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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Fri Mar 22 2019
Journal Name
Journal Of Pharmaceutical Sciences And Research
Evaluation of the efficacy of caries removal using papain gel (Brix 3000) and smart preparation bur (in vivo comparative study)‏
...Show More Authors

Publication Date
Sun Sep 04 2016
Journal Name
Baghdad Science Journal
Comparative Study of Grains, Flours and Baking Quality of Wheat Cultivar (Uruq) with Other Wheat Cultivars (Triticumaestivum L.) in Iraq
...Show More Authors

The grain hardness, wet and dry gluten contents, protein and ash contents are determined in grains from different cultivars of wheat which are important in food products, either which are present in raw materials or in final products. Wheat is also a very important food raw material, and flour as the final product of milling. The importance of knowing the physical and chemical properties of wheat and flour is due to the determination of quality and kind of flour which is produced after the milling process. In this work, some physical and chemical properties of different wheat cultivars are determined and the comparisons of these characteristics are performed in both wheat and flour. Uruq Wheat sample (W5) has the highest results when compar

... Show More
View Publication Preview PDF
Crossref (2)
Crossref
Publication Date
Wed Mar 04 2026
Journal Name
Journal Of Language Studies
Opening the Box of Suffering, Unleashing the Evils of the World’: Pandora and her Representation in Nineteenth-Century American Poetry
...Show More Authors

View Publication
Publication Date
Fri Aug 25 2023
Journal Name
Enterprenuership Journal For Finance And Bussiness
Argumentative Accounting conservatism and the performance of institutions listed on the Iraq Stock Exchange in light of the Coronavirus pandemic
...Show More Authors

This study aims to test whether the institutions listed on the Iraq Stock Exchange have a significant correlation between the level of conservative accounting practice with the level of market share returns during the Coronavirus pandemic period as one of the policies to confront the economic repercussions of the Coronavirus pandemic. Furthermore, the sample included institutions listed on the Iraq Stock Exchange during the 2019 and 2020 years, i.e., the period before the Coronavirus pandemic and during the Coronavirus pandemic for the purpose of comparison. The market value to book value model was used, and the study found that conservative institutions had achieved the highest level of market share prices compared to non-conservat

... Show More
View Publication
Crossref
Publication Date
Wed Jan 01 2025
Journal Name
Aip Conference Proceedings
Histomorphometric and histochemical study of the adrenal gland in adult males of the Iraqi pin-tailed sandgrouse bird (Pterocles alchata)
...Show More Authors

The adrenal gland is a vital endocrine gland that secretes many important hormones in the daily life of birds. It is located in the Iraqi Pterocles alchata bird on both sides of the aorta in the front and side of the cranial lobe of the kidney at the caudal end of the lungs, triangular shape with a creamy yellow color. The statistical analysis showed no significant differences between the weight and length of the right and left glands. Histologically the gland of the sandgrouse bird capsule contains autonomic nodes consisting of nerve cells and the average thickness of the capsule is 42.69±1.81μm, the parenchyma of the gland is divided into two areas; the cortex and medulla in addition to the blood sinuses. The cortex area is divided into

... Show More
View Publication
Scopus Crossref
Publication Date
Sun Dec 01 2019
Journal Name
Journal Of Accounting And Financial Studies ( Jafs )
Evaluation the Emotional Intelligence of Administrative and Audit leaderships in the Federal Board of Supreme Audit to achieve audit Effectiveness
...Show More Authors

The Psychologists have noticed, not long ago, that the man’s success and happiness in life do not only depend on his degree and education, which express on his mental intelligence but also they need another kind of intelligence called emotional intelligence. The research aims at identifying the emotional intelligence level of the top and administrative leaderships in the Federal Board of Supreme Audit by evaluating their emotional intelligence when the administrative and audit leaderships face emotional interactions by dealing with administrative and audit stuffs in the Board. The research problem is focused on the following question “Is the emotional intelligence of the top and administrative leaderships in the Fede

... Show More
View Publication Preview PDF
Publication Date
Mon Dec 27 2021
Journal Name
Palarch's Journal Of Archaeology Of Egypt/egyptology
The social and artistic connotations of the mural paintings of the Iraqi woman in the popular movement-an analytical study
...Show More Authors

In the contemporary political history of Iraq, a unique protest broke out on October 1st, 2019. This protest reappeared on October 25th and lasted up to the following weeks making this protest as the most comprehensive and deepest one. It has the possibility of lengthening and the diversification of methods among all the social protesting movements during the century for Iraq. This desperate youth movement presents various images and methods to highlight the image of the protesting movement. The role of the Iraqi woman was clear, which was embodied through the mural paintings expressing her artistic and social role in conveying and expressing the goal of the protest. The aim of the current research is to identify the social artistic implica

... Show More
Publication Date
Wed Jun 19 2019
Journal Name
Journal Of Accounting And Financial Studies ( Jafs )
Impact of Self-Assessment on Income and Sale Tax Collection' From the Point View of Income Tax Auditors in Jordan
...Show More Authors

This study aimed to show the extent of compliance with the income taxpayer  to provide tax returns and increase the speed of collection of these taxes in addition to increasing confidence in  Income Tax department and reduce the number of cases transferred to the courts and promote taxpayer awareness in charge of the importance of self-assessment system, and study sought to investigate the effect of the existence of records documents, technical audit, and computational audit and documentary audit on income tax collections in Jordan, from the point of viewof Jordanian income tax auditors ,results shows there's a strong  relation between these variables and Income Tax collections.

View Publication Preview PDF
Crossref
Publication Date
Sun Jul 01 2001
Journal Name
Bulletin Of The Iraq Natural History Museum (p-issn: 1017-8678 , E-issn: 2311-9799)
A COMPARATIVE STUDY OF ECOLOGICAL AND GENETICAL ADAPTATION OF THREE IRAQI FRESH WATER SNAILS IN RESPECT TO HEAVY METAL POLLUTION
...Show More Authors

A comparative study was carried out on ecological and genetical adaptation of three Iraqi
freshwater snails, Physa acuta, Melanopsis buccinoidea and Melanoides tuberculata, in
respect to acute toxicity of heavy metals (Zn, Cd and Hg). Longevity are used as poisoning
tolerance criterion. LT 50 and LT 100 were determined for the studied snails at (0.5, 1, 5, and
10 ppm), for the three metals. Results indicated that Physa acuta had a higher tolerance than
Melanopsis buccinoidea and Melanoides tuberculata, which was the lower one. Previous
exposure to heavy metals in the original habitat was affecting on experimental tolerance and
no relationships of physical and chemical factors (total hardness, temperature, D. O. and

... Show More
View Publication Preview PDF
Publication Date
Fri Jan 01 2021
Journal Name
Review Of International Geographical Education Online
Quality of Transition to E-Learning under Corona pandemic: An Application Study in College of Administration and Economics, Baghdad University
...Show More Authors

E-learning is a lifeline for the educational process, which contributed to the sustainability of working educational organizations and prevented them from stopping, so the study came to measure the compatibility between E-learning quality dimensions (information technology, educational curricula, teaching methods, and intellectual capital of educational institution) as an independent variable, and educational services quality dimensions represented by (safety, tangibility, reliability and Confidence) as a dependent variable. The sample was 150 teachers was drawn from the College of Administration and Economics community of 293 teachers through the use of several statistical methods to measure the degree of correlation and impact between the

... Show More
Scopus