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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 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
...Show More Authors

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

... Show More
Preview PDF
Publication Date
Sat Dec 31 2022
Journal Name
Iraqi Journal Of Market Research And Consumer Protection
EFFECT OF ADDING QUERCETIN TO TRIS EXTENDER IN SOME SEMEN CHARACTERISTICS OF AWASSI RAMS AFTER DIFFERENT PERIODS OF CRYOPRESERVATION: EFFECT OF ADDING QUERCETIN TO TRIS EXTENDER IN SOME SEMEN CHARACTERISTICS OF AWASSI RAMS AFTER DIFFERENT PERIODS OF CRYOPRESERVATION
...Show More Authors

ABSTRACT

The study evaluated the effect of adding quercetin to some characteristics of the sperm of the ram. This study was conducted in the animal field, Department of Animal Production, College of Agricultural Engineering Science, University of Baghdad for the period 5/12/2021 to 20/2/2022. In this experiment, 3 rams were used at the age of 2-2.5 years and weighed 50-55 kg. The semen was collected early in the morning and once a week and the semen was pooled to remove the individual differences. The treatments were divided: quercetin-free control group, treatment T1 (3 µL/mL quercetin), T2 treatment (6 µL/mL quercetin), T3 treatment (9 µL/mL quercetin). The result of the study showed

... Show More
View Publication Preview PDF
Publication Date
Tue Nov 01 2016
Journal Name
Journal Of Engineering
Automatically Maintain Climatic Conditions inside Agricultural Greenhouses
...Show More Authors

In this work, a novel system is designed to remote monitor / automatic control of the temperature, humidity and soil moisture of the agricultural greenhouses. In the proposed system, the author used the mentioned sensors for monitoring the climatic conditions of the agricultural greenhouses; and the system makes a controlling process to fix the required parameters for plant growth by running / stopping the fan, air exchanger and irrigation devices when any changes happened in these parameters. The presented system is based on XBee protocol in the implemented wireless sensor star topology network (WSN) to monitor the agricultural greenhouses in real time, and used the GSM and Internet technologies to monitor the agricultu

... Show More
View Publication Preview PDF
Publication Date
Tue May 19 2026
Journal Name
Journal Of Baghdad College Of Dentistry
Enamel defect of primary and permanent teeth in relation to nutrients daily intake among Down's syndrome children in comparison to normal children
...Show More Authors

Background: Any child with Down's syndrome does not develop in the same manner as normal child. Therefore, the child should not be viewed as being like everyone else. Developmental enamel defects in primary teeth have been found at least twice as frequently in disabled children as in control children. Down's syndrome consumed protein more than the recommended daily allowance compared to other disabled groups. Therefore, the aim of this study was to investigate developmental defects of enamel and their relations to nutrient intake among Down's syndrome children in comparison to normal children. Materials and Methods: A sample consisted of fifty institutionalized Down's syndrome children (study group) and 50 normal children (control group)

... Show More
View Publication Preview PDF
Publication Date
Sun Feb 03 2019
Journal Name
Journal Of The College Of Education For Women
The Iraqi- Kuwaiti relations after 2003
...Show More Authors

The Iraqi- Kuwaiti relations had witnessed a lot of problems which had its impact on them, at the fore front is the frontier issue, and the Iraqi invasion of Kuwait in 1990 which led to the severance of relations between them and had strengthened the disagreement and the dispute and raised the animosity and tension.
After 2003, Iraq has witnessed a lot of changes which affected Iraq and the region as a whole.
Under the new political developments in Iraq, a now phase has started in the relations between the two parts. which is based on the emphasis on building new relations based on the mutual respect and non intervention in the internal affairs of both countries, and in accordance with the principles of the international law, and w

... Show More
View Publication Preview PDF
Publication Date
Sat Dec 01 2018
Journal Name
Political Sciences Journal
American - Irani Relations after Nuclear Agreement
...Show More Authors

Summary

The fundamental turning point in American policy towards the Iran was the success of the Islamic revolution in Iran 1979 . Since than U S policy has been hostile to Iran . After the events 11 September 2001 , there was an American idea of dialogue with some countries opposed to US policy , including Iran . In 2004 the United States launched the Greater Middle East project , which contain a range of political , economic and cultural proposals for the region , all of which were in the interest of the United States and ( Israel ) , which Iran opposed . The failure of U S projects in region prompted the United States to agree with Iran on the nuclear file . On 8 May 2018 U S President Donald Trump of

... Show More
View Publication Preview PDF
Crossref
Publication Date
Wed Feb 20 2019
Journal Name
Political Sciences Journal
China's Middle East policy after 2001
...Show More Authors

The foreign policy of china is considered an important subject generally, in addition its very significant towards the Middle East specifically. It is the most valued topic, that needs deep academic investigations in order to identify the important factors causes and its consequences, this kind of research provides a proper understanding to the researchers and politicians, it will prove the reasons for China's with the impact to the region, the rivalry with the United States in the coming years

View Publication Preview PDF
Crossref
Publication Date
Fri Sep 30 2011
Journal Name
Iraqi Journal Of Chemical And Petroleum Engineering
Experimental Study on Carbon Steel Corrosion and its Inhibition Using Sodium Benzoate Under Different Operating Conditions
...Show More Authors

Corrosion experiments were carried out to investigate the effect of several operating parameters on the corrosion rate and corrosion potential of carbon steel in turbulent flow conditions in the absence and presence of sodium benzoate inhibitor using electrochemical polarization technique. These parameters were rotational velocity (0 - 1.57 m/s), temperature (30oC – 50oC), and time. The effect of these parameters on the corrosion rate and inhibition efficiency were investigated and discussed. It was found that the corrosion rate represented by limiting current increases considerably with increasing velocity and temperature and that it decreased with time due to the formation of corrosion product layer. The corrosion potential shifted t

... Show More
View Publication Preview PDF
Publication Date
Sun Jun 30 2024
Journal Name
Iraqi Journal Of Science
Efficient Computational Methods for Solving the One-Dimensional Parabolic Equation with Nonlocal Initial and Boundary Conditions
...Show More Authors

     The primary objective of the current paper is to suggest and implement effective computational methods (DECMs) to calculate analytic and approximate solutions to the nonlocal one-dimensional parabolic equation which is utilized to model specific real-world applications. The powerful and elegant methods that are used orthogonal basis functions to describe the solution as a double power series have been developed, namely the Bernstein, Legendre, Chebyshev, Hermite, and Bernoulli polynomials. Hence, a specified partial differential equation is reduced to a system of linear algebraic equations that can be solved by using Mathematica®12. The techniques of effective computational methods (DECMs) have been applied to solve some s

... Show More
View Publication
Scopus (2)
Crossref (1)
Scopus Crossref
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
...Show More Authors

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

... Show More
View Publication Preview PDF
Crossref