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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Smart Innovation, Systems And Technologies
The Effect of Two Training Approaches with (Hanging–Heavy) Ropes in Developing Some Physical Abilities and Accuracy of Shooting—In Front of Handball
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Publication Date
Thu Feb 29 2024
Journal Name
Iraqi Journal Of Science
Facile Synthesis of Copper Nanocubes in Aqueous Phase for Catalytic Esterification Using Green-Conditions
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     This work demonstrated a simple and environmentally friendly method for synthesizing silica-supported copper nanocubes (CuNCs/SiO2). The copper nanocubes, with a size of 15 ± 5 nm, were synthesized using green reagents and conditions. Ascorbic acid, water, and di-n-butyl sulfide were employed as reducing agent, solvent, and stabilizing ligand, respectively. The designed nanoscale catalyst was utilized for the esterification of acetic acid to methyl acetate at room temperature. The catalyst exhibited high efficiency, converting 80% of the reactant to the desired product (methyl acetate) after 24 hours of reaction at room temperature. The size and shape of copper nanocubes were characterized by transmission electron microsco

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Publication Date
Mon Aug 01 2016
Journal Name
Journal Of Engineering
Galvanic Corrosion of Carbon Steel -Stainless Steel Couple in Sulfuric Acid under Flow Conditions
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Galvanic corrosion of stainless steel 316 (SS316) and carbon steel (CS) coupled in 5% wt/v sulfuric acid solution at agitation velocity was investigated. The galvanic behavior of coupled metals was also studied using zero resistance ammeter (ZRA) method. The effects of agitation velocity, temperature, and time on galvanic corrosion current and loss in weight of both metals in both free corrosion and galvanic corrosion were investigated. The trends of open circuit potential (OCP) of each metal and galvanic potential (Eg) of the couple were, also, determined. Results showed that SS316 was cathodic relative to CS in galvanic couple and its OCP was much more positive than that of CS for all investigated ranges of

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Publication Date
Mon Feb 04 2019
Journal Name
Journal Of The College Of Education For Women
Iraqi-Saudi Relations After 2003
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Iraqi-Saudi Relations have witnessed a state of rapprochement over decades. However, this rapprochement was temporary and could not overcome the differences that formed the core of Iraqi-Saudi relations after 2003, relations between Iraq and Saudi Arabia deteriorated with the Iraqi governments that followed the rule of Iraq after 2003, especially the government of Nuri Al-Maliki in which relations reached the end of mutual accusations between the two parties. In order to promote the relationship between the two countries, a culture of moderation has to be propagated especially in the field of religion and the religious institution should be encouraged to open up to other sects and to recognize all sects as prelude to combating the cultur

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Publication Date
Wed Aug 31 2022
Journal Name
Al-kindy College Medical Journal
Efficiency and Safety of Desferioxamine Chelation Therapy in Paediatric Patients with Transfusion-Dependent Anaemia: Experience of two Centres from Sudan
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Background: Repeated blood transfusion   is   the main   therapeutic option for transfusion-dependent anaemias with consequent iron overload and organ damage .Therefore iron chelating agents are important protective measures for these patients. The aim of this study was  to investigate  the efficiency and safety of Desferroxamine  in paediatrics population subjected  to iron overload as a consequence  of repeated transfusion in a group of  Sudanese children  

Subjects & Methods: This was a descriptive cross-sectional hospital based study.  Conducted in two main paediatric reference hospitals   in, Su

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Publication Date
Tue Sep 01 2015
Journal Name
Ama, Agricultural Mechanization In Asia, Africa And Latin America
Effect of three honeycomb interplant distances on yield and it components of two cultivars of bean
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A factorial experiment (2× 3) in randomized complete block design (RCBD) with three replications was conducted to examine the effect of honeycomb selection method using three interplant distances on yield and its components of two cultivars of bean, Bronco and Strike. Interplant distances used were 75× 65 cm, 90× 78 cm, and 105× 91 cm (row× plant) represent short (high plant density), intermediate (intermediate plant density), and wide (low plant density) distance, respectively. Parameters used for selection were number of days from planting to the initiation of first flower, number of nodes formed prior to first flower, and number of main branches. Results showed significant superiority of the Bronco cultivar represented in the number

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Publication Date
Tue Jun 15 2021
Journal Name
Al-academy
The directing vision and two display technologies in the Iraqi Child Theater: عباس قاسم كاظم
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  The current research contains four chapters. The first topic included the methodological framework that included the problem of research and the need for it, and then the importance of the research, and then the aim of the research, its limits and the definition of terms linguistically, conventionally and procedurally. The second chapter (the theoretical framework) contained two topics, the topic The first is titled: The Outward Vision in Child Theater Performances, while the second topic was titled: Presentation Technology in Child Theater, Chapter Four (Research Procedures), which organized the research community and analyzed its sample, and the fourth chapter contained research results, conclusions and recommendations. The prop

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Publication Date
Wed Sep 14 2016
Journal Name
Journal Of Baghdad College Of Dentistry
Comparison of Immunoglobulin IgA Level in the Stimulated Saliva of Caries-Free and Caries-Active Children Aged 7-10 Years
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Background: Salivary immunoglobulin IgA plays an essential role in the immune response against dental caries. This studywas conducted to compare the salivary IgA levels and flow rate of stimulated saliva in caries active and caries free children. Materials and methods: The present study included sixty healthy children age 7-10 yearswho were divided into two groups. They were caries free and caries active children (30 children in each group). Assessment and recording of caries – experience were through the application of Decayed, Missing and Filled Tooth Index (DMFT) and (dmft) index, for permanent and deciduous teeth respectively. After dental examination, stimulated saliva samples were collected from the subjects and performed und

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Publication Date
Thu Sep 01 2016
Journal Name
J Bagh College Dentistry
Comparison of Immunoglobulin IgA level in the stimulated saliva of caries-free and caries-active children aged 7-10 year
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Background: Salivary immunoglobulin IgA plays an essential role in the immune response against dental caries. This studywas conducted to compare the salivary IgA levels and flow rate of stimulated saliva in caries active and caries free children. Materials and methods: The present study included sixty healthy children age 7-10 yearswho were divided into two groups. They were caries free and caries active children (30 children in each group). Assessment and recording of caries – experience were through the application of Decayed, Missing and Filled Tooth Index (DMFT) and (dmft) index, for permanent and deciduous teeth respectively. After dental examination, stimulated saliva samples were collected from the subjects and performed und

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Publication Date
Sun May 15 2022
Journal Name
Bionatura
Comparison between the presence and absence of mixing in the anaerobic biological treatment of liquid waste for the cheese industry
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Many nations are seeing an increase in water pollution from dairy and cheese production due to the high organic and fat content in their waste products and the high temperature of their waste products, which elevates the water temperature and causes loss to ecosystem components. Reusing industrial wastewater that has been treated to guarantee no harm has been done to the environment is being hampered by a lack of water. This study compares the presence and absence of mixing in the anaerobic biological treatment of liquid waste for the cheese industry. To decrease heat exchange with the external environment, cube-shaped anaerobic reactors with dimensions of (30 x 30 x 30) cm and thick glass (10 mm) were utilized in this investigation

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