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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Thu Apr 11 2019
Journal Name
Iraqi Journal Of Market Research And Consumer Protection
STUDY THE MICROBIAL CONTAMINATION OF BROKEN AND CRACKED COMMERCIAL TABLE EGG IN BAGHDAD MARKETS AND ITS ECONOMIC EFFECT: STUDY THE MICROBIAL CONTAMINATION OF BROKEN AND CRACKED COMMERCIAL TABLE EGG IN BAGHDAD MARKETS AND ITS ECONOMIC EFFECT
...Show More Authors

The aim of this novel native study was to determine the microbial contamination of broken and cracked imported commercial table egg in Baghdad markets and its economic effect. A total of 21510 commercial chicken table eggs were checked and surveyed from retail markets in different popular regions of Baghdad city during a year period from January 3rd to December 28th of 2018 and its microbial contamination were studied. Results revealed that significant differences (P<0.01) were appeared in the studied microbial counts during months of the study and significant differences (P<0.01) in the average counts between broken and cracked eggs and sound (not bro

... Show More
View Publication Preview PDF
Publication Date
Mon Jan 01 2024
Journal Name
Scripta Medica
Effect of proteolytic enzymes and insulin sensitiser in treatment of joint osteoarthritis in diabetic patients
...Show More Authors

Background/Aim: Knee osteoarthritis is a frequently crippling chronic condition. Numerous pharmacological medications have been successfully utilised to treat knee osteoarthritis. This research aimed to compare the efficiency of metformin and serratiopeptidase in treating and preventing osteoarthritis development via distinct mechanisms. Methods: Between 1 January and 30 May 2019, a randomised-clinical-trial was done at Al-Kindy Hospital on 80 osteoarthritis patients, divided in two groups. Group I was given metformin 850 mg orally, whereas Group II was given serratiopeptidase 20 mg and metformin 850 mg orally. Parameters in these groups were compared with forty healthy normal controls. Results: Following treatment, patients in Grou

... Show More
View Publication
Scopus (1)
Scopus Crossref
Publication Date
Sun Dec 03 2017
Journal Name
Baghdad Science Journal
Determination of the Level of some Adipokines in Hypo-and Hyperthyroids Patients in Baghdad City
...Show More Authors

Determination of the level of adipokines (obestatin, vaspin, tumor necrosis factor-? and interleukin-6)in hypo-and hyperthyroid patients from Educational Baghdad Hospital in Baghdad City was investigated. Fifty patients with hypothyroidism and Fifty patients with hyperthyroidism were selected. A control group of thirty euthyroid persons was included. Blood was collected by vein puncture and serum was separated and stored at –20C. Adipokines (obestatin, vaspin, tumor necrosis factor-? and interleukin-6) were estimated using ELISA method. The findings show a significant (p<0.05) increase in obestatin level in hypothyroid patients, while there is no significant difference in hyperthyroid patientsas compared with the euthyroid subjects.

... Show More
View Publication Preview PDF
Scopus (3)
Crossref (1)
Scopus Crossref
Publication Date
Sun Dec 16 2018
Journal Name
Al-academy
Employment of Folk Games and Tales in Developing the Skills of Spontaneous Acting in Kindergartens
...Show More Authors

Some may think that the games, especially the folk games, are just a means of entertainment and fun and children may resort to them to alleviate the tension they are experiencing at home or school, but the truth is that they carry values and meanings that can be invested in education because they contribute to the development of the personality of the child and enhance self- confidence. The objective of the research is to learn how to use folk games to develop children's acting and   performance skills in the   kindergartens.

