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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Jan 01 2021
Journal Name
Indian Journal Of Forensic Medicine & Toxicology
Evaluation of Morphological (Macroscopic and Microscopic) Parameters of Placentas in Pregnancies Complicated by Preeclampsia, Diabetes and Preeclampsia and Diabetes.
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This study was done to compare the morphometric parameters of placentas in well controlled patients with preeclampsia, diabetes, and preeclampsia-diabetes with that of normal uncomplicated placentas. Patients & Methods: A total of Twenty four placentas were freshly collected. Six placentas for control group and eighteen placentas for complicated group (preeclamptic-diabetic and preeclamptic--diabetic subgroups). The placentas were grossly examined (shape, number of cotyledons, weight, and thickness). After suitable fixation, tissue processing and sectioning, the sections were stained by hematoxylin and eosin to study the general morphology and morphometry of the following parameters: number of terminal villi, number of syncytial knots, numb

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Publication Date
Mon Jan 26 2026
Journal Name
Al–bahith Al–a'alami
The role of witchery and astrology programs in spreading illusion and myth
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« The emergence of satellite channels has led to fundamental changes in the supposed role of television, making it a center of culture and an important tributary to social upbringing and influencing the attitudes and values of individuals and in making public opinion regarding various issues, some television programs target ordinary people at home by virtue of the nature of their subjects, where there is a large audience of viewers, who consume and absorb what is offered to them from the cultural production of those satellite channels that play with the aspirations of groups of society to find metaphysical or magic solutions to their social problems or psychological delusions. The media, through its various messages, contributes to brin

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Publication Date
Tue Jun 01 2021
Journal Name
Political Sciences Journal
Violence and Extremism in Iraq: Approaches to Motives and Means of Confrontation
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     After the year 2003, Iraq went through multiple waves of violence and at different levels on the security, intellectual, political and social levels. Behind that stood several motives and incentives to enable violence that represented the first axis of research, the most important of which was the political motives that circulated an atmosphere that politics against society and transformed power into a field of political brutality against the individual and the group at once. There are also cultural, intellectual, media and economic motives such as weak cultural independence, poverty, marginalization, unemployment and want, and the absence of a media discourse that rejects violence but incites it, on the other ha

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Publication Date
Sun Mar 04 2012
Journal Name
Baghdad Science Journal
Replication and attenuation of foot and mouth disease virus in chick embryo
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This study includes replication and attenuation of foot and mouth disease virus type O which isolated from infected calves. Many passages for the virus in chick-Embryo were established as a substitute method to the tissue culture which is highly caustic in contrast to the chick embryo. The virus passed ten consequent passages which lead to the reduce of the titer of the virus from 106.53 TCID50/ 0.1 ml in cattle testis tissue culture to 103 TCID50/ 0.1 ml. the pathogenecity of attenuated FMD virus were also studied in both chick-embryo and guinea pigs. Using agar gel diffusion test precipitation antibodies was detected in guinea pig serum after 14 and 21 days post exposure to the attenuated virus. The inoculated guine

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Publication Date
Sun Aug 04 2024
Journal Name
International Journal Of Home Science
The phenomenon of drugs in Iraq and its international and national impacts
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Abstract Drug addiction is considered a criminal behavior, which led the Iraqi legislator to prohibit and criminalize it, imposing penalties on those who use or even approach it. This aims to limit its presence in Iraq and reduce unethical behaviors, leveraging the divine prohibition to curb it. The legislator also encourages media organizations to raise awareness about the dangers of this substance, which has contributed to reducing the phenomenon of drugs in Iraq.

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Publication Date
Sun Sep 30 2012
Journal Name
College Of Islamic Sciences
Abolition and suspension in the verbs of the novice and the news
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In the Name of God, the Most Gracious, the Most Merciful
     Praise be to God, who taught the pen anthropology unless he knows, and peace and blessings be upon the master of bullying, and the imam of the eloquent Prophet Muhammad, the sincere and faithful, and his family and companions as a whole and whoever followed him to the Day of Judgment. And after:
       The science of grammar is among the most important of all language sciences at all, if not the most important of its sciences, due to the multiplicity of its doctrines and schools, the diversity of its methods, its phenomena and subjects, as well as the connection of this science with the most honorable languages,

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Publication Date
Sun Mar 04 2012
Journal Name
Baghdad Science Journal
Levels of Elements in Milk and Yoghurt
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This study aimed to know the concentration of elements content in dairy products. Nine samples collected from the local market in Baghdad, two samples of milk and seven of yoghurt.The results were followed: The ratio of Aluminum In Aluminum cans That is used for storage milk and industrialize yoghurt is about 95.5% ,this ratio is against [1] which said that pureness of Aluminum used in Aluminum cans should not be less than 98-99% . and the ratio of Cadmium reached to 0.001% which is also against [1] which assure that the Aluminum cans should be clean from that element, mean while the concentration of Iron, Copper and Zinc were within the standard level. The highest concentration of Iron was in treatment B2(canon yoghurt)it was 9.95 m

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Publication Date
Sat Apr 02 2022
Journal Name
Journal Of Accounting And Financial Studies ( Jafs )
Impact of Contractual Budget In Support Of Sustainable Development Applied Research In The Ministry Of Housing And Construction And Public Municipalities
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The research starts from studying the contractual budget, which is one of the modern trends in preparing public budgets, both operational and capital, in addition to meeting the requirements of the global trend to achieve sustainable growth in all fields, whether financial or non-financial, and tools for the contractual budget have been identified (participation contracts, planning Implementation, monitoring) and studying its impact in supporting sustainable development through its dimensions (economic, social, and environmental). The method of the questionnaire was adopted as a main tool in collecting information on research variables and distributing it to a sample of (70) individuals who dictate positions of professional respo

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Publication Date
Wed Dec 30 2020
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Identification and Isolation of Caffeic, Chlorogenic and Ferulic Acids in Aerial Parts of Capparis spinosa wildly grown in Iraq
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Capparis spinosa is one of the oldest genera grown in Iraqi land with worldwide traditional medicinal uses beside the culinary uses. These uses were own to the presence of many phytochemical including flavonoids, polyphenols. Among the reported polyphenolic acids are caffeic, chlorogenic and ferulic acids with well-known powerful antioxidant properties. The present work aimed to identify the presence of these polyphenolic acids in Iraqi caper naturally gown in the rural area of middle Iraq following standard chromatographic procedures. Aerial parts of the plant (buds, berries and leaves) were extracted with hydroalcoholic solvent by maceration method. Thin layer chromatographic techniques and HPLC analysis were performed to iden

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Publication Date
Sat Mar 02 2024
Journal Name
International Development Planning Review
EXTRAPOLATION OF THE MACHINE AND ITS EFFICIENCY IN DEVELOPING THE SKILL PERFORMANCE AND ACCURACY OF DRIBBLING IN YOUTH FOOTBALL
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Relying on modern work strategies, such as adopting scientific inductions, consolidates the information in the learner’s memory, develops the skill work of the football player, and raises the efficiency of their motor abilities. From this standpoint, the researcher, who is a teacher at the University of Baghdad, College of Physical Education and Sports Sciences, and follows most of the sports club teams in youth football, believes that there must be From extrapolations through the machine and employing it in the field to serve the skill aspect and benefit from scientific technology in development and making it a useful tool to serve the sports field in football, as the goal of the research was the efficiency of machine extrapolation in de

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