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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Thu May 18 2023
Journal Name
J Pure Appl Microbiol.
The Immunohistochemical Staining of Vimentin and E-Cadherin in Bladder Cancer Patients Infected with Hepatitis C Virus
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The invasion and spread of cancer cells are two of the most notable characteristics of malignant tumors. Recent studies suggest that the epithelial-mesenchymal transition (EMT) has been linked to this significant occurrence. It is linked to the absence of the epithelial brow and the presence of mesenchymal facial hair. The aims of the present study were to explore the immunohistochemical staining of vimentin and E-cadherin ex vivo as EMT markers and assess their potential as predictive biomarkers for transitional cell cancer (TCC). In this study, 55 paraffin-embedded biopsies from TCC patients and 10 autopsies that appeared to be normal were included. Immunohistochemistry was used to produce patterns of vimentin and E-cadherin expression. W

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Publication Date
Sat Oct 01 2022
Journal Name
Baghdad Science Journal
Assessment of Obesity, Dyslipidemia, Hyperglycemia, and Pro-Inflammatory Cytokines as Cardiovascular Disease Risk Factors in Acromegaly Patients
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Cardiovascular disease is one of the most common comorbidities associated with enlarged extremities, occurring in 60 % of patients with acromegaly. The aim of this study is to evaluate the relationship of growth hormone and insulin such as growth factor-1 with obesity, dyslipidemia, hyperglycemia, and pro-inflammatory cytokines (IL-2, IL-6, IL-10), as risk factors for cardiovascular disorder in acromegaly patients. Eighty subjects were included and categorized into two groups: 40 acromegaly patients and 40 of the control group. The results indicated weight excess, hyperglycemia, hypertension, lipid disorder, and elevated levels of interleukins (2, 6, and 10). The correlation of both GH and IGF-1 with each of weight, BMI, systolic blood p

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Publication Date
Thu Apr 01 2021
Journal Name
Biochemical And Cellular Archives
Improvement in the Growth of Cumin Plant, Cuminum Cyminum L. with Spraying Tryptophan and Iq Combi Nanofertilizer
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The experiment was carried out in the Department of Biology, College of Education for Pure Science –Ibn AL Haitham, University of Baghdad, Iraq, during the growing season 2017 – 2018. The objective was to find out the effect of foliar spraying of tryptophan and IQ COMBI nano fertilizer on cumin plants. The obtained results show that both tryptophan and IQ COMBI nano fertilizer increased plant height, root length, shoot dry weight, the content of nitrogen, phosphorus, potassium, protein percentage, no. compound umbel.plant-1, wt. seeds. plant-1. The optimum treatment combination was calculated as 30 mg.L-1 tryptophan, 1000mg.L-1 IQ COMBI nano fertilizer, which gave the highest values for most of the parameters studied

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Publication Date
Mon Jan 01 2018
Journal Name
Research Journal Of Pharmacy And Technology
Evaluation of Hesperidin Protective Effect on Lipopolysaccharide-Induced Inflammation and Lipid Peroxidation in BALB/c male mice
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Publication Date
Sun Jun 05 2016
Journal Name
Baghdad Science Journal
Evaluation of Serum Malondialdehyde, Glutathione and Lipid Profile Levels in Iraqi Females with Type 2 Diabetes Mellitus
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This study is carried out on patients with type 2 diabetes mellitus to assess the lipid profile, malondialdehyde and glutathione. Our study is concerned with 51 (Iraqi Arab females) patients of type 2 diabetes mellitus compared with 31 control subjects unified in age, sex and ethnic background. Lipid profile is measured by using commercially available kits, while the serum MDA and glutathione levels are measured by means of sandwich ELISA test using commercially available kits. Serum MDA is significantly higher (P<0.001) while glutathione is significantly lower (P<0.001) in type 2 diabetic patients when compared to the control. The normal levels of MDA (3.82 ± 0.77n mol/ml) and GSH (2.23 ± 0.54 µg/ml) recorded for the non-diabetic female

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Publication Date
Sun Sep 06 2015
Journal Name
Baghdad Science Journal
The Bactericidal Effect of CO2 Laser on Pseudomonas aeruginosa Isolated from Wound and Burn Infections, In-Vitro
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A total of 60 cotton swabs are collected from patients suffering from burn wound and surgical site infections admitted to Baghdad Teaching Hospital and Burn Specialist Hospital in Baghdad city during 9/2013 to 11/2013. All cotton swabs are cultured initially on blood agar and MacConkey agar and subjected for standard bacteriological procedures for bacteriological diagnosis. Twenty samples out of sixty are identified as Pseudomonas aeruginosa by conventional methods. The results of antibiotic susceptibility test illustrate that the antibiotics resistance rate of Pseudomonas aeruginosa isolates is as follows:100% (2020) for ceftriaxone, cefepime and carbencillin, 70% (14/20) for amikacin, 65%(13/20) for tobramycin, ceftazidim and gentamycin,

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Publication Date
Fri Mar 01 2024
Journal Name
الذكوات البيض
The problem of employing political discourse and its role in promoting community peace: Iraq as a model
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After 2003, Iraq witnessed new challenges represented by the predominance of sectarian discourses, hatred and extremism at the expense of moderate political discourse and the predominance of sub-affiliations and external agendas at the expense of national affiliation, which led to the creation of an unsafe or stable environment dominated by the character of violence and terrorism. Moderate discourse would work to fuse sub-affiliations into one melting pot in which it would be the first loyalty to the homeland and not to the tribe, party or sect... Etc., and this in turn will contribute to promoting peaceful coexistence between the various other sub-affiliations within the framework of one community construction

Publication Date
Thu Jan 31 2019
Journal Name
Journal Of The College Of Education For Women
The historical presence of Arab tribes and clans in the administratire regions (disputed ) ) 1800 m -1921 m)
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(disputed areas) before the establishment of the national government in Iraq in 1921, had to search for Arab tribes and clans in which the recipe group is available as a social organization coherent based on the foundations of several of them tribalism and her Land relates know Deira in those areas during the period that preceded the establishment of the national government in Iraq in 1921, and based on the inter girls primary sources and published mostly before the establishment of the national government in Iraq, the source of their information search and direct inquiry.
Research has proved that the tribes and clans of Arab exist in all districts described by (disputed), except (judicial Akre and Tilkaif) and varying degrees of time

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Publication Date
Fri Jan 15 2010
Journal Name
Anbar Journal Of Agricultural Sciences 8 (1)‏
Effect of Trichoderma spp. in inoculium levels on sour orange (Citrus arantium) seed germination and seedling growth‏
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Publication Date
Mon Mar 15 2021
Journal Name
Al-academy
The art Formation and its aesthetic role in the design of digital commercial advertising: سند فؤاد محمد
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Digital commercial advertising depends on artistic formations to achieve attraction and arousal of attention, which is one of the most important communication factors that the designer seeks to achieve and is considered a key key to recognizing the beauty of the topic and its functional value. Reframe formal vocabulary.
The research included the introduction and includes the research problem and the need for it, which focused on the following question: What is the aesthetic role of artistic formation in the design of commercial advertising?
The aim of the research was: To reveal the aesthetic role of artistic formation in commercial advertising.
It also included the importance of research and research boundaries, as well as def

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