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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Tue Jan 01 2019
Journal Name
Iraqi Journal Of Agricultural Sciences
Effect of magnetic field on the growth, multiplication and concentration of the volatile oil of rosemary officinalis in vitro
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Publication Date
Sun Jun 01 2014
Journal Name
Baghdad Science Journal
Effect of Some Medicinal Plants on the Activity of Some Immunological Factors in Saliva and Serum of Type –?? Diabetics
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The study involved 45 male and 45 females of diabetic patients type- ?? aged from 40-69years , and with the same numbers of males and females for control , all the patients and controls were without any periodontal diseases and without any systemic disease. Diabetic patients were divided in to three groups according to the degree of periodontitis , and the inflamed gingiva of all groups of diabetic patients were treated with the dried fruits powder (crude) of medicinal plants Quercus robur , Thuja occidenalis , Terminalia chebula, Anethum graveolens , respectively and mixture. Some immunological and antimicrobial factors (IgA, Lactoferrin , Lysozyme ) , were detected in serum and saliva of diabetic patients and the control

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Publication Date
Thu Nov 01 2018
Journal Name
Iraqi National Journal Of Nursing Specialties
Assessment of Nurses Implementation of Universal Precautions in the AIDS Wards of Ibn-Zuheir and Ibn- Al- Kahteeb Hospitals
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A descriptive study was conducted at two Epidemic Hospitals in Baghdad from 1st of August( 2003) to 1st of October (2004) in order to identify the nursing staff working in AIDS word to implementation of universal precautions for patients with AIDS and relation to some variable. The sample is consisted of (50) nurses who are working in AIDS ward in Ibn- Zuheir and Ibn- Al- Kahteeb Hospitals. Instruments consist of (20) items related with demographic characteristics of nurses and universal precautions items . Validity of the instrument was established through a panel of( 4) experts in specific fields . Descrip

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Publication Date
Mon Dec 20 2021
Journal Name
Bulletin Of The Iraq Natural History Museum (p-issn: 1017-8678 , E-issn: 2311-9799)
IMPACT OF THARTHAR ARM WATER ON COMPOSITION AND DIVERSITY OF COPEPODA IN TIGRIS RIVER, NORTH OF BAGHDAD CITY, IRAQ
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This study is considered to be the first on this sector of Tigris River after 2003, to evaluate the effect of Tharthar Arm on the composition and diversity of Copepoda in Tigris River. Six sampling sites were selected; two on the Tharthar Arm and four sites along the Tigris River, one before the confluence as a control site and the others downstream the confluence; thirty-five copepod taxa were recorded, 34 taxa in the Tigris River and 25 taxa in the Tharthar Arm.
The highest density of Copepoda was in site 2 at Tharthar Arm was 265584.2 Ind./m3 lead to an increasing in Copepoda density in Tigris River from 63878.2 Ind./m3 in site 1 before the confluence to 127198.3 Ind./m3 in site 4 immediately downstream the confluence. Also, the me

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Publication Date
Mon Jan 01 2024
Journal Name
Brazilian Dental Science
Evaluation of flexural strength and degree of conversion of temporary crown materials at different aging periods in artificial saliva
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Objective: Evaluate the effects of different storage periods on flexural strength (FS) and degree of conversion (DC) of Bis-Acryl composite and Urethane dimethacrylate provisional restorative materials. Material and Methods: A total of 60 specimens were prepared from four temporary crown materials commercially available and assigned to four tested groups (n = 15 for each group): Prevision Temp, B&E CROWN, Primma Art, and Charm Temp groups. The specimens were stored in artificial saliva, and the FS was tested after 24 h, 7 d, and 14 d. A standard three-point bending test was conducted using a universal testing machine. Additionally, the DC was determined using a Fourier transform infrared spectroscopy (FTIR) device. The data were analyzed st

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Publication Date
Tue Nov 09 2021
Journal Name
Journal Of Accounting And Financial Studies ( Jafs )
Artificial intelligence in accounting education and its role in achieving sustainable development goals in the Kingdom of Bahrain/University of Applied Sciences as a model
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The research aims to show the relationship between artificial intelligence in accounting education and its role in achieving sustainable development goals in the Kingdom of Bahrain. The research dealt with the role of artificial intelligence applications in accounting education at the University of Applied Sciences as a model for Bahraini universities to achieve sustainable development goals. The application of artificial intelligence in accounting education achieves seven of the seventeen sustainable development goals. It also concludes that there is an artificial intelligence infrastructure in the Kingdom of Bahrain, as it occupies a leading regional position in digital transformation, as Bahrain ranks first in the Arab world i

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Publication Date
Sun Jan 01 2023
Journal Name
International Journal Of Environmental Science And Development
Estimation of the Concentrations of Some Pollutants Resulting from the Use of Arabian Bakhour and Their Effect in Patients with Asthma in the City of Baghdad
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This research focus on studying 3 types of Bakhour in the markets of Baghdad city and assessing their impact on the quality of life for asthmatic whom used Bakhour at their houses through investigating particles physical properties, also estimating the levels of heavy metals (Cd, Cu, Mn, Pb and Zn), Particulate Matter PM2.5, PM10, Total Volatile Organic Compounds (TVOC) and formaldehyde (HCHO). The quality of life for asthmatic patients whom use Bakhour was assessing by Mini Asthma Quality of Life Questionnaire. The results indicated that shapes of Bakhour particles were irregular or spherical. Burning process generated the higher percent of PM ˂1μm. Type 2 Bakhour showed the highest percent of <1μm which was 73%.The amount of

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Publication Date
Sun Dec 01 2019
Journal Name
Al- Mohtaref Journal
Impact of The Use of Electronic Concept Mapping Strategy in Learning and Retaining Some of The Skills of The Ground-Moving Carpet in Women's Artistic Gymnastics
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The study aimed to identify the use of the electronic concept maps method in learning some of the skills of the floor exercises in the artistic gymnastics for third graders ,as well as to identify the best group between the two research groups (experimental And the officer to learn and retain some of the skills of the floor exercises in the artistic gymnastics of the research subject , and the experimental method was used and included the sample research on students of the collage of Physical Education and Sports Sciences/University of Baghdad, third grade, and has selected (10) Students for each group of The experimental and controlling groups randomly by lottery and after the completion of the period of implementation of the experiment wh

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Publication Date
Sat Dec 01 2018
Journal Name
Journal Of Economics And Administrative Sciences
The Degree of Management Practice of Roaming and Its Role in Achieving Organizational Justice ((An analytical Study of the Opinions of Directors in Anbar Education Directorate))
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Abstract

This Study aimed to investigate the reality of the application of the degree of management practice by Walking Around, namely (discovery of facts, improvement of communication, motivation, development, creativity and feedback) and Its role in achieving organizational justice (procedural justice, distributive justice, Interactional Justice),The availability of the core principles of this system from the point of view of the senior management personnel in the Directorate of Anbar Education, and the importance of research in the philosophical rooting of the nature of the variables as a modern administrative terminology, the research dealt with a problem expressed by a number of intellectual and appl

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Publication Date
Wed Oct 28 2020
Journal Name
International Journal Of Agricultural And Statistical Sciences 16
Effect of nano-fertilizers and amino acids on the growth and yield of broccoli
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