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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Wed Jul 22 2015
Journal Name
Iraqi Journal Of Market Research And Consumer Protection
Studying the Optimal Conditions for Extraction of Local Basil Seeds Gum.: Studying the Optimal Conditions for Extraction of Local Basil Seeds Gum.
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This study aimed to determine the optimal conditions for extracting basil seed gum in addition to determine the chemical components of basil seeds. Additionally, the study aimed to investigate the effect of the mixing ratio of gum to ethanol when deposited on the basis of the gum yield which was1:1, 1:2, 1:3 (v/v) respectively. The best mixing ratio was one size of gum to two sizes of ethanol, which recorded the highest yield. Based on the earlier, the optimal conditions for extracting basil seed gum in different levels which included pH, temperature, mixing ratio seeds: water and the soaking duration were studied. The optimal conditions were: pH 8, temperature of 60°C, mixing ratio seeds: water 1:65 (w/v) and soaking duration of 30 min

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Publication Date
Sun Mar 01 2020
Journal Name
International Journal Of Modern Physics E
Investigation of halo structure of neutron rich 14B, 15C, 19C and 22N nuclei in the two body model
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The two body model of (Core+n) within the radial wave functions of the cosh potential has been used to investigate the ground state features such as the proton, neutron and matter densities, the root mean square (RMS) nuclear proton, neutron, charge and mass radii of unstable neutron-rich 14B, 15C, 19C and 22N nuclei. The calculated results show that the two body model with the radial wave functions of the cosh potential succeeds in reproducing neutron halo in these nuclei.

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Publication Date
Sun May 07 2017
Journal Name
Ibn Al-haitham Journal For Pure And Applied Sciences
Development Of Two Different Spectrophotometric Methods For The Determination Of Atropine Drug In Pure Form And Pharmaceutical Preparations
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Two methods have been applied for the spectrophotometric determination of atropine, in
bulk sample and in dosage form. The methods are accurate, simple, rapid, inexpensive and
sensitive. The first method depending on the extraction of the formed ion-pair complex with
bromphenol blue (BPB) as a chromogenic reagent in chloroform, use phthalate buffer of pH
3.0; which showed absorbance maxima at 413 nm against reagent blank. The calibration
graph is linear in the ranges of 0.5-40 µg.mL
-1
with detection limit of 0.363µg.mL
-1
. The
second method depending on the measure of the absorbance maxima of the formed charge-transfer complex with 2,3-dichloro-5,6-dicyano-p-benzoquinone (DDQ) at 457 nm against

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Publication Date
Sat Jul 01 2000
Journal Name
Bulletin Of The Iraq Natural History Museum (p-issn: 1017-8678 , E-issn: 2311-9799)
COMPARATIVE ECOLOY OF TWO SPECIES OF BIVALVE CORBICULA FL UMINEA AND CORBICULE FL UMINALIS IN SHATT AL-ARAB
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Some aspects of population dynamics of both corbicula species inhabiting intertidal zone of
shatt al-Arab are described. These informations are explained in accordance with the possible
occurrence of competition between the two related species.

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Publication Date
Fri Jun 01 2007
Journal Name
Journal Of The College Of Languages (jcl)
TECHNIQES OF SURREALISM: A STUDY IN TWO NOVELS BY THOMAS PYNCHON, V. AND THE CRYING OF LOT 49
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Surrealism is a twentieth-century literary and artistic movement oriented toward the liberation of the mind. Surrealism is a reaction to the philosophy of rationalism which was believed to be the cause of the disaster of World War I. It emphasizes the expression of the imagination as revealed in dreams and presented without conscious control, the unexpected juxtapositions of objects, the withdrawal of the self, and the exploitation of chance effects.
Surrealism began in Paris in the early 1920s, as Europe emerged from the devastation of World War I. A group of writers, artists, and filmmakers, led by the poet André Breton, adopted the word surréaliste (meaning, roughly, "super-real") as a label for their artistic activities. Influen

