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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Jan 01 2002
Journal Name
Msc Thesis
Anatomical , Histological and Ultrastructural Study of the Hypophysis and Epiphysis Cerebri in Common Quail . Coturnix coturnix coturnix L
...Show More Authors

View Publication
Publication Date
Sun Sep 22 2019
Journal Name
Baghdad Science Journal
Synthesis and Characterization of New Selenonitrone Derivative and Its Effect on Breast Cancer Cell Line Viability in Vitro
...Show More Authors

          New nitrone and selenonitrone compounds were synthesized. The condensation method between N-(2-hydroxyethyl) hydroxylamine and substituted carbonyl compounds such as [benzil, 4, 4́-dichlorobenzil and  2,2́ -dinitrobenzil] afforded a variety of new nitrone compounds while the condensation between N-benzylhydroxylamine and substituted selenocarbonyl compounds such as [di(4-fluorobenzoyl) diselenide and (4-chlorobenzoyl selenonitrile] obtained selenonitrone compounds. The condensation of N-4-chlorophenylhydroxylamine with dibenzoyl diselenide obtained another type of selenonitrone compounds. The structures of the synthesized compounds were assigned based on spectroscopic data (FT-IR,

... Show More
View Publication Preview PDF
Scopus (5)
Scopus Clarivate Crossref
Publication Date
Wed Feb 04 2026
Journal Name
Journal Of Baghdad College Of Dentistry
Oro-facial manifestations, oxidative stress marker and antioxidant in serum and saliva of patients with Beta thalassemia major
...Show More Authors

Background: Beta thalassemia is a typically autosomal recessive form of severe anemia which is caused by an imbalance of two types of protein (alpha and beta) subunits of hemoglobin. Oxidative stress imbalance is the equilibrium between pro-oxidant\antioxidant statuses in cellular system, which results in damaging the cells. Antioxidant is a chemical that delays the start or slows the rate of lipid oxidation reaction and it play a very important role in the body defense system against reactive oxygen species. The aims of this study were to recorded the oro-facial manifestations in beta thalassemic patients and assess the oxidative stress marker malondialdehyde in serum and salivs and their role in the pathogenesis of beta thalassemia and ev

... Show More
View Publication Preview PDF
Publication Date
Mon Aug 01 2022
Journal Name
Journal Of Medicine And Life
Effect and benefit of percutaneous coronary intervention in chronic total occlusion on ventricular repolarization: QT correction and dispersion
...Show More Authors

ST segment, T wave changes, QT interval changes, and QTc dispersion are among the parameters used to diagnose ischemic heart disease. The increase in the QT dispersion can be caused by myocardial ischemia, among other heart diseases, whereas cardiac diseases such as coronary artery disease (CAD) can be diagnosed by observing an abnormally high QTc dispersion. This study aimed to evaluate the variations in the QTc dispersion (depolarization and repolarization) of surface electrocardiography as a result of percutaneous coronary intervention (PCI) in patients with chronic total occlusion. This study took place in the Iraqi Center for Heart Disease from October 2020 to February 2021. 110 patients who suffered from chronic occlusion of t

... Show More
View Publication
Scopus (13)
Crossref (6)
Scopus Crossref
Publication Date
Thu Jun 15 2017
Journal Name
Journal Of Baghdad College Of Dentistry
Assessment Of Vascular And Lymphatic Vessels Density In Benign Vascular Lesions Using CD34 And D2-40 Immunohistochemical Markers
...Show More Authors

Background: Vascular tumors and malformations, comprising a broad category of lesions often referred to as vascular anomalies. Hemangioma, represents a variety of vascular lesions (both malformations and tumor), while lobular capillary hemangioma is a common vascular lesion of the skin and mucous membranes that occurs mainly in children and young adults. Lymphangiomas are malformations of the lymphatic system. At the level of light microscopy the small lymphatics vessels may be similar to capillaries and sometimes are only tentatively identified by the nature of their contents or by immunohistochemical staining procedure. This study aimed to assess the vascular and lymphatic vessels density in benign vascular lesions using CD34 and D2-40 im

... Show More
View Publication Preview PDF
Crossref
Publication Date
Thu Dec 28 2023
Journal Name
The Iraqi Journal Of Veterinary Medicine
Molecular Identification and Phylogenetic Analysis of Salmonella‎ species ‎Isolated from Diarrheal Children and Dogs in Baghdad Governorate, ‎Iraq‎
...Show More Authors

