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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Thu Jun 25 2020
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Comparison Between Conventional and Supersaturable Self-nanoemulsion Loaded with Nebivolol: Preparation and In-vitro/Ex-vivo Evaluation
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Nebivolol (NBH) is a third-generation B1-blocker with high selectivity and vasodilation activity. Nevertheless, nebivolol exhibits low oral bioavailability, which may adversely affect its efficacy. Recently, supersaturable self-nanoemulsion (Su-SNE) is an advanced SNE approach that can address low bioavailability The study aims to prepare nebivolol-loaded Su-SNE by reduction the amount of the prepared conventional SNE to half. Besides, an appropriate polymer type and concentration to prevent NBH precipitation upon oral administration have investigated.. A conventional self-nanoemulsion (formula A) was prepared by dissolving NBH in 500 mg vehicle mixture of imwitor®988: cremophor-EL: propylene glycol. Then, eight Su-SNE formul

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Publication Date
Fri Sep 01 2023
Journal Name
Iraqi Journal Of Physics
Employment of Silicon Nitride Films Prepared by DC Reactive Sputtering Technique for Ion Release Applications
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In this work, silicon nitride (Si3N4) thin films were deposited on metallic substrates (aluminium and titanium sheets) by the DC reactive sputtering technique using two different silicon targets (n-type and p-type Si wafers) as well as two Ar:N2 gas mixing ratios (50:50 and 70:30). The electrical conductivity of the metallic (aluminium and titanium) substrates was measured before and after the deposition of silicon nitride thin films on both surfaces of the substrates. The results obtained from this work showed that the deposited films, in general, reduced the electrical conductivity of the substrates, and the thin films prepared from n-type silicon targets using a 50:50 mixing ratio and deposited on both

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Publication Date
Thu Apr 25 2019
Journal Name
Iraqi Journal Of Market Research And Consumer Protection
BIOLOGICAL ACTIVITY OF THE CAROTENOIDS WHICH ARE PRODUCED FROM LOCAL ISOLATE Rhodotorula mucilaginosa AND DETRERMINATION THE CONDITIONS AFFECTING THEIR STABILITY: BIOLOGICAL ACTIVITY OF THE CAROTENOIDS WHICH ARE PRODUCED FROM LOCAL ISOLATE Rhodotorula mucilaginosa AND DETRERMINATION THE CONDITIONS AFFECTING THEIR STABILITY
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Biological activity of the carotenoids which are produced fromchemically-mutaed local isolate of Rhodotorula mucilaginosawas studied. The results showed variation of inhibition activity of caritenoids against different types of pathogenic bacteria include, Staph aureus, E. coli, B. subtilis and Salmo. typh., the number declined from 2×107cell/ml to 2×104, 5×104, 2×105, 9×105 cell/ml respectively after 24hour. The produced carotenoids from alocal mutant Rhodotorula mucilaginosa revealed an antioxidant activity as free radical removal of 85.6%. Carotinoides revealed a highest stability in petroleum ether solvent for 30 days at room temperature. It found that the pigment was more stability in sesame oil compared with sun flower and coc

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Publication Date
Thu Nov 01 2018
Journal Name
Journal Of Economics And Administrative Sciences
Comparison of Multistage and Numerical Discretization Methods for Estimating Parameters in Nonlinear Linear Ordinary Differential Equations Models.
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Many of the dynamic processes in different sciences are described by models of differential equations. These models explain the change in the behavior of the studied process over time by linking the behavior of the process under study with its derivatives. These models often contain constant and time-varying parameters that vary according to the nature of the process under study in this We will estimate the constant and time-varying parameters in a sequential method in several stages. In the first stage, the state variables and their derivatives are estimated in the method of penalized splines(p- splines) . In the second stage we use pseudo lest square to estimate constant parameters, For the third stage, the rem

