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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Jun 25 2020
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Diuretic Effect of Prosopis farcta in Comparison with Spironolactone and Hydrochlorothiazide in Hypertensive Rats
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Prosopis farcta has been used traditionally for several diseases as cardiovascular, kidney, diabetes, bacterial infection and it has diuretic activity. This study was designed to evaluate the diuretic effects of P. farcta extract in comparison with spironolactone and hydrochlorothiazide in normal and hypertensive rats.Forty eight rats, were divided into Two groups. The First group was consist of Twelve normotensive rats, to represent the control group and normal treated group receiving 50 mg/Kg of P. farcta extract; Six rats in each group.

The Second group involved 36 hypertensive rats, were divided into six subgroups, each of six rats. The First subgroups served as a positive control, the Second, Third

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Publication Date
Sun Jun 03 2012
Journal Name
Baghdad Science Journal
Influence of chemical and physical conditions on the production of bacteriocin by Aeromonas hydrophila
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Aeromonas hydrophila have been isolated as a cause of a cute gastroenteritis in 23 (5.6%) of 410 patients. Other bacterial enteropathogens have been isolated from 387 patients with diarrhea, were 19 different strains. A. hydrophila occurred more commonly in children with acute diarrhea, the results showed that 18(78.26%) isolates of A. hydrophila found in children under 10 years old ,distributed to 10(43.47%) in male and 8(34.78%) in female ,and in adults with diarrhea 5 (21.73%). In the other hand, we noticed frequency of isolation was higher in male 14(60.86%) when compared with 9(39.14%) in female. Six strains of A. hydrophila have been observed to have bacteriocin activity against 12 of 23 different A. hydrophila ,as well as Staphy

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Publication Date
Sun Jan 01 2023
Journal Name
Aip Conference Proceedings
Histological changes in the uterus and implantation status in pregnant mice after oral administration of Maca powder
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Publication Date
Thu Mar 01 2018
Journal Name
International Journal Of Oral And Maxillofacial Surgery
Assessment of facial asymmetry before and after the surgical repair of cleft lip in unilateral cleft lip and palate cases
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Publication Date
Sun Jun 30 2013
Journal Name
Al-khwarizmi Engineering Journal
Efficiency Prediction and Performance Characterization of Photovoltaic Solar Panel at Baghdad Climate Conditions
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The performance of a solar cell under sun radiation is necessary to describe the electrical parameters of the cell. The Prova 200 solar panel analyzer is used for the professional testing of four solar cells at Baghdad climate conditions. Voltage -current characteristics of different area solar cells operated under solar irradiation for testing their quality and determining the optimal operational parameters for maximum electrical output were obtained. A correlation is developed between solar cell efficiency h and the corresponding solar cell parameters; solar irradiance G, maximum power Pmax, and production date P. The average absolute error of the proposed correlation is 5.5% for 40 data points. The results also show th

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Publication Date
Sun Sep 06 2009
Journal Name
Baghdad Science Journal
Effect of food on growth and fecundity Brine Shrimp Artemia spp. laboratory Conditions
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This in order to test the effect of food on growth and fecundity, two kinds of food have been used the algae Scendesmus quadricaudae and fresh water shrimp powder. For two generations, growth and productivity have been followed up. The fresh water shrimp has been noticed as a food better than algae, because it caused recording, for the two generation higher length rate for the weeks of experiment. The individuals length rate at the end of the forth week reached 9.35 and 9.48 mm for the first generation and second generation respectively. The average length weekly increase rate for the first and second generations individuals feeding on dried shrimp was higher through the first and second week compared to what was recorded when feeding alga

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Publication Date
Wed Jan 01 2025
Journal Name
Medical Journal Of Babylon
Optimum Conditions for Pyomelanin Production and Characterization from Local Isolates of Pseudomonas aeruginosa
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Nowadays, there is increased interest in the biosynthesis of microbial melanin related to their numerous biological functions and applications in many fields, especially in medical fields, including immune-modulating, antimicrobial antibiotic, antiviral antivenin, anticancer, antitumor activity, and anti-biofilm activity. Pyomelanin is a hydrophobic macromolecule that is typically dark brown or black in color, formed by the oxidative polymerization of phenolic or indolic compounds. Pyomelanin is reported to be safe for consumption, thus providing a crucial strategy for biocontrol of biofilm. Furthermore, natural pyomelanin is known as a potent antioxidant, photoprotective, and free radical scavenging. Objective: This study focuses on the

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Publication Date
Sun Mar 26 2017
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Spectrophotometric Determination of Nitrofurantoin Drug in its Pharmaceutical Formulations Using MBTH as a Coupling Reagent
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A direct, sensitive and efficient spectrophotometric method for the determination of nitrofurantoin
drug (NIT) in pure as well as in dosage form (capsules) was described. The suggested method was
based on reduction NIT drug using Zn/HCl and then coupling with 3-methyl-2-benzothiazolinone
hydrazone hydrochloride (MBTH) in the presence of ammonium ceric sulfate. Spectrophotometric
measurement was established by recording the absorbance of the green colored product at 610 nm.
Using the optimized reaction conditions, beer’s law was obeyed in the range of 0.5-30 μg/mL, with
good correlation coefficient of 0.9998 and limits of detection and quantitation of 0.163 and 0.544
μg/mL, respectively. The accuracy and

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Publication Date
Sun Oct 01 2017
Journal Name
Al–bahith Al–a'alami
Issues of Media Trials in Iraqi after 2003
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The Supreme Judicial Council decided on July 3, 2003, to set up a court to deal with the issues of publication and media. This court tries to solve the problems of media and publishing in both its civil and penal aspects. The decision of establishing the court represents a new and important step to be taken by the Iraqi Judicial Council for the tremendous development witnessed by media sector in general and press in particular especially after 2003.
This study includes two main axes: the first one deals with the most important crimes of publication in the Iraqi legislations such as the crimes of defamation, libel, insult, indecency, and incitement; the second deals with an analytical survey of the completed cases i.e. the issues tha

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Publication Date
Wed Feb 20 2019
Journal Name
Political Sciences Journal
the circulation of power in Iraq after 2003
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The deliberation and exchanged of power is a matter of political importance For the Iraqi political system after 2003, The deliberation of power and its democratic transition and electoral integrity Is a good indicator of political stability and progress In the Iraqi parliamentary political system , The transfer of authority in terms of adopting the deliberative approach represents a structural and institutional dimension of the political process , it led the power to become Authority of the Foundation Exercised in accordance with the Constitution and the law not real power , And lead to the recognition of the existence of an official parliamentary opposition and its right to take political power later through the ballot box Makes the pr

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