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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Jan 01 2011
Journal Name
College Of Engineering Journal
Study the Effect of Cutting Conditions for turning process on the Machined Surface
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Surfaces quality is one of the most specified customer requirements for machine parts. The major indication of surfaces quality on machined parts is surface roughness. The research aim is to study the cutting conditions and their effects on the surface roughness. This paper utilizes regression models to predict surface roughness over the machining time for variety of cutting conditions in turning. In the experimental part for turning, different types of materials (Aluminum alloy, Copper alloy, and Gray cast iron) were considered with different cutting speed ( ) and feed rate ( ). A mathematical Model depending on statistical-mathematical method between surface roughness (Rz ) and cutting condition ( , ) were derived, for the three materials

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Publication Date
Tue Nov 07 2017
Journal Name
Spe Symposium: Production Enhancement And Cost Optimisation
Wettability Alteration of Carbonate Rocks via Nanoparticle-Anionic Surfactant Flooding at Reservoirs Conditions
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Nanofluids, liquid suspensions of nanoparticles (NPs) dispersed in deionized (DI) water, brine, or surfactant micelles, have become a promising solution for many industrial applications including enhanced oil recovery (EOR) and carbon geostorage. At ambient conditions, nanoparticles can effectively alter the wettability of the strongly oil-wet rocks to water-wet. However, the reservoir conditions present the greatest challenge for the success of this application at the field scale. In this work, the performance of anionic surfactant-silica nanoparticle formulation on wettability alteration of oil-wet carbonate surface at reservoir conditions was investigated. A high-pressure temperature vessel was used to apply nano-modification of oil-wet

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Publication Date
Thu May 31 2012
Journal Name
Al-khwarizmi Engineering Journal
Restrained Edges Effect on the Dynamics of Thermoelastic Plates under Different End Conditions
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Frequency equations for rectangular plate model with and without the thermoelastic effect for the cases are: all edges are simply supported, all edges are clamped and two opposite edges are clamped others are simply supported.   These were obtained through direct method for simply supported ends using Hamilton’s principle with minimizing Ritz method to total energy (strain and kinetic) for the rest of the boundary conditions. The effect of restraining edges on the frequency and mode shape has been considered. Distributions temperatures have been considered as a uniform temperature the effect of developed thermal stresses due to restrictions of ends conditions on vibration characteristics   of a plate with different

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Publication Date
Mon Jan 01 2024
Journal Name
Aip Conference Proceedings
Investigation of the optimum cutting conditions during turning aluminum alloy using Taguchi method
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Publication Date
Tue Mar 31 2015
Journal Name
Iraqi Journal Of Chemical And Petroleum Engineering
Performance of Corrosion Inhibitors Blend for Simulated Industrial Cooling Waters under Dynamic Conditions
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   The inhibitive action of a blend of sodium nitrite/sodium hexametaphosphate (SN+SHMP) on corrosion of carbon steel in simulated cooling water systems (CWS) has been investigated by weight loss and electrochemical polarization technique. The effect of temperature, velocity, and salts concentrations on corrosion of carbon steel were studied in the absence and presence of mixed inhibiting blend. Also the effect of inhibitors blend concentrations (SN+SHMP), temperatures, and rotational velocity, i.e., Reynolds number (Re) on corrosion rate of carbon steel were investigated using Second-order Rotatable Design (Box-Wilson Design) in performing weight loss and corrosion potential approach. Electrochemical polarization measurements

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Publication Date
Fri Mar 01 2024
Journal Name
Baghdad Science Journal
A Comparison between Ericson's Formulae Results and Experimental Data Using New Formulae of Single Particle Level Density
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The partial level density PLD of pre-equilibrium reactions that are described by Ericson’s formula has been studied using different formulae of single particle level density . The parameter  was used from the equidistant spacing model (ESM) model and the non- equidistant spacing model (non-ESM) and another formula of  are derived from the relation between  and level density parameter . The formulae used to derive  are the Roher formula, Egidy formula, Yukawa formula, and Thomas –Fermi formula. The partial level density results that depend on  from the Thomas-Fermi formula show a good agreement with the experimental data.

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Publication Date
Fri Dec 01 2017
Journal Name
Journal Of Economics And Administrative Sciences
A Comparison between Methods of Laplace Estimators and the Robust Huber for Estimate parameters logistic regression model
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The logistic regression model regarded as the important regression Models ,where of the most interesting subjects in recent studies due to taking character more advanced in the process of statistical analysis .                                                

The ordinary estimating methods is failed in dealing with data that consist of the presence of outlier values and hence on the absence of such that have undesirable effect on the result.    &nbs

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Publication Date
Mon Feb 14 2022
Journal Name
Journal Of Educational And Psychological Researches
Comparison between Rush Model Parameters to Completed and Lost Data by Different Methods of Processing Missing Data
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The current study aims to compare between the assessments of the Rush model’s parameters to the missing and completed data in various ways of processing the missing data. To achieve the aim of the present study, the researcher followed the following steps: preparing Philip Carter test for the spatial capacity which consists of (20) items on a group of (250) sixth scientific stage students in the directorates of Baghdad Education at Al–Rusafa (1st, 2nd and 3rd) for the academic year (2018-2019). Then, the researcher relied on a single-parameter model to analyze the data. The researcher used Bilog-mg3 model to check the hypotheses, data and match them with the model. In addition

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Publication Date
Wed Feb 01 2023
Journal Name
Journal Of Engineering
A Comparison of Dispute Resolution Provisions between the Joint Contract Tribunal and the Iraqi Standard Bidding Document
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Due to a party's violation of his obligations or responsibilities indicated in the contract, many engineering projects confront extensive contractual disputes, which in turn need arbitration or other forms of dispute resolution, which negatively impact the project's outcome. Each contract has its terms for dispute resolution. Therefore, this paper aims to study the provisions for dispute resolution according to Iraqi (SBDW) and the JCT (SBC/Q2016) and also to show the extent of the difference between the two contracts in the application of these provisions. The methodology includes a detailed study of the dispute settlement provisions for both contracts with a comparative analysis to identify the differences in the appli

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Publication Date
Mon Jun 01 2020
Journal Name
Journal Of Engineering
Reliability Analysis of Multibit Error Correcting Coding and Comparison to Hamming Product Code for On-Chip Interconnect
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Error control schemes became a necessity in network-on-chip (NoC) to improve reliability as the on-chip interconnect errors increase with the continuous shrinking of geometry. Accordingly, many researchers are trying to present multi-bit error correction coding schemes that perform a high error correction capability with the simplest design possible to minimize area and power consumption. A recent work, Multi-bit Error Correcting Coding with Reduced Link Bandwidth (MECCRLB), showed a huge reduction in area and power consumption compared to a well-known scheme, namely, Hamming product code (HPC) with Type-II HARQ. Moreover, the authors showed that the proposed scheme can correct 11 random errors which is considered a high

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