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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Thu Oct 01 2020
Journal Name
Journal Of Engineering
Chemical-Free Greywater Treatment Using Aeration, Sedimentation, Followed by Granular Activated Carbon Filter (GAC) -A Case Study of Baghdad city household
...Show More Authors

Greywater is a possible water source that can be improved for meeting the quality required for irrigation. Treatment of greywater can range from uncomplicated coarse filtration to advanced biological treatment. This article presents a simple design of a small scale greywater treatment plant, which is a series of physical and natural processes including screening, aeration, sedimentation, and filtration using granular activated carbon filter and differentiates its performance with sand filter. The performance of these units with the dual filter media of (activated carbon with sand) in treatment of greywater from Iraqi house in Baghdad city during 2019 and that collected from several points including washbasins, kitchen si

... Show More
View Publication Preview PDF
Crossref (1)
Crossref
Publication Date
Thu Sep 20 2007
Journal Name
Journal Of Physical Education
The effect of high-intensity interval training (using weights) during the special preparation period on functional variables among junior basketball players
...Show More Authors

This study is concerned with the comparison of the results of some tests of passing and dribbling of the basketball of tow different years between teams of chosen young players in Baghdad. Calculative methods were used namely (Arithmetic mean, Value digression and T.test for incompatible specimens). After careful calculative treatments, it has been that there were abstract or no abstract differences in the find results of chestpass, highdribble and cross-over dribble. The clubs were: (Al-Khark, Air defence, Police and Al-Adamiyah) each one separate from the other for the year (2000-2001). After all that many findings were reached such as the lack of objective valuation (periodical tests) between one sport season and the other. In the light

... Show More
Preview PDF
Publication Date
Mon Mar 27 2023
Journal Name
8th Engineering And 2nd International Conference For College Of Engineering – University Of Baghdad: Coec8-2021 Proceedings
Experimental study of natural convection heat transfer on an enclosure partially filled porous medium heated from below by constant heat flux
...Show More Authors

This study reports on natural convection heat transfer in a square enclosure of length (L=20 cm) with a saturated porous medium (solid glass beads) having same fluid (air) at lower horizontal layer and free air fill in the rest of the cavity's space. The experimental work has been performed under the effects of heating from bottom by constant heat flux q=150,300,450,600 W/m2 for four porous layers thickness Hp (2.5,5,7.5,1) cm and three heaters length δ(20,14,7) cm. The top enclosure wall was good insulated and the two side walls were symmetrically cooled at constant temperature. Four layers of porous media with small porosity, Rayleigh number range (60.354 - 241.41) and (Da) 3.025x10-8 has been investigated. The obtained data of temperatu

... Show More
View Publication
Scopus (3)
Crossref (4)
Scopus Crossref
Publication Date
Thu May 01 2025
Journal Name
Journal Of Industrial And Engineering Chemistry
An innovative combination of anodic oxidation using Cu/SnO2–Sb2O5 rotating cylinder anode with TiO2 photocatalytic process for treating hospital wastewater
...Show More Authors

View Publication
Scopus (2)
Crossref (2)
Scopus Clarivate Crossref
Publication Date
Fri Sep 29 2023
Journal Name
International Journal Of Nanoscience
Preparation of N-A Cysteine-capped CdTe/CdS/ZnS core/shell/shell QDs as a Selective Probe for Detecting Damaged DNA
...Show More Authors

In this study, NAC-capped CdTe/CdS/ZnS core/double shell QDs were synthesized in an aqueous medium to investigate their utility in distinguishing normal DNA from mutated DNA extracted from biological samples. Following the interaction between the synthesized QDs with DNA extracted from leukemia cases (represents damaged DNA) and that of healthy donors (represents undamaged DNA), differential fluorescent emission maxima and intensities were observed. It was found that damaged DNA from leukemic cells DNA-QDs conjugates at 585 nm while intact DNA (from healthy subjects) DNA–QDs conjugates at 574 nm. The obtained results from the optical analyses indicate that the prepared QDs could be utilized as probe for detecting disrupted DNA th

