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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Jan 01 2025
Journal Name
Medical Journal Of Babylon
Optimum Conditions for Pyomelanin Production and Characterization from Local Isolates of Pseudomonas aeruginosa
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Nowadays, there is increased interest in the biosynthesis of microbial melanin related to their numerous biological functions and applications in many fields, especially in medical fields, including immune-modulating, antimicrobial antibiotic, antiviral antivenin, anticancer, antitumor activity, and anti-biofilm activity. Pyomelanin is a hydrophobic macromolecule that is typically dark brown or black in color, formed by the oxidative polymerization of phenolic or indolic compounds. Pyomelanin is reported to be safe for consumption, thus providing a crucial strategy for biocontrol of biofilm. Furthermore, natural pyomelanin is known as a potent antioxidant, photoprotective, and free radical scavenging. Objective: This study focuses on the

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Publication Date
Sun Jun 30 2013
Journal Name
Al-khwarizmi Engineering Journal
Efficiency Prediction and Performance Characterization of Photovoltaic Solar Panel at Baghdad Climate Conditions
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The performance of a solar cell under sun radiation is necessary to describe the electrical parameters of the cell. The Prova 200 solar panel analyzer is used for the professional testing of four solar cells at Baghdad climate conditions. Voltage -current characteristics of different area solar cells operated under solar irradiation for testing their quality and determining the optimal operational parameters for maximum electrical output were obtained. A correlation is developed between solar cell efficiency h and the corresponding solar cell parameters; solar irradiance G, maximum power Pmax, and production date P. The average absolute error of the proposed correlation is 5.5% for 40 data points. The results also show th

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Publication Date
Fri Dec 01 2017
Journal Name
Journal Of Economics And Administrative Sciences
The relationship between foreign direct investment and economic growth in Iraq after 2003(reality and ambition)
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Foreign direct investment is considered one of important bases to blind economy for many. Countries as if the main stage for developing national economy ,so for this ,many of countries give great prominence to the role of drivel foreign investment due to its importance as one of economic growth pillars in the developing countries. They offer a support for modern technology, organizational and managerial skills.        

  Dneto the importance of direct foreign investment on the economic growth, today, we discover that Iraq in need to rebnlid the in frastructuve and renew what has been destroyed during was in many production and export institutions . as wel

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Publication Date
Thu Feb 16 2023
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Phytosterol Profile in Iraqi Lactuca serriola after Purification and Isolation by Combiflash and HPLC (Conference Paper )#
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One of these plants utilized in traditional medicine is Lactuca seriolla Linn., which belongs to the Asteraceae family. It goes by a variety of common names in the world, including prickly lettuce, wild lettuce, jagged lettuce, and Kahu and khas. The work aimed to isolate and characterize some bioactive constituent(s) from the aerial part of Lactuca serriola utilizing  Combiflash NEXTGEN and high-performance liquid chromatography (HPLC). Lactuca serriola (aerial part) was extracted with 80% ethanol, then fractionated with hexane. Then 250 mg of hexane extract was mixed with 4 g of silica gel and loaded in cartilage, then bounded to the gold column of combi flash using a solvent system comprised of ethyl acetat

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Publication Date
Tue Dec 01 2020
Journal Name
Ieee Transactions On Industrial Electronics
Cascaded-Extended-State-Observer-Based Sliding-Mode Control for Underactuated Flexible Joint Robot
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This article presents a new cascaded extended state observer (CESO)-based sliding-mode control (SMC) for an underactuated flexible joint robot (FJR). The control of the FJR has many challenges, including coupling, underactuation, nonlinearity, uncertainties and external disturbances, and the noise amplification especially in the high-order systems. The proposed control integrates the CESO and SMC, in which the CESO estimates the states and disturbances, and the SMC provides the system robustness to the uncertainty and disturbance estimation errors. First, a dynamic model of the FJR is derived and converted from an underactuated form to a canonical form via the Olfati transformation and a flatness approach, which reduces the complexity of th

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Publication Date
Sun Jan 01 2023
Journal Name
Dental Hypotheses
Assessment of Salivary Levels of the RANKL and RANK in Patients with Healthy Gingiva on Reduced Periodontium Versus Periodontitis: An Analytical Cross-Sectional Study
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Publication Date
Fri Jan 01 2021
Journal Name
Aip Conference Proceedings
A study of the safety and security conditions followed in the X-ray clinics in the Al-Amiriya-Baghdad
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Publication Date
Fri Dec 15 2017
Journal Name
Journal Of Baghdad College Of Dentistry
Comparison of periodontal health status in relation to IQ in right- and left handed individuals
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Background: Periodontal disease (PD) is a chronic inflammatory condition characterized by destruction of supporting structures of the teeth. Intelligence quotient (IQ) was potentially reported to significantly associated with prevalence of gingivitis. Mild gingivitis was obtained in high IQ levels while moderate gingivitis may be attributed to poor oral hygiene seen among the subjects having low IQ levels. Method: One hundred volunteers aged between 20-45 years old were enrolled in this study, patients were equally divided into right- and left-handed (50 patients each)and each group then subdivided into patients with healthy gingiva(10), patients with gingivitis (20), and patients suffering from periodontitis (20).An IQ questionnaire was p

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Publication Date
Sun Dec 01 2019
Journal Name
Plant And Archeaf
EFFECT OF SPRAYING IRON AND ZINC CONCENTRATIONS IN GRAIN AND LEAF CONTENT FOR TWO VARIETIES OF WHEAT CROP
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EFFECT OF SPRAYING IRON AND ZINC CONCENTRATIONS IN GRAIN AND LEAF CONTENT FOR TWO VARIETIES OF WHEAT CROP

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Publication Date
Sun Feb 12 2012
Journal Name
Institute Of Advanced Studies In English
Cohesive Devices in English and Arabic with Analysis of Two of Hemingway's Novels and their Translations
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DBN Rashid, 2012 - Cited by 2

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