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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Nov 26 2019
Journal Name
Journal Of Engineering
The Experimental Assessment of R134a and Its Lower GWP Alternative R1234yf in an Automobile Air Conditioning System
...Show More Authors

Reducing global warming potential (GWP) of refrigerants is needed to the decrease of ozone-depleting of refrigeration systems leakages. Refrigerant R1234yf is now used to substitute R134a inside mobile air conditioning systems. Thermodynamic properties of R1234yf are similar to R134a. Also, it has a very low GWP of 4, compared to 1430 for R134a, making it a proper choice for future automobile refrigerants. The purpose of this research is to represent the main operating and performance differences between R1234yf and R134a. Experimental analysis was carried out on the automotive air conditioning system (AACS) with 3 kW nominal capacity, to test and compare the performance of R134a with R1234yf. Experiments were accomplish

... Show More
View Publication Preview PDF
Crossref (2)
Crossref
Publication Date
Mon May 24 2021
Journal Name
Awej For Translation & Literary Studies
Embodied Oppression and Psychological Trauma: The Subjugation of O-lan's in Pearl Buck’s Novel the Good Earth
...Show More Authors

Publication Date
Thu Apr 18 2019
Journal Name
Al-kindy College Medical Journal
The Immediate And Intermediate Results Of Percutaneous Balloon Aortic Valvuloplasty In Patients With Congenital Valvular Aortic Stenosis
...Show More Authors

Background: Aortic valve stenosis results from minor to severe degrees of aortic valve maldevelopment. This stenosis causes mild to severe obstruction of the left ventricular outflow .

Objectives : to study the immediate and intermediate results of percutaneous balloon aortic valvuloplasty in patients with congenital valvular aortic stenosis .

Type of the study: A prospective study.

Methods: The study was done on thirty five patients with congenital valvular aortic stenosis who had percutaneous balloon aortic valvuloplasty  in Ibn Al- Bitar Center for Cardiac Surgery from May 2009 to February 2011.

Results

... Show More
View Publication Preview PDF
Crossref
Publication Date
Mon May 01 2023
Journal Name
Journal Of Pure And Applied Microbiology
The Immunohistochemical Staining of Vimentin and E-Cadherin in Bladder Cancer Patients Infected with Hepatitis C Virus
...Show More Authors

Scopus (23)
Scopus
Publication Date
Wed Dec 01 2021
Journal Name
Baghdad Science Journal
Useing the Hierarchical Cluster Analysis and Fuzzy Cluster Analysis Methods for Classification of Some Hospitals in Basra
...Show More Authors

In general, the importance of cluster analysis is that one can evaluate elements by clustering multiple homogeneous data; the main objective of this analysis is to collect the elements of a single, homogeneous group into different divisions, depending on many variables. This method of analysis is used to reduce data, generate hypotheses and test them, as well as predict and match models. The research aims to evaluate the fuzzy cluster analysis, which is a special case of cluster analysis, as well as to compare the two methods—classical and fuzzy cluster analysis. The research topic has been allocated to the government and private hospitals. The sampling for this research was comprised of 288 patients being treated in 10 hospitals. As t

... Show More
View Publication Preview PDF
Scopus (6)
Crossref (3)
Scopus Clarivate Crossref
Publication Date
Mon Aug 12 2024
Journal Name
دراسات دولية
Towards formulating a new social contract: The political system in Iraq: the dialectic of continuity and permanence
...Show More Authors

The social contract represents a set of laws and determinants agreed upon by a group of individuals in order to organize society for the better.This agreement guarantees them to live in peace according to the pre-agreed laws, and on the basis of that, it represents the key to resolving the crisis relations between the state and society, and this is what prompted Iraqi society to move towards the formulation of a new social contract through popular protest movements in 2019.To overcome the old social contract that shook the trust between the state and society as a result of its negative outputs at various political, economic and social levels, and many problems emerged that hindered the process of building the social contra

... Show More
View Publication
Publication Date
Tue Aug 01 2017
Journal Name
Journal Of Economics And Administrative Sciences
Measure the level of banking performance in accordance with the e-marketing and total quality management requirements
...Show More Authors

Acquires Find importance of the overall quality and e-marketing management have become important factors in evaluating the performance of banks, which are related to the life of the community intimately, so it is important that the banks applying comprehensive quality and e-marketing management requirements in order to maintain their performance and determine their level, as well as the manifest importance of research in part, practical linking the requirements of total quality management and banking performance on the one hand and between the e-marketing and performance banking on the other hand, through the provision of scientific bases that can be based on the banks in question, as it kicks off the research problem in that mos

... Show More
View Publication Preview PDF
Crossref
Publication Date
Fri Sep 15 2023
Journal Name
Journal Of Water Resources And Geosciences
Evaluation of Water and Wheat Productivity under Center Pivot Sprinkler Irrigation in Desert Soils/Holly Karbala Governorate
...Show More Authors

Two field experimسents were conducted in one of the fields of the Agriculture Division of Ain Al-Tamr /Holy Karbala Governorate at two sites of different textures during the agricultural season 2020/2021. The first site has sandy loam texture (gypsum soils). The second site has loamy sand texture (calcareous soils). The factors of the study included: The first factor included two types of soil, gypsum and calcareous soil. The second factor is the tillage systems (no-tillage, spring spike harrows, disc harrows, and mold board plow). The experiment was designed in the two study sites according to the RCBD with three replications. The Valley type center pivot irrigation system was evaluated before planting, three speeds, 30, 50 and 100% of th

... Show More
View Publication Preview PDF
Publication Date
Wed Aug 30 2023
Journal Name
Baghdad Science Journal
A relationship study of coronavirus (COVID-19) infection, blood groups, and some related factors in Iraqi patients
...Show More Authors

Many studies of the relationship between COVID-19 and different factors have been conducted since the beginning of the corona pandemic. The relationship between COVID-19 and different biomarkers including ABO blood groups, D-dimer, Ferritin and CRP, was examined. Six hundred (600) patients, were included in this trial among them, 324 (56%) females and the rest 276 (46%) were males. The frequencies of blood types A, B, AB, and O were 25.33, 38.00, 31.33, and 5.33%, respectively, in the case group. Association analysis between the ABO blood group and D-dimer, Ferritin and CRP of COVID-19 patients indicated that there was a statistically significant difference for Ferritin (P≤0.01), but no-significant differences for both D-dimer and CRP.

... Show More
View Publication Preview PDF
Scopus (6)
Crossref (3)
Scopus Crossref
Publication Date
Sat Sep 01 2018
Journal Name
Journal Of Al-nahrain University Of Science
Contaminated Fungi in the Biology Department laboratories and Antagonistic Potentiality of MyrtrusCommunisVolatile oil Against the Isolated Fungi
...Show More Authors

View Publication
Crossref