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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Nov 01 2019
Journal Name
Advances In Intelligent Systems And Computing
Analysis of the Relationship Between Traffic Accidents with Human and Physical Factors in Iraq
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Publication Date
Sun Sep 07 2014
Journal Name
Baghdad Science Journal
Qualitative and Quantitative study of Epipelic algae in Tigris River within Baghdad City, Iraq
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The present study conducted to study epipelic algae in the Tigris River within Baghdad city for one year from September 2011 to August 2012 due to the importance role of benthic algae in lotic ecosystems. Five sites have been chosen along the river. A total of 154 species of epipelic algae was recorded belongs to 45 genera, where Bacillariophyceae (Diatoms) was the dominant groups followed by Cyanophyceae and Chlorophyceae. The numbers of common types in three sites were 47 species. Bacillariophyceae accounted 88.31% of the total number of epipelic algae, followed by Cyanophyceae 7.14 % and Chlorophyceae 4.55%. A 85 species (29 genera) recorded in site 1, 103 species (34 genera) in site2, 112 species (35 genera) in site3, 96 species

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Publication Date
Thu Dec 01 2022
Journal Name
Baghdad Science Journal
Simultaneous Ratio Derivative Spectrophotometric Determination of Paracetamol, Caffeine and Ibuprofen in Their Ternary Form
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A new, accurate, precise and economic two spectrophotometric methods for determination of Paracetamol (Par), Ibuprofen (Ibu), and Caffeine (Caf) were suggested. Those methods were the first and second ratio derivative spectrum using a double devisor. Par, Ibu, and Caf showed many useful peaks for their quantified determination. The validity of all analysis modes for determination of the three compounds, peak to baseline, peak area and peak to peak were according to ICH. The linearity of two methods was between 5 µg/ml as a lower concentration and 50 µg/ml as the highest concentration for three compounds. Recovery percentage was around 100% and relative standard deviation was less than 2.6%. The methods were applied successfully in the

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Publication Date
Tue Apr 19 2022
Journal Name
Al Mustansiriyah Journal Of Pharmaceutical Sciences
Effect of pioglitazone treatment on serum chemerin and vaspin levels in polycystic ovary syndrome.
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Abdominal fat synthesizes a variety of adipokines, including vaspin and chemerin, that affect the resistance to insulin. This research was conducted to demonstrate the effect of pioglitazone, one insulin sensitizer used to decrease insulin resistance, on these adipokines in   obese patients with polycystic ovary (PCOS). Twenty-five obese women with PCOS were treated with pioglitazone 15mg/bid for 12 weeks. Modifications in fasting blood glucose (FBG), serum fasting insulin (FSI), chemerin and vaspin serum levels, follicle stimulation hormone (FSH), luteinizing hormone (LH), testosterone (T), and in baseline and post-therapy were assessed. Body mass index decreased without any substantial variance after 12 weeks of piogl

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Publication Date
Sun Jun 01 2025
Journal Name
Microbial Biosystems
Distribution and association of an usp genotoxin gene with biofilm formation in E. coli
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Uropathogenic specific protein is a genotoxic protein targeting the DNA, leading to mutations and modifications in the normal cell's DNA and subsequently, cancer development. This study aims to determine the prevalence of the usp gene in Uropathogenic Escherichia coli isolated from females with urinary tract infections and study its correlation with biofilm formation. One hundred and five urine specimens were collected from female patients (20 to 55 years old) with urinary tract infections attending hospitals. Traditional laboratory methods using selective and differential culture media were used for initial bacterial isolation and identification, and molecular techniques that targeted a segment of the 16SrRNA gene with a specific primer pa

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Publication Date
Mon Apr 01 2019
Journal Name
International Journal Of Pharmaceutical Research
Sensitive spectrophoto metric determination of doxycycline in pure and dosage forms using p-bromanil
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A simple, precise, and sensitive spectrophotometric method has been established for the analysis of doxycycline. The method includes direct charge transfer complexation of doxycycline withp-Bromanil in acetonitrileto form a colored complex. The intensely colored product formed was quantified based on the absorption band at 377 nm under optimum condition. Beer’s law is obeyed in the concentration range of 1–50 μg.mL-1 with molar absorptivity of 1.5725x104 L.mol-1.cm-1, Sandell's sensitivity index (0.0283) μg.cm-2, detection limit of 0.1064 μg.mL-1, quantification limit 0.3224 μg.mL-1 and association constant of the formed complex (0.75x103). The developed method could find application in routine quality control of doxycycline and has

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Publication Date
Wed Mar 29 2017
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
A Comparative Biochemical Study of Proteins Profile in Iraqi Children and Adolescent with ?-Thalassemia
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The aim of the present research is to study different protein fractions in sera of children and adolescent with  β –thalassemia major and minor and to compare the results with that of healthy control.One hundred fifty children and adolescents were enrolled in this study,including 50 patients with β- thalassemia major , 50 patients with  β- thalassemia minor as pathological control group and another apparently 50 healthy individuals as a control group. The age of all studied  groups ranged from (4-18)years.Total protein, albumin and immunoglobulins were estimated in sera of all subjects.  A Significant  decrease  was  found  in  the  total  protein and  albumin&nb

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Publication Date
Mon Jan 25 2021
Journal Name
Journal Of Craniofacial Surgery
Cone Beam Computed Tomography Evaluation of the Morphological Variation and Width in Mandibular Condyle
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Publication Date
Wed May 02 2018
Journal Name
Indian Journal Of Natural Sciences
Histological and Histochemical Characters of the Pancreas in the Adult Indigenous Gazelle (Gazella subgutturosa)
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LO Hamza, Indian Journal of Natural Sciences, 2018 - Cited by 3

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Publication Date
Thu May 21 2015
Journal Name
Environmental Monitoring And Assessment
Water quality monitoring of Al-Habbaniyah Lake using remote sensing and in situ measurements
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