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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Mon Mar 28 2022
Journal Name
Politeia-journal Of Political Theory Political Philosophy And Sociology Of Politics
State-building and Ethnic Pluralism in Iraq after 2003
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The research article deals with the process of building or rebuilding the state in Iraq after 2003 in its various dimensions, in light of the vision and foundational procedures that were developed and supervised by the United States in cooperation with the new leaders of Iraq based on the mechanism of sectarianethnic representation, and diagnosing the imbalances that arose out of that vision and the accompanying procedures, which led to the emergence of new variables in the political process, especially in the post-ISIS* phase, which produced important challenges to the political system and the Iraqi state. The political dynamics and balances emerging after ISIS* represented at the same time opportunities and risks in the process of

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Publication Date
Sat Jun 30 2007
Journal Name
Al-kindy College Medical Journal
Pyogenic Discitis in Female after Delivery and Pelvic Surgery
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Background: Pyogenic discitis most frequently occurs
after home delivery, hemorridectomy, and dilatation and
curettage. Discitis is generally due to blood borne bacterial
invasion of the disc from adjacent end-plate via
communicating vessels. Infective discitis remains an
uncommon, but potentially serious cause for back pain.
Delayed diagnosis can occur and a high index of suspicion
may occur.
Methods: The study included 30 patients suffering from
localized low back pain with limitation of movement.
Diagnosis was made by history, physical examination and
investigation mainly E.S.R and MRI.
Results: 50.3% of patient with discitis had a history of
vaginal delivery, 15% had a history of hemorridectomy

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Publication Date
Wed Aug 01 2018
Journal Name
Journal Of Economics And Administrative Sciences
Privatization Thesis and its trends in Iraq after 2003
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The concept of privatization is built on the basis of the transfer of assets and services of the public sector to the private sector this concept has appeared in the eighties of the last century whene the high oil prices took place and recession solution swept the world Which called for the freedom of the market and left the room for the private sector to take the initiatine in economic activity.         Both the IMF have   adopted this thesis in their programs of the structural adjustment in light of external and internal factors helped to Create the conditions to accept thesis that under the pretext of achieving a number of economic goals.

In Iraq in spite of

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Publication Date
Thu Jun 23 2022
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Flow Injection Spectrophotometric Technique for Determining of Genistein in Pure and Supplements Formulations Through Diazotization Coupling Reaction
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Genistein (GEN) is The major isoflavone found in soybeans, has a number of cardiovascular health benefits, Postmenopausal syndrome and osteoporosis. A direct flow injection analysis method for estimation of (GEN) in pure and supplements formulation . This system is based on diazotization coupling reactions between procaine penciline (PR) and genistein in basic medium, they formed yellow dyes have maximum absorption at 416 nm. Calibration curve were constructed over different GEN concentrations, linearity for GEN was 10-100 µg.mL-1 and detection limits of 1.51 ?g/mL. In the FIA technique, all analytical factors were analyzed and optimized. The established method was successfully used to determine GEN in the formulations of its supplement

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Publication Date
Fri Dec 26 2025
Journal Name
Journal Of Baghdad College Of Dentistry
Pharyngeal airway volume and its relationship to the facial morphology in nasal breathing and mouth breathing subjects (A comparative computerized tomography study)
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Background: The value of lateral cephalometric radiographs to evaluate the pharyngeal airway is limited because it provided 2-dimensional (2D) images of complex 3-dimensional (3D) anatomic structures. Three dimensional analyses of the airway volumes are required to understand oral and pharyngeal adaptations in mouth breathing and nasal breathing subjects. The aim of this study was to measure the pharyngeal airway volume and the size of the face, then compare between pharyngeal airway volume in mouth breathing and nasal breathing subjects and find the gender difference in each group, also to study the relation between pharyngeal airway volume and the size of the face. Material and Methods: Fifty patients including 28 males and 22 females wit

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Publication Date
Fri Dec 26 2025
Journal Name
Journal Of Baghdad College Of Dentistry
The Effect of Plasma Treatment on Shear Bond Strength of High Impact Acrylic Resin Denture Base Lined with Two Types of Soft Lining Materials after Immersion in Distilled Water and Denture Cleanser
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Background: In dentistry, dentist takes the advantages of soft lining materials due to the viscoelastic properties. The major problem is the adhesion of the soft liner with the denture base material. Materials and Methods: Heat cured of high impact acrylic resin specimens prepared with dimensions 75x13x13mm for shear bond strength test, soft lining material (Refit and Mollosil) with a 3-mm thickness and used to join each two acrylic blocks. Also four specimens with the same previous dimensions utilized for chemical and physical surface analysis. The specimens grouped as control (without plasma) and experiment (with oxygen plasma) treated high impact acrylic specimens. Results: Plasma treatment increased the shear bond strength for both Refi

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Publication Date
Sun Dec 31 2023
Journal Name
College Of Islamic Sciences
The book Al-Durr Al-Manzoum in the dropping of prayer and fasting by Issa Al-Safti Al-Hanafi, who died in the year (1143 AH)
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At the conclusion of my research for this readiness, I am ready to show the most important results I have reached, of which I can mention the most important:
Sheikh Al-Safti was a memorizer and jurist, and all the scientific strokes that he left behind for subsequent generations were in the disciplines of Hanafi jurisprudence, and this does not obscure the opinions of the jurists of other schools of thought. But among them: that these lines continue on a group of fatwas for the later in the gold of Abu Hanifa, may God have mercy on him, and then the books of fatwas usually refer to what is below the evidence.

He has no shock other than the knowledge of jurisprudence; And for this reason, it is due to the fact that the s

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Publication Date
Fri Jan 19 2024
Journal Name
Turkish Journal Of Pharmaceutical Sciences
Taste Masking of Steroids for Oral Formulations
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Publication Date
Fri Jun