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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Sat Jun 15 2019
Journal Name
Drug Invention Today
Mucoadhesive oral in situ gel of itraconazole using pH-sensitive polymers: Preparation, and in vitro characterization, release and rheology study
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Publication Date
Sun Jul 01 2018
Journal Name
Journal Of Educational And Psychological Researches
The healthy personality and its relation to the academic achievement of school and university teacher
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Personality regard as one of the human soul pillars that has been built throughout the life of people, starting from the fertilizing process to different stages of people ages. Over time, numerous scientific studies have shown that fetus has the ability to hear and feel and he is being stereotyped since the first stages of formation. Accordingly, the process of forming human personality set up since that date. Besides, the socialization means that take different resources to enhance human personality such as holy Quran, school, social media, and social environment. The emergence of social media made the world as a small village which gives the chance for all people, over the world, to obtain the knowledge easily and limitless. Thus, the

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Publication Date
Sun Mar 06 2011
Journal Name
Baghdad Science Journal
Detection of Extraintestinal Pathogenic Escherichia coli among Normal Stool Flora of Young, Healthy, Unmarried Males & Females as Predisposing Factor to Extraintestinal Infections:A Comparison Study
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In this study we surveyed the dominant normal stool flora of randomly selected healthy, young (18-23 years old), unmarried (doctrinal) Iraqi college students (males and females) for the carriage of extraintestinal pathogenic E. coli (ExPEC). ExPEC virulence was detected phenotypically by mannose resistant hemagglutination of human red blood cells (MRHA) and mannose sensitive (MS) agglutination of Bakers' yeast (Saccharomyces cerevisceae). From 88 college students, 264 E. coli isolates were obtained (3 isolates per person): 123 from 41 females and 141 from 47 males. Of these isolates, 56% (149/264) caused MS agglutination of yeast cells and 4.16% (11/264) showed MRHA. Eighty two percent (9/11) of the isolates with MRHA also caused MS agglu

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Publication Date
Wed Aug 09 2017
Journal Name
Ibn Al-haitham Journal For Pure And Applied Sciences
Relationship Between Lipid Peroxidation and Vitamine (E) ,  -Tocooherol Supplementation in Sera of Apparntly Healthy Individuals
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  In an attempt to shed a light on the possible relationship between lipid peroxidation and some antioxidant.         The effect of vitamine E (as a potent antioxidant free radical scavenger) on the serum levels of Total cholesterol (TC) and Triacylglycerols (TG) was studied and the lipid peroxidation marker (MDA) was measured.       The study includes (50) healthy donors from males and females who had given vitamine E at a rate of (400IU) daily for one month and were divided into two groups. 1. Group (A) : included (25) males donors (20-40) years old, before and after giving vitamine E. 2. Group (B) : included (25) females donors (20-40) years old , before and af

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Publication Date
Wed Aug 09 2017
Journal Name
Ibn Al-haitham Journal For Pure And Applied Sciences
A comparison Between Two Etchants Used to Etch Surface of CR-39 Nuclear Track Detector
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    The search included a comparison between two etchands for etch CR-39 nuclear track detector, by the calculation of bulk etch rate (Vb) which is one of the track etching parameters, by two measuring methods (thichness and change mass). The first type, is the solution prepared  from solving NaOH in Ethanol (NaOH/Ethanol) by varied normalities  under temperature(55ËšC)and etching time (30 min) then comparated with the second type the solution prepared from solving NaOH in water (NaOH/Water) by varied normalities with (70ËšC) and etching time (60 min) . All detectors were irradiated with (5.48 Mev) α-Particles from an 241Am source in during (10 min). The results that Vb would increase with the increase of

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Publication Date
Sun Jun 03 2012
Journal Name
Baghdad Science Journal
Spectrofluorimetric method for the determination of glibenclamide in pharmaceutical formulations
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A sensitive spectrofluorimetric method for the determination of glibenclamide in its tablet formulations has been proposed. The method is based on the dissolving of glibenclamide in absolute ethanol and measuring the native fluorescence at 354 nm after excitation at 302 nm. Beers law is obeyed in the concentration of 1.4 to 10 µg.ml-1 of glibenclamide with a limit of detection (LD) of 0.067 µg.ml-1 and a standard deviation of 0.614. The range percent recoveries (N=3) is 94 - 103.

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Publication Date
Sun Sep 01 2013
Journal Name
Baghdad Science Journal
Spectrophotometric method for the determination of Captopril in pharmaceutical formulations
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A simple, rapid and sensitive spectrophotometric method has been developed for the determination of captopril in aqueous solution. The method is based on reaction of captopril with 2,3-dichloro 1,4- naphthoquinon(Dichlone) in neutral medium to form a stable yellow colored product which shows maximum absorption at 347 nm with molar absorptivity of 5.6 ×103 L.mole-1. cm-1. The proposed method is applied successfully for determination of captopril in commercial pharmaceutical tablets.

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Publication Date
Mon Sep 16 2019
Journal Name
Ibn Al-haitham Journal For Pure And Applied Sciences
Determination of Ibuprofen in Pharmaceutical Formulations Using Differential Pulse Polarography
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     A reliable differential pulse polarographic (DPP) method has been developed and applied for the determination of ibuprofen IBU in dosage form with dropping mercury electrode (DME) versus Ag/AgCl. The best peak was found at cathodic peak of -1.18 V in phosphate buffer at pH=4 and 0.025M of KNO3 as supporting electrolyte. In order to obtaine the highest sensitivity, instrumental and experimental parameters were examined including the type and concentration of supporting electrolyte, pH of buffer solution, pulse amplitude and voltage step time. Diffusion current showed a direct linear relationship to ibuprofen concentration in the range of (5 – 30) μg. mL-1 (2.43× 10-5

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Publication Date
Tue Apr 22 2025
Journal Name
Journal Of Baghdad College Of Dentistry
A Comparison between the Horizontal Condylar and Bennett Angles of Iraqi Full Mouth Rehabilitation Patients by Using Two Different Articulator Systems (An In-Vivo Study)
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Background: Errors of horizontal condylar inclinations and Bennett angles had largely affected the articulation of teeth and the pathways of cusps. The aim of this study was to estimate and compare between the horizontal condylar (protrusive) angles and Bennett angles of full mouth rehabilitation patients using two different articulator systems. Materials and Methods: Protrusive angles and Bennett angles of 50 adult males and females Iraqi TMD-free full mouth rehabilitation patients were estimated by using two different articulator systems. Arbitrary hinge axis location followed by protrusive angles and Bennett angles, estimation was done by a semiadjustable articulator system. A fully adjustable articulator system was utilized to locate th

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Publication Date
Wed May 24 2017
Journal Name
Ibn Al-haitham Journal For Pure And Applied Sciences
Comparative Study of Serum lactic Acid, Lactate Dehydrogenase and Lipid Profile in Ischemic Heart Disease Patients and Healthy Control
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 The term ischemic heart disease (IHD) defines a disease spectrum of diverse etiology, with the common factor being on imbalance between myocardial oxygen supply and demand . Fifty patients (30 male and 20 female) attending Ibn- Al- betar cardic center, the mean age of male was 65 years and 58 years for female were included in the present study , Thirty healthy subjects ( 15 male and 15 female ) of matched age were used as control groups.  Some biochemical parameters including lipid and lipoprotein, total cholesterol (TC) , triglycerides (TG), high density lipoprotein (HDL) and low density lipoprotein (LDL), in addition to lactic acid and lactate dehydrogenase (LDH) activities , were evaluated in the sera of IHD patient groups

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