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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Feb 10 2019
Journal Name
Journal Of The College Of Education For Women
Denotation of Stanza and couplet between the two sonnets
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The stanza in the sonnet has been defined as a set of poetic lines followed after proem
and be the same meter as that of proem in complete stanza, but in rhyme scheme different
from that meter. The couplet is defined as set of poetic lines that followed the stanza and be as
the same meter as that of stanza, but with different rhyme scheme. This definition is approved
by all specialized in field of Andalus literature and it was also proven to them that this
construction emptied of indications. This meter has endeavored to prove that that there were a
difference in denotation for meaning between the stanza and couplet. Thus, the sonneteers
have outweighed the sonnet of the blind "Tutaili" to their sonnets as they felt

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Publication Date
Mon Mar 08 2021
Journal Name
Baghdad Science Journal
Performance quality of single and ?two stage solar concentrators
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The performance of single and two stage solar concentrator were studied ' " The ratio of the primary to the secondary mirrors diameter is taking to be 0.5, depending on the theoretical calculation for the accumulated energy by the concentrator with ratio between 0.0 to 0.9. The design of the systems were designed and examined by using a ray-tracing program. The efficiency of the single and the two stage concentrators are calculated and compared with and without cooling systems.

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Publication Date
Wed Jul 01 2020
Journal Name
Journal Of Engineering
One and Two-Dimensional Hydraulic Simulation of a Reach in Al-Gharraf River
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One and two-dimensional hydraulic models simulations are important to specify the hydraulic characteristics of unsteady flow in Al-Gharraf River in order to define the locations that facing problems and suggesting the necessary treatments. The reach in the present study is 58200m long and lies between Kut and Hai Cities. Both numerical models were simulated using HEC-RAS software, 5.0.4, with flow rates ranging from 100 to 350 m3/s. Multi-scenarios of gates openings of Hai Regulator were applied. While the openings of Al-Gharraf Head Regulator were ranged between 60cm to fully opened. The suitable manning roughness for the unsteady state was

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Publication Date
Sat Dec 30 2023
Journal Name
Iraqi Journal Of Pharmaceutical Sciences( P-issn 1683 - 3597 E-issn 2521 - 3512)
Isolation, Identification, and Quantification of Two Compounds from Cassia glauca Cultivated in Iraq
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The Cassia glauca Lam. is the tree that belongs to the Fabaceae family and is native to India has many uses in indigenous systems of medicine, folk medicine, and traditional Brazilian medicine. Has many pharmacological activities such as anti-diabetic, antibacterial, antifungal, antioxidant, anti-hemolytic, anticancer, cardio-protective, and Hepato-protection.  The aim of study is to Isolation, identification, and quantification of some compounds from aerial parts of Cassia glauca since no phytochemical investigation had previously been done in Iraq for this plant. The aerial parts were defatted in n. hexane for 48 hours. The defatted materials were extracted in 85% ethanol using the hot method (soxhlet), then the extract was fra

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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
Wed Jun 24 2020
Journal Name
Basic Education College Magazine For Educational And Humanities Sciences
The healthy behavior of the Arab citizen in light of the Corona crisis 2020-6-24
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Abstract: The world witnessed the speed of a dangereuse virus now as Corona or Covid 19, which left many deaths in light of the inability of local and international Heath agencies to find a suitable vaccine to eliminate it and limit its spread, which negatively affected humain life in its various fields, and remains adopting healthy behaviors and habits A healthy Heath is the best solution to face the spread of the epidemic until realistic solutions that eliminate the virus are found.

Publication Date
Thu Dec 29 2016
Journal Name
Ibn Al-haitham Journal For Pure And Applied Sciences
Comparison in Some Biochemical and Hematological Tests Between Chronic Hepatitis B and C
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  Chronic viral hepatitis is an important health problem in the world, where hepatitis B virus (HBV) or hepatitis C virus (HCV) infections are the main causes of liver insufficiency. The study included 100 blood samples from patients with chronic viral hepatitis, fifty of them with HBV infection and 50 with HCV infection. Twenty apparently healthy age and gender matched subjects were included as a control group. Out of the 50 patients with HBV, 36(72%) were males and 14(28%) were females. Thirty two (64%) patients with HCV were males and 18(36%) were females. The mean age for HBV patients was 36.9 ± 15.8 year and for HCV patients it was 39.9 ±14.2 year.  The results of the liver function tests showed no significant differ

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Publication Date
Sun Aug 30 2020
Journal Name
Journal Of Economics And Administrative Sciences
Assessing the Iraqi general budget in light of corruption and fluctuations in oil prices, and their repercussions on unemployment rates after 2003
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The researcher highlighted the general budget in Iraq for the period (2003-2018) facing the challenges of administrative and financial corruption, in addition to the fluctuations in oil prices, the repercussions and many problems suffered and will suffer the Iraqi government in the process of preparing the general budget of the state and weak contribution of the agricultural and industrial sectors and other economic sectors and neglect altogether, oil has become the main supplier in funding Iraq's budget after 2003, and the impact on the unemployment rates in Iraq, which recorded fluctuating rates and then increased during the period (2012-2018) to achieve this, an inductive method was adopted, using theoretical and descriptive a

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Publication Date
Thu Jan 30 2025
Journal Name
Iraqi Journal Of Science
Development of A New Colorimetric-Flow System Approach for The Determination of Cefotaxime Sodium in Pharmaceutical Formulations
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     A new colorimetric-flow injection method has been developed and validated for the detection of Cefotaxime sodium in pharmaceutical formulations. This method stands out for its rapid and sensitive nature. The formation of a brown-colored complex between Cefotaxime sodium and the Biuret reagent in a highly alkaline environment serves as the basis for the detection. The intensity of this colored complex is measured using a custom-built Continuous Flow Injection Analyzer, enabling accurate quantification of Cefotaxime sodium. Optimization studies of the chemical and physical parameters such as dilution of Biuret reagent, effect of the medium basicity, flow rate, sample loop and others have been investigated. The calibration gra

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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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