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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Aug 01 2023
Journal Name
Baghdad Science Journal
Corrosion Inhibition of Medium Carbon Steel in the Acidic Medium Using Alcoholic and Aqueous Extract of Kujarat Tea Plant
...Show More Authors

This study deals with the corrosion inhibition of metal corrosion process of medium carbon steel using 1M HCl for kinetic studies and rate reaction determination. The weight loss method is applied to pieces of Medium carbon steel divided to Cubans with dimensions (0.4*2*2.4) cm , and use Tafel Extrapolation Method, the samples were polished using carbide silicon paper with dimensions of (180,200,400,600,800,1000). The samples were immersed in the alcoholic medium ethanol at a temperature 293K for 3hr. Natural inhibitor Kujarat Tea (Hibiscus sabdarriffa L.) is used which is extracted in aqueous and alcoholic medium, different concentrations (1000،2000, 3000) ppm have been used ; The best concentration found through the results is a conce

... Show More
View Publication Preview PDF
Crossref
Publication Date
Sat Feb 26 2022
Journal Name
Sport Tk-revista Euroamericana De Ciencias Del Deporte
Effect of physical exertion training on bio-kinetic abilities in weightlifting among students of Physical Education and Sports Sciences
...Show More Authors

The objective of this research was to study the effect of physical exertion training on bio-kinetic abilities in weightlifting among students of Physical Education and Sports Sciences. The present study had a pre-posttest experimental design in which participants were recruited in two groups: experimental group and control group. A total of 30 students of Physical Education and Sports Sciences constituted the sample of the study. The sample selection was done by a comprehensive inventory method. Participants were equally allocated into two groups with n=15 in each group. Participants of experimental group were made to perform special physical exercises with three training units per week during eight weeks. The statisti

... Show More
View Publication Preview PDF
Scopus Crossref
Publication Date
Wed Jun 17 2020
Journal Name
Journal Of Research In Medical And Dental Science
Impact of Thumb Sucking Habit on Eruption of Permanent Teeth and Intelligence Quotient Among Children in Karbala City, Iraq
...Show More Authors

Background: There is a pronounced controversy regarding the dental and mental consequences of thumb sucking habit, which is a familiar nonnutritive pattern of sucking. Commonly, this behavior is harmless, yet those who sustain this pattern may have dental alterations and emotional difficulties. Children’s intelligence level influences their capabilities to judge, evaluate and handle priorities and/or problems profoundly and precisely. Thumb sucking habit might be a manner of liberating the psychological tenseness among several children. Objective: The purpose of this study is to assess the prevalence of thumb sucking habit and its relation to the eruption of permanent teeth and IQ among children aged 6-7 years old. Subjects and methods: I

... Show More
Publication Date
Wed Feb 25 2026
Journal Name
Journal Of Physical Education
The Effect of Using Teaching Aid on the Development of Straight Forehand and Backhand Shot Performance in Lawn Tennis
...Show More Authors

The problem of the research lies in finding aiding means that improve and facilitate learning artistic skills during the main part of a teaching sessions due to their great importance in developing the accuracy of forehand and backhand skills in tennis. Players are usually faced with difficulties at the beginning of learning due to lack of coordination in ball striking thus including a teaching aid will have a positive effect on learning some forehand and backhand skills. The research aimed at designing exercises using teaching aid in tennis as well as identifying the effect of these exercises on the accuracy of performing forehand and backhand shots in tennis. The researcher used the experimental method on (38) tennis players from Al Zewra

... Show More
View Publication Preview PDF
Publication Date
Sat Dec 01 2018
Journal Name
Baghdad Science Journal
Seasonal variation and modeling of disinfection by-products (DBPs) in drinking water distribution systems of Wassit Province Southeast Iraq
...Show More Authors

Scopus (8)
Scopus
Publication Date
Mon Jan 01 2018
Journal Name
Indian Journal Of Public Health Research & Development
Environmental Assessment of the Quality of Water and the Hydrochemical Formula Used for Some Groundwater Wells in Karbala Governorate
...Show More Authors

View Publication
Scopus (1)
Scopus Crossref
Publication Date
Sun Jun 05 2016
Journal Name
Baghdad Science Journal
Effect of varicocelectomy on sperm parameters, oxidative stress and Chromatin maturity in seminal fluid of infertile patients with varicocele
...Show More Authors

This study aimed to determine the effect of varicocelectomy on sperm parameters, oxidant- antioxidant status and chromatin maturity percent. The current study has been conducted on 154 infertile patients complaining from varicocele and varicocelomized men in addition to 25 fertile men as control. The results revealed significant decrease (P<0.05) in sperm concentration, progressive motile sperm percent, normal sperm morphology percent, GSH, SOD1, CAT levels and chromatin maturity percent and significant increase (P<0.05) in MDA and ROS concentrations in infertile patients with varicocele when compared to fertile men. The results revealed improvement (P<0.05) of sperm parameters quality, GSH, SOD1, CAT, MDA, ROS concentration and chromatin m

... Show More
View Publication Preview PDF
Crossref
Publication Date
Mon Mar 13 2017
Journal Name
Journal Of Baghdad College Of Dentistry
Effect of Tea Tree, Thymus Vulgaris and Nigella Sativa Oils on The Elimination of Enterococcus Faecalis (In Vitro Study)
...Show More Authors

ABSTRACT Background: The main goal of chemomechanical endodontic treatment is the reduction or elimination of microorganisms from root canal system. The intracanal medicaments were used to enhance the disinfection process. This study was conducted to evaluate the antibacterial effect of thymus vulgaris, tea tree essential oils and cold pressed black seed oil (BSO) against E.faecalis. Materials and methods: E.faecalis was isolated from ten patients in need for endodontic treatment. The sensitivity of E.faecalis to the tested oils was evaluated in different concentrations in agar well diffusion method and compared with calcium hydroxide. The sensitivity of E.faecalis to vapor of the tested oils was also evaluated, in disk vaporization method

... Show More
View Publication Preview PDF
Crossref (6)
Crossref
Publication Date
Fri Apr 30 2021
Journal Name
Onkologia I Radioterapia
The prevalence of lymph proliferative disorders in a group of Iraqi patients and its relation to blood indices parameters
...Show More Authors

Abstract: Lymphoproliferative Disorders (LPDs) are a group of neoplasms affecting various cells within lymphoid system. Each type has different treatment a..70619

View Publication
Scopus (1)
Scopus
Publication Date
Sun Apr 01 2018
Journal Name
Journal Of Educational And Psychological Researches
The psychological, social and academic problems that encounter students of college of education in Al-Anbaar University /Al-qaim
...Show More Authors

The study aims to identify the psychological, social, and academic problems that encounter students at the college of education. To this end, the researcher utilized the descriptive approach, where a questionnaire was used as a tool to collect the study data. The findings of study revealed that the main academic problems are inability to understand what the students read, lack of concentration over the process of studying. The Difficulty of preparation for test. Lack of ability to memorize quickly. As for the prominent social problems: the excessive usage of social media that drove students away from their main tasks, the Lack of participation in social activities, the scarcity the religious information. The psychological problems includ

... Show More
View Publication Preview PDF