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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Oct 29 2022
Journal Name
International Ophthalmology
Comparison of corneal flap thickness predictability and architecture between femtosecond laser and sub-Bowman keratomileusis microkeratome in laser in situ keratomileusis
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Publication Date
Sun Sep 15 2024
Journal Name
Journal Of Baghdad College Of Dentistry
Assessment of surface microhardness of enamel surface treated with Nano- HAP serum before and after bleaching
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Background: Although bleaching is typically considered a safe procedure, various investigations have found minor negative effects and changes in mineral composition. The aim was to Evaluate and compare the efficacy of using Nanohydroxyapatite serum on surface microhardness of enamel surface before and after bleaching with chemically cured Boost bleaching. Material and methods: ten sound human permanent upper and lower premolar teeth were used and their roots were removed 2 mm apically to the cementoenamel junction, the crowns were sectioned mesiodistally into two halves buccal and lingual/palatal, the buccal surface was further subdivided into two halves. The samples were embeded in an acrylic resin, resulting in 30 specimens divide

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Publication Date
Fri Jan 01 2021
Journal Name
Iraqi National Journal Of Nursing Specialties
Assessment of Women’s Knowledge about Health Promotion after Cesarean Delivery at Maternity and Pediatric Hospital in Al-Samawa City
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Objective(s): To assess women’s knowledge about health promotion after a cesarean delivery and to determine the association between women’s knowledge and their demographic data of age, level of education, and monthly income. Methodology: A descriptive design is carried out to assess women’s knowledge about health promotion after cesarean delivery at Maternity and Pediatric Hospital in Al-Samawa City. This study starts from 26th of September 2020 up to 16th March 2021. Sample of (100) woman who are at reproductive age, pregnant (prime or multipara) who have planned to have birth by elective cesarean section or had previous elective caesarian section without medical indication or women who had cesarean section with medical indication or

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Publication Date
Sun Jun 27 2021
Journal Name
Iraqi National Journal Of Nursing Specialties
Assessment of Women’s Knowledge about Health Promotion after Cesarean Delivery at Maternity and Pediatric Hospital in Al-Samawa City
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Objective(s): To assess women’s knowledge about health promotion after a cesarean delivery and to determine the association between women’s knowledge and their demographic data of age, level of education, and monthly income.
Methodology: A descriptive design is carried out to assess women’s knowledge about health promotion after cesarean delivery at Maternity and Pediatric Hospital in Al-Samawa City. This study starts from 26th of September 2020 up to 16th March 2021. Sample of (100) woman who are at reproductive age, pregnant (prime or multipara) who have planned to have birth by elective cesarean section or had previous elective caesarian section without medical indication or women who had cesarean section with medical indicat

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Publication Date
Thu Aug 13 2026
Journal Name
Journal Of Engineering
Aerodynamic Characteristics Comparison between Spiroid and Blended Winglets
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A numerical and experimentally investigation for two types of winglets (spiroid and blended), which are used to reduce the induced drag caused by the trailing vortices were presented and discussed in this work. The SOLIDWORK 2016 was used to model a rectangular wing geometry of NACA2415 cross-sectional airfoil with blended and spiroid airfoils (2415 and 0012). The steady, incompressible N.S equations with standard (

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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
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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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
Thu Aug 13 2026
Journal Name
Al–bahith Al–a'alami
SPECIALIZED JOURNALISM IN IRAQ : (After The Events of 09-04-2003)
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The specialized Journalism plays an important role in our daily lives using all of its different ways, including news, caricature, commentary and dialogue. The specialized Journalism deserves vigilance and interest for it is caring about having a new media system. It is meant by “specialization”, first: identifying the areas of work in which the person concerned possesses great knowledge in the specialty resulting from a long experience, it also means being able to continuously develop required skills in that specialty. The specialization is not only a feature of the press, but also a feature of human development; thousands of years ago, the primitive society consisted of people from different specializations: fishermen, farmers, her

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Publication Date
Mon Jun 16 2025
Journal Name
Water, Air, & Soil Pollution
Polymer Nanocomposite Adsorbents for the Removal of Pharmaceutical Formulations the Aquatic Environment: A Review
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Water, an essential element for life, is becoming increasingly contaminated due to the continuing discharge of hazardous substances into our water sources. Pharmaceuticals, industrial chemicals, dyes, colorants, heavy metals, and pesticides are examples of some of the organic and inorganic substances that persistently contaminate water systems and traditional wastewater treatment systems are not designed to remove dissolved organic constituents, which is why their entry into the environment is so ubiquitous. Common pharmaceuticals such as aspirin, amoxicillin, ciprofloxacin, paracetamol, and ibuprofen, are amongst the most substantial contributors to water pollution The efficient and eco-friendly management of pharmaceutical pollutants pres

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