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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Tue Jan 01 2019
Journal Name
Plant Archives
Ecological survey of aquatic macrophytes in Al-Huwaizah Marsh southern of Iraq after inclusion in the world Heritage list
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Publication Date
Sat Jun 25 2022
Journal Name
International Journal Of Drug Delivery Technology
Comparison of Sizes of Zinc Oxide Nanoparticles Extracted from Staphylococcus lugdunensis and Berberis vulgaris Plant Extract Against Some Types of Bacteria and Yeast
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Staphylococcus lugdunensis, isolation between 12.5 to 1.8% routine works may be a possible peroral route of infective endocarditis and found in the oral cavity by examined using saliva. Similar supragingival plaque isolation was observed. The increased bacteria resistance to antibiotics multiple have led to novel methods for resistance bacteria; antimicrobial agents are well known (ZnO NPs) by biological method and are lower toxicity and biology safety ZnNOPs activity by plant extraction and less toxicity as well as bio-safe. The nanoparticle was synthesized by biological method (Green) by barberry (Berberis vulgaris) extract. In this study using (WAD) method using different concentrations between (128, 64, 32, and 16) mg/mL of ZnO NPs, The

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Publication Date
Sat Jun 25 2022
Journal Name
International Journal Of Drug Delivery Technology
Comparison of Sizes of Zinc Oxide Nanoparticles Extracted from Staphylococcus lugdunensis and Berberis vulgaris Plant Extract Against Some Types of Bacteria and Yeast
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Staphylococcus lugdunensis, isolation between 12.5 to 1.8% routine works may be a possible peroral route of infective endocarditis and found in the oral cavity by examined using saliva. Similar supragingival plaque isolation was observed. The increased bacteria resistance to antibiotics multiple have led to novel methods for resistance bacteria; antimicrobial agents are well known (ZnO NPs) by biological method and are lower toxicity and biology safety ZnNOPs activity by plant extraction and less toxicity as well as bio-safe. The nanoparticle was synthesized by biological method (Green) by barberry (Berberis vulgaris) extract. In this study using (WAD) method using different concentrations between (128, 64, 32, and 16) mg/mL of ZnO

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Publication Date
Sun Jun 02 2013
Journal Name
Baghdad Science Journal
Comparison of Maximum Likelihood and some Bayes Estimators for Maxwell Distribution based on Non-informative Priors
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In this paper, Bayes estimators of the parameter of Maxwell distribution have been derived along with maximum likelihood estimator. The non-informative priors; Jeffreys and the extension of Jeffreys prior information has been considered under two different loss functions, the squared error loss function and the modified squared error loss function for comparison purpose. A simulation study has been developed in order to gain an insight into the performance on small, moderate and large samples. The performance of these estimators has been explored numerically under different conditions. The efficiency for the estimators was compared according to the mean square error MSE. The results of comparison by MSE show that the efficiency of Bayes est

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Publication Date
Tue Jun 01 2010
Journal Name
Al-khwarizmi Engineering Journal
Comparison of the RLS and LMS Algorithms to Remove Power Line Interference Noise from ECG Signal
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    Biomedical signal such as ECG is extremely important in the diagnosis of patients and is commonly recorded with a noise. Many different kinds of noise exist in biomedical environment such as Power Line Interference Noise (PLIN). Adaptive filtering is selected to contend with these defects, the adaptive filters can adjust the filter coefficient with the given filter order. The objectives of this paper are: first an application of the Least Mean Square (LMS) algorithm, Second is an application of the Recursive Least Square (RLS) algorithm to remove the PLIN. The LMS and RLS algorithms of the adaptive filter were proposed to adapt the filter order and the filter coefficients simultaneously, the performance of existing LMS

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Publication Date
Sun Jun 02 2013
Journal Name
Baghdad Science Journal
Comparison of Maximum Likelihood and some Bayes Estimators for Maxwell Distribution based on Non-informative Priors
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In this paper, Bayes estimators of the parameter of Maxwell distribution have been derived along with maximum likelihood estimator. The non-informative priors; Jeffreys and the extension of Jeffreys prior information has been considered under two different loss functions, the squared error loss function and the modified squared error loss function for comparison purpose. A simulation study has been developed in order to gain an insight into the performance on small, moderate and large samples. The performance of these estimators has been explored numerically under different conditions. The efficiency for the estimators was compared according to the mean square error MSE. The results of comparison by MSE show that the efficiency of B

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Publication Date
Sun Mar 03 2013
Journal Name
Baghdad Science Journal
Comparison the Formation of Spark Corona Discharge between Tap and distilled Waters at Liquid Electrode System
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In this paper, we studied the spark corona discharge in tap and distillited waters. The results show the shape of cone that generated on the tip of capillary tube is different with conductivity of liquids. The blue glow appears at the end of capillary tube and the drop extends into a cone. In addition, the conducitivity is affected on the relationship between the appearance of the blue glow discharge with the applied voltage. The size of the cone decreases with an increase in applied voltage. The cone diameter at the base of capillary tube oscillates with period approximately 1 Sec. this oscillates in the cone diameters is due to the change distance between the liquid electrode and the surface of liquid. The intensity of spark corona dis

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Publication Date
Sat Dec 31 2022
Journal Name
Journal Of Economics And Administrative Sciences
Comparison of Robust Circular S and Circular Least Squares Estimators for Circular Regression Model using Simulation
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In this paper, the Monte-Carlo simulation method was used to compare the robust circular S estimator with the circular Least squares method in the case of no outlier data and in the case of the presence of an outlier in the data through two trends, the first is contaminant with high inflection points that represents contaminant in the circular independent variable, and the second the contaminant in the vertical variable that represents the circular dependent variable using three comparison criteria, the median standard error (Median SE), the median of the mean squares of error (Median MSE), and the median of the mean cosines of the circular residuals (Median A(k)). It was concluded that the method of least squares is better than the

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Publication Date
Sun Sep 01 2013
Journal Name
Baghdad Science Journal
Study Analytical of The Effect Magnesium ion Concentration to Determination the Total Hardness And Comparison Spectrophotometry
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The determination hardness in water raised to rivers caused several problem in the validity of the water used depends on where determination ions concentration calcium and magnesium in salts carbonate and sulfate , this possibility of separation between of these ions and the resulting impact on concentration and determination the degree of hardness water and appreciation between the insolvent water quality . It study the effect of the impact of concentration magnesium ion in determination the quality of the water has turned out to be Mg concentration more than 60% of the total content of hardness is borderline in hardness effect the determination. Adopted in this research determination the ions in two method titration by EDTA solution and

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Publication Date
Sun Mar 07 2010
Journal Name
Baghdad Science Journal
The Direct Gene Injection Using of Egg Yolk Emulsion as Carrier and its Comparison with Liposomes.
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The efficiency of egg yolk emulsion in coating DNA and its delivery across cellular membranes was evaluated in comparison with liposomes DOPE . The murine leukemia viral oncogene v-abl , cloned on pBR322 was used as a DNA substrate for direct injection into mice tissue . the DNA complexes were prepared by mixing the DNA with egg yolk emulsion and liposome . Each was directly injected into mice peritoneal cavity with proper control. The gene delivery was examined phenotypically by blood analysis and cytogenetic analysis . Chromosomal changes were detected in the bone marrow as from the fourth day post inoculation through the eleventh day when chromosomal ring s could be seen . this was accompanied by decrease in the WBC count ,

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