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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
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
Wed Jul 01 2015
Journal Name
Al–bahith Al–a'alami
Photos of Women in Iraqi Feature Films after 2003
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The research seeks to examine the image of women in Iraqi films produced after 2003 over the answer to questions such as “ level of the representation of women and appearing in films and features that are attributable to them and their relationships with men and their interests and tendencies , activities and ways and methods pursued to achieve their goals , or what appeared to be trying to achieve and whether made movies vivid and varied models for women, or confined to a rigid model and duplicate Is films raised issues concerning women? The research seeks to examine the image of women in Iraqi films produced after 2003 over the answer to questions such as “ level of the representation of women and appearing in films and features th

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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

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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
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
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
Wed Apr 01 2015
Journal Name
Al–bahith Al–a'alami
Methods of US propaganda in Iraq- A Study of Coalition Provisional Authority and US Army Data after 2003
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with an organized propaganda campaign. This military campaign was helped to formulate its speech by many institutions, research centers, and knowledge and intelligence circles in order to mobilize public opinion gain supporters and face the opponents by different means depending on a variety of styles to achieve its required effects. 
          After the US occupation of Iraq, US media fighters sought to influence the Iraqi public opinion and making them convinced them of the important presence of US military forces in Iraq which necessitated finding its justification through the use of persuasive techniques in its intensive propaganda campaigns. 
  This research discusses the most important

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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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