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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Wed Nov 24 2021
Journal Name
International Journal Of Drug Delivery Technology
Comparison among the Synthesis of Some Azomethine Derivatives by Classical and Non-classical Methods
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الوصف In this time, most researchers toward about preparation of compounds according to green chemistry. This research describes the preparation of 2-fluoro-5-(substituted benzylideneamino) benzonitrile under reflux and microwave methods. Six azomethine compounds (B1-6) were synthesized by two methods under reflux and assisted microwave with the comparison between the two methods. Reflux method was prepared of azomethine (B1-6) by reaction of 5-amino-2-fluorobenzonitrile with some aldehyde derivatives with (50–100) mL of absolute ethanol and some quantity of GAA and time is limited between (2–5) hours with a yield between (60–70) percent with recrystallization for appropriate solvents. But the microwave-assisted method was synthe

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Publication Date
Fri Nov 01 2019
Journal Name
Journal Of Engineering
A Comparison Study of Brine Desalination using Direct Contact and Air Gap Membrane Distillation
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Membrane distillation (MD) is a hopeful desalination technique for brine (salty) water. In this research, Direct Contact Membrane Distillation (DCMD) and  Air Gap Membrane Distillation (AGMD) will be used. The sample used is from Shat Al –Arab water (TDS=2430 mg/l). A polyvinylidene fluoride (PVDF) flat sheet membrane was used as a flat sheet form with a plate and frame cell. Several parameters were studied, such as; operation time, feed temperature, permeate temperature, feed flow rate. The results showed that with time, the flux decreases because of the accumulated fouling and scaling on the membrane surface. Feed temperature and feed flow rate had a positive effect on the permeate flux, while permeate temperatu

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Publication Date
Fri Jun 25 2021
Journal Name
International Journal Of Drug Delivery Technology
Comparison among the Synthesis of Some Azomethine Derivatives by Classical and Non-classical Methods
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In this time, most researchers toward about preparation of compounds according to green chemistry. This research describes the preparation of 2-fluoro-5-(substituted benzylideneamino) benzonitrile under reflux and microwave methods. Six azomethine compounds (B1-6) were synthesized by two methods under reflux and assisted microwave with the comparison between the two methods. Reflux method was prepared of azomethine (B1-6) by reaction of 5-amino-2-fluorobenzonitrile with some aldehyde derivatives with (50–100) mL of absolute ethanol and some quantity of GAA and time is limited between (2–5) hours with a yield between (60–70) percent with recrystallization for appropriate solvents. But the microwave-assisted method was synthesized of co

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Publication Date
Wed Aug 31 2022
Journal Name
Al-kindy College Medical Journal
A comparison of cross sections for Selenium -73 radioisotopes produced by accelerators and reactors
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Background: Selenium-73 with half- life of 7.15 hour emits β+ in nature and has six stable isotopes which are ( 74Se,76Se,77Se,78Se,80Se and 82Se ). Selenium-73 has many applications in technology and radioselenium compounds of metallic have found various applications in medicine. Objective:  To make a comparison between different reactions that produced cross sections of Se-73 radioisotopes. Subjects and methods: The feasibility of the production of Selenium -73 via various nuclear reactions was investigated. Excitation functions of 73Se production by the reactions of 75As (p,3n), 169Tm( d,x), 74Se, natSe, natBr (p,x) , 75As (d,4n), natGe (3He,x), 70Ge (α, n), and 72Ge (α, 3n) and neutron capture were calculated using the avail

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Publication Date
Fri Apr 22 2022
Journal Name
Asian Journal Of Water, Environment And Pollution
An Ecological Comparison of Benthic Invertebrate Communities Between Sewage and Tigris River Water – Baghdad
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In the current study, two sites were selected from the city of Adhamiya, central Baghdad. The first site is the Adhamiya Corniche, which includes a sample of river water and the second includes domestic sewage in the same area. The total density of benthic invertebrates was 775 ind/m2, which is divided into 15 taxa. Biological indices were found, such as the stability index, the abundance index, the biodiversity index (Shannon’s index), the homogeneity index, and the invader’s guide. The result showed an increase in the density of benthic invertebrates, as well as an increase in the diversity of these organisms.

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Publication Date
Thu Jun 30 2022
Journal Name
International Journal Of Drug Delivery Technology
Comparison among the Synthesis of Some Azomethine Derivatives by Classical and Non-classical Methods
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Publication Date
Wed Aug 01 2018
Journal Name
Journal Of Economics And Administrative Sciences
Comparison Some Estimation Methods Of GM(1,1) Model With Missing Data and Practical Application
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This paper presents a grey model GM(1,1) of the first rank and a variable one and is the basis of the grey system theory , This research dealt  properties of grey model and a set of methods to estimate parameters of the grey model GM(1,1)  is the least square Method (LS) , weighted least square method (WLS), total least square method (TLS) and gradient descent method  (DS). These methods were compared based on two types of standards: Mean square error (MSE), mean absolute percentage error (MAPE), and after comparison using simulation the best method was applied to real data represented by the rate of consumption of the two types of oils a Heavy fuel (HFO) and diesel fuel (D.O) and has been applied several tests to

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Publication Date
Fri Dec 30 2022
Journal Name
Iraqi Journal Of Chemical And Petroleum Engineering
Comparison of Estimation Sonic Shear Wave Time Using Empirical Correlations and Artificial Neural Network
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Wellbore instability and sand production onset modeling are very affected by Sonic Shear Wave Time (SSW). In any field, SSW is not available for all wells due to the high cost of measuring. Many authors developed empirical correlations using information from selected worldwide fields for SSW prediction. Recently, researchers have used different Artificial Intelligence methods for estimating SSW. Three existing empirical correlations of Carroll, Freund, and Brocher are used to estimate SSW in this paper, while a fourth new empirical correlation is established. For comparing with the empirical correlation results, another study's Artificial Neural Network (ANN) was used. The same data t

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Publication Date
Wed Aug 31 2022
Journal Name
Al-kindy College Medical Journal
A comparison of cross sections for Selenium -73 radioisotopes produced by accelerators and reactors
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Background: Selenium-73 with half- life of 7.15 hour emits β+ in nature and has six stable isotopes which are ( 74Se,76Se,77Se,78Se,80Se and 82Se ). Selenium-73 has many applications in technology and radioselenium compounds of metallic have found various applications in medicine.

Objective:  To make a comparison between different reactions that produced cross sections of Se-73 radioisotopes.

Subjects and methods: The feasibility of the production of Selenium -73 via various nuclear reactions was investigated. Excitation functions of 73Se production by the re

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Publication Date
Wed Jan 01 2020
Journal Name
Dental Research Journal
Impact of a mixture of nanofiller and intrinsic pigment on tear strength and hardness of two types of maxillofacial silicone elastomers
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Background: The ideal maxillofacial prosthesis should have fine and thin boundaries that bindwith the surrounding facial structures and possess high tear strength.This study aims to determinethe best percentages of nanofiller (TiO2) and intrinsic pigment (silicone functional intrinsic) thatcould be mixed in as additives to improve the tear strength of Cosmesil M511 andVST50F siliconeelastomers with the least effect on their hardness.Materials and Methods: In this in vitro experimental study, a total of 80 samples, 40 for eachelastomer, were fabricated. Each elastomer sample was split into two equal groups to test for tearstrength and Shore A hardness. Each group consisted of 20 samples, including 10 control sampleswithout additives and 10 e

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