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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Dec 17 2022
Journal Name
Iraqi Journal Of Laser
PDF Photodynamic effect of Rose Bengal activated by low-level laser light on S. aureus : Qusay K. Abbas*, Layla M. Hassan
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Abstract: Background: Staphylococcus aureus is Gram-positive bacteria that lives as a normal flora in living organisms but can be pathogenic to humans. Although a relatively unspectacular, nonmotile coccoid bacterium, S. aureus is a dangerous human pathogen in both community-acquired and nosocomial infections. Due to the increasing emergence of new strains of this antibiotic-resistant bacteria, it has become essential to approach different methods to control this pathogen. One of these methods is the antimicrobial photodynamic inactivation process using a low-level laser, in this paper, the Photodynamic effects of Rose Bengal and LLLL on the virulence factors of S.aureus were evaluated.

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Publication Date
Mon Aug 05 2024
Journal Name
Food And Bioprocess Technology
Development of an Innovative Reinforced Food Packaging Film Based on Corn Starch/Hydroxypropyl Methylcellulose/Nanocrystalline Cellulose Incorporated with Nanogel Containing Quercetin
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Publication Date
Sun Jul 09 2023
Journal Name
Journal Of Engineering
A Comparative Study of Various Intelligent Algorithms Based Nonlinear PID Neural Trajectory Tracking Controller for the Differential Wheeled Mobile Robot Model
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This paper presents a comparative study of two learning algorithms for the nonlinear PID neural trajectory tracking controller for mobile robot in order to follow a pre-defined path. As simple and fast tuning technique, genetic and particle swarm optimization algorithms are used to tune the nonlinear PID neural controller's parameters to find the best velocities control actions of the right wheel and left wheel for the real mobile robot. Polywog wavelet activation function is used in the structure of the nonlinear PID neural controller. Simulation results (Matlab) and experimental work (LabVIEW) show that the proposed nonlinear PID controller with PSO
learning algorithm is more effective and robust than genetic learning algorithm; thi

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Publication Date
Sun Jan 01 2023
Journal Name
Aip Conference Proceedings
The optical properties of mawsonite Cu6Fe2SNS8 [CFTS] thin films effected by red laser irradiation deposited via semi-computerized spray pyrolysis technique
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Publication Date
Wed Jan 12 2022
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Evaluating the Impact of Pharmacist Counselling for Asthmatic Children at Karbala Teaching Hospital for Children: An Interventional Prospective Study (Conference Paper )#
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Asthma is one of the most common chronic, non-communicable diseases affecting children worldwide. The estimated prevalence of pediatric asthma in Iraq is 15.8%. Physiologic, inflammatory and structural factors contribute to the development of asthma. Assessment and monitoring of asthma control can be done by a validated children asthma control test (CACT). Management of asthma must address three components which are an appropriate management plan, the most appropriate medication if necessary, and the use of safe and effective medication. The management plan should consider patient counseling and education about the definition of asthma, signs, and symptoms, the pathophysiology of asthma, common triggers for asthma and how can avoid them,

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Publication Date
Sun Nov 01 2020
Journal Name
Journal Of Materials Research And Technology
Immobilization of l-asparaginase on gold nanoparticles for novel drug delivery approach as anti-cancer agent against human breast carcinoma cells
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Publication Date
Wed May 10 2023
Journal Name
Journal Of Engineering
REMOVAL OF PHENOLIC COMPUNDS FROM AQUEOUS SOLUTIONS BY ADSOPTION ONTO ACTIVTED CARBONS PREPARED FROM DATE STONES BY CHEMICAL ACTIVATION WITH FeCl3
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Activated carbon prepared from date stones by chemical activation with ferric chloride (FAC) was used an adsorbent to remove phenolic compounds such as phenol (Ph) and p-nitro phenol (PNPh) from aqueous solutions. The influence of process variables represented by solution pH value (2-12), adsorbent to adsorbate weight ratio (0.2-1.8), and contact time (30-150 min) on removal percentage and adsorbed amount of Ph and PNPh onto FAC was studied. For PNPh adsorption,( 97.43 %) maximum removal percentage and (48.71 mg/g) adsorbed amount was achieved at (5) solution pH,( 1) adsorbent to adsorbate weight ratio, and (90 min) contact time. While for Ph adsorption, at (4) solution pH, (1.4) absorbent to adsorbate weight ratio, and (120 min) contact

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Publication Date
Mon Apr 04 2011
Journal Name
Ibn Al-haitham J.for Pure &appl.sci
Anew Spectrophotometric Method For The Determination of La (III) With 3-Hydroxy -4-(2-hydroxy –Phenyl azo)Naphthalene -1-Sulfonic Acid
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A simple, rapid and sensitive spectrophotometric method has been proposed for the determination of La (III) using 3-hydroxy -4-(2-hydroxy-phenyl azo) naphthalene -1- sulfonic acid as a chromogenic reagent. This method is based on the formation of a red-pink colored complex, upon the reaction of La(III) with the reagent in an alkaline medium (pH= 9.50), having a maximum absorbance at 459 nm. Beer's law is valid in the concentration range 0.512 µg.ml-1 with a Sandell's sensitivity value of 0.0188 µg.cm-2 and molar absorptivity of 7376.12 L.mol-1.cm-1. The stoichiometric composition of the chelate is 1:3. The effect of the presence of different cations as interferants in the determination of La(III) under the given optimum conditions wer

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Publication Date
Sun Oct 06 1996
Journal Name
Iraqi Journal Of Chemistry
Synthesis of new Schiff bases derived from [3-amino-3-C-cyano-3-deoxy-1,2:5,6-di-O-isopropylidene-α-D-allofuranose
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Aromatic Schiff-bases are known to have antibacterial activity, but most of these compounds are sparingly soluble in water. The present work describes the synthesis of new Schiff-bases derived from branched aminosugars. Treatment of 3-Amino-3-Cyano-3-Deoxy-1,2:5,6-Di-O-Isopropylene-α-D-Allofuranose (1) with the aldehydes (2) under reflux in methanol afforded the Schiff-bases (3) in good yields. The new Schiff-bases were in accord with their NMR, IR spectral data and elemental analysis.

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Publication Date
Mon May 01 2023
Journal Name
Human Gene
The G allele of the ADAM33 T1 polymorphism (rs2280091) is a risk factor associated with asthma severity among the Iraqi Arab population
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Background: The gene encoding a disintegrin and metalloproteinase domain 33 (ADAM33) is known to be associated with asthma in different ethnic groups. In Iraq, among the Arab ethnic background, this association has not yet been highlighted. Methods: One hundred and ninety-two asthmatics were examined; 118 males and 74 females (mean age 38.23 ± 9.13 years). The control group was 183; 110 males and the rest were females. The SNP of rs2280091 A/G (T1) was studied here to determine adam33 genotyping status using polymerase chain reaction–restriction fragment length polymorphism (PCR–RFLP). The level of total IgE was measured using enzyme-linked immunosorbent assay (ELISA). Results: Significant differences (p = 0.004) in the frequencies of

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