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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Jun 01 2015
Journal Name
Journal Of Engineering
Variation of Compression Index and Swelling Index with Degree of Saturation in Unsaturated Soils
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The variation of compression index Cc and swelling index Cs with the degree of saturation S was studied on unsaturated and fully saturated soils for different degrees of saturation (100%, 91%, 85%, 75%, 60%), several mathematical equations were found to describe these relationships, these equations can be used to predict settlement during the consolidation process in unsaturated and fully saturated soils.

 

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Publication Date
Thu Dec 26 2019
Journal Name
Bulletin Of The Iraq Natural History Museum (p-issn: 1017-8678 , E-issn: 2311-9799)
ANALYSIS OF MICROFACIES AND DEPOSITIONAL ENVIRONMENT OF LIMESTONE IN YOSONEGORO AREA, GORONTALO PROVINCE, INDONESIA
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    The research location is the northern part of the Basin of Limboto Lake; the focus of the research is the limestone outcrop with 24 meter thickness in Yosonegoro area. The purpose of the study is to find out facies, standard microfacies and depositional environment on Limboto limestone. The research method carried out consisted of three methods namely the measured section, petrographic analysis and biostratigraphy analysis.

 

The limestone facies in the Yosonegoro area consist of two facies. Then, based on sedimentary structure, composition, color, precipitation texture, terrestrial origin components and the organism content, the two facies can divided into three different microfacies. Paleobathyme

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Publication Date
Tue Mar 01 2022
Journal Name
Iraqi Journal Of Physics
Effect of Copper on Tensile and Hardness of Al-Si Alloy in Automotive Application
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In current research Copper was employed for preparing a ternary system of Al–Si alloy in different (0.2–2.5 wt. %) the best was taken is (1.5%wt) of copper that circumstances of solidification for improving the mechanical performance of the available in aluminium alloy. Cast iron molds were prepared to obtain tensile strength testing specimens. Alloys were prepared by employing gas furnaces. The molten metal was poured into a preheated cast-iron mold. The obtained alloy structures were studied using an X-ray diffractometer and optical microscopy. The mechanical performance of the prepared alloys was examined under the influence of different hardening conditions in both heat and non-heat-treated conditions. The outcomes showed at the

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Publication Date
Thu Feb 05 2026
Journal Name
Al–bahith Al–a'alami
Public relations of Iraqi companies and their role in the marketing of national products
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based on the importance of public relations in companies, I will discussed the issue of public relations and its role in marketing national products, given what these companies represent of great importance in terms of providing products and services to large segments of Iraqi society, which necessitated the need to search and investigate the role and importance of activities that Provides public relations in Iraqi companies in all categories( public, private and mixed).
the study tables and theirinterpretations, results and recommendations, and the studyreachedseveralresults, including the positive and the negative, the positive including the success in marketing the products by the number of companies in the Fairswhere the level of

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Publication Date
Thu Dec 01 2022
Journal Name
Baghdad Science Journal
Predictive Significance of Interleukins 17A and 33 in Risk of Relapsing–Remitting Multiple Sclerosis
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Cytokines are signaling molecules between inflammatory cells that play a significant role in the pathogenesis of a disease. Among these cytokines are interleukins (ILs) 17A and 33, and accordingly, the current case-control study sought to investigate the role of each of the two cytokines in the risk of developing multiple sclerosis (MS). Sixty-eight relapsing-remitting MS (RRMS) Iraqi patients and twenty healthy individuals (control group) were enrolled. Enzyme linked immunosorbent assay (ELISA) kits were used to determine serum levels of IL-17A and IL-33. Results revealed that IL-17A and IL-33 levels were significantly higher in MS patients than in controls (14.1 ± 4.5 vs. 7.5 ± 3.8 pg/mL; p < 0.001 and 65.3 ± 16

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Publication Date
Sat Jun 01 2024
Journal Name
Results In Control And Optimization
Impact of wind flow and global warming in the dynamics of prey–predator model
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Publication Date
Mon Aug 01 2011
Journal Name
Journal Of Engineering
NUMERICAL INVESTIGATION OF STATIC AND DYNAMIC STRESSES IN SPUR GEAR MADE OF COMPOSITE MATERIAL
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In this current work, Purpose; to clearly the fundamental idea for constructing a design and
investigation of spur gear made of composite material its comes from the combination of (high
speeds, low noise, oil-les running, light weight, high strength, and more load capability)
encountered in modern engineering applications of the gear drives, when the usual metallic gear
cannot too overwhelming these combinations.
An analyzing of stresses and deformation under static and dynamic loading for spur gear tooth
by finite element method with isoparametric eight-nodded in total of 200 brick element with 340
nods in three degree of freedom per node was selected for this analysis. This is responsible for the
catastropic fa

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Publication Date
Fri Apr 12 2019
Journal Name
Journal Of Economics And Administrative Sciences
Compare between simex and Quassi-likelihood methods in estimation of regression function in the presence of measurement error
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       In recent years, the attention of researchers has increased of semi-parametric regression models, because it is possible to integrate the parametric and non-parametric regression models in one and then form a regression model has the potential to deal with the cruse of dimensionality in non-parametric models that occurs through the increasing of explanatory variables. Involved in the analysis and then decreasing the accuracy of the estimation. As well as the privilege of this type of model with flexibility in the application field compared to the parametric models which comply with certain conditions such as knowledge of the distribution of errors or the parametric models may

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Publication Date
Thu Nov 04 2021
Journal Name
Nat. Volatiles & Essent. Oils
Using The Aqueous Extract Of Allium Sativum In Improvement Of Some Physiological And Immunological Parameter In Albino Rats
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The current study was designated to investigate the effect ofAllium sativumon some physiological and immunological parameters in rats. thirty adult rats were divided into three groups (10 rat for each). G1: served as healthy control, G2 :rats were treated with 150 mg\kg of Allium sativum, G3: treated with 300 mg\kg of Allium sativum. All treated animals were givenorally for 30 days. The aspartate , ) ALT ( alanine transaminase on some parameters were investigated such as garlic effects of total and differential counts of white blood , ) LDH ( lactate dehydrogenase ), AST ( transaminase cells(WBC) like Lymphocyte, Monocyte, Neutrophil, Basophil, Eosinophil,as

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Publication Date
Mon Mar 27 2017
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Isolation and Characterization of Iridoid Glycoside (Gardenoside) Present in the Leaves of Gardenia jasminoides J.Ellis Cultivated in Iraq
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Iridoid glycosides are a group of naturally occurring chemical compounds. They are a large family of compounds biosynthesized by plants, they often have pharmacological effects. The aim of this study is to isolate and identified iridoid glycoside in a newly studied, cultivated in Iraq named Gardenis jasminoides. The medicinal importance of iridoid glycoside, on one hand and absence of phytochemical investigation on leaves of Gardenia on the other hand, acquired this study its importance. Many compounds were isolated from leaves plant part one of these compounds was identified by different chemical analysis like: melting point (MP), thin layer chromatography (TLC), Fourier transforms infrared spectra (FTIR) and high performance l

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