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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Fri Jul 21 2023
Journal Name
Journal Of Engineering
CATHODIC PROTECTION OF CARBON STEEL IN 0.1N NaCl SOLUTION UNDER FLOW CONDITIONS USING ROTATING CYLINDER ELECTRODE
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The effect of applied current on protection of carbon steel in 0.1N NaCl solution (pH=7) was investigated under flow conditions (0-0.262 m/s) for a range of temperatures (35-55°C) using rotating cylinder electrode. Various values of currents were applied to protect steel from corrosion, these were Iapp.=Icorr., Iapp.=2Icorr. and Iapp.=2.4Icorr. under stationary and flow conditions. Corrosion current was measured by weight loss method. The variation of protection potential with time and rotation velocity at various applied currents was assessed. It is found that the corrosion rate of carbon steel increases with rotation velocity and
has unstable trend with temperature. The protection current required varies with temperature and it inc

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Publication Date
Fri Mar 01 2019
Journal Name
Al-khwarizmi Engineering Journal
Study The Influence of Forming Conditions Like Deformation Speed on Void Closure in Open Die Forging
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This paper presents an investigation to the effect of the forming speed on healing voids that inhabit at various size in an ingot. The study was performed by using finite element method with bilinear isotropic material option, circular type voids were considered. The closure index was able to predict the minimum press force necessary to consolidate voids and the reduction. The simulation was carried out, on circular cross-section lead specials containing a central void of different size. At a time with a flat die, different ratio of inside to outside radius was taken with different speed to find the best result of void closure.

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Publication Date
Wed Mar 01 2023
Journal Name
International Journal Bioautomation
Photobiomodulation Effect of 850 nm Near-infrared Diode Laser on the Release of M1-related Cytokines Inmonocytic THP-1 Cells
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Photobiomodulation (PBM) is a form of the use of visible red and Near-infrared (NIR) light at low power, where a laser light photon is absorbed at the electronic level, without heat production. PBM can be applied in wide range of treatment to help the wound, inflammation, edema, and pain reduction. However, there is a lack of scientific documentation regarding its actual effects. Objectives: This study assesses the impact of PBM on the release of M1-related cytokine in monocyte cells with particular emphasis on interleukin-1β (IL-1β) and Tumour Necrosis Factor α (TNF-α). Methods: Tamm-Horsfall Protein 1 (THP-1) macrophages M1 cells have been exposed to the light from the diode laser of 850nmat different doses (0, 0.6, 1.2 and 3.

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Publication Date
Tue Jan 01 2013
Journal Name
Iraqi Journal Of Physics
A comparison between PCA and some enhancement filters for denoising astronomical images
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This paper includes a comparison between denoising techniques by using statistical approach, principal component analysis with local pixel grouping (PCA-LPG), this procedure is iterated second time to further improve the denoising performance, and other enhancement filters were used. Like adaptive Wiener low pass-filter to a grayscale image that has been degraded by constant power additive noise, based on statistics estimated from a local neighborhood of each pixel. Performs Median filter of the input noisy image, each output pixel contains the Median value in the M-by-N neighborhood around the corresponding pixel in the input image, Gaussian low pass-filter and Order-statistic filter also be used. Experimental results shows LPG-PCA method

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Publication Date
Tue Mar 24 2009
Journal Name
Proceeding Of 3rd Scientific Conference Of The College Of Science, University Of Baghdad.
A Comparison Between Galactic and Large Magellanic Cloud (LMC) Interstellar Extinction Curves
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Average interstellar extinction curves for Galaxy and Large Magellanic Cloud (LMC) over the range of wavelengths (1100 A0 – 3200 A0) were obtained from observations via IUE satellite. The two extinctions of our galaxy and LMC are normalized to Av=0 and E (B-V)=1, to meat standard criteria. It is found that the differences between the two extinction curves appeared obviously at the middle and far ultraviolet regions due to the presence of different populations of small grains, which have very little contribution at longer wavelengths. Using new IUE-Reduction techniques lead to more accurate result.

Publication Date
Wed Feb 20 2019
Journal Name
Iraqi Journal Of Physics
A comparison between PCA and some enhancement filters for denoising astronomical images
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This paper includes a comparison between denoising techniques by using statistical approach, principal component analysis with local pixel grouping (PCA-LPG), this procedure is iterated second time to further improve the denoising performance, and other enhancement filters were used. Like adaptive Wiener low pass-filter to a grayscale image that has been degraded by constant power additive noise, based on statistics estimated from a local neighborhood of each pixel. Performs Median filter of the input noisy image, each output pixel contains the Median value in the M-by-N neighborhood around the corresponding pixel in the input image, Gaussian low pass-filter and Order-statistic filter also be used.

Experimental results shows LPG-

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Publication Date
Thu Jan 09 2020
Journal Name
Plant Archives
Molecular Study of Two Fungi Millerozyma Farinosa and Candida Orthopsilosis by PCR Using Its Gene and Phylogenetic Structuring Tree Isolated from Diabetic Patient in Baghdad
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Diabetic mellitus is one of the main risk factors of fungal infections because poor glycemic control is associated with a high level of glucose in blood and saliva which could be treated as nutrient to fungi. This study aimed to isolate and identification of pathogenic fungi from diabetic patient. 140 samples were taken from different places of human body from the national center of diabetic patients that related to Mustansiriyah University / college of medicine and Al-yarmuk Hospital in Baghdad. 84 sample (60%) tested positive to fungi and 56 sample (40%) tested negative to fungi. The most frequented fungi isolated have been chosen for molecular identification by PCR (Millerozyma farinosa and Candida orthopsilosis) using specific pri

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Scopus
Publication Date
Tue Dec 17 2013
Journal Name
Al-kindy College Medical Journal
Levels of Some Proinflammatory Cytokines in Obese Women with Polycystic Ovary Syndrome after Metformin Therapy
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Publication Date
Sun Jun 30 2013
Journal Name
Al-kindy College Medical Journal
Levels of Some Proinflammatory Cytokines in Obese Women with Polycystic Ovary Syndrome after Metformin Therapy
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Background: Polycystic ovary syndrome is a heterogeneous disorder and its etiology appears to be complex and multifactorial; characterized by hyperandrogenism, chronic anovulation and infertility. It’s associated with evidence of low-grade chronic inflammation, as indicated by the presence of elevated levels of high sensitive C- reactive protein levels, interleukin-6 and tumor necrosis factor-α. The source of excess circulating tumor necrosis factor-α in obese Polycystic ovary syndrome patient is likely to be the adipose tissues while in lean women increased visceral adiposity has been proposed as a source of excess tumor necrosis factor-α.Objectives: to evaluate the levels of high sensitive C- reactive protein, tumor necrosis facto

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Publication Date
Sun Sep 29 2024
Journal Name
مجلة نسق
The diplomatic role of IGAD in regional peacemaking: Sudan after 2011 as a case study
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The research discusses the most important goals and means of IGAD in making peace in Sudan and then regional peace.

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