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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Jul 01 2016
Journal Name
Bulletin Of The Iraq Natural History Museum (p-issn: 1017-8678 , E-issn: 2311-9799)
STUDY THE EFFECT OF DIFFERENT TYPES OF STRESS ON SOME BLOOD CONSTITUENTS AND PLASMA BIOCHAMICALS IN MALE RATS
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    The objective of this work was to determine and compare the physiological changes in some: blood components (packed cell volume and hemoglobin) and plasma biochemical parameters (glucose, total protein, albumin, cholesterol and triglycerides) under 3 day of different types of stress: water deprivation, starvation, overcrowding and handling stress. Twenty five male Wister rats weighted 100-120 gm, were divided randomly into five groups: control, water deprivation, starvation, overcrowding and handling stress. On the third day of stress the animals anesthetized for blood collection; the results of blood component revealed a significant increase in PCV and a significant decrease in Hb of water deprivation group and starva

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Publication Date
Tue Dec 01 2015
Journal Name
Journal Of Economics And Administrative Sciences
Qualification Of Human Resources To Apply Electronic Management A case study In The Ministry Of Science And Technology
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     This research aims to shed light on the reality of the process of rehabilitation of human resources for the implementation of electronic management practice in the ministry, and availability requirements of the application of electronic management and diagnosis of the most important stages and steps that can be followed in the process of transition towards electronic management to keep abreast of developments in the field of information technology, has been the application of this research in the Ministry of science and technology on a group of heads of departments and directors of the people in the departments of the Ministry through the use of case study method, which includes cohabitation field intervi

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Publication Date
Mon Jan 02 2017
Journal Name
Journal Of Educational And Psychological Researches
The impact of teaching with analogies in collection of chemistry students grade average and their attitudes towards article
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this research aims to identify the impact of teaching with ana logies in collection of chemistry students grade average.And direction in order to verify to the zero hypothesis has been formulated and validated,The researcher conducted experiment lasted a full semester as experimental design was chosen (exactly)two equal one pilot and another officer.The research community has been  selected one of intentional Middle School of the Education Directorate in B aghdad Karkh second either search sample consisted of (68) students from second grade average (34 ) Students for each group randomly selected research groups was equal to the following variables (lifetime months,parent of first grade chemistry degrees average test informat

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Publication Date
Wed Jul 01 2015
Journal Name
Bulletin Of The Iraq Natural History Museum (p-issn: 1017-8678 , E-issn: 2311-9799)
APPROPRIATENESS OF EUCALYPTUS CAMAL / DULENSIS, CASUARINA EQUISETIFOLIA AND OLEA EUROPAEA TREES IN SHELTERBELT OF AL-ASHRAF NAJAF CITY
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    The research has conducted on shelterbelt of Al-Ashraf Najaf city to explore suitability of four Eucalyptus camaldulensis Dehnh. Forms and two other tree species; Casuarina equisetifolia and Olea europaea to the local dominant sever conditions. Development in growth was studied through the interval of five years. Growth parameters included height, DBH stem diameter, main stem height, crown diameter, and stem girth were investigated. Distance from water supply was inspected, too. Results showed superiority of E. camaldulensis upon other species. Investigations showed weakness in growth of C. equisetifolia where most of trees could not resist because of their position in oppos

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Publication Date
Sun Jul 21 2024
Journal Name
Al-rafidain Journal Of Medical Sciences ( Issn 2789-3219 )
Assessment of the Knowledge and Practice on Safe Handling of Anticancer Drugs among Pharmacists in Iraqi Healthcare Settings
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Background: Occupational exposure to hazardous drugs occurs in all aspects of anticancer drug handling. Proper recommendations and guidelines should be applied to control and reduce exposure. Objective: To assess pharmacists' knowledge and practice regarding the safe handling of anticancer drugs. Methods: A cross-sectional study was conducted at seven major hospitals in Baghdad City, Iraq, from December 2023 to February 2024. A pre-designed questionnaire was given to pharmacists who handled anticancer drugs in chemotherapy units. The questionnaire comprises sociodemographic data, knowledge of the safe handling of cytotoxic drugs and thoughts about exposure and risk, practices for safely handling cytotoxic drugs, and challenges for s

