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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Sat Jun 15 2024
Journal Name
Journal Of Legal Sciences
Scientific chairs of Iraqi universities and their role in achieving sustainable development goals
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تهدف الدراسة إلى استعراض ظهور كراسي اليونسكو في الجامعات العراقية والأنشطة التي تم تنفيذها لتحقيق أهداف التنمية المستدامة، حيث تم إنشاء كل كرسي لتحقيق أحد هذه الأهداف التي تركت أثرها على بعض القطاعات التعليمية والاجتماعية ، وبالتالي تنبع أهمية الدراسة من الحاجة إلى الإشارة إلى إنشاء كراسي اليونسكو في الجامعات العراقية والأنشطة التي عززت إنشائها ونشاطها ومبادراتها المحلية والدولية, وكذلك تحديد ما حقق

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Publication Date
Thu Sep 15 2022
Journal Name
Al-academy
Color diversity and its aesthetic value in the designs of children's fashion fabrics
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Fabric design is one of the arts in which humans participate functionally and aesthetically. Researching its design aspects is an important goal, especially after taking technical developments to cover many of its fields. Modern designs emphasize the importance of preparing designs and implementing them according to the child’s ability, inclinations and desires (mental, psychological and emotional). ), as the child is the real focus of the design idea, and the designer has paid most of his attention to the requirements and needs of this stage (childhood stage) because of its importance in the life of society, as he focused his attention on implementing designs that could achieve stability and stability in the child’s psyche through s

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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)
Isolation and Identification of Phenolic Compounds from Dianthus orientalis Wildly Grown in Iraq.
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The plant Dianthus Orientalis that belongs to the Caryphyllaceae family is one of the useful plants in Iraq. Its seeds are commonly used for toothache. This project provides the first comprehensive research done in Iraq and the world to study the phytochemicals and the methods of extraction and isolation of active constituents from Dianthus orientalis wildly grown in Iraq. The plant was harvested from Penjwin in AL-Sulaymaniyah city, Iraq in September 2019.The whole plant were washed carefully, dried in shade area for two weeks, and milled in a mechanical grinder to a coarse powder. The plant was defatted by maceration with hexane for 7days and dried after that extracted by cold extraction methods using

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Publication Date
Wed Sep 14 2016
Journal Name
Journal Of Baghdad College Of Dentistry
Immunohistochemical Expressions of AKT, ATM and Cyclin E in Oral Squamous Cell Carcinoma
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Background: Understanding the pathogenesis and molecular basis of Oral Squamous Cell Carcinoma (OSCC) has increased rapidly over the past few years that is essential to improve patient's prognosis and treatment modalities. The purpose of this study to evaluate the Immunohistochemical expressions of AKT, ATM, AND Cyclin E in oral squamous cell carcinoma Materials and methods: This study was performed on a forty formalin-fixed paraffin-embedded blocks which histopathologically diagnosed as Oral Squamous Cell Carcinoma. All cases were collected from the Histopathological Laboratory from patients treated surgically at Maxillofacial surgery Department at Ramadi Teaching Hospital, Iraq. Results: The immunohistochemical staining of AKT showed pos

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Publication Date
Sun Apr 17 2016
Journal Name
Al-academy
Optical patterns and aesthetic values in the halls of events: رواء مصطفى خلف
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current research Cares about study patterns of optical and aesthetic values in the halls of occasions (weddings) because of their importance in providing an atmosphere of joy. The problem was through the study of light and its impact on the receiver and found a researcher that interior spaces allocated to the halls inappropriate in terms of functional and aesthetic so necessitated the need to study this phenomenon in order to be addressed through the study of light and its impact on the users of those spaces where research aims to current detection properties patterns optical in the internal spaces of the halls and identify some of the aesthetic values of the lighting for the interior spaces.The search consists of four chapters, the firs

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Publication Date
Wed Dec 30 2015
Journal Name
College Of Islamic Sciences
Rooting non-violence in the Holy Quran And models of the Prophet application
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The term “non-violence” is a means of political, social, and advocacy that excludes force in reaching its objectives, and lacks infringement of the rights of non-violence. The policy of non-violence is a beautiful logic of the whole of Islamic creation, in that it is an integral part of the whole structure of Islam and it is a policy of brilliant and brilliant saying in the Almighty: `` Neither level nor good or bad, pay what is better, If that between you and him enmity as if he were intimate guardian (Suratvsalat, verse: 34. Has According to the prophet of Islam, it means that God gives to kindness (kindness) what does not give to violence (Sunan Abu Dawood, 4/255). These terms accurately communicate what is meant by violence and n

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Publication Date
Thu Jun 01 2017
Journal Name
كلية التربية للبنات
The rights of orphans in the Old Testament and Islam, a Comparative Study
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Allah Almighty has aggrandized the position of orphans and elevated their status in the society and has given the graces for those who sponsor the orphan and care for and protecting them, even those who rub their heads. The divine care is manifested in the verses of the Holy Bible and the Holy Quran. Therefore, the whole world cared for the orphan, and called for the rights of the orphans in the conferences and the channels. But all that was little effort that does not meet what the orphan need and some were only ink on paper that were not applied. All that mentioned above is necessary in dealing with the study (the rights of orphans in the Old Testament and Islam, a Comparative Study). The study was divided into a Preface and four inquirie

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Publication Date
Tue Nov 06 2018
Journal Name
Iraqi National Journal Of Nursing Specialties
Determination of Quality Assurance for Maternal and Child Health Services in Baghdad City
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Objective: To determine the quality assurance for maternal and child health care services in Baghdad City.
Methodology: A descriptive study is conducted throughout the period of November 28th 2008 to October 10th
2009. A simple random sample of (349) is selected through the use of probability sampling approach. The study
sample was divided into four groups which include (220) consumers, (35) medical staff, (72) nursing staff and (22)
organization structure (primary health care centers). Data were collected through the use of assessment tools. It was
comprised of four questionnaires and overall items included in these questionnaires are (116) items. The study
included assessment of organization structure. Data were colle

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Publication Date
Mon Feb 19 2018
Journal Name
Al-academy
Employing cultural forms in the works of Mohammed Ghani Hikmat and Murtada Haddad
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Man always reacts by employing data that he lives inside Artworks and he tries to make them an ideal speech that shows the most important intellectual trends to which he belongs, as it happened in the formal building of the ancient arts . Mesopotamia is one of the civilizations that interacted with the intellectual legibility transforming into visual symbols, so it is difficult for the researcher to interpret these symbols without considering the nature of these civilizations in general .
This current search aims to identify similarities and differences in the recruitment of cultural shapes between the works of the sculptors (Mohammed Ghani Hikmat and Murtada Haddad) .
Researcher adopted an approach of analytical description of the

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Publication Date
Fri Dec 29 2023
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Consequences of Anabolic Androgenic Steroids Abuse in Males, Sexual Hepatic and Metabolic Perspective
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Abstract

Background: anabolic androgenic steroids (AASs) are becoming increasingly popular between bodybuilders and people who want to enhance their physiques. However, according to the rise of the Internet and laws prohibiting sales of these substances without prescription, the route of obtaining and administration practices have become more and more dangerous.

Objective: Anabolic-androgenic steroids represents a group of synthetic testosterone derivatives its play an important role in clinical treatment. These group of drugs are widely abused among the general public to increase lean body weight and improve athletic performance. It has been reported that AAS use can cause many adverse e

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