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Bioequivalence and Pharmacokinetics Comparison of Two Formulations of Extended-Release Pentoxifylline Tablets in Healthy Subjects after Fasting and Fed Conditions

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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Oct 01 2016
Journal Name
Journal Of Engineering
Numerical and Experimental Analysis of Aircraft Wing Subjected to Fatigue Loading

This study deals with the aircraft wing analysis (numerical and experimental) which subjected to fatigue loading in order to analyze the aircraft wing numerically by using ANSYS 15.0 software and experimentally by using loading programs which effect on fatigue test specimens at laboratory to estimate life of used metal (aluminum alloy 7075-T651) the wing metal and compare between numerical and experimental work, as well as to formulate an experimental mathematical model which may find safe estimate for metals and most common alloys that are used to build aircraft wing at certain conditions. In experimental work, a (34) specimen of (aluminum alloy 7075-T651) were tested using alternating bending fatigue machine rig. The t

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Publication Date
Sat Jan 13 2018
Journal Name
Journal Of Engineering
Performance Evaluation of RIPng, EIGRPv6 and OSPFv3 for Real Time Applications

In this modern Internet era and the transition to IPv6, routing protocols must adjust to assist this transformation. RIPng, EIGRPv6 and OSPFv3 are the dominant IPv6 IGRP (Interior Gateway Routing Protocols). Selecting the best routing protocol among the available is a critical task, which depends upon the network requirement and performance parameters of different real time applications. The primary motivation of this paper is to estimate the performance of these protocols in real time applications. The evaluation is based on a number of criteria including:  network convergence duration, Http Page Response Time, DB Query Response Time, IPv6 traffic dropped, video packet delay variation and video packet end to end de

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Publication Date
Sat Apr 01 2023
Journal Name
Bulletin Of Electrical Engineering And Informatics
Implementation and performance evaluation of multi level pseudo random sequence generator

In this paper, introduce a proposed multi-level pseudo-random sequence generator (MLPN). Characterized by its flexibility in changing generated pseudo noise (PN) sequence according to a key between transmitter and receiver. Also, introduce derive of the mathematical model for the MLPN generator. This method is called multi-level because it uses more than PN sequence arranged as levels to generation the pseudo-random sequence. This work introduces a graphical method describe the data processing through MLPN generation. This MLPN sequence can be changed according to changing the key between transmitter and receiver. The MLPN provides different pseudo-random sequence lengths. This work provides the ability to implement MLPN practically

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Publication Date
Sat Dec 17 2022
Journal Name
Journal Of Al-ma'moon College
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Publication Date
Fri Dec 29 2023
Journal Name
Iraqi Journal Of Agricultural Sciences
OPTIMIZING MEDIA STERILIZATION VIA CHLORINE DIOXIDE AND AUTOCLAVING OF PAULOWNI MICROPROPAGATION

This study was aimed to investigat integrated system for in vitro growth of paulownia plants by assessing the efficacy of chlorine dioxide (ClO2) as an alternative to autoclave in sterilizing culture medium. Therefore, this study was devised to compare autoclave sterilization at three different times (5, 10, and 15) minutes and three different concentrations of ClO2 (0, 0.4, 0,8, 1) mg/L. The results showed that, compared with (0.4) mg/L concentration,  concentrations of (0.8 and 1) mg/L are more effective at sterilizing the culture medium. ClO2 sterilization improved individual single node growth more than autoclave sterilization. Since ClO2 is non-toxic, it could be used as a safe alternative to autoclave when propagating paulown

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Publication Date
Tue Jun 15 2021
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Solubility and Dissolution Enhancement of Ebastine by Surface Solid Dispersion Technique

Ebastine (EBS) is a non-sedating antihistamine with a long duration of action. This drug has predominantly hydrophobic property causing a low solubility and low bioavailability. Surface solid dispersions (SSD) is an effective technique for improving the solubility and dissolution rate of poorly soluble drugs by using hydrophilic water insoluble carriers.

The present study aims to enhance the solubility and dissolution rate of EBS by using surface solid dispersion technique. Avicel® PH101, Avicel® PH 102, croscarmellose sodium(CCS) and sodium starch glycolate(SSG) were used as water insoluble hydrophilic carriers.

The SSD formulations of EBS were prepared by the solvent evaporation method in different drug:  carrier

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Publication Date
Sun May 01 2016
Journal Name
Energy Conversion And Management
Stability and thermophysical properties of non-covalently functionalized graphene nanoplatelets nanofluids

A pioneering idea for increasing the thermal performance of heat transfer fluids was to use ultrafine solid particles suspended in the base fluid. Nanofluids, synthesized by mixing solid nanometer sized particles at low concentrations with the base fluid, were used as a new heat transfer fluid and developed a remarkable effect on the thermophysical properties and heat transfer coefficient. For any nanofluid to be usable in heat transfer applications, the main concern is its long-term stability. The aim of this research is to investigate the effect of using four different surfactants (sodium dodecyl benzene sulfonate (SDBS), sodium dodecyl sulfate (SDS), cetyl trimethylammonium bromide (CTAB), and gum Arabic (GA)), each with three different

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Publication Date
Thu Jun 30 2022
Journal Name
Iraqi Journal Of Science
The Effect of Mutual Interaction and Harvesting on Food Chain Model

       This paper treats the interactions among four population species. The system includes one mutuality prey, one harvested prey and two predators. The four species interaction can be described as a food chain, where the first prey helps the second harvested prey. The first and the second predator attack the first and the second prey, respectively, according to Lotka-Volterra type functional responses. The model is formulated using differential equations. One equilibrium point of the model is found and analysed to reveal a threshold that will allow the coexistence of all species. All other equilibrium points of the system are located, with their local and global stability being assessed. To back up the conclusions of the mathema

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Publication Date
Wed May 26 2021
Journal Name
Communications In Mathematical Biology And Neuroscience
Modelling and stability analysis of the competitional ecological model with harvesting

The interplay of predation, competition between species and harvesting is one of the most critical aspects of the environment. This paper involves exploring the dynamics of four species' interactions. The system includes two competitive prey and two predators; the first prey is preyed on by the first predator, with the former representing an additional food source for the latter. While the second prey is not exposed to predation but rather is exposed to the harvest. The existence of possible equilibria is found. Conditions of local and global stability for the equilibria are derived. To corroborate our findings, we constructed time series to illustrate the existence and the stability of equilibria numerically by varying the different values

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Publication Date
Thu Dec 05 2013
Journal Name
Robotica
Modeling, stability and walking pattern generators of biped robots: a review
SUMMARY<p>Biped robots have gained much attention for decades. A variety of researches have been conducted to make them able to assist or even substitute for humans in performing special tasks. In addition, studying biped robots is important in order to understand human locomotion and to develop and improve control strategies for prosthetic and orthotic limbs. This paper discusses the main challenges encountered in the design of biped robots, such as modeling, stability and their walking patterns. The subject is difficult to deal with because the biped mechanism intervenes with mechanics, control, electronics and artificial intelligence. In this paper, we collect and introduce a systematic discussion of modelin</p> ... Show More
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