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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Wed Jun 29 2022
Journal Name
College Of Islamic Sciences
Obscene speech in the Qur'anic perspective An objective study based on the verses and interpretation of the Noble Qur’an in diagnosis and treatment
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The most famous thing a person does is talk. He loves and hates, and continues with it confirming relationships, and with it, too, comes out of disbelief into faith. Marry a word and separate with a word. He reaches the top of the heavens with a kind word, with which he will gain the pleasure of God, and the Lord of a word that the servant speaks to which God writes with our pleasure or throws him on his face in the fire. Emotions are inflamed, the United Nations is intensified with a word, and relations between states and war continue with a word.

What comes out of a person’s mouth is a translator that expresses the repository of his conscience and reveals the place of his bed, for it is evidence of

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Publication Date
Thu Oct 01 2020
Journal Name
Biochemical & Cellular Archives
STUDY THE EFFECT OF LINUM USITATISSIMUM (FLAX SEEDS) AND EUCALPTUS ROSTRATA (ECALYPTUS) LEAVES EXTRACTS ON PSEUDOMONAS AERUGINOSA GROWTH IN VIVO AND IN VITRO
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This study included the isolation and diagnosis of Pseudomonas aeruginosa from cases of burns samples. 100 samples were collected from resident patients at Al-Kindi Teaching Hospital, who suffer from different types of burns. Pseudomonas aeruginosa was isolated and diagnosed with 39% of the total samples. The cold and hot aqueous and alcoholic extract of flaxseeds oil was prepared and its inhibitory efficacy has been studied on the growth of isolated Pseudomonas aeruginosa. It is revealed that both extracts of flaxseeds oil had a high inhibitory effect on Pseudomonas aeruginosa growth. The Minimum Inhibitory Concentration (MIC) of flaxseed oil on the studied bacteria was also estimated, which was 25 mg/ml. In conclusion, the efficacy of fla

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Publication Date
Tue Oct 10 2023
Journal Name
Current Trends In Biotechnology And Pharmacy
In silico Molecular Docking and Scrutinizing Druglike Properties of Selected Phytoconstituents Against TAK1, Xanthin Oxidase, and IL-1 β Targets in Gouty Arthritis
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Publication Date
Tue Feb 05 2019
Journal Name
Journal Of The College Of Education For Women
The Concept of Value in De Saussair Linguistics and their Extension in the Book (Arabic Language, Its Meaning and Structure) by Tammam Hassan
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This research was distributed into two sections, the first section was concerned with the concept of value for De Saussair and its methodological impact on his linguistic structural conceptions with respect of the distinction between synchronism and diachronism, the value role of linking function between the sounds and the though, the basing of his theoretical conception on the language being a form and not a material according to this principle and the value impact on the demonstration that the linguistic element acquires its functional importance from the relations inside the language system. It also stopped at the methodological impact of value on defining the analytical linguistic unit and the value role in semantics through the prin

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Publication Date
Sat May 11 2024
Journal Name
Tech Hub Journal
The prevailing leadership Patterns and personal traits and their relationship to innovative thinking of female physical education teachers in middle schools in Baghdad
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Teachers play a critical role in planning, organizing, coordinating, monitoring, and instructing, hence the topic of leadership styles receives a lot of attention. As a result, the physical education school is regarded as the most significant component of the educational process because it has the ability to weave together the teaching and educational skills, attitudes, and capacities that its students develop. Fits into their identities through her relationship with them. Teachers play a critical role in planning, organizing, coordinating, monitoring, and instructing, hence the topic of leadership styles receives a lot of attention. As a result, the physical education school is regarded the most significant aspect in the educational proces

