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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Sep 14 2016
Journal Name
Journal Of Baghdad College Of Dentistry
Comparison of Immunoglobulin IgA Level in the Stimulated Saliva of Caries-Free and Caries-Active Children Aged 7-10 Years
...Show More Authors

Background: Salivary immunoglobulin IgA plays an essential role in the immune response against dental caries. This studywas conducted to compare the salivary IgA levels and flow rate of stimulated saliva in caries active and caries free children. Materials and methods: The present study included sixty healthy children age 7-10 yearswho were divided into two groups. They were caries free and caries active children (30 children in each group). Assessment and recording of caries – experience were through the application of Decayed, Missing and Filled Tooth Index (DMFT) and (dmft) index, for permanent and deciduous teeth respectively. After dental examination, stimulated saliva samples were collected from the subjects and performed und

... Show More
View Publication Preview PDF
Crossref (5)
Crossref
Publication Date
Sun May 15 2022
Journal Name
Bionatura
Comparison between the presence and absence of mixing in the anaerobic biological treatment of liquid waste for the cheese industry
...Show More Authors

Many nations are seeing an increase in water pollution from dairy and cheese production due to the high organic and fat content in their waste products and the high temperature of their waste products, which elevates the water temperature and causes loss to ecosystem components. Reusing industrial wastewater that has been treated to guarantee no harm has been done to the environment is being hampered by a lack of water. This study compares the presence and absence of mixing in the anaerobic biological treatment of liquid waste for the cheese industry. To decrease heat exchange with the external environment, cube-shaped anaerobic reactors with dimensions of (30 x 30 x 30) cm and thick glass (10 mm) were utilized in this investigation

... Show More
View Publication
Scopus (1)
Crossref (1)
Scopus Crossref
Publication Date
Wed Jan 01 2025
Journal Name
Veterinary World
Comparison of the sequences of the viral capsid protein 1 and viral capsid protein 2 encoded genes in symptomatic and asymptomatic cases of canine parvovirus 2 in dogs
...Show More Authors

Background and Aim: Canine parvovirus 2 (CPV-2) is a highly contagious virus that infects wild and domestic canines. Despite the use of a routine vaccination protocol, it is endemic in Iraq. The genetic drift of CPV-2 is a major issue worldwide because it abrogates virus control. In Iraq, there is a knowledge gap regarding the genetic sequences of asymptomatic and symptomatic CPV-2 cases. Therefore, this study aimed to perform a genetic analysis of viral capsid protein 1 (VP1) and viral capsid protein 2 (VP2), two major capsid-encoding genes, to demonstrate the possible role of certain mutations in triggering infection. Materials and Methods: Symptomatic and asymptomatic cases (n = 100/each) were tested by a polymerase chain reacti

... Show More
View Publication Preview PDF
Scopus Clarivate Crossref
Publication Date
Wed Feb 01 2023
Journal Name
Petroleum Science And Technology
Lithofacies and electrofacies models for Mishrif Formation in West Qurna oilfield, Southern Iraq by deterministic and stochastic methods (comparison and analyzing)
...Show More Authors

View Publication
Scopus (17)
Crossref (13)
Scopus Clarivate Crossref
Publication Date
Sat Oct 01 2022
Journal Name
Baltic Journal Of Law & Politics
The position of Iraq in Russia's foreign policy after the year 2000 AD
...Show More Authors

This research deals with the foreign policy and the Russian trends towards Iraqafter the year 2000 AD, the international variables that affect that bilateralrelationship and the importance of the position and weight of Iraq in the MiddleEast and the attempt to include Iraq in the international organizations and blocsled by China and the Russian Federation such as the Shanghai CooperationOrganization, and joining the Chinese Belt and Road project to serve interests TheIraqi economy, and an attempt to extend its influence through security alliances inthe region in general, and Iraq in particular, as the quadrilateral center of the waron terrorism in which Russia, Iran, Iraq and Syria participated, which strengthensbilateral relations between

... Show More
Preview PDF
Publication Date
Fri Sep 08 2023
Journal Name
Hammurabi Journal For Studies
The Impact of the Political Process on Government Stability in Iraq After 2003
...Show More Authors

The research in the variables of the political process and government stability tried to show the impact of the political process on political stability first, and then on government stability second, given that the political process that was established in 2005 was aimed at achieving legitimacy, and its most prominent tools are elections, leading to achieving political stability, including government stability. The issue of governmental stability is one of the important issues in Iraq, but it has not been achieved, as a result of several factors, including problems in political action, as the political process has not succeeded in leading Iraq to stability.

View Publication Preview PDF
Publication Date
Tue Mar 19 2019
Journal Name
Political Sciences Journal
Rentierism effect on the democratic choice of the state In Iraq after 2003
...Show More Authors

The linguistic meaning of the verse in the Arabic dictionaries applies very much to the reality of rent and its effect. This is true of economic growth as a continuous increase in real per capita income in addition to the same thing. Therefore, development does not necessarily achieve a comprehensive and structural increase of the various economic sectors. As the rent came in the sense of a terrible land open Maim any fertilized. And the camel is a ma'aya and a ra'i: that is, it goes in the pasture and returns itself. This is similar to the extraction of oil after it is ready for investment and earn its revenue as soon as it exists or is extracted by external parties. If the rent is first linked to agriculture, especially the fertile lan

... Show More
View Publication Preview PDF
Crossref
Publication Date
Mon Dec 30 2024
Journal Name
مجلة الكوفة للعلوم القانونية والسياسية
MANIPULATION OF SOFT POWER IN THE US COMPREHENSIVE STRATEGY TOWARDS FRANCE AFTER 2001
...Show More Authors

Although the events of September 2001 marked the United States' employment of solid forces in its direct comprehensive strategy to counter terrorist organizations and any other challenges to US national security, the United States did not lose sight of the importance of the cultural variable. The cultural variable is the United States' most important instrument of soft power in ensuring its dominance of the international system and promoting its global project. France viewed US soft power as a threat to its own civilizational pattern. Therefore, France considers culture to be an inherent component of its national personality and a cornerstone of its international standing as a major force. Additionally, the US-French political and economic

... Show More
View Publication
Publication Date
Sun May 01 2016
Journal Name
2016 Al-sadeq International Conference On Multidisciplinary In It And Communication Science And Applications (aic-mitcsa)
Review and performance comparison of VANET protocols: AODV, DSR, OLSR, DYMO, DSDV & ZRP
...Show More Authors

View Publication
Scopus (25)
Crossref (14)
Scopus Crossref
Publication Date
Sun Sep 01 2013
Journal Name
Baghdad Science Journal
Comparison study of Interleukin-1 alpha between Unstable Angina and Acute Myocardial Infarction patients
...Show More Authors

Multiple studies support a role for inflammation in the pathogenesis of coronary atherosclerosis and unstable cardiac syndromes. However, of the known pro-inflammatory cytokines, only elevated plasma levels of interleukin-6(IL-6) have been linked to Unstable Angina. We sought to examine the plasma levels of other major proinflammatory cytokines in similar clinical settings patients with unstable angina and acute myocardial infarction and the relationship extent between them. This study aimed to investigate and compare the level of IL-1 in Unstable Angina and Acute Myocardial Infarction patients. Thirty patients with unstable angina and thirty patients with Acute Myocardial Infarction, also thirty healthy individual as control were included

... Show More
View Publication Preview PDF
Crossref