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Publication Date
Thu Jan 20 2022
Journal Name
Journal Of Clinical Medicine
Comparison of the Safety and Efficacy of Laser Versus Pneumatic Intracorporeal Lithotripsy for Treatment of Bladder Stones in Children
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This study aimed to compare the safety and efficacy of laser lithotripsy and pneumatic lithotripsy, the two most commonly used transurethral lithotripsy methods for treating bladder stones in children in Iraq. Between January 2013 and December 2016, 64 children with bladder stones were included in this prospective randomized study, after ethical committee approval and written consent from the children’s parents or caregivers were obtained. Patients were assigned randomly by computer software to two groups treated with either pneumatic cystolithotripsy or laser lithotripsy. A 9 Fr. semirigid ureteroscope was used to pass the lithotripter through and fragment the stone. A catheter of 8–12 Fr. was then introduced and kept in place

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Publication Date
Sun Mar 03 2013
Journal Name
Baghdad Science Journal
The ability of Pisum sativum plant to use tricalcium super phosphate (TSP) in the presence and absence of mycorrhizal fungi under field conditions
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Efficiency of Pisum sativum plants in using tricalcium super phosphate (TSP) in presence and absence of mycorrhizal fungi was evaluated in the field experiment in College of Science / Al-Mustansiriyah University. The experiment comprised of (6) treatments prepared from the interaction of two levels of inoculation [non-inoculation with fungus F0 and inoculation with Glomus mosseae fungus (F1)]. And three levels of phosphorus: 0,20,40 Kg P/ha. The experimental size was (1x2)m. Irrigation and hand-weeding were done when needed. The following plant measurements were recorded: (Shoots dry weight, concentration of N and P% in addition to percentage of root infection with mycorrhizal fungi at flowering 50% of plants. The re

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Publication Date
Mon Jun 17 2019
Journal Name
Ibn Al-haitham Journal For Pure And Applied Sciences
The Effect of Two Antigen Preparations From Group A Streptococcus on Phagocytosis and Cellular Counts of Neutrophils and Monocytes in Albino Mice
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The phagocytic activity of peritoneal and blood cells counts with neutrophils and monocytes were evaluated in albino mice treated wtth two antigen preparations (A and B) from group A streptococci (GAS). Antigen A included water bathed bacteria at 70 °C for 60 minutes, while in Antigen B the bacteria was autoclaved at 121° C for 15 minutes. The animals were treated with 12 intraperitoneal doses of the antigens with intervals of three days (36 days). The 12th dose was a challenge dose (live bacteria). The first three doses of Antigen A increased the phagocytic index (PI) to a range of 76.46-78.69%, then a gradual decreased percentage was observed, especially at the challenge dose (PI=6.42%). The count of neutrophils and monocytes fol

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Publication Date
Sun Dec 30 2018
Journal Name
Baghdad Science Journal
Comparative morphological and histological study of the pecten oculi in two species of Iraqi birds (Falco tinnunculus L. and Streptopelia decaocto F.)
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Study showed structure of pecten oculi in the Kestrel Falco tinnunculus L.was
Pleated type and consisted of 17 folds which were thick. While in the Collared Dove
Streptopelia decaocto F. was Vaned type and consisted of 13 folds and it described
thin. The illustrated histological study of pecten oculi folds in the Kestrel and the
Collared Dove was composed of large number of capillaries, large blood vessels and
pigment cells which were few in Kestrel compare with the Collared Dove. The bridge
in the Kestrel and the Collared Dove pecten oculi was consisted of connective tissue,
many pigment cells, and contains on little capillaries and it linked the membrane to
the internal limiting membrane of the retina in the Kes

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Publication Date
Sun Apr 30 2023
Journal Name
Al-kindy College Medical Journal
Persistent Intraocular Pressure Elevation after Silicon Oil Removal in Patients with Post-Pars Plana Vitrectomy: IOP Level After SO Removal
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Background: It is well-known that silicon oil (SO) injection into the vitreous cavity after pars plana vitrectomy is usually associated with high intraocular pressure.

Objectives: To determine the influence of silicon oil (SO) removal on IOP level after pars plana vitrectomy for spontaneous rhegmatogenous retinal detachment (RRD)

Subjects and Methods: A prospective study was conducted at Ibn Al-Haitham eye teaching hospital, Baghdad- Iraq. Intraocular pressure (IOP) was measured pre and post SO removal in patients who have underwent retinal detachment surgery with SO injection of 1000 centistokes (cSt) viscosity. Baseline IOP was measured for all the patient before the SO

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