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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Jun 15 2018
Journal Name
Journal Of Baghdad College Of Dentistry
Comparison of certain radiomorphometric facial indices in different facial types of Iraqi adults using Cone Beam Computed Tomography
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Background: The human face has its special characteristics. It may be categorized into essentially three kinds in horizontal and vertical directions: short or brachyfacial, medium or mesofacial and long or dolichofacial. The aim of this study was to describe several orofacial indices and proportions of adults, according to gender in Iraqi subjects by using cone beam computed tomography . materials and methods: This prospective study included 100 Iraqi patients (males and females) ranging from 20 to 40 years. All subjects attended the Oral and Maxillofacial Radiology Department of Health Specialist Center for Dentistry in AL Sadr city in Baghdad taking cone beam computed tomography scan for different diagnostic purposes from October 2016 to

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Publication Date
Sun Jan 01 2023
Journal Name
Al-bayan Journal For Medical And Health Sciences
Effect of Nd:YAG Laser Surface Treatment on Wettability of Thermoplastic Acrylic in Comparison with Heat-Cure Acrylic resin
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Aim of the study: This study's goal was to determine how laser surface alteration affected wettability of injectable thermoplastic acrylic and heat cure acrylic denture base materials. Materials and methods: Injectable thermoplastic acrylic resin (Deflex) and heat cure acrylic (Procryla) were used in this study to produce forty-disc shaped specimens, 20 specimens for each material type. The control group was made up of ten samples of each type of plastic denture base material. The other ten samples were treated with a nano-pulse fiber-optic lens Nd:YAG laser. The results were looked at with the Kruskal-Wallis test and the unpaired t-test (a=.05). Results: Compared to the control groups, the laser-treated groups were more likely to sti

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Publication Date
Fri Jun 16 2023
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Evaluation the Effect of Phytosterol Fraction of Chenopodium Murale in Comparison with Tacrolimus on Mice Induced Atopic Dermatitis
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Atopic dermatitis (atopic eczema), is a common familial chronic inflammatory skin disease, determined by xerosis, itching, scaly and erythematous skin lesions, and high serum levels of IgE. Between 10 to 20% of children and 1 to 3% of adults worldwide affected by it and has negative medical and social effect on patients and their families. To evaluate the effectiveness of Phytosterol Fraction of Chenopodium Murale on induced atopic dermatitis (AD) of mice; Forty mice were included in the study, divided in to four groups (10 mice/group): apparently healthy, induced AD without treatment, induced AD treated with Tacrolimus 0.1% ointment, and induced AD treated with Phytosterol Fraction of Chenopodium Murale cream 3% topica

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Publication Date
Wed Feb 01 2023
Journal Name
Journal Of Engineering
Applying the WaterGEMS Software to Conduct a Comparison of the Darcy-Weisbach and Hazen-Williams Equations for Calculating the Frictional Head Loss in a Selected Pipe Network
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Darcy-Weisbach (D-W) is a typical resistance equation in pressured flow; however, some academics and engineers prefer Hazen-Williams (H-W) for assessing water distribution networks. The main difference is that the (D-W) friction factor changes with the Reynolds number, while the (H-W) coefficient is a constant value for a certain material. This study uses WaterGEMS CONNECT Edition update 1 to find an empirical relation between the (H-W) and (H-W) equations for two 400 mm and 500 mm pipe systems. The hydraulic model was done, and two scenarios were applied by changing the (H-W) coefficient to show the difference in results of head loss. The results showed a strong relationship between both equations with correlation coefficients of 0.999,

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Publication Date
Fri Apr 01 2022
Journal Name
Journal Of Engineering
Numerical study of natural convection in an annulus between two concentric cylinders provided with metal foam fins
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Natural convection in an annular space provided with metal foam fins attached to the inner cylinder is studied numerically. The metal foam fins made of copper were inserted in different axial sections with three fins in each section. The temperature of the inner cylinder is kept constant while the annular outer surface is adiabatic. The thickness effect of the inner pipe wall was considered. Naiver Stokes equation with Boussinesq approximation is used for the fluid regime while Brinkman-Forchheimer Darcy model is used for metal foam. In addition, the local thermal non-equilibrium condition in the energy equation of the porous media is presumed. The effect of Rayleigh numb

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Publication Date
Fri Dec 15 2023
Journal Name
Iraqi Journal Of Laser
The Reliability of Two Different Laser Wavelengths in Inducing Bone Healing Around Dental Implants: Comparative Clinical Trial
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Background/purpose: Dental implantology involves different treatments that have been used in conjunction with dental implant surgery to increase implant stability and bone regeneration process. Photobiomodulation( PBM) can be one of these techniques. The objective of this study was to evaluate the bone density around implants. Materials and methods: in this study, 10 individuals had 20 implants inserted in the posterior of their mandibles. each patient received two implants the left side served as the control whereas the right side served as the study group with a diode laser (same patients). measurements were made for each implant. Measurements were obtained using cone-

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Publication Date
Thu Apr 25 2019
Journal Name
University Of Thi-qar Journal
Evaluation the Geotechnical Properties of Oil-Polluted Soil from Two Selected Areas in Thi-Qar Governorate-Iraq
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Oil pollution of the soil due to a leakage in oil tubes, transportation of products, or during oil excavations can change the soil physical and mechanical, chemical, and biological properties. Consequently, the soil may or may not be eligible for engineering construction projects and it may need a significant treatment. Therefore, it is required to have a better understanding of the general behavior and the corresponding geotechnical properties upon pollution particularly for those areas associated with oil explorations and industry like Thi-Qar Governorate. Fine and coarse soils from two sites at the University of Thi-Qar are artificially contaminated with oil products ranging from 0% to 10% of their dry weight. Testing programs have been

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Publication Date
Tue Sep 29 2020
Journal Name
Reaction Kinetics, Mechanisms And Catalysis
Development of two-step noncatalytic esterification of waste cooking oil for biodiesel preparation
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An innovative two-step noncatalytic esterifcation technique was proposed to synthesize alkyl esters from free fatty acids simulated in waste cooking oil, as a pretreatment process for biodiesel production, without adding any catalyst under normal conditions of pressure and temperature. The efect of methanol:oil molar ratio, reaction time, mixing rate, and reaction temperature were investigated. The results confrmed that the conversion of the reaction was increased when increasing the methanol molar ratio and decreased in prolonged reaction temperature. High conversion (94.545%) was successfully achieved at optimized conditions of 115:1, 65:1 methanol:oil molar ratio in the frst step and second step, respectively, other conditions i

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Publication Date
Tue Jan 17 2017
Journal Name
International Journal Of Computer Applications
Improving of Photovoltaic Cell Performance by Cooling using Two different Types of Fins
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Publication Date
Mon Oct 01 2018
Journal Name
The Saudi Dental Journal
Evaluation of some mechanical properties of a new silicone elastomer for maxillofacial prostheses after addition of intrinsic pigments
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Objective: The approximate life span of a silicone maxillofacial prosthesis is as short as1.5–2 years of clinical service, then a new prosthesis should be fabricated. The most common reasonfor re-making the prosthesis is silicone mechanical properties degradation. The aim of this studywas to assess some mechanical properties of VST-30 silicone for maxillofacial prostheses after addi-tion of intrinsic pigments.Methods: Two types of intrinsic pigments (rayon flocking and burnt sienna); each of them wasincorporated into silicone. One hundred and twenty samples were prepared and split into 4 groupsaccording to the conducted tests (tear strength, hardness, surface roughness, and tensile strengthand elongation percentage) with 30 samples for ea

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