The research included a theoretical introduction of three sections: the first section: education through play. The second section: the folk tale and the development of imagination and the

... Show More
View Publication Preview PDF
Crossref
Publication Date
Fri Aug 01 2014
Journal Name
Journal Of Economics And Administrative Sciences
The impact of strategic approach in the effectiveness of small and medium Enterprises in Iraq
...Show More Authors

The purpose of this research highlight the achievement of the effectiveness of small and medium enterprises dimensions and conformable to analyze the relationship between business strategies and human resources management strategies , and launched search of a dilemma thought provoking fundamental questions revolve around the search is the lack of appropriate strategies in these enterprises to help them continuity and permanence in business and markets , as these enterprises lack the human resources management strategies appropriate , as well as business strategies that make them withstand the changes in the market environment is changing and volatile . It was to

... Show More
View Publication Preview PDF
Crossref
Publication Date
Fri Dec 26 2025
Journal Name
Foro De Profesores De Ele(universitat De València)
Study of the difficulties and strategies of learning atonic pronouns in ELE teaching in Iraq
...Show More Authors

The objective of this study is to analyze the difficulties faced by intermediate-level Iraqi students in the use of Spanish unstressed pronouns as a foreign language (ELE). Through a mixed methodology, a descriptive and explanatory analysis was conducted based on written and oral productions of B1-level students at the University of Baghdad.The results show that factors such as interference from the native language (Arabic) and English, as well as grammatical differences between Spanish and Arabic, generate difficulties in the correct use of unstressed pronouns. A contrastive teaching approach is proposed that takes advantage of students' cognitive abilities to highlight similarities and differences between both languages.This stu

... Show More
View Publication Preview PDF
Publication Date
Tue Jun 16 2020
Journal Name
Baghdad Science Journal
Qualitative and Quantitative Evaluation of Active Constituents in Callus of Lavandula angustifolia plant in Vitro
...Show More Authors

This study was conducted to describe a protocol for the callus establishing culture of Lavandula angustifolia plant and estimating their content of volatile oil. The quantity of volatile oil callus tissues was compared with that of leaves production. Callus was induced from leaf explants on Murashige and Skoog medium (MS) supplemented with Naphthalene acetic acid (NAA) and Benzyl adenine (BA) in different concentrations. Maximum callus fresh weight was obtained in the combination of 10 mg/L BA and 3 mg/L NAA which reached 18 g after four weeks. The results of this work showed that the  quantity of volatile oil from the highest fresh weight callus was 6 ml compared with quantity of 18g of leaves which gave 0.5 ml. Volatile o

... Show More
View Publication Preview PDF
Scopus (13)
Crossref (5)
Scopus Clarivate Crossref
Publication Date
Mon Mar 01 2021
Journal Name
Journal Of Physics: Conference Series
Determination of some biochemical parameters in sera of normotensive and hypertensive obese female in Baghdad
...Show More Authors
Abstract<p>Obesity is a disease describe a case of excessive accumulation of body fats. Obesity is linked to the morbidity of human health, such as the development of hypertension. The study designed to investigate the levels of glucose, urea, creatinine, and lipid profile parameters in sera of obese female and hypertensive obese female. The study included 90 subjects who divided onto three groups equally, in which they are healthy control, normotensive obese, and hypertensive obese. A significant elevation (P<0.01) has observed in the level of glucose, urea, creatinine, triglycerides (TGs), cholesterol, LDL-C, and VLDL-C in obese females compared with control, yet only TGs and VLDL-C were si</p> ... Show More
View Publication
Scopus (4)
Crossref (2)
Scopus Crossref
Publication Date
Wed Jan 01 2020
Journal Name
Annals Of Tropical Medicine And Public Health
The role of electrolytes and inflammatory biomarkers in the development of febrile seizure in children
...Show More Authors

View Publication
Scopus (2)
Crossref (1)
Scopus Crossref
Publication Date
Thu Mar 30 2017
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Clinical Evaluation of Melatonin Alone and in Combination with Pizotifen in the Prophylaxis of Migraine
...Show More Authors

The treatment of migraine headache targets the neurovascular mechanism and involves the use of serotonin receptor antagonists. Some of these drugs are used for the treatment of acute attacks; while others are effective as prophylactic measures to decrease the duration and frequency of attacks. Pizotifen, a 5-HTA antagonist, is one of the prophylactic drugs for which the clinical use resulted in low outcomes in reducing migraine symptoms. Melatonin, a serotonin derived neurohormone, was reported to exert many functions like sleep induction, anti-inflammatory, neurovascular regulation, cytoprotection and modulation of neurotransmitter release.  In the view of the involvement of serotonin in the pathophysiology of migraine a

... Show More
View Publication Preview PDF
Crossref