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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
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 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
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 Sep 01 2021
Journal Name
Baghdad Science Journal
On Comparison Study between Double Sumudu and Elzaki Linear Transforms Method for Solving Fractional Partial Differential Equations
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        In this paper, double Sumudu and double Elzaki transforms methods are used to compute the numerical solutions for some types of fractional order partial differential equations with constant coefficients and explaining the efficiently of the method by illustrating some numerical examples that are computed by using  Mathcad 15.and graphic in Matlab R2015a.

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Publication Date
Thu May 28 2020
Journal Name
Iraqi Journal Of Science
Comparison between Horizontal and Vertical OFETs by Using Poly (3-Hexylthiophene) (P3HT) as an Active Semiconductor Layer
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In this paper, a comparison between horizontal and vertical OFET of Poly (3-Hexylthiophene) (P3HT) as an active semiconductor layer (p-type) was studied by using two different gate insulators (ZrO2 and PVA). The electrical performance output (Id-Vd) and transfer (Id-Vg) characteristics were investigated using the gradual-channel approximation model. The device shows a typical output curve of a field-effect transistor (FET). The analysis of electrical characterization was performed in order to investigate the source-drain voltage (Vd) dependent current and the effects of gate dielectric on the electrical performance of the OFET. This work also considered the effects of the capacitance semiconductor on the performance OFETs. The value

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Publication Date
Thu Jun 01 2017
Journal Name
Journal Of Economics And Administrative Sciences
A Comparison Between Maximum Likelihood Method And Bayesian Method For Estimating Some Non-Homogeneous Poisson Processes Models
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Abstract

The Non - Homogeneous Poisson  process is considered  as one of the statistical subjects which had an importance in other sciences and a large application in different areas as waiting raws and rectifiable systems method , computer and communication systems and the theory of reliability and many other, also it used in modeling the phenomenon that occurred by unfixed way over time (all events that changed by time).

This research deals with some of the basic concepts that are related to the Non - Homogeneous Poisson process , This research carried out two models of the Non - Homogeneous Poisson process which are the power law model , and Musa –okumto ,   to estimate th

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Publication Date
Thu Dec 01 2022
Journal Name
Baghdad Science Journal
Comparison between RSA and CAST-128 with Adaptive Key for Video Frames Encryption with Highest Average Entropy
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Encryption of data is translating data to another shape or symbol which enables people only with an access to the secret key or a password that can read it. The data which are encrypted are generally referred to as cipher text, while data which are unencrypted are known plain text. Entropy can be used as a measure which gives the number of bits that are needed for coding the data of an image. As the values of pixel within an image are dispensed through further gray-levels, the entropy increases. The aim of this research is to compare between CAST-128 with proposed adaptive key and RSA encryption methods for video frames to determine the more accurate method with highest entropy. The first method is achieved by applying the "CAST-128" and

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Publication Date
Sat Nov 30 2024
Journal Name
Research Journal Of Chemistry And Environment
Evaluation of blue textile dye decolorization by immobilized polyphenol oxidase using pumice stone under optimum conditions
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Industrial dyes are major pollutants in wastewater and river water with an initial visible concentration of 1 mg/L. Recent studies have shown the possibility of using polyphenol oxidase in catalytic biological treatment due to its ability to oxidize a large number of dyes and pollutants in wastewater and the flexibility to work in wide ranges of temperature, pH and salinity. It is easy availability as well as the low economic cost resulting from its use in biological treatments, this enzyme polyphenol oxidase was used. The findings in this study showed that the extraction of polyphenol oxidase (PPO) from potato peel was homogenized with potassium phosphate buffer (0.1 M, pH 7) at a ratio of 1:10 (weight: volume) for two min. The res

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Publication Date
Thu Nov 01 2018
Journal Name
Computers & Fluids
Assessing moment-based boundary conditions for the lattice Boltzmann equation: A study of dipole-wall collisions
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Publication Date
Wed Jun 30 2021
Journal Name
Iraqi Journal Of Chemical And Petroleum Engineering
Optimal Operating Conditions for Adsorption of Heavy Metals from an Aqueous Solution by an Agriculture Waste
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   The aim of this work is to detect the best operating conditions that effect on the removal of Cu2+, Zn2+, and Ni2+ ions from aqueous solution using date pits in the batch adsorption experiments. The results have shown that the Al-zahdi Iraqi date pits demonstrated more efficient at certain values of operating conditions of adsorbent doses of 0.12 g/ml of aqueous solution, adsorption time 72 h, pH solution 5.5 ±0.2, shaking speed  300 rpm, and smallest adsorbent particle size needed for removal of metals.  At the same time the particle size of date pits has a little effect on the adsorption at low initial concentration of heavy metals. The adsorption of metals increases with increas

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