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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Tue Dec 20 2022
Journal Name
Bulletin Of The Iraq Natural History Museum (p-issn: 1017-8678 , E-issn: 2311-9799)
FIRST RECORD OF TWO DIPLECTANID MONOGENOIDS FROM THREE SPARID FISHES IN IRAQI MARINE WATERS
...Show More Authors

Parasitological examination of gills of three species of sparid fishes in the territorial waters of Iraq was performed, two diplectanid monogenoids were isolated and described; Lamellodiscus indicus Tripathi, 1959 from both Haffara seabream Rhabdosargus haffara (Forsskål, 1775) and Goldline seabream R. sarba (Forsskål, 1775) and Protolamellodiscus senilobatus Kritsky, Jiménez-Ruiz and Sey, 2000 from King soldierbream Argyrops spinifer (Forsskål, 1775). The record of the parasites is considered new to the parasite fauna of Iraq. The redescription of L. indicus for the first time which is collected from a new distribution area (Arabian Gulf). R. haffara is considered a new host record .

View Publication Preview PDF
Scopus (5)
Crossref (3)
Scopus Crossref
Publication Date
Sun Mar 01 2020
Journal Name
Baghdad Science Journal
A New Two Derivative FSAL Runge-Kutta Method of Order Five in Four Stages
...Show More Authors

A new efficient Two Derivative Runge-Kutta method (TDRK) of order five is developed for the numerical solution of the special first order ordinary differential equations (ODEs). The new method is derived using the property of First Same As Last (FSAL). We analyzed the stability of our method. The numerical results are presented to illustrate the efficiency of the new method in comparison with some well-known RK methods.

View Publication Preview PDF
Scopus (5)
Crossref (1)
Scopus Clarivate Crossref
Publication Date
Thu Jun 30 2022
Journal Name
Iraq Journal Of Market Research And Consumer Protection
COMPARISON BETEEEN THE CONSUMPTION OF RED MEAT AND WHITE MEAT FOR ASAMPLE OF CITIZENS OF THE CITY OF BAGHDAD/ AN EXPLORATORY STUDY
...Show More Authors

Three hundred Iraqi people participated in demographic and attitudes study about red and white meat consumption. The mean age of the participants was 50 SD ± 11 years (mean 30-72); 51% were females and 49% males, mostly in forties who lived ≥ 5 years in Baghdad. The results showed that 80% of individuals prefer red meat. A 90% of people prefer fresh meat compared to frozen and processed meat. A 60% of people buy meat from popular markets. Nearly 87% of respondents believe the improving of livestock sector is essential and 80% of people confirmed there are obstacles to development this sector. An 80% of participates thought the reasons of the high prices of local fresh meat is the lack of planning and support to livestock sector. A survey

... Show More
Preview PDF
Crossref
Publication Date
Tue Aug 18 2020
Journal Name
Journal Of Mechanics Of Continua And Mathematical Sciences
THE COMPARISON OF THE METHODS ESTIMATING THE FRACTIONAL DIFFERENCES OF PARAMETER AND ITS DEPENDENCE ON ESTIMATION THE BEST LINEAR MODEL OF TIME SERIES IN THE ENVIRONMENTAL FIELD
...Show More Authors

View Publication
Crossref
Publication Date
Sun Apr 17 2016
Journal Name
Al-academy
Conditions The chromatography in the design the positions waiting passenger transport buses: مصعب حسن عبد
...Show More Authors

running the requirement color important place in object of life activity both public and private, Fallon makes represents energy expressive and aesthetic in designing furniture street, especially (positions waiting buses passenger transport)which took looms large in attention receiver designer also, through civilized development and urban and change the city. Requirement, The positions of waiting progress jobs service and that would interact to produces Photos aesthetic Furniture for space street and understand receiver, affect the operation his life and the development of his environment and his psyche and culture of because they entity variable and sophisticated, impose on us to find foundations a design and conditions of chromatic esp

... Show More
View Publication Preview PDF
Crossref
Publication Date
Thu Oct 21 2021
Journal Name
Physical Review E
Lattice Boltzmann method with moment-based boundary conditions for rarefied flow in the slip regime
...Show More Authors

View Publication
Scopus (12)
Crossref (9)
Scopus Clarivate Crossref
Publication Date
Tue Jan 24 2023
Journal Name
Archives Of Razi Institute
PCR-RFLP Analysis of Insulin-Like Growth Factor 2 Gene Polymorphisms in Two Commercial Broiler Chicken Strains (Cobb 500 and Hubbard F-15) and Their Associations with Performance Traits
...Show More Authors

The present research aimed to study the polymorphisms of the chicken insulin-like growth factor 2 (IGF2) in two commercial broiler breeds (Cobb 500 and Hubbard F-15). In total, 300 avian blood samples were obtained. The genomic DNA was isolated using a fast salt-extraction technique. Moreover, polymerase chain reaction (PCR) was used to amplify 1146 bp fragments of the gene. The amplified fragments were subjected to restriction enzyme digestion using the HinfI endonuclease enzyme, and the digested products were separated on a 2% agarose gel. The findings indicated that there were two alleles, T and C, for the target locus, with frequencies of 73.3% and 26.7%, respectively. Three distinct genotype variations, TT, TC, and CC, were found, with

... Show More
Preview PDF
Scopus
Publication Date
Sat Jan 01 2022
Journal Name
Biochemical And Cellular Archives
Gene expression of PIP aquaporin (VRPIP2;7) gene in Vigna radita L. plant exposure to melatonin under drought stress conditions
...Show More Authors

The study aimed to detect the VrPIP2;7 gene using PCR approach, as well as to know the effect of the treatment with four increased melatonin concentrations of 50, 100, 150 and 200 ppm in addition to control treatment were 0 ppm on the gene expression of plasma membrane intrinsic proteins (PIP) genes in Vigna radiata L. plant exhibition for five periods of drought which is irrigation every 24 hours, 48 hours, 5 days, 10 days and every 15 days. The electrophoresis of agarose gel at a concentration of 2% showed one band when detecting the VrPIP2;7 gene with a sizeable 732 bp and using the 100 bp volume index. This gene was selected for sequencing study based on its importance as well as on the results of its gene expression. The sequencing of

... Show More
View Publication Preview PDF
Publication Date
Wed Oct 10 2018
Journal Name
Bulletin Of The Iraq Natural History Museum (p-issn: 1017-8678 , E-issn: 2311-9799)
TWO NEW RECORDS OF DWARF SNAKES OF THE GENUS EIRENIS JAN, (REPTTILIA, COLUBRIDAE) IN IRAQI KURDISTAN (NORTH AND NORTHEASTERN OF IRAQ) WITH ANNOTATED CHECKLIST, FOR THE GENUS EIRENIS IN IRAQ
...Show More Authors

    Two dwarf snakes were discovered, Eirenis thospitis Schmidtler & Lanza from Sereen mountain, north east of Arbil  and E. rothii Jan from Saffin mountain North of Arbil  city  North of Iraqi Kurdistan. Supported by description and important notes on variation. In addition summarized list for 9 species of the genus Eirenis Jan in Iraq is also presented.  

View Publication Preview PDF
Publication Date
Sun Jan 01 2017
Journal Name
Iraq Journal Of Agricultural Research
THE COMPARATIVE STUDY OF THE TOTAL COSTS AND NET REVENUE OF DIFFERENT TILLAGE SYSTEMS USING TWO TYPES OF SEEDLINGS IN THE PRODUCTION OF BARLEY GREEN VARIETY SAMEER IN THE GYPSUM SOILS
...Show More Authors