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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Jun 11 2017
Journal Name
Ibn Al-haitham Journal For Pure And Applied Sciences
Study of Percentage of Red and White Muscles in Two Species of Bony Fishes Tenualosa ilisha (Hamilton , 1822) and Cyprinus carpio (Linnaeus , 1758)
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 The present study aimed to estimate percentage of red and white muscles fibers in two species of bony fishes belong to two different families which represented by Tenualosa ilisha (Hamilton , 1822) that belongs to the family Clupeidae and Cyprinus carpio (Linnaeus , 1758) that belongs to the family Cyprinidae . The samples were collected from local market at holy Karbala province. The results show difference clear in mean values of muscles numbers at different studied length groups, and the percentage of red muscles fibers were less than that of white muscle fibers at different body regions (R1,R2,and R3) among species.  The total average of red muscle fibers values ranged between (4.23 - 11.08 %) while the total average of wh

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Publication Date
Sun Jan 04 2015
Journal Name
Journal Of Educational And Psychological Researches
The Relationship between Social Anxiety and Mindfulness In Iraqi Women Living In Iraq And The UK; A Comparison Study
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The continuous pressure of work and daily life and the increasing financial and social stress that Iraqi women are experiencing (both inside and outside Iraq) is one of the main causes of anxiety, particularly in those of working class women. This group of women carry the burden of carrying out multiple roles and responsibilities at the same time. All this collectively make them more prone to developing anxiety compared to men. In addition, the physiological and psychological nature of women, as females, on top of the other roles in life, like being a wife or mother or daughter or sister, all add extra pressure on women especially for those who are considered as productive working individuals in the society. In order to study the relatio

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Publication Date
Thu Jun 15 2023
Journal Name
Romanian Neurosurgery
Similarities and differences between two coincidently gravitational bullet cases
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Many cases of gravitational bullets are reported in developed and non-developed countries. However, few papers highlighted these cases in the literature. In our study, we present two cases of gravitational bullets that have an unusual coincidence in the injury characteristics through their ages, and gender, the site of the inlet.

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Publication Date
Sat Jun 01 2019
Journal Name
Collegian
Medication adherence and predictive factors in patients with cardiovascular disease: A comparison study between Australia and Iraq
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Publication Date
Thu Jun 25 2020
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Comparison Between Conventional and Supersaturable Self-nanoemulsion Loaded with Nebivolol: Preparation and In-vitro/Ex-vivo Evaluation
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Nebivolol (NBH) is a third-generation B1-blocker with high selectivity and vasodilation activity. Nevertheless, nebivolol exhibits low oral bioavailability, which may adversely affect its efficacy. Recently, supersaturable self-nanoemulsion (Su-SNE) is an advanced SNE approach that can address low bioavailability The study aims to prepare nebivolol-loaded Su-SNE by reduction the amount of the prepared conventional SNE to half. Besides, an appropriate polymer type and concentration to prevent NBH precipitation upon oral administration have investigated.. A conventional self-nanoemulsion (formula A) was prepared by dissolving NBH in 500 mg vehicle mixture of imwitor®988: cremophor-EL: propylene glycol. Then, eight Su-SNE formul

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Publication Date
Thu Jun 25 2020
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn: 1683 - 3597 , E-issn : 2521 - 3512)
Comparison Between Conventional and Supersaturable Self-nanoemulsion Loaded with Nebivolol: Preparation and In-vitro/Ex-vivo Evaluation
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Nebivolol (NBH) is a third-generation B1-blocker with high selectivity and vasodilation activity. Nevertheless, nebivolol exhibits low oral bioavailability, which may adversely affect its efficacy. Recently, supersaturable self-nanoemulsion (Su-SNE) is an advanced SNE approach that can address low bioavailability The study aims to prepare nebivolol-loaded Su-SNE by reduction the amount of the prepared conventional SNE to half. Besides, an appropriate polymer type and concentration to prevent NBH precipitation upon oral administration have investigated.. A conventional self-nanoemulsion (formula A) was prepared by dissolving NBH in 500 mg vehicle mixture of imwitor®988: cremophor-EL: propylene glycol. Then, eight Su-SNE formulas wit

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Publication Date
Wed Jun 03 2020
Journal Name
Political Sciences Journal
Obstacles to achieving societal peace in Iraq after 2018
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    Community peace is achieved in law-based states Constitutional institutions with competence and powers, and otherwise that peace is shaken and begins to collapse. The movement of individuals and groups in the State is regulated by law The law and its proper application without selectivity or exception, and then the sense of equal opportunity and equal rights grows every citizen looks at his spouse, what he has, and when he is unbalanced, a sense of frustration and stealing of rights is generated Societal peace suffers from the shocks of instability and what is reflected in the surrounding environment. Instead of production, demolition takes place, which impedes the achievement of the required peace.  

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Publication Date
Tue Aug 20 2019
Journal Name
Political Sciences Journal
Israeli foreign policy towards Iraq after occupation in 2003
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Summery of the Study: The Israeli interest in Iraq was not the result of the 2003 US war, which ended with its occupation, but Iraq was still at the top of Israeli concerns, as it was due to its interest and desire to occupy the Zionist movement for a number of reasons, most importantly its religious position in the Jews and control It is a sacred religious duty, so Israel has employed all its organs, institutions, relations and espionage networks in order to penetrate it and perpetuate its existence, and succeeded in achieving its foreign policy objectives at a time when the area was open to it without opposition or competition thanks to its strategic alliance with the states Of the United States of America, which has been able to penet

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Publication Date
Wed Feb 20 2019
Journal Name
Political Sciences Journal
Iraqi Woman Political situation in Quota Framework after 2003
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Abstract Since 2003. Iraq has begun a new phase in its modern history, which was after a long period of tyranny, repression of freedom of expression, and women were no better off than men; they suffered marginalization and exclusion, but after the fall of the former regime and the adoption of a parliamentary system of government, The level of participation in the government; where it approved the share of women in the legislative authority called "quota" which reflects the legislative level of a certain proportion of the seats in Parliament, amounting to 25%, and this is approved by the Iraqi constitution for 2005. But it is noticeable that women in parliament did not work within the quota; in other words they belonged to the pol

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Publication Date
Sun Jan 01 2017
Journal Name
Advances In Animal And Veterinary Sciences
Dogs' hormonal levels drop after surgical gonadectomy in Iraq
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