This work aimed to use conventional PCR to identify Salmonella‎ spp. that ‎were isolated from diarrheal children and healthy and diarrheic dogs based on four ‎virulence genes, hilA, stn, spvR‎, and marT. Sixteen Salmonella‎ isolates including: 9 ‎isolated from children's diarrhea from three species (S. Typhimurium, S. Enteritidis, S. ‎Typhi) and seven isolated from dogs including (S. Typhimurium, S. Enteritidis, S. ‎Muenchen), were identified primarily by several methods. The PCR products of the 16S ‎rRNA gene were sequenced and examined using BLAST analysis to find differences and ‎similarities between these Iraqi isolates and already-known global strains in order to ‎construct the phylogenetic tree of S.

... Show More
View Publication
Scopus (1)
Scopus Crossref
Publication Date
Wed Mar 30 2022
Journal Name
College Of Islamic Sciences
The Neglected Narrators in " Weak and Abandoned narrators" Book of Al-Darqutni and Their Relationship to the Abandonment
...Show More Authors

 

The research handles the prominent books of The Weak and Unknown Narrators , which is written by Imam Abu Al-Hasan Al-Daraqutni. It contains a brief introduction about the book and about Abu Bakr Al-Barqani, as well as Abi Mansour Ibn Hamkan.

The research handles the issue of unknown narrators and their relationship to the abandonment stipulated in the preamble to the book.

The research dealt with the identification and comparison between the sayings of Al-Daraqutni and his students - especially Al-Burqani, the publisher of his knowledge, as he is the one who narrated the sayings of Al-Daraqutni. The study concluded that the principle is to abandon the me

... Show More
View Publication Preview PDF
Crossref
Publication Date
Tue Dec 01 2020
Journal Name
Egyptian Journal Of Medical Human Genetics
Association between ABO blood groups and susceptibility to COVID-19: profile of age and gender in Iraqi patients
...Show More Authors
Abstract<sec> <title>Background

A case-control study was performed to examine age, gender, and ABO blood groups in 1014 Iraqi hospitalized cases with Coronavirus disease 2019 (COVID-19) and 901 blood donors (control group). The infection was molecularly diagnosed by detecting coronavirus RNA in nasal swabs of patients.

Results

Mean age was significantly elevated in cases compared to controls (48.2 ± 13.8 vs. 29.9 ± 9.0 year; probability [p] < 0.001). Receiver operating characteristic anal

... Show More
View Publication
Scopus (22)
Crossref (16)
Scopus Clarivate Crossref
Publication Date
Mon Jun 01 2015
Journal Name
Journal Of Economics And Administrative Sciences
Display, analyze and evaluate the alternatives selected models used in the measurement and disclosure of corporate social responsibility
...Show More Authors

       The economic development and intense competition may make economic units neglected the social aspect as a service workers and the environment, the community and focus on the economic side and achieve profitability only, which puts it in a position of accountability of trade unions and bodies, environment, health, civil society organizations and the focus of many studies accounting in order to clarify social activities and disclosed in the financial statements, increasing pressure from multiple parties calling for governments to issue laws and regulations oblige economic units to disclose complete and accurate information in a timely manner for all social activities and be subj

... Show More
View Publication Preview PDF
Crossref
Publication Date
Sat May 01 2021
Journal Name
European Journal Of General Dentistry
Assessment of Serum Interleukin-1β and Interleukin-6 Levels in Patients with Chronic Periodontitis and Coronary Heart Disease
...Show More Authors
Abstract<p> Objective The aim of this study was to assess whether serum cytokine levels correlate with clinical periodontal parameters in health or disease.</p><p> Materials and Methods Male subjects (40–60 years) with CP (n = 30), CP + CHD (n = 30), and healthy controls (n = 20) had plaque index (PLI), gingival index (GI), bleeding on probing, probing pocket depth (PPD), and clinical attachment level (CAL) evaluated. Serum IL-1β and IL-6 levels were quantified using enzyme-linked immunosorbent assay.</p><p> Results PLI, GI, PPD, and CAL were significantly higher in patients with CP + CHD compared to those with CP. Serum levels of IL-1β and IL-6 were also si</p> ... Show More
View Publication
Scopus (15)
Crossref (14)
Scopus Crossref