... Show More
View Publication
Scopus (2)
Crossref (2)
Scopus Clarivate Crossref
Publication Date
Mon May 01 2023
Journal Name
Chemical Engineering Research And Design
Treatment of petroleum refinery wastewater by electrofenton process using a low cost porous graphite air-diffusion cathode with a novel design
...Show More Authors

View Publication
Scopus (30)
Crossref (30)
Scopus Clarivate Crossref
Publication Date
Thu Dec 14 2023
Journal Name
Optical And Quantum Electronics
Enhancing response characteristics of palladium-doped vanadium pentoxide on a porous silicon substrate as gas sensor synthesized by pulsed laser deposition
...Show More Authors

View Publication
Scopus (3)
Crossref (2)
Scopus Clarivate Crossref
Publication Date
Sun Dec 22 2019
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Ex-vivo Ex-Vivo Absorption Study of a Novel Dabigatran Etexilate Loaded Nanostructured Lipid Carrier Using Non-Everted Intestinal Sac Model
...Show More Authors

Abstract

The purpose of our study was to develop Dabigatran Etexilate loaded nanostructured lipid carriers (DE-NLCs) using Glyceryl monostearate and Oleic acid as lipid matrix, and to estimate the potential of the developed delivery system to improve oral absorption of low bioavailability drug, different Oleic acid ratios effect on particle size, zeta potential, entrapment efficiency and loading capacity were studied, the optimized DE-NLCs shows a particle size within the nanorange, the zeta potential (ZP) was 33.81±0.73mV with drug entrapment efficiency (EE%) of  92.42±2.31% and a loading capacity (DL%) of 7.69±0.17%. about 92% of drug was released in 24hr in a controlled manner, the ex-vivo intestinal p

... Show More
View Publication Preview PDF
Scopus (16)
Crossref (7)
Scopus Crossref
Publication Date
Sun Oct 26 2025
Journal Name
Journal Of Contemporary Medical Sciences
Comparative Evaluation of Early Pregnancy Outcomes Following Ovulation Induction with Letrozole Versus Clomiphene Citrate: Evidence from a Prospective Iraqi Cohort Study
...Show More Authors

Objectives: To compare early pregnancy outcomes, including miscarriage, ectopic pregnancy, multiple pregnancy, and congenital anomalies, among women who conceived following ovulation induction with letrozole or clomiphene citrate. Methods: A prospective comparative observational study was conducted at Al-Elwiya Maternity Teaching Hospital and a private clinic in Baghdad, Iraq, from March 2023 to December 2024. One hundred infertile women aged 21–35 years who conceived after ovulation induction with either letrozole (5 mg/day) or clomiphene citrate (100 mg/day) for five days (cycle days 3–7) were enrolled. Participants were followed through early pregnancy with serial sonography at 6, 8–11, and 18–20 weeks of gestation. Data

... Show More
View Publication
Crossref
Publication Date
Sat Dec 17 2022
Journal Name
Iraqi Journal Of Laser
PDF Photodynamic effect of Rose Bengal activated by low-level laser light on S. aureus : Qusay K. Abbas*, Layla M. Hassan
...Show More Authors

Abstract: Background: Staphylococcus aureus is Gram-positive bacteria that lives as a normal flora in living organisms but can be pathogenic to humans. Although a relatively unspectacular, nonmotile coccoid bacterium, S. aureus is a dangerous human pathogen in both community-acquired and nosocomial infections. Due to the increasing emergence of new strains of this antibiotic-resistant bacteria, it has become essential to approach different methods to control this pathogen. One of these methods is the antimicrobial photodynamic inactivation process using a low-level laser, in this paper, the Photodynamic effects of Rose Bengal and LLLL on the virulence factors of S.aureus were evaluated.

... Show More
View Publication Preview PDF