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Bioequivalence and Pharmacokinetics Comparison of Two Formulations of Extended-Release Pentoxifylline Tablets in Healthy Subjects after Fasting and Fed Conditions
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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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.

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Publication Date
Wed Jun 30 2021
Journal Name
Journal Of Economics And Administrative Sciences
Comparison of Hurst exponent estimation methods
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Through recent years many researchers have developed methods to estimate the self-similarity and long memory parameter that is best known as the Hurst parameter. In this paper, we set a comparison between nine different methods. Most of them use the deviations slope to find an estimate for the Hurst parameter like Rescaled range (R/S), Aggregate Variance (AV), and Absolute moments (AM), and some depend on filtration technique like Discrete Variations (DV), Variance versus level using wavelets (VVL) and Second-order discrete derivative using wavelets (SODDW) were the comparison set by a simulation study to find the most efficient method through MASE. The results of simulation experiments were shown that the performance of the meth

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Publication Date
Tue Jun 01 2021
Journal Name
Journal Of Economics And Administrative Sciences
Comparison of Hurst exponent estimation methods
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Publication Date
Sat Jul 01 2023
Journal Name
Journal Of Accounting And Financial Studies ( Jafs )
The market value between the two dilemmas of profit distribution and retention: an analytical study in the Iraqi stock market
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Abstract:

             The distribution or retention of profits is the third decision among financial management decisions in terms of priority, whether at the level of theory or practice, as the issue of distribution or retention is multi-party in terms of influence and impact, as determining the optimal percentage for each component is still the subject of intellectual debate because these decisions are linked to the future of the organization and several considerations, The research focus on the nature of the policies followed by the Iraqi banking sector As the sample chosen by the intentional sampling method was represented by the Commercial Bank of

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Publication Date
Sun Feb 03 2019
Journal Name
Journal Of The College Of Education For Women
The concept of suspense and mystery with some references to dickens s Novels ; A tale of two cities and Great expectations
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Publication Date
Wed Feb 20 2019
Journal Name
Political Sciences Journal
Article The problem of nuclear proliferation and its impact on the formula of strategic balance in the Middle East after the events of September 11, 2001
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The issue of nuclear proliferation is one of the most vital issues as it reflects a form of dealing in the field of international relations. Therefore, the Middle East region has taken great interest in reducing the levels of nuclear armament and acquiring nuclear power within the strategic framework of the international and regional powers. The establishment of a nuclear-weapon-free zone in the Middle East region is currently one of the most important international and regional arrangements for controlling the levels of nuclear proliferation and attempting to build a state of stability and balance. In the Middle East and the world. The importance of the research comes from the fact that it deals with an important and vital issue

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Publication Date
Thu Dec 30 2004
Journal Name
Iraqi Journal Of Chemical And Petroleum Engineering
History of a Two-Phase Bubble Condensing in an immiscible Liquid
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Publication Date
Wed Aug 01 2018
Journal Name
Journal Of Zankoy Sulaimani - Part A
A Comparison Study on the Formation of Administrative and Leadership Policies for the Team and Individual Olympic Games in the Iraqi National Olympic Committee
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The planning for the formation of administrative policies and guidance through leadership are important things for managing administrative processes and sporting activities. As both contribute in the stability of the administrative conditions, and their development in the sport federations, whether they both were attentive about team and individual Olympic Games. The two researchers observe that, there is a variation in the correct way of application. Particularly in the formulation of administrative policies and leadership describing it as, modern management standards for both team and individual Olympic Games in the Iraqi National Olympic Committee. That led to cause a misconception and lack of clarity for some administrators of those uni

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Publication Date
Fri Dec 31 2021
Journal Name
Political Sciences Journal
The application of smart power in the regional power struggle in the Middle East after 2011
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Receipt date:12/7/2020 accepted date:24/1/2021 Publication date:31/12/2021

 Creative Commons License This work is licensed under a Creative Commons Attribution 4.0 International License.

The constant characteristic of international relations is the constant change due to political, economic and military developments in addition to technology, and this in turn has led to many transformations in the concept of power, its uses, and the elements that form power and its distribution, and according to those variables, the concept of power has shifted from hard to soft, up to smart powe

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Publication Date
Fri May 01 2015
Journal Name
Journal Of Nuclear Medicine
Comparison of in vivo uptake of radioactive gold nanoparticles formulated using phytochemicals
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1267 Objectives Aim to evaluate 198Au nanoparticles (AuNP) biodistribution and uptake in a human prostate model for treatment. Many phytochemicals are known to have anti-tumor properties but have short half-lives in vivo. We hypothesized that using these phytochemicals to formulate and coat AuNP would inhibit enzyme cleavage and enhance their anti-tumor properties. Initial evaluations were performed in SCID mice bearing PC3 tumors. Methods : 198AuNP were formulated with the following gum Arabic, epigalocatechin gallate (EGCg) pomegranate extract and mangiferin extract. The resultant nanoparticles were evaluated in normal mice and in human prostate bearing SCID mice. The tumor bearing mice were injected intratumorally with 3-5 uCi of 198A

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Publication Date
Sat Feb 01 2020
Journal Name
Journal Of Economics And Administrative Sciences
Economic policies and their ability to reform the investment climate Case Study Iraq after 2003
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The investment climate is the main engine of economic development. If an appropriate and attractive investment climate is created that takes into account economic, administrative, political and environmental issues, it will contribute to the development of industry, transfer of technology, diversification of agricultural production, increased productivity, the promotion of a green economy and support for sustainable and inclusive growth. Thus, analyzing the investment climate of a country can provide reasons and roots for the complexity of the problems in the economy. In the Iraqi economy, the problem has not been rooted in the economy, but the roots of the problem are deeper and inherent in the management of the economy. Investm

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