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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Jan 01 2022
Journal Name
Chemical Methodologies
Determination of the Quantity of Losartan Active Ingredient in the Medication Formulations via Turbidimetric-Flow Injection Technique
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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
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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Publication Date
Sat Mar 25 2023
Journal Name
International Journal Of Drug Delivery Technology
Improvement of Entrapment and Ocular Permeability of Ganciclovir Nanostructured Lipid Carriers Using Various Conditions of Preparations
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Ganciclovir (GCV) is a drug included in BCS-Class III, having high solubility and low permeability. It is a synthetic acyclic nucleoside analog of 2′-deoxyguanosine, considered a potent inhibitor of herpes viruses and cytomegalovirus (CMV) infection. Herpes simplex virus (HSV) infections are very common and are also considered a major cause of corneal blindness. This study intended to advance a pioneering nanostructured lipid carriers (NLCs) system for improving the ocular permeability of GCV. Several procedures were used for the preparation. Cold homogenization, solvent injection, and emulsifi cationultrasonication methods. A mixture of palmitic acid (PA) and oleic acid (OA) as a lipid matrix, cremophore EL, and transcutol HP wer

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Publication Date
Tue Feb 01 2022
Journal Name
Baghdad Science Journal
Flow Injection Analysis with Turbidity Detection for the Quantitative Determination of Mebeverine Hydrochloride in Pharmaceutical Formulations
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The main objective of this paper is to develop and validate flow injection method, a precise, accurate, simple, economic, low cost and specific turbidimetric method for the quantitative determination of mebeverine hydrochloride (MbH) in pharmaceutical preparations.  A homemade NAG Dual & Solo (0-180º) analyser which contains two identical detections units (cell 1 and 2) was applied for turbidity measurements. The developed method was optimized for different chemical and physical parameters such as perception reagent concentrations, aqueous salts solutions, flow rate, the intensity of the sources light, sample volume, mixing coil and purge time. The correlation coefficients (r) of the developed method were 0.9980 and 0.9986 for cell

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Publication Date
Fri Jan 01 2021
Journal Name
Materials Today: Proceedings
Evaluation of mechanical properties and cytotoxicity of maxillofacial silicone material after incorporation of zirconia nanopowder
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Resilient polymeric materials such as silicone elastomers are currently used for maxillofacial prostheses construction but the strength of these materials and their clinical performance need to be optimized with the addition of reinforcing fillers. This study investigates the effect of zirconia nanopowder addition on tear strength, tensile strength, elongation at break, Shore A hardness, surface roughness and cytotoxicity of VST-50 maxillofacial silicone. Silicone base was mixed with different amounts (1%, 2% and 3%) of zirconia nanopowder using a vacuum mixer. Silicone without filler was used as control for comparison. Scanning Electron Microscopy and Atomic Force Microscopy were utilized to assess the efficiency of high-shear vacuum mixin

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Publication Date
Thu Jul 01 2021
Journal Name
Journal Of Pharmaceutical And Biomedical Analysis
An optoelectronic flow-through detectors for active ingredients determination in the pharmaceutical formulations
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An optoelectronic flow-through detector for active ingredients determination in pharmaceutical formulations is explained. Two consecutive compact photodetector’s devices operating according to light-emitting diodes-solar cells concept where the LEDs acting as a light source and solar cells for measuring the attenuated light of the incident light at 180˚ have been developed. The turbidimetric detector, fabricated of ten light-emitting diodes and five solar cells only, integrated with a glass flow cell has been easily adapted in flow injection analysis manifold system. For active ingredients determination, the developed detector was successfully utilized for the development and validation of an analytical method for warfarin determination

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Publication Date
Sun Jun 03 2012
Journal Name
Al-kindy College Medical Journal
Ultrasound of the Rotator Cuff: A Comparison of Ultrasonographic and Physical Examination Finding in SeventyCases
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Background : Shoulder pain is a common problem that can pose difficult diagnostic and therapeutic challenges for the family physician It is the third most common musculoskeletal complaint in the general population, and account for 5% of all general practitioners musculoskeletal consults Objective: To determine the diagnostic performance of ultrasonography compared with the physical examination for detection of rotator cuff tears in painful shoulder syndrome. Method: Prospective study was done on seventy patients (48 male, 22 female), age ranged between 30-70 years (mean age 50 years), From February 2007 to July 2011, were subjected to comparative study in Al-Kindy teaching hospital with rotator cuff tears, including physical and ultrasonogr

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Publication Date
Fri Jan 05 2024
Journal Name
Al-academy
The Place in the work of artists Nuri Alrawi and Saad Altai (Comparison Study)
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The Transformation of environments surrounding human which called (place), formed an intermediate compresser in forming awareness pictures, human knowledge, culture and thought features, and changing the systems and contexts of human societies, which led to a change the rhythm of life as a whole. So according to that the place will be encodes according to these data for psychological connotations, lead to human sense of harmony with the place in different manner format, here the search problem lies when trying to detect how Iraqi artist deliberating with the place concept, wondering how to investing place in the contemporary Iraqi drawing within its reference dimension, and showing mechanisms from comparative study for the works of two a

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