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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Fri Oct 01 2010
Journal Name
Iraqi Journal Of Community Medicine
Clinico-epidemiological and Histopathological Study of Syringoma in Iraqi Patients
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KE Sharquie, HA Hassan, AA Noaimi, IRAQI JOURNAL OF COMMUNITY MEDICINE, 2010

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Publication Date
Sun Feb 03 2019
Journal Name
Journal Of The College Of Education For Women
Shifting Sand of English in Iraq language Policy and Planning
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Shifting Sand of English in Iraq language Policy and Planning

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Publication Date
Sun Feb 10 2019
Journal Name
Journal Of The College Of Education For Women
Effect Repetition of Anticyclone and on thermal characteristic in Iraq
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Anticyclone of synoptic studies that influence weather and climate of Iraq, The aim of
the study is to clarify the effect variation of repetition of Anticyclone and effect on thermal
characteristic in Iraq were pressure level has been analyzed (1000) millibars and that because
of pressure level is the closet to the earth surface and the clarity of climatic phenomenon
based on a systematic analysis of synoptic seeking maps and observation and (12:00)
according to timing GMT for five climatic stations which is (Mosul, Kirkuk, Baghdad, Rutba,
and Basra) and so far three consecutive climatic cycles which is first climatic cycle for period
(1986-1976). and second climatic cycle for period (1997-1987) and third climatic cy

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Publication Date
Sun Mar 03 2013
Journal Name
Baghdad Science Journal
Species of Centaurium Hill. in Iraq and its geographical distribution
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Comparative taxonomic study has been compeleted for the species of the. genus Centaurium Hill. of Iraq. So the morphological characters were studied comparatively for the first time form Iraqi materials. Stems, leaves ,infloresences and reproductive organs characters were a good taxonomic importance. Geographical distrtribution has been done for the species of the genus in addition to the environment information. The results were presented with schedules, tables, maps and micrographs. Taxonomic key for the species separation was also presented.

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Publication Date
Sun Feb 10 2019
Journal Name
Journal Of The College Of Education For Women
The Role of Design And Decoration in Enriching Children’s Clothes
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As the child is growing up, he goes through different phases which will be accompanied by physical and psychological changes. These changes set the basis for processes of designing and making children's clothes which in turn give its required benefits and meet the physiological, psychological and community needs. That will help provide the child with healthy physical and psychological growth.
The aim of this research is to recognize the decoration of clothes by colors and drawings and its role in clothes' richness and children's education. The research limits are objective, The limits are for female (3-5) years old. The research was done in teaching kindergarten in the college of education for women in 2016. The researchers found many

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Publication Date
Tue Mar 28 2017
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Preparation and in-Vitro Evaluation of Mucoadhesive Clotrimazole Vaginal Hydrogel
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Clotrimazole (CLO) is an antimycotic imidazole derivative applied locally for the treatment of vaginal yeast infections. In this study, CLO was formulated as vaginal mucoadhesive hydrogel, using different types of mucoadhesive polymers to ensure prolonged contact between active ingredient and vaginal mucosa.

Physicochemical properties of the prepared formulas were evaluated as a visual inspection, pH, swelling index, spreadability, and mucoadhesive characteristics, in addition to an in-vitro drug release. The influence of type and concentration of polymers as CMC-Na (1.5, 2.5, and 3.5%w/w), carbopol 940( 0.25, 0.5, and 1 %w/w) and poloxamer 407 (15, 25, 30%w/w) on CLO release  from the prepared gels were also invest

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Publication Date
Fri Jan 05 2024
Journal Name
Al-academy
Reading in the Scenery of the performance and its developments
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The importance of this research in studying the actor life existence on the stage through the performance art;where as all the literary theatrical dimensions didn't ignore the importance of the actor's performance.
So, it is shed a light on the nature of the scenery in the actor's performance and what its representations in the temporary directions ……..
The research set off from the imitation as a human instinct to the performance of the actor in post-modernity theater; so the researcher found that there is a question must be answered which is :Is the actor live a regression state in his theatrical performance ,or that the performance of the actor connect with collective conscience of human being which is repeated in certain

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Publication Date
Tue Jan 02 2018
Journal Name
International Journal Of Science& Nature
HYPOTHYROIDISM IN PEDIATRIC PATIENTS: MODE OF PRESENTATION AND TREATMENT OUTCOME
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ABSTRACT The present study was conducted to determine the mode of presentation of hypothyroidism in pediatric patients and the effects of timing of diagnosis and therapy on the patient’s outcome. The study involved review and evaluation of the medical records of 41 registered patients in the Endocrine clinic of Children Welfare Teaching Hospital in Baghdad during the period from January 1991 to July 2007. Forty one patients included in this study. Twenty four (58.5%) were males and17 (41.4%) were females with a male to female ratio of 1.4:1, their age range is 40 days to12.3 years. The majority of the studied patients were infants 19(47%). The most commonly observed presenting features were growth retardation and short stature. The best t

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Publication Date
Wed Apr 01 2015
Journal Name
Al–bahith Al–a'alami
The Role of Internet and its Applications in Spreading Rumors
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The study tries to answer several questions posed by the subject, one of the important: How the Internet promotes rumor? And what are the most Internet applications that promote rumor? And the practical ways to reduce these negative? Using the process of in vestige and reading theoretical heritage available in this field, and inferred the numbers and statistics marked the uses of the Internet and its applications over recent years, and the characteristics of each these tools in the field of collection, processing, and dissemination of information

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Publication Date
Sat Jun 16 2012
Journal Name
University Of Nebraska-lincoln
Occurrence and Effect of Algal Neurotoxins in Nebraska Freshwater Ecosystems
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Algae are photosynthetic microorganisms that play important role in aquatic ecosystems as they are the primary producers in aquatic food webs. Several groups of algae are capable of producing toxins that impact aquatic ecosystems, especially managed systems. Cyanobacteria are the most important algae in freshwaters, and many species produce cyanotoxins including hepatotoxins and neurotoxins. The potent cyano-neurotoxins β-N-methylamino-L-alanine (BMAA), 2, 4-diaminobutyric acid dihydrochloride (DABA), and anatoxin-a are especially critical with regards to public and animal health problems.

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