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Publication Date
Sun Dec 30 2007
Journal Name
Iraqi Journal Of Chemical And Petroleum Engineering
The Effect of Time and Corrosion Products Formation on Corrosion Rate of Carbon Steel Pipe Under Turbulent Flow Conditions
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The effect of time (or corrosion products formation) on corrosion rates of carbon steel pipe in aerated 0.1N NaCl
solution under turbulent flow conditions is investigated. Tests are conducted using electrochemical polarization
technique by determining the limiting current density of oxygen reduction in Reynolds number range of 15000 to 110000
and temperature range of 30 to 60oC. The effect of corrosion products formation on the friction factor is studied and
discussed. Corrosion process is analyzed as a mass transfer operation and the mass transfer theory is employed to
express the corrosion rate. The results are compared with many proposed models particularly those based on the
concept of analogy among momentum, heat,

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Publication Date
Mon Aug 11 2025
Journal Name
Journal Of Baghdad College Of Dentistry
Effect of small cardamom extracts on Mutans streptococci and Candida Albicans in comparison to chlorhexidine gluconate and de-ionized water (In vivo study (
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Background: Small cardamom or green cardamom is the dried fruit of the tall perennial herbaceous plant, Elettaria cardamomum Maton belonging to the family Zingiberaceae. The major use of small cardamom on world wide is for domestic culinary purpose and in medicine. This study was conducted to test the effect of small cardamom extracts on Mutans streptococci and Candida Albicans in comparison to 0.2% chlorhexidine gluconate and de-ionized water in vivo. Materials and Methods: Mutans streptococci and Candid Albicans were isolated, purified and diagnosed according to morphological characteristic and biochemical test. In this experiments, the effect of control agents and small cardamom extracts as a mouth rinses was tested on the saliva

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Publication Date
Sat Aug 01 2020
Journal Name
Iop Conference Series: Materials Science And Engineering
Comparison of Single and Group Jet Grout Columns Settlement Based on Field Test and Theoretical Methods
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Abstract<p>The settlement evaluation for the jet grouted columns (JGC) in soft soils is a problematic matter, because it is influenced by the number of aspects such as soil type, effect mixture between soil and grouting materials, nozzle energy, jet grouting, water flow rate, rotation and lifting speed. Most methods of design the jet-grouting column based on experience. In this study, a prototype single and group jet grouting models (single, 1*2, and 2*2) with the total length and diameter were (2000 and 150 mm) respectively and clear spacing (3D) has been constructed in soft clay and subjected to vertical axial loads. Furthermore, different theoretical methods have been used for the estimation </p> ... Show More
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Publication Date
Wed May 13 2020
Journal Name
Nonlinear Engineering
Two meshless methods for solving nonlinear ordinary differential equations in engineering and applied sciences
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Abstract<p>In this paper, two meshless methods have been introduced to solve some nonlinear problems arising in engineering and applied sciences. These two methods include the operational matrix Bernstein polynomials and the operational matrix with Chebyshev polynomials. They provide an approximate solution by converting the nonlinear differential equation into a system of nonlinear algebraic equations, which is solved by using <italic>Mathematica</italic>® 10. Four applications, which are the well-known nonlinear problems: the magnetohydrodynamic squeezing fluid, the Jeffery-Hamel flow, the straight fin problem and the Falkner-Skan equation are presented and solved using the proposed methods. To ill</p> ... Show More
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Publication Date
Fri Jan 08 2010
Journal Name
Al-kindy College Medical Journal
Maternal and fetal outcomes in emergency versus elective two or more previous cesarean deliveries
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Publication Date
Wed Jun 30 2010
Journal Name
Al-kindy College Medical Journal
MATERNAL AND FETAL OUTCOMES IN EMERGENCY VERSUS ELECTIVE TWO OR MORE PREVIOUS CAESAREAN DELIVERIES
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Background: Women with previous two or
more caesarean deliveries are usually
managed by elective cesarean section to avoid
the possible risks of labor.
Objective: To compare the relative risks of
maternal and fetal outcomes in emergency
versus elective previous two or more
caesarean deliveries
Design: Randomized prospective clinical
study
Setting: Al-Elweya Maternity Teaching
Hospital, from 1st of March to 31st of
September 2008.
Methods: The study groups, those who had
previous two or more caesarean deliveries,
were included from the hospital admissions.
The 1st group (102 women) presented in labor
and was managed by caesarean delivery as
soon as it was possible. The second group (7

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