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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Aug 30 2024
Journal Name
Iraqi Journal Of Science
Investigation of Flagellum genes FleN and FlgE and Gene Expression of FleN Gene in Pseudomonas Aeruginosa Clinical Isolates
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The opportunistic multidrug resistance pathogen Pseudomonas aeruginosa has one or several flagella, and the numbers of these sophisticated machines are regulated by the flagellar regulator gene FleN. The flagellar hook gene FlgE is important for its synthesis, motility and tolerance to antibiotics. Bacteriahave resistance to antibiotics, especially to cephalosporin beta-lactam antibiotics. For the current study, 102 clinical specimens were collected and identified using routine laboratory tests and confirmed by Vitek-2 compact system.  A total of 33 isolates of P. aeruginosa were identified. The antibiotic susceptibility test was done by the Vitek 2 Compact system. Flagellar gene detected by conventional PCR revealed that the FleN

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Publication Date
Sun Mar 13 2011
Journal Name
Baghdad Science Journal
Impact of Rhizobial strains Mixture, Phosphorus and Zinc Applications in Nodulation and Yield of Bean(Phaseolus vulgaris L.)
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Pot experiment was carried out at the College of Agriculture – Baghdad University during autumn season, 2007. Thirteen treatments were formulated to evaluate the effectiveness of four applications of Phosphorus (0, 60, 60×2 and 120 Kg P. h-1) and three applications of Zinc (0, 25×2 mg Zn. L-1 and 50 mg Zn. Kg soil-1) along with inoculating seeds of bean with strains mixture 889 and 1865 and non-inoculated treatment, on nodulation, yield and protein content in seeds (N%). The results showed that inoculated plants exceeded on non-inoculated one in all the studied characteristics. While, P and Zn, applications at the rate of 60×2 kg/ha and 25×2 mg/L respectively, significantly, increased, nodulation, yield, protein content in se

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Publication Date
Sun Dec 12 2010
Journal Name
Journal Of Planner And Development
The stage of change and institution-building and its impact on the structure of housing policy in Iraq
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The research examines the reality of the housing sector in Iraq and the stage of change and institution-building, which is increasingly challenging to respond to development needs. The legal legislation in Iraq over the last five years indicates a significant shift towards decentralization, with powers and services being delegated from federal ministries to regional levels Localization and growth in cities and urban centers is an added factor that requires responses from local governments to strengthen the capacity of their institutions to engage in national policy debate at the re
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Publication Date
Sun Sep 07 2014
Journal Name
Baghdad Science Journal
Analysis of Fatty Acid Composition in the Seed and flower oil of Syrian Ligustrun Lucidum and olive oil
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The fatty acid composition in the seed and flower of Ligustrun lucidum and olive oil was studied by Gas Chromatography. Results showed that the main components of seed oil were Palmitic (C16:0) 5,893% ,Palmitolic acid (C16:1)0,398%, Steaeic (C18:0)2,911% ,Oleic (C18:1)74,984%,Linoleic (C18:2) 12,959%,and Linolenic (C18:3) 0,997%. The proportion of unsaturated fatty acid was above 89,338%, so the seed oil of L. lucidum ait belonged to unsaturated oil which possessed promising application. The components of flower oil were Palmitic (C16:0) 65,674% ,Palmitolic acid (C16:1)6,516%, Steaeic (C18:0)2,641% ,Oleic (C18:1)14,707%,Linoleic (C18:2) 3,113%,and Linolenic (C18:3) 2,70%. The proportion of unsaturated fatty acid and saturated fatty acid wa

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Publication Date
Thu Mar 30 2017
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Detection of Carbohydrate Antigen CA19-9 Levels in Sera and Tissues' Homogenate of Breast and Thyroid Benign Cases
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         The aims of the present study are to evaluate the levels of CA19-9 in sera and tissues' homogenate of breast and thyroid benign patients in order to assess its use as an early diagnostic parameter in differentiation between malignant and benign cases. The study was conducted on 8 patients with breast benign tumor and 8 patients with thyroid benign tumor, by the enzyme linked immunosorbent assay (ELISA) technique. The results of CA19-9 levels in sera were (15 ±1.58 and 10.67 ±2.08)U/ml respectively compared with serum CA19-9 levels of control group which was 7.74 ±4.92 U/ml, the results were found to be highly significantly in breast tumor patients and non significantly in thyroid

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Publication Date
Tue Dec 30 2008
Journal Name
Al-kindy College Medical Journal
Clinical Evaluation of the Levels of CEA,CA15-3 and AlphaFeto Protein in Malignant and Benign Pleural Effusion
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Background: Pleural effusion is a common clinical
problem.
Objective: The aim of the study was to evaluate the
diagnostic utility of Carcino embryonic antigen
(CEA), CA 15- 3, and alpha-feto protein ( AFP ) as
a tumor markers in serum and pleural effusion and
evaluate the value of combining them as a diagnostic
tools that are complementary to cytology in the
diagnosis of malignancies .
Methods: Forty patients (18 malignant and 22 benign
pleural effusion) were included in this study .The
serum and effusion levels of CEA, CA 15 – 3 and
AFP were measured using immunoradiometric assay
Results: from the 40 effusions studied 26 were
exudates and 14 were transudates. The level of
pleural effusions

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Publication Date
Wed Jan 28 2026
Journal Name
Journal Of Baghdad College Of Dentistry
The Electrophoretic Deposition of Nano Al2O3 and AgNO3 on CpTi Dental Implant (An in vitro and in vivo study)
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Background: Even the wide use of dental implants, still there is a proportion of implants are failed due to infection. Much considerable attention has been paid to modify the implant surface. Coating of dental implant with a biocomposite material of suitable properties can improve osseointegration. And this is the main concern of this study. The aim of present study was to evaluate the use of a biocomposite coating of dental implant with (ceramic nano Al2O3 and metalic AgNo3) on the bond strength at bone – implant interface and tissue reaction. Materials and methods: A total number of forty-eight screws, CpTi dental implant used in this study. Half of these screws were coated with a biocomposite material of nano (Al2O3and AgNo3), thi

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Publication Date
Wed Aug 01 2018
Journal Name
Journal Of Economics And Administrative Sciences
((Human Resource Staffing Strategy and and its impact in the high performance A Field research in Ministry of Agriculture))
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Abstract

were determine the problem of current research to answer the  question on the consciousness of the Ministry of Agriculture to adopt Staffing  strategy and identify the shortcomings  as the independent variable, represented by the three dimensions (recruitment , selection, placement) and its impact on high performance, as  dependent   variable is described  in  four dimensions (leadership, strategy, structure and processes, culture), in this research were  Used  analytical descriptive  style . This research aims to identify the correlation and impact  of Staffing strategy at high-performance in Ministry of Agriculture , To clarify the relationship between

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Publication Date
Sun Mar 02 2014
Journal Name
Baghdad Science Journal
An Ecological and Identification Study for Algae in Groundwater of Selected Area in Tikrit city and It’s Surrounding Area
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The present study is carried out to identify the algae in the groundwater of the three areas of Tikrit city, including (the center of Tikrit , the region of AL-Jazira , Awainat village) by nine wells, a depths ranged between 9 meter at well 8 and 110 meter at wells 3 and 5 . And examined the environmental characteristics of physical, chemical and biological factors during the study period from September 2009 to June 2010. It is obtained that wells in the study area is lower alkalinity, average it ranged (6.448-7.418). It was noted that the values of the dissolved oxygen are few and almost non-existent in some cases it ranged between (6.5-6.3)mg/l , analysis of biological oxygen demand refers to wells water (clean- very clean) average

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Publication Date
Sun Aug 01 2021
Journal Name
Biochemical & Cellular Archives,
ANTIMICROBIAL ACTIVITY OF CHITOSAN AND/OR GUM ARABIC IN THE LOCAL PRODUCE SOFT AND HARD CHEESE IN BAGHDAD CITY
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antimicrobial solutions against Coliforms, E. coli O157: H7, yeasts and molds were evaluated by agar well diffusion method. Chitosan (CH) exhibited best antimicrobial activity against the treated microorganisms at concentration of (5%) with contact time for 6hrs at refrigeration temperature (4ÚC), zones of inhibition for (GA) and (CH) for each solution alone ranging from (0 to 10 mm), chitosan solution (CH) exhibited both antibacterial and antifungal activities, Gum Arabic washing solution showed significant antibacterial activity (P < 0.05) against the microorganisms at concentration (15%), without inhibitory effect against E. coli O157:H7 at concentration (10%), in the current study the results confirmed that (15%) (w/v) of GA and 5%

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