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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Sat Dec 31 2016
Journal Name
Al-kindy College Medical Journal
Comparison between Open Mini-incision Thyroidectomy and Conventional Thyroidectomy: Clinical Experience and Literatures Review
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Background: Thyroid surgery is most common endocrine surgery in general surgical practice. Objectives: the aim of this work is to evaluate the feasibility, benefits and outcomes of open mini-incision thyroidectomy and compared the results with that of conventional thyroidectomy. The comparison between the two groups was in term of incision length, amount of blood loss, time of operation, postoperative pain, hospital stay and the cosmetic outcomes.Type of the study: this is a single-blinded randomized controlled studyMethods: This study compared the advantages and outcomes of 22 patients subjected to mini-incision thyroidectomy (Group A) with the equal numbers of patients subjected to conventional thyroidectomy (Group B).Results: the oper

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Publication Date
Fri Oct 30 2020
Journal Name
International Journal Of Agronomy
Molybdenum Induces Growth, Yield, and Defence System Mechanisms of the Mung Bean (Vigna radiata L.) under Water Stress Conditions
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Water stress has a negative impact on the yield and growth of crops worldwide and consequently has a global impact on food security. Many biochemical changes occur in plants as a response to water stress, such as activation of antioxidant systems. Molybdenum (Mo) plays an important part in activating the expression of many enzymes, such as CAT, POD, and SOD, as well as increasing the proline content. Mo therefore supports the defence system in plants and plays an important role in the defence system of mung bean plants growing under water stress conditions. Four concentrations of Mo (0, 15, 30, and 45 mg·L−1) were applied to plants, using two approaches: (a) seed soaking and (b) foliar application. Mung bean plants were subject

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Publication Date
Sun Oct 01 2017
Journal Name
Journal Of Engineering
Comparison the Physical and Mechanical Properties of Composite Materials (Al /SiC and Al/ B4C) Produced by Powder Technology
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In this investigation, metal matrix composites (MMCs) were manufactured by using powder technology. Aluminum 6061 is reinforced with two different ceramics particles (SiC and B4C) with different volume fractions as (3, 6, 9 and 12 wt. %). The most important applications of particulate reinforcement of aluminum matrix are: Pistons, Connecting rods etc. The specimens were prepared by using aluminum powder with 150 µm in particle size and SiC, B4C powder with 200 µm in particle size. The chosen powders were mixed by using planetary mixing setup at 250 rpm for 4hr.with zinc stearate as an activator material in steel ball milling. After mixing process the powders were compacted by hydraulic

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Publication Date
Sat Aug 01 2015
Journal Name
Journal Of Engineering
Determination of the Optimum Conditions in Evaluation of Kiwi Juice as Green Corrosion Inhibitor of Steel in Hydrochloric Acid
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The corrosion protection of low carbon steel in 2.5 M HCl solution by kiwi juice was studied at different temperatures and immersion times by weight loss technique. To study the determination of the optimum conditions from statistical design in evaluation of a corrosion inhibitor, three variables, were considered as the most dominant variables. These variables are: temperature, inhibitor concentration (extracted kiwi juice) and immersion time at static conditions.

These three variables are manipulated through the experimental work using central composite rotatable Box – Wilson Experimental Design (BWED) where second order polynomial model was proposed to correlate the studied variables with the corrosion rate o

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Publication Date
Thu Jan 30 2020
Journal Name
Al-kindy College Medical Journal
Comparison between the Patterns of Common Breast Diseases Presenting as Breast Lumps in Pregnant and Non-Pregnant Married Women
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Background: Breast lump is one of the most common prevalent complaint of patients attending breast clinics.

Objective: To determine if there is any change in the pattern of common breast, diseases presenting as breast lumps between pregnant and non-pregnant women among patients attending Al-Elwiya Breast Clinic.

Methods: This is a cross – sectional study, with convent's patient sampling setting in AL-Elwiya Breast Cancer Early Detection Clinic from 1st Feb. to 1st May 2018, we collected data from patients with breast lumps including the age groups, pregnancy status, parity status, previous breast diseases, hormonal drugs, menstrual cycle, breast fe

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Publication Date
Sun Sep 01 2013
Journal Name
Baghdad Science Journal
Flammability action of tires material after adding flame inhibitor
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Magnesium hydroxide was used as flame inhibitor to increased flame resistance for tires .Magnesium hydroxide was adding with (5%,10%) weight percents to rubber master batch of tire and then exposed the resulting material to a flame generated from gas torch with (10 mm) exposure distance . Method of measuring the surface temperature opposite to the flame was used to determine the heat transferred through tire material. The results were obtained shows enhanced flame resistance for tire by added magnesium hydroxide and this resistance increased by increasing hydroxide Percentage .

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Publication Date
Thu Jun 30 2011
Journal Name
Fac Med Baghdad
Prevalence of Anemia among Iraqi Patients after Renal Transplantation
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Background: Although the issue of anemia after renal transplantation (RT) has received increasing attention lately, the data on the exact prevalence of post-transplantation anemia (PTA) in the Iraqi patients are limited. Objective: In this study we sought to determine the prevalence of PTA among Iraqi patients and to correlate the renal allograft function measurements and the use of immunosuppressant with the prevalence of anemia. Patients and Methods: One hundred and twelve (74 male, 38 female) kidney transplant recipients (KTR) attending the kidney transplant center at surgical specialties hospital were studied. All patients were on maintenance, combined immunosuppressive therapy. The renal function tests [blood urea, serum cre

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Publication Date
Tue Dec 15 2015
Journal Name
Iraqi Journal Of Market Research And Consumer Protection
Determination of some Optimum Conditions for Bioremediation of Some Heavy Metals by Saccharomyces cerevisiae: Determination of some Optimum Conditions for Bioremediation of Some Heavy Metals by Saccharomyces cerevisiae
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The study aimed to determine of some Optimum conditions for bioremediation and removing of seven mineral elements included hexavalent chromium, nickel, cobalt, cadmium, lead, iron and copper as either alone or in group by living and heat treated cells of baker’s yeast Saccharomyces cerevisiae. The dried baker's yeast from Aldnaamaya China Company was used in this study. Biochemical tests was used to ensure yeast belonging to S. cerevisiae and then used to remove the mentioned mineral elementes under different conditions which included incubation period, pH, and temperature. It was found that the best of these conditions was 60 minutes for duration of incubation, 6 for pH, 25 ᵒC for temperature. During the study the behavior of living

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Publication Date
Fri Dec 31 2021
Journal Name
مجلة العلوم السياسية
The Role of the Iraqi parliament in the adoption of the federal budget after 2005
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The approval of the federal general budget in Iraq is one of the most important competencies of the legislative authority , Being one of the important financial and monetary policy instruments on which the state depends for its economic growth , Hence, the obstruction of the approval of the federal budget due to sectarian quotas, the absence of national interest, and the emergence of bargaining processes between political parties belonging to the regions and sectarianism , As well as the absence of economic plans and programs as a result of non-cognition and understanding of the nature of its supposed political system applied in Iraq and the absence of specialists would le

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Publication Date
Fri Dec 31 2021
Journal Name
Political Sciences Journal
The Role of the Iraqi parliament in the adoption of the federal budget after 2005
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Receipt date: 2/2/2021 accepted date: 4/6/2021 Publication date: 12/31/2021

Creative Commons License This work is licensed under a Creative Commons Attribution 4.0 International License.

The approval of the federal general budget in Iraq is one of the most important competencies of the legislative authority , Being one of the important financial and monetary policy instruments on which the state depends for its economic growth , Hence, the obstruction of the approval of the federal b

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