electrostatic unipotential lens three-electrode accelerating and decelerating L=5 mm operated under finite and infinite magnification conditions. The electrode shape of the electrostatic lens was then determined from the solution of the Laplace's equation's. the results showed low values of spherica

... Show More
View Publication Preview PDF
Publication Date
Sun Oct 01 2017
Journal Name
Al–bahith Al–a'alami
Issues of Media Trials in Iraqi after 2003
...Show More Authors

The Supreme Judicial Council decided on July 3, 2003, to set up a court to deal with the issues of publication and media. This court tries to solve the problems of media and publishing in both its civil and penal aspects. The decision of establishing the court represents a new and important step to be taken by the Iraqi Judicial Council for the tremendous development witnessed by media sector in general and press in particular especially after 2003.
This study includes two main axes: the first one deals with the most important crimes of publication in the Iraqi legislations such as the crimes of defamation, libel, insult, indecency, and incitement; the second deals with an analytical survey of the completed cases i.e. the issues tha

... Show More
View Publication Preview PDF
Crossref
Publication Date
Wed Feb 20 2019
Journal Name
Political Sciences Journal
the circulation of power in Iraq after 2003
...Show More Authors

The deliberation and exchanged of power is a matter of political importance For the Iraqi political system after 2003, The deliberation of power and its democratic transition and electoral integrity Is a good indicator of political stability and progress In the Iraqi parliamentary political system , The transfer of authority in terms of adopting the deliberative approach represents a structural and institutional dimension of the political process , it led the power to become Authority of the Foundation Exercised in accordance with the Constitution and the law not real power , And lead to the recognition of the existence of an official parliamentary opposition and its right to take political power later through the ballot box Makes the pr

... Show More
View Publication Preview PDF
Crossref
Publication Date
Mon Mar 08 2021
Journal Name
Baghdad Science Journal
Brucella antibod titres base line in the healthy individuals in haweja city
...Show More Authors

152 sera were collected from healthy individuals residing A;-Haweja City were tested for antibody titers for brucella antigens by slide agglutination test

View Publication Preview PDF
Publication Date
Sun Jan 01 2023
Journal Name
Aip Conference Proceedings
Histological changes in the uterus and implantation status in pregnant mice after oral administration of Maca powder
...Show More Authors

View Publication Preview PDF
Scopus Crossref
Publication Date
Mon Nov 01 2021
Journal Name
Journal Of Physics: Conference Series
Light scattering detector based on light-emitting diodes-Solar cells for a flow analysis of Warfarin in pure form and pharmaceutical formulations
...Show More Authors
Abstract<p>Continuous turbidimetric analysis (CTA) for a distinctive analytical application by employing a homemade analyser (NAG Dual & Solo 0-180°) which contained two consecutive detection zones (measuring cells 1 & 2) is described. The analyser works based on light-emitting diodes as a light source and a set of solar cells as a light detector for turbidity measurements without needing further fibres or lenses. Formation of a turbid precipitated product with yellow colour due to the reaction between the warfarin and the precipitation reagent (Potassium dichromate) is what the developed method is based on. The CTA method was applied to determine the warfarin in pure form and pharmaceu</p> ... Show More
View Publication
Scopus (10)
Crossref (3)
Scopus Crossref