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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 02 2024
Journal Name
Methods And Objects Of Chemical Analysis
Simultaneous Spectrophotometric Determination of Piroxicam, Naproxen, Diclofenac Sodium and Mefenamic Acid in Pharmaceutical Formulations by Partial Least Squares Method
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A chemometric method, partial least squares regression (PLS) was applied for the simultaneous determination of piroxicam (PIR), naproxen (NAP), diclofenac sodium (DIC), and mefenamic acid (MEF) in synthetic mixtures and commercial formulations. The proposed method is based on the use of spectrophotometric data coupled with PLS multivariate calibration. The Spectra of drugs were recorded at concentrations in the linear range of 1.0 - 10 μg mL-1 for NAP and from 1.0 - 20 μg mL-1 for PIR, DIC, and MEF. 34 sets of mixtures were used for calibration and 10 sets of mixtures were used for validation in the wavelength range of 200 to 400 nm with the wavelength interval λ = 1 nm in methanol. This method has been used successfully to quant

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Publication Date
Fri Jul 01 2022
Journal Name
Rawal Medical Journal
Macular thickness correlation with gender and age in a sample of healthy eyes of Iraqi population utilizing optical coherence tomography
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Publication Date
Fri Aug 01 2025
Journal Name
Imam Jaafar Al-sadiq University Journal Of Human And Social Sciences
Examination of Identity and Alienation in Postcolonial Literature: Analysis of Nervous Conditions by Tsitsi Dangarembga
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This research explores the themes of identity and alienation in Tsitsi Dangarembga's famous novel, Nervous Conditions, through Kimberlé Crenshaw's intersectionality theory. The story takes place in postcolonial Zimbabwe and delivers a fascinating illustration of the intersecting domains of gender, race, class, and colonial legacies that shape the characters' experiences of identity and alienation. Benefitting from Crenshaw's intersectional paradigm, this article explores the multidimensional interface of societal categorizations and power relations in the novel, revealing the complex dynamics of individuals as they negotiate their identities in a postcolonial context. Through a thorough examination of Tambudzai's journey and the problems o

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Publication Date
Thu Aug 31 2017
Journal Name
Journal Of Engineering
The Phenomenon of Division and Modification of The Individual Houses in Baghdad after 2003
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The Research deals with the negative phenomena which appeared in the urban scenes of the  Iraqi cities after 2003, particularly trespassing the architectural design of the urban Individual houses.  Many academic researchers , critics, and cultural circles, drawn attention to the impact of  political and cultural variable change on such phenomena  without detailed  analysis . The research problem  is set according to central questions : If the phenomena is the trespass , what
are the sides which are being trespassed  in the division of the individual house? , If the diagnosis of the phenomena denotes perceived repetition of the cases , So what's size of this transposes on the architectural design of t

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Publication Date
Tue Dec 15 2020
Journal Name
Aip Conference Proceedings
The water bodies in the Southern East of Iraq before and after 2018
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This study is concerned with the recent changes that occurred in the last three years (2017-2019) in the marshes region in southern Iraq as a result of the changes in the global climate, the study included all the water bodies in the five governorates that are located in the southern regions of Iraq (Wasit, Maysan, Dhi-Qar, Qadisiyah and Basrah), which represent the marshes lands in Iraq. Scenes of the Landsat 8 satellite are used to create a mosaic to cover the five governorates within a time window with the slightest difference between the date of the scene capture, not to exceed 8 days. The results of calculating the changes in water areas were obtained using the classifier support vector machine, where high accuracy ratios were recorded

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Publication Date
Sun Jan 27 2019
Journal Name
Journal Of The College Of Education For Women
Historical Paths of the Political Conflict in Iraq and its Development After 3002
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Following the political development in Iraq Since 7112 exposed kind of political traditions about how to manage the conflicts that have different Iraqi powers .That what was clear since the formation of permanent government since in 7112 .
The case of conflict between political powers in administrating Iraq state and the withdrawal of American Forcesintroduces questions:
0-Is it possible that that the beginning of Iraq state building shall ease this conflict and peacemaking in the post-conflict period?
7- To what extent the Iraqi powerswas to manage their disputes in non-military like elections which was held in 7112?
2- What is the range of the extent of the political operation after the American withdrawal?
The important

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Publication Date
Sun Jun 02 2013
Journal Name
Baghdad Science Journal
Evaluation of ELectrolytes in Adult Patients with Acute Leukemia before and after Chemotherapy
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Abstract:Leukemia is a cancer of early blood forming cells. Most of them are cancers of white blood cells , however some leukemias start in other blood cell types.Electrolytes have modulatory effects on several biological mechanisms in the body namely as stabilizers,element of structures, essential element for hormonal function and also co-factors for a number of enzymes.In this study serum electrolytes levels were measured in patients with acute leukemia (AL) disorders before and after chemotherapy(anthracycline, doxorubicin, cytarabine ,prednisone, vincristine and doxorubicin) during one month and compared with that of control group. Blood samples were obtained from (43) patients (28 males and 15 females) aged (15-55)years;juset before an

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Publication Date
Sun Jun 02 2013
Journal Name
Baghdad Science Journal
Comparison of The Effect of Aqueous Extracts of two Plants, Origanum Vulgare L. and Fenugreek Seeds with Anticancer Drug Cis-Platin on the Growth of Cancer Cell Lines
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This study involved the effect of the aqueous extracts of two plants, Origanum vulgare L.(1), Trigonella Foenum Graecum L. (Fenugreek) seeds(2) on the growth of cancer cell lines. Rhabdomyo sarcomas (RD) of human cell line and female intestine cells of Albino mice (L20B) in vitro System. These extracts were compared with the known anticancer drug Cis-platinum(Cis-Pt) as a positive control. The phytochemical tests were used for screening the active compounds in plants. The inhibition activity assay was used as a parameter of the cytotoxic effect of these extracts. Cancer cell lines were treated with four concentrations of Cis-platin, 31.25, 62.5, 125 and 250 ?g/ml for 72 hour exposure time. The same concentrations were used for the other ext

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Publication Date
Wed Jan 01 2020
Journal Name
Journal Of Southwest Jiaotong University
A Recognition System for Subjects' Signature Using the Spatial Distribution of Signature Body
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This investigation proposed an identification system of offline signature by utilizing rotation compensation depending on the features that were saved in the database. The proposed system contains five principle stages, they are: (1) data acquisition, (2) signature data file loading, (3) signature preprocessing, (4) feature extraction, and (5) feature matching. The feature extraction includes determination of the center point coordinates, and the angle for rotation compensation (θ), implementation of rotation compensation, determination of discriminating features and statistical condition. During this work seven essential collections of features are utilized to acquire the characteristics: (i) density (D), (ii) average (A), (iii) s

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Publication Date
Sun Dec 06 2009
Journal Name
Baghdad Science Journal
Study of the Porosity of Certain pharmaceutical Tablets using Mercury Intrusion Porosimeter
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Porosity and pore structure are important characteristics of pharmaceutical tablets, since they influence the physical properties, such as mechanical strength, density and disintegration time. This paper is an attempt to investigate the pore structure of four different paracetamol tablets based on mercury porosimetry. The intrusion volumes of mercury were used to calculate the pore diameter, pore volume and pore size distribution. The result obtained indicate that the variation of the pore volume in the tablets followed the sequence:- S.D.I. Iraq? Pharmacare,Dubai-U.A.E.? Bron and Burk(UK) London?Lark Laboratories(India), while the variation of surface area followed the sequence:- S.D.I. Iraq? Lark Laboratories(India)? Pharmacare,Dubai-U.A

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