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Publication Date
Mon Dec 31 2018
Journal Name
Iraqi Journal Of Market Research And Consumer Protection
THE EFFECT OF ALCOHOLIC EXTRACT OF Borage officinalis ON MONOAMINE OXIDASE (MAO) AND ACETYLCHOLINESTERASE (AChE) IN HUMAN SERUM IN VITRO.: THE EFFECT OF ALCOHOLIC EXTRACT OF Borage officinalis ON MONOAMINE OXIDASE (MAO) AND ACETYLCHOLINESTERASE (AChE) IN HUMAN SERUM IN VITRO.
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This study was designed to show the inhibitory effect of different concentrations of alcoholic extract of Borage officinalis on the Monoamine oxidase (MAO) and Acetylcholinesterase (AChE) enzymes in human serum. The results obtained from the study exhibited that alcoholic extract of Borage officinalis caused inhibition to enzymes activity with all concentrations of the extract. The results also showed that when the concentration of the extract was (0.001 mg/ml), the percentage of inhibition was (4.3% with MAO and 15.2% with AChE) and this percentage increases until reaching up to (74.7% with MAO and 84.18% with AChE) when the concentration of the extract was (0.1 mg/ml). From the kinetic parameters, studies found that alcoholic extract o

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Publication Date
Fri Feb 01 2019
Journal Name
Sci.int.(lahore)
TIME MANAGEMENT AND ITS RELATIONSHIP TO THE STAFF PERFORMANCE IN THE FACULTIES OF PHYSICAL EDUCATION AND SPORTS SCIENCES AT UNIVERSITY OF BAGHDAD
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The study aimed to identify the importance of time in the Faculties of Physical Education and Sports Sciences at the University of Baghdad, as well as to identify the relationship between time management and the level of staff functional performance. The research population consisted of the staff members who work in the Faculties of Physical Education and Sports Sciences for Girls in Al-Jadriya for the academic year 2017-2018. A random sample of 50 staff members from each faculty were selected, that is the total number was (100) staff members. The researchers identified the concept of time management and functional performance, after that a questionnaire consisting of (39) statements and (6) parts presented to a specialized group of experts

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Publication Date
Thu Jan 01 2015
Journal Name
Al–bahith Al–a'alami
Identify trends of media students about satellite channels specialized and its role in the satisfaction of their wishes and develop their abilities
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This search is field research, which aims to explore the trends of students in media department toward specialized Satellite Channels and identify the knowledge capacity and its role in the development of their knowledge’s, represented by watching those channels as well as media students' habits exposed by those channels. As to the public is a key element in the process and substantive communication, the Sociological studies information on that article information is not complete its work, but that he was receiving from before receiving, and send every piece of information content in order to achieve a certain goal, therefore, is the future of receiving such information in order to achieve a particular goal, which is

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Publication Date
Mon Apr 01 2024
Journal Name
Iop Conference Series: Earth And Environmental Science
Effect of potassium nitrate, licorice extract and planting date on field emergence and growth of maize (Zea mays L.) in spring season
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Low temperature and high relative humidity in the spring season led to decrease of field emergence ratio and growth in maize. Planting dates and seeds stimulation can be appropriate fix. Field experiment was conducted in the two spring seasons of 2022 and 2023. Randomize complete block design with split-plot arrangement and four replications was used. Planting date treatments (February 15th, March 1st and 15th and April 1st, 15th) were placed in main plots. Seeds stimulation treatments (potassium nitrate 6 mg L-1 + licorice extract 6 g L-1 as well as treatment of soaking with distilled water only) were placed in subplots. Seeds stimulation (potassium nitrate+licorice extract) or planting date of February 15th were superior at traits of fiel

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Publication Date
Tue Dec 26 2017
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
A Comparative Study of Blood Levels of Manganese, Some Macroelements and Heavy Metals in Obese and Non-Obese Polycystic Ovary Syndrome Patients
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Polycystic ovary syndrome (PCOS) is a prevalent condition in women of reproductive age. It is characterized by androgen excess and chronic anovulation. Some trace elements, macroelements, and heavy metals have been linked to pathophysiological mechanisms of PCOS .

To study the alterations in the serum levels of the trace element manganese (Mn), some macroelements, magnesium(Mg) and calcium (Ca), and the heavy metals cadmium (Cd) and lead (Pb), in obese and non-obese PCOS patients; and the association of these alterations with some of the hormonal changes occurring in PCOS.

The study was carried out at Kamal Al-Samarrai Hospital (Center for Infertility treatment and in vitro Fertilization "IVF") Baghdad- Iraq. Eig

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