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Publication Date
Sun Dec 30 2018
Journal Name
Journal Of Engineering
Investigation of R134a Flow Boiling Heat Transfer and Pressure Drop in the Evaporator Test Section of Refrigeration System
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This paper presents an experimental and theoretical analysis to investigate the two-phase flow boiling heat transfer coefficient and pressure drop of the refrigerant R-134a in the evaporator test section of the refrigeration system under different operating conditions. The test conditions considered are, for heat flux (13.7-36.6) kW/m2, mass flux (52-105) kg/m2.s, vapor quality (0.2-1) and saturation temperature (-15 to -3.7) ˚C. Experiments were carried out using a test rig for a 310W capacity refrigeration system, which is designed and constructed in the current work. Investigating of the experimental results has revealed that, the enhancement in local heat trans

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Publication Date
Tue Mar 30 2021
Journal Name
Baghdad Science Journal
Detection of Leishmania tropica Using Nested-PCR and Some of Their Virulence Factors in Thi-Qar Province, Iraq
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Cutaneous leishmaniasis is one of endemic diseases in Iraq. It is considered as widely health problem and is an uncontrolled disease. The aim of the study is to identify of Leishmania species that cause skin lesions among patients in Thi-Qar Province, South of Iraq, also to detect some virulence factors of L. tropica. This study includes three local locations, Al-Hussein Teaching, Suq Al-Shyokh General and Al-Shatrah General Hospitals in Province for the period from the beginning of December 2018 to the end of September 2019. The samples were collected from 80 patients suffering from cutaneous leishmaniasis, both genders, different ages, various residence places and single and multiple lesions. Nested-PCR technique was

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Publication Date
Fri May 23 2025
Journal Name
Reproductive Health Of Woman
Molecular detection of Rubella virus (1E genotype) in clinical sample of pregnant women, and it’s related to abortion
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Pregnant women who have rubella may potentially pass the infection on to their unborn offspring. A congenital rubella infection can result in a miscarriage, stillbirth, and congenital rubella syndrome. The only member of the Togaviridae family’s Rubivirus genus, the Rubella virus (RV) is a positive-polarity, single-stranded RNA virus genome surrounded by a lipoprotein envelope with spike-like, hemagglutinin-containing surface projections.The objective: to determine the Rubella virus (1E genotype) in pregnant woman and its relation to spontaneous miscarriage.Materials and methods. A total of 174 women which visited Al-Elweya Teaching Hospital, Baghdad, Iraq, were screened according to the following criteria: women with a history of

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Publication Date
Thu Dec 09 2021
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Preparation and In vitro Characterization of Aceclofenac Nanosuspension (ACNS) for Enhancement of Percutaneous Absorption using Hydrogel Dosage Form
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         Aceclofenac (AC) is an orally active phenyl acetic acid derivative, non-steroidal anti-inflammatory drug with exceptional anti-inflammatory, analgesic and antipyretic properties. It has low aqueous solubility, leading to slow dissolution, low permeability and inadequate bioavailability. The aim of the current study was to prepare and characterize AC-NS-based gel to enhance the dissolution rate and then percutaneous permeability. NS.s were prepared using solvent/antisovent precipitation method at different drug to polymer ratios (1:1, 1:2, and 1:3) using different polymers such as poly vinyl pyrrolidone (PVP-K25), hydroxy propyl methyl cellulose (HPMC-E5) and poloxamer® (388) as stabilizer

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Publication Date
Wed May 18 2016
Journal Name
مجلة كلية التربية الاساسية
Effect of citric and glutamic acids on physiological characteristics and yield of Vicia faba L.
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The field experiment was conducted in garden of Department of Biology, College of Education for Pure Sciences (Ibn- Al-Haitham), University of Baghdad during the season of growth (2014-2015). The experiment aimed to study the effect of citric acid with two concentration 10, 20 mg. L-1 and glutamic acid with two concentration 50, 100 mg. L-1 on growth and yield of broad bean (Vicia faba). The results were showed an increased in plant height, leaves number. Plant dry weight, chlorophyll content flowers number, absolute growth rate, crop growth rate, legume length and dry weight, legumes number, seed dry weight compared with control plants.