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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Sep 06 2009
Journal Name
Baghdad Science Journal
Regeneration and Cormels Production of White Prosperity and Priscilla Gladiolus Varities In Vitro
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Plant regeneration and cormel production was carried out from callus cultures initiated from White Prosperity and Priscilla Gladiolus Varities. It is aimed to produce plants and cormels in vitro all year round. The study included many experiments, these were the effect of Naphthalene acetic acid (NAA) and Kinetin (Kin) interaction on callus initiation, effect of Benzyl adenine (BA) on shoot regeneration from callus culture, effect of NAA on rooting after 30, 40 and 50 days in culture. The role of the type of agricultural medium (Peat moss or river sand and their mixture on plantlets survival after weaning was studied. Results showed that the interaction between NAA and Kin induced callus on axillary bud explants. Callus was best ini

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Publication Date
Sun Sep 27 2020
Journal Name
Journal Of The College Of Education For Women
The Term Delay and its Jurisprudences in the Section of Punishments and Felonies
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Different Arabic and Islamic societies are free of evil instincts. Therefore, certain provisions of legitimacy came to stress the importance of the intentions of sharia to achieve the interests of all people that involve several aspects, including the five fundamental things: religion, oneself, offspring, mind and money. Almighty Allah has specified certain punishments on those who violate these things by imposing punishments on the part of the criminal to preserve souls. He imposes the penalty of theft to preserve property, the Hadd punishment for adultery to preserve the symptoms, the punishment on the drunk to preserve the mind, and the Hadd punishment for the apostate to preserve the religion. By the adherence to these punishments li

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Publication Date
Tue Sep 01 2015
Journal Name
Iosr Journal Of Dental And Medical Sciences
Prevalence of prediabetes and metabolic syndrome and their association in an Iraqi sample
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Abstract: Background: Prediabetes and are increasing in prevalence all over the world, they each carry risks to the future development of diabetes mellitus and cardiovascular disease. These risks will be greatly exaggerated if they occur together in the same individual. The aim of the study was to find the prevalence and the association of prediabetes and metabolic syndrome, in addition to analyzing the correlation of the risk factors that lead to their development. Material and Methods: This was a cross-sectional, simple random study that included 300 Iraqi individuals, aged between 30-75 years, who accepted to take part in this study were recruited. Result: Prevalence of prediabetes and metabolic syndrome was (33.66%) and (42%) r

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Publication Date
Wed Mar 10 2021
Journal Name
Baghdad Science Journal
Quantitative and qualitative assessment of the basic components and effective in Acol plant
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Key components estimated in Acol total plant leaves and the results were as follows plant Acol humidity 72%

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Publication Date
Thu Jan 31 2019
Journal Name
Journal Of The College Of Education For Women
Use of Internet by Universities Teachers and Benefits in Teaching and Scientific Research
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The research aims to shed light on the internet and how to employ them and to take advantage of applications in scientific research among faculty members, from a survey the opinions of professors at the University of Alanbar and Almustansiriah, to see the reality of use of the Internet and ways to invest in the service of scientific research.
The follow descriptive analysis approach , which is appropriate to the nature of this study concerned with exploring the views on the uses of the Internet. The study reached the field the following results:
1- There are(60) % of respondents use the Internet on an ongoing basis to see new information and keep pace with scientific developments in the field of specialty and the average use of the

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Publication Date
Mon Nov 06 2023
Journal Name
Al- Ustath Journal
INFINITIVAL AND GERUNDIAL CONSTRUCTIONS OF ASPECTUAL VERBS IN SELECTED BRITISH AND AMERICAN NOVELS
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Abstract Infinitives and gerunds are non-finite verb forms which cannot be indicated by tense, number, or person. The construction of non-finite verbs is intricate because of their nature of meanings, forms, and functions. The major problem is that both infinitival and gerundial complements have identical functions and occupy identical positions in the sentences. Thus, there is a confusion in using an infinitival and gerundial forms after aspectual verbs. The selection of either one of these two forms as complements is controlled syntactically or semantically. Moreover, both forms can be used usually with similar predicate but with neat difference in meaning. In addition, there are problems with controlling the use of aspect, since aspectua

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Publication Date
Sun Jun 03 2012
Journal Name
Baghdad Science Journal
Study of Liver and Kidney functions in non-pregnant, pregnant and preeclamptic women
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Three groups of subjects have been divided (25/group): healthy normotensive non-pregnant women (Group A), normal normotensive pregnant women (Group B), and women with preeclampsia (Group C).The levels of serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin , creatinine , blood urea nitrogen, triglyceride , total cholesterol and glucose have been estimated in all subjects. All measured parameters were determined by spectrophotometric analysis. The results showed a significant(P<0.05) increase in serum ALT, AST, blood urea nitrogen, triglyceride and total cholesterol levels in group B as compared to group A. However creatinine, total bilirubin and glucose levels did not show any statistical significant alt

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Publication Date
Fri May 02 2014
Journal Name
International Journal Of Scientific & Technology Research
Synthesis, Structure And Characterization Of Zns Qds And Using It In Photocatalytic Reaction
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ZnS nanoparticles were prepared by a simple microwave irradiation method under mild condition. The starting materials for the synthesis of ZnS quantum dots were zinc acetate (R & M Chemical) as zinc source, thioacetamide as a sulfur source and ethylene glycol as a solvent. All chemicals were analytical grade products and used without further purification. The quantum dots of ZnS with cubic structure were characterized by X-ray powder diffraction (XRD), the morphology of the film is seen by scanning electron microscopy (SEM). The particle size is determined by field effect scanning electron microscopy (FESEM), UV-Visible absorption spectroscopy and XRD. UV-Visible absorption spectroscopy analysis shows that the absorption peak of the as-prep

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Publication Date
Sat Oct 31 2020
Journal Name
The Egyptian Journal Of Otolaryngology
Incidence and recovery of smell and taste dysfunction in COVID-19 positive patients
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Abstract<sec> <title>Background

This study aims to find the chemosensitive dysfunction incidence in COVID-19-positive patients and its recovery.

We collected the data from sixty-five patients, all COVID-19 positive, quarantined in-hospital between 5 April 2020 and 17 May 2020, by a questionnaire distributed in the quarantine ward.

Results

Smell dysfunction appeared in 89.23% with or without other symptoms of COVID-19. 39.66% of them recovered the sense of smell. Taste dysfunction found in 83.08% patients with other COVID-19 symptoms. Only 29.63% of them recovered. The recovery took 1–3 weeks, and most

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Publication Date
Tue Jun 25 2024
Journal Name
African Journal Of Biological Sciences
Toxic effect of Thiamethoxam and Lambda cyhalothrin on Nephrotoxicity and Hematological in rats
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Thiamethoxam is a synthetic organic insecticide belong to The most significant new class of pesticides created in the last thirty years is neonicotinoids. This study's objective was to determine the effect of thiamethoxam, lambda cyhalothrin and their combination on biochemical parameters, the levels of free radicals and enzymes activities liver of male.Forty Rats ( 150-170 g ) were used. animals Were separated into four groups, each with ten rats.The Gp1 was used as control, the Gp2 was used to study the effect of thiamethoxam for 3weeks, the Gp3 was employed to examine the impact of lambda cyhalothrin for 3 weeks and the Gp4 was used to research the impact of thiamethoxam and lambda cyhalothrin for 3 weeks. thiamethoxam and/or lambda cyha

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