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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Sep 01 2023
Journal Name
Advancements In Life Sciences
Investigation of pathogenic Streptococci species in local and imported mozzarella soft cheese in Baghdad city
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Background: The present work investigated the profile and biodiversity of the pathogenic streptococci species isolated from local and imported mozzarella soft cheese in Baghdad City from October 2022 to January 2023. The study aimed to examine the molecular characterization of 16Sr RNA gene in some streptococcus species isolates from mozzarella soft cheese in Baghdad city Methods: From 50 samples, 8 isolates in all were found and identified based on the VITEK, molecular, and sequencing of the 16SrRNA gene. The eight isolates represented Lactococcus cremoris. Streptococcus alactolyticus, Streptococcus sanguinis, and Streptococcus thoraltensis. The isolates were subjected to conventional PCR and electrophoresis to detect the 16SrRNA gene usi

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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)
Study the Distribution of Rotavirus Genotypes in Vaccinated and non Vaccinated Children in Babylon Province
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Rotaviruses, a major cause of gastroenteritis in children worldwide accounts for around half a million deaths annually. Vaccine against the virus has been recommended by the WHO to be involved in the national immunization program.To evaluate the genetic characterization of rotavirus among children with acute gastroenteritis in Babylon province is warranted. Children complained of diarrhea with rotavirus infection detected in their stool were involved in the study. The age range was 10 months to 60 months and with retrogradechecking of rotavirus vaccine history. Rotavirus genotypes were detected by reverse transcription-polymerase chain reaction (RT-PCR).A total number of 40 children with rotavirus gastroenteritis were used to examine the

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Publication Date
Mon Feb 09 2026
Journal Name
Chemical And Process Engineering Research
Spectrophotometric Determination of Sulfanilamide in Pure and in Synthetic Sample based on Condensation Reaction Method
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A new, Simple, sensitive and accurate spectrophotometric methods have been developed for the determination of sulfanilamide (SNA) drug in pure and in synthetic sample. This method based on the reaction of sulfanilamide (SNA) with 1,2-napthoquinone-4-sulphonic acid (NQS) to form N-alkylamono naphthoquinone by replacement of the sulphonate  group of the naphthoquinone sulphonic acid by an amino group. The colored chromogen shows absorption maximum at 455 nm. The optimum conditions of condensation reaction forms were investigated by: (1) univariable method, by optimizing the effect of experimental variables; (different bases, reagent concentration, borax concentration and reaction time),     (2) central  composite design (CCD) including

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Publication Date
Sun Jun 02 2013
Journal Name
Baghdad Science Journal
Bacterial Isolates and Their Antibiograms of Burn Wound Infections in Burns Specialist Hospital in Baghdad
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A total of 54 out of 67 (80.59%) of burn wound swab showed growth of one, or two, or three bacterial pathogens. Pseudomonas aeruginosa was the commonest pathogen, isolated in 48.14% of swab samples, followed by Klebsiella pneumoniae (31.48%), Staphylococcus aureus (27.77%), Acinetobacter baumanii (14.81%), Escherichia coli (7.40%), and Citrobacter freundii, Providencia stuartii, Enterobacter cloacae, with 1.85% isolation percentage for each. All bacterial isolates were tested against 19 antibiotics, and showed multi-drug resistance to 10 antibiotics, or more. The most effective antibiotics were the fifth-generation cephalosporin, ceftobiprole, and and antibiotic combinations, as Ceftazidime / clavulanic acid, and Cefoperazone /sulbactam, an

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Publication Date
Sun Oct 06 2013
Journal Name
Journal Of Educational And Psychological Researches
Following model educational offenders in collection and Alasbaka of fifth grade students preparatory in history
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Following model educational offenders in collection and Alasbaka of fifth grade students preparatory in history A. M. Dr Prepared by: Dr. Bashaer Mawloud Tawfeeq, The Center of Educational and Psychological Studies Baghdad University - There is no difference statistically significant at the 0.05 level of significance between the average scores of the following students studying using model and offenders and who are studying in the usual manner (traditional) in the collection - There is no difference statistically significant at the 0.05 level of significance between the mean scores for the following students studying using model and offenders and who are studying in the usual manner (traditional) in retention Find limits: Current search

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Publication Date
Fri May 16 2014
Journal Name
Journal Of The College Of Basic Education
interaction of L-Threonine in aqueous THFA and in mixed aqueous solutions at 298.15 K
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Publication Date
Sun Sep 01 2013
Journal Name
Journal Of Economics And Administrative Sciences
Measuring and analysing inequality in the Distribution of Economic Welfare in Suleimania Governorate during (2007):
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Abstract

 The issue of inequality in distribution of income and / or consumption expenditure is related to economic welfare because there is an inverse relationship between the economic welfare on the one hand, and the degree of inequality, on the other hand. Despite the fact that inequality is considered as normal phenomenon in every society, but if it exceeded certain limits it will lead to undesirable economic, social and political consequences. Therefore, the availability of indicators about inequality is a necessary tool for planning and evaluation of economic development programs. So, current study is aiming at measuring and analyzing the degree of inequality in distribution of consumpti

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Publication Date
Tue Mar 30 2021
Journal Name
Iraqi Journal Of Science
Changes in Serum Levels of Lipid Profile Parameters and Proteins in Toxoplasma gondii Seropositive Patients
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The influence of Toxoplasma gondii on some biochemical parameters has lately gained an increasing attention. The aim of this study was to assess the levels of some biochemical parameters in Toxoplasma positive and negative subjects. An analytical case–control study was achieved in Baghdad for the period from October 2018 until March 2019. Forty nine females participated in this study, with an age range of 18-55 years. The participants were separated into two groups, namely Toxoplasma positive subjects (n=21) and Toxoplasma negative subjects (n=28), based on enzyme-linked immunosorbent assay (ELISA). Blood and serum samples were collected from all subjects to evaluate the serum levels of cholesterol, triglycerides, high density lip

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Publication Date
Sat Feb 01 2020
Journal Name
Journal Of Economics And Administrative Sciences
The Reality of Agricultural Policies and Their Role in Achieving Sustainable Agricultural Development in Iraq
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   The Agricultural Policy is one of the most important tools adopted by the state to guide its economic and social activities through the delivery of suitable agricultural commodities to the consumer and in return to deliver agricultural inputs to the agricultural producers at the lowest possible cost to contribute in achieving a profit that helps the agricultural product to continue in the production process with the same efficiency and ambition. So as to help increase the contribution of the agricultural sector to GDP and achieve the best picture of sustainable agricultural development.

The research aimed at identifying the reality of agricultural policies and their role in achieving sustaina

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Publication Date
Tue Apr 28 2020
Journal Name
Iraqi Journal Of Veterinary Sciences
Detection and pathogenicity of Listeria monocytogenes in common carp (Cyprinus carpio) fish in Baghdad, Iraq
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