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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Wed Oct 23 2013
Journal Name
Journal Of Microbiology And Biotechnology Research
Optimization of flocculation conditions of exopolysaccharide biofloculant from Azotobacter chrococcum and its potential for river water treatment
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Bacteria strain H8, which produces high amount of exopolysaccharide (EPS), was isolated from soil, and identified as strain of Azotobacter chrococcum by its biochemical /physiological characteristics, EPS was extracted, partially purified and used as bioflocculant. The biochemical analysis of the partially purified EPS revealed that it was an alginate. analysis of EPS by Fourier transform infrared spectrometry (FTIR) show that the -OH groups present in bioflocculant are clearly seen at 3433.06 cm-1, the peaks attributed to the -CH3 groups present at 2916.17 cm-1 , and some distinct peaks such as carboxyl group showed strong absorption bands at 1604.66 cm-1, 1411.80 cm-1 and 1303.79 cm-1 indicate the chemical structure of alginate. The effe

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Publication Date
Thu Jun 01 2023
Journal Name
Iraqi Journal Of Physics
Studying the Effect of Initial Conditions and System Parameters on the Behavior of a Chaotic Duffing System
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This work presents a five-period chaotic system called the Duffing system, in which the effect of changing the initial conditions and system parameters d, g and w, on the behavior of the chaotic system, is studied. This work provides a complete analysis of system properties such as time series, attractors, and Fast Fourier Transformation Spectrum (FFT). The system shows periodic behavior when the initial conditions xi and yi equal 0.8 and 0, respectively, then the system becomes quasi-chaotic when the initial conditions xi and yi equal 0 and 0, and when the system parameters d, g and w equal 0.02, 8 and 0.09. Finally, the system exhibits hyperchaotic behavior at the first two conditions, 0 and 0, and the bandwidth of the chaotic

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Publication Date
Mon Apr 01 2024
Journal Name
Medical Journal Of Babylon
Clinical Evaluation and Comparison between Effects of Rituximab and Prednisolone with Imuran to Neutrophils and Platelet Counts in Pemphigus Vulgaris Patients
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Background: Pemphigus vulgaris (PV) is an autoimmune vesiculobullous mucocutaneous disease with life-threatening consequences. Rituximab (RTX) has recently emerged as an effective treatment for PV. Objectives: This study aims to determine changes in neutrophil and platelet counts for PV patients treated with RTX or corticosteroids combined with Imuran (azathioprine). Materials and Methods: The present cross-sectional study was conducted in the Department of Dermatology at Baghdad Teaching Hospital, Baghdad, Iraq. Thirty PV patients received two types of treatment: 15 patients were administered RTX and 15 patients took corticosteroids with Imuran (azathioprine). Neutrophil and platelet counts were detected at the hospital laboratory. Results

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Publication Date
Tue Dec 29 2020
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
The Effect of Ginkgo biloba Extracts on Candida albicans Isolated from Healthy Persons
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The objective was to study the effect of prepared ginkgo biloba extracts against Candida albicans isolated from healthy persons. Conducting susceptibility test, biofilm formation test, phytochemical screening test, and antioxidant activity test. One hundred oral swabs sample were obtained from healthy persons with oral lesion attending dentistry teaching hospital in dentistry college, their age ranged from 1-30 years of both sexex. The studied samples collected through 8 months (April - December / 2018). This study included two different types of ginkgo bilola extracts were prepared as aqueous and ethanolic extracts. Many tests were used, which included isolation and identification of C.albicans, conduct susceptibility test, biofilm form

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Publication Date
Fri Dec 01 2023
Journal Name
Political Sciences Journal
China's Soft Power and Diplomacy towards Middle East Region after 2011
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The study deals with China's soft power and diplomacy in the Middle East, and it focuses specifically on the tools and foundations of China's soft diplomacy and how it achieves its goals in the region in addition to its challenges in the region. In this regard, the study also focuses on the Chinese Belt and Road Initiative and its soft foundations and how they serve China’s diplomacy and soft power in the region. The study ends with a set of conclusions, perhaps the most prominent of which is that diplomacy and soft power have become a fundamental pillar of China's foreign policy to achieve its foreign goals and to establish an international system compatible with China's principles. As for the Middle East, China has established a poli

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Publication Date
Fri Dec 31 2021
Journal Name
Political Sciences Journal
The US-Iranian dispute and its repercussions on Iraq After 2003
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Receipt date: 8/8/2020 acceptance date: 9/11/2020 Publication date: 31/12/2021

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

           The American-Iranian relations have been characterized by tensions since the arrival of the guardian jurist regime in Iran to leadership in 1979, as it was considered a turning point not only in the cont

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Publication Date
Wed Jul 01 2020
Journal Name
Campos En Ciencias Sociales
Leadership and Post-Conflict State Rebuilding: Iraq after 2003 Case Study
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The Iraqi political and social arena has been characterized, subjectively and objectively, by the weakness of leadership building. This has led to a leadership crisis, which is reflected in the quality of the outcome of the process of rebuilding the state in Iraq. Thus, this building process has lacked the simplest requirements and conditions of success. It has suffered from a major and obvious failure: the situation in Iraq has raised conflict leaders, not constructive leaders, and this confirms the existence of a cultural crisis in the production of conscious, aware leadership compatible with democratic action. The weakness of leadership in Iraq is reflected in a series of ongoing crises that require radical solutions in accordance with l

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Publication Date
Tue Dec 30 2014
Journal Name
Iraqi Journal Of Chemical And Petroleum Engineering
Comparison between Electroplating and Electroless on Plastic Surface
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We report a method of converting non-conductive plastic surfaces into conductive by plating either copper electroless or copper electroplating -carbon black containing bending Agent onto Perspex plastics . Various approaches have been studied in order to comparing properties of the plated copper for two methods such as scanning electron microscopy (SEM),thickness, roughness, porosity, tensile Strength and elongation. The results show that the surface of electroplating was uniform, compact, and continuous and it had an obvious metallic sheen, while the surface of plated copper for electroless for it had many pores. Also observed that the coating was composed of small cells. Thes

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Publication Date
Mon Mar 23 2020
Journal Name
Journal Of Engineering
Aerodynamic Characteristics Comparison between Spiroid and Blended Winglets
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Publication Date
Sun Jun 12 2011
Journal Name
Baghdad Science Journal
Comparison between Direct and Coherent Optical Communication System
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The work in this paper focuses on the system quality of direct and coherent communication system for two computers. A system quality is represented by Signal to Noise ratio (SNR) and Bit Error Rate (BER). First part of the work includes implementation of direct optical fiber communication system and measure the system quality .The second part of the work include implementation both the( homodyne and heterodyne)coherent optical fiber communication system and measure the system quality . Laser diode 1310 nm wavelength with its drive circuit used in the transmitter circuit . A single mode of 62.11 km optical fiber is selected as transmission medium . A PIN photo detector is used in the receiver circuit. The optical D-coupler was u

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