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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Mon Mar 30 2020
Journal Name
Iraqi Journal Of Chemical And Petroleum Engineering
Simulation of Two Phase Flow Mixing Co – Current in T Junction Using Comsol
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The analysis, behavior of two-phase flow incompressible fluid in T-juction is done by using "A Computational Fluid Dynamic (CFD) model" that application division of different in industries. The level set method was based in “Finite Element method”. In our search the behavior of two phase flow (oil and water) was studed. The two-phase flow is taken to simulate by using comsol software 4.3. The multivariable was studying such as velocity distribution, share rate, pressure and the fraction of volume at various times.  The velocity was employed at the inlet (0.2633, 0.1316, 0.0547 and 0.0283 m/s) for water and (0.1316 m/s) for oil, over and above the pressure set at outlet as a boundary condition. It was observed through the program

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Publication Date
Thu Oct 03 2024
Journal Name
Dentistry 3000
The Combined Effect of Two Natural Extracts on Enamel Remineralization (in vitro Study)
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Objective: Dental caries is a chronic infectious disease that is prevalent worldwide in all age groups. Numerous attempts have been made to develop conservative approaches to halt caries progression and restore enamel defects. This study aimed to investigate the effect of applying grape seed extract and chicken eggshell extract on the microhardness of demineralized enamel in permanent teeth. Methods: Forty-eight sound upper first premolars were used. Following demineralization with the demineralizing solution for 96 hours, they were distributed into four groups consistent with the treatment agent used: group A was treated with casein phosphopeptide amorphous calcium phosphate (as a control group), group B was treated with grape se

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Publication Date
Mon Aug 18 2025
Journal Name
Journal Of The College Of Basic Education
Rationing two test in strength endurance for young under the age of 16
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Publication Date
Wed Aug 16 2023
Journal Name
مجلة الاستاذ للعلوم الانسانية والاجتماعية- كلية التربية ابن رشد – جامعة بغداد،
Using the Theory of Conceptual Metaphor in Two Sonnets by Victorian Female Poets
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This study has applied the theoretical framework of conceptual metaphor theory to the analysis of the source and target domains of metaphors that are used in two English nineteenth century sonnets, both written by contemporaneous female poets. The quantitative and qualitative results of the textual analysis have clearly revealed that Elizabeth Barrett Browning’s sonnet 23 centres around the conceptual mapping of the journey of love and life with that of possession. In contrast, Christina Rossetti’s sonnet Remember tackles the central conceptual mapping of death as a journey in relation to its further experiential connections. In addition, the application of conceptual metaphor theory in identifying the frequencies and densities of metap

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Publication Date
Tue Jun 15 2010
Journal Name
Journal Of Baghdad College Of Dentistry
Prosthodontist’s ability to detect parallelism of two lines used in occlusal plane determination
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Background: Prosthodontists estimated the parallelism of the occlusal plane to different anatomical landmarks, which was somewhat arbitrary and depended mainly on their vision. The aim of this research was to assess the degree of accuracy of prosthodontists in determining the parallelism of two lines. This research was aimed to assess which technique would be more accurate for the prosthodontist to distinguish parallelism; the comparison of the occlusal plane with the interpupillary line or with the inferior border of the earlobes. Materials and methods: Twenty eight prosthodontic specialists were included in this research. Illustrations of two lines with different tilts were presented to the participants to distinguish whether parallel or

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Publication Date
Tue Dec 01 2009
Journal Name
Bulletin Of The Iraq Natural History Museum (p-issn: 1017-8678 , E-issn: 2311-9799)
DISTINCTION BETWEEN TWO SPECIES OF THE GENUS EXOCHOMUS REDTENB. (COLEOPTERA : COCCINELLIDAE) IN IRAQ
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The present paper attempts to establish a distinction between Exochomus negripennis (Er.) and E. quadripustulatus L., depending on the characters of femoral line, male genitalia and spermatheca.

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Publication Date
Tue Jan 01 2019
Journal Name
International Journal Of Agricultural And Statistical Sciences,
The comparison of several methods for calculating the degree of heritability and calculating the number of genes II. Yield components
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Publication Date
Sun Sep 30 2007
Journal Name
Iraqi Journal Of Chemical And Petroleum Engineering
Dynamics of a single Condensing Two-Phase Bubble
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The dynamics of a single condensing two-phase bubble of two different dispersed-continuous systems were studied. The systems were, CCl4 - water and CCl4 - 100% glycerol. Cinephotography was used to determine the change in height, diameter and time. These results were used to determine the experimental rise velocity of the bubble, which was compared with a theoretical one based on some equations used. It was found that the velocity of the first system remained almost constant, while it decreased gradually for the second system.

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Publication Date
Tue Jun 04 2024
Journal Name
Asian Journal Of Water, Environment And Pollution
Biodegradation of Two Textile Dyes by Bacillus Subtilis
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This study revealed the efficiency of Bacillus subtilisin degrading two textile dyes (disperse red and disperse yellow), the rates of red dye removal when measured after 24, 48, 72 and 96 hours for the concentrations of 50 ppm were 51.67, 67.56, 84.67 and 95.33%, for the concentration 150 ppm were 41.67, 62.67, 80.67 and 89.67%, while for the concentration 300 ppm were 25.67, 42.67, 71.67 and 84.33%. The results of yellow dye removal showed that the concentration of 50 ppm were 49.67, 65.33, 83.33 and 92.67%, for the concentration of 150 ppm were 38.33, 60.33, 77.33 and 87.33%, and for the concentration, 300 ppm were 24, 36.67, 68.33 and 81.67%, when measured after 24, 48, 72 and 96 hours. Results recorded a slight decrease in pH valu

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Publication Date
Mon Mar 01 2010
Journal Name
Journal Of Economics And Administrative Sciences
Two side properties of EWMA control panels unilaterally
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This study, establishes two stochastic monotonicity results concerning the run length of an upper one –sided Exponentially Weighted Moving Average (EWMA) control charts, based on the logarithm of the sample variance, for monitoring a process standard deviation, these properties cast interesting light on the control chart performance, and their extension to other one –sided EWMA control charts.

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