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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 18 2019
Journal Name
Asian Journal Of Chemistry
Determination of Chemicals and its Isotopic Composition in Tigris River,Iraq
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Stable isotope (?18O, ?D) values were determined along with the chemical compositions at 10 different locations along the Tigris river between Baghdad-Ammara cities of Iraq. The physico-chemical parameters and isotopic data were measured. The sampling site represents 34 % of total Tigris river in the republic of Iraq. The systematically increased in values of stable isotope as move from the downstream of the river and the most significantly appears at Kut lake. This increase occurs as a result of several factors, viz. (a) evaporation occurs low water level in the river and its tributaries, and (b) return flow water to the river from irrigation water in groundwater systems. The change in ion distribution and in the isotopic values related di

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Publication Date
Sat Dec 11 2021
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Community Pharmacists' Attitudes and Practice in the Management of Minor Ailments
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This study aimed to know the attitudes and practice of pharmacists regarding the management of minor ailments in Iraqi community pharmacies. A cross-sectional study for 320 community pharmacists was conducted during February 2020 using a newly developed and validated questionnaire. Only 4.4% of pharmacists prefer not to deal with minor ailment cases. Minority (15.6%) of participated pharmacists refer more than half of minor ailment cases they face to the physician. Regarding the assessment of minor ailments using WWHAM technique, what are the symptoms are the most commonly asked questions by pharmacists. Only 49.1% mentioned that they ask all WWHAM questions. On the other hand, most pharmacists (90%) educate their patients about the dosi

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Publication Date
Fri Jan 01 2010
Journal Name
The New Iraqi Journal Of Medicine
Seroprevalence of Hepatitis B and Hepatitis C virus infection in Iraq.
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Publication Date
Tue Aug 15 2023
Journal Name
Al-academy
Government slogans and the reflection of visual identity in their designs
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There is no doubt that development is a human necessity and an urgent technical imperative that science imposes on all aspects of societal life. Especially in the field of graphic design, as logos are among the most prominent graphic achievements of an interactive nature with the requirements of the technical and functional era to serve the recipient and the continuity of interaction with him through a visual message sent to him constantly to remind him of what he interacted with in advance, which is known as visual identity, and during the process of developing logos especially And by providing designs that suit the contemporary technical and functional development, we often see the logo lose its visual identity. Therefore, the research

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Publication Date
Thu Feb 06 2020
Journal Name
Political Sciences Journal
The effect of the media in forming knowledge and political awareness
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Abstract The dissemination of knowledge is no longer confined to schools and universities, not even books. For nearly two centuries, the media have become prominent in disseminating knowledge and culture, in its public and particularly political aspects. After the development of the media from newspapers and magazines to the visual media, their role has increased from the dissemination of abstract information and abstract knowledge towards the process of forming new knowledge through what it publishes and broadcasts from different programs such as drama, news and talk shows. The impact of the media has changed the overall community awareness. Half a century ago the media was not so powerful and widespread. The evolution of the 1990s made

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Publication Date
Sat Jan 02 2021
Journal Name
Journal Of The College Of Languages
Cultural Diversity in Native and Non-Native Speakers of English Communication
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With the advancement of technology ,the study of cross-cultural communication via on line has become an important and researchable topic in linguistic theory and its applications.The aims of this study are two- fold (a) exploring the influence of cultural diversity on on-line interaction between American native speakers (NSs) and Iraqi non-native speakers (NNSs) of English which, together with other factors might potentially lead to what Thomas(1983) calls "pragmatic failure" (PF), a main cause of communication breakdowns and (b) specifying which type of PF occurs more frequently between the two groups along with the reasons behind such failures. To achieve these objectives , a number of online chats conducted between

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Publication Date
Thu Aug 15 2019
Journal Name
Arab World English Journal For Translation And Literary Studies
Silence as a Tactic of Communication in Pragmatics, Novel, and Poetry
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Publication Date
Wed Mar 29 2017
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Preparation and Evaluation of Chloramphenicol as Thermosensitive Ocular in- situ Gel
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The purpose of this study was to develop poloxamer-based in-situ gel of chloramphenicol aiming to increase bioavailability and prolong corneal contact time, controlling drug release, and enhancing ocular bioavailability. The in-situ gel was prepared using different concentrations of poloxamer 407 combined with hydroxypropyl methyl cellulose (HPMC) or carbapol 940 to achieve gelation temperature about physiological temperature and improve rheological behavior and gelling properties of poloxamer gel. The prepared formulations were evaluated for their appearance, pH, and sol-gel transition temperature. The formulations F2, F3, and F5 have a gelation temperature within the accepted range 35-370C an

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Publication Date
Sat Jan 02 2021
Journal Name
Journal Of The College Of Languages (jcl)
Cultural Diversity in Native and Non-Native Speakers of English Communication
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With the advancement of technology ,the study of  cross-cultural communication via on line  has become  an important and researchable topic in linguistic theory and its applications.The  aims of  this study are two- fold (a)  exploring the influence of cultural diversity on on-line interaction between American  native  speakers (NSs) and  Iraqi non-native speakers (NNSs) of English which, together with other factors might potentially lead to what Thomas(1983) calls  "pragmatic failure" (PF), a main cause of communication breakdowns  and (b) specifying  which  type of PF  occurs more frequently between the two groups along with the reasons behind such failures. To achie

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Publication Date
Tue Dec 01 2020
Journal Name
International Journal Of Electrical And Computer Engineering
Analysis of threats and security issues evaluation in mobile P2P networks
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Technically, mobile P2P network system architecture can consider as a distributed architecture system (like a community), where the nodes or users can share all or some of their own software and hardware resources such as (applications store, processing time, storage, network bandwidth) with the other nodes (users) through Internet, and these resources can be accessible directly by the nodes in that system without the need of a central coordination node. The main structure of our proposed network architecture is that all the nodes are symmetric in their functions. In this work, the security issues of mobile P2P network system architecture such as (web threats, attacks and encryption) will be discussed deeply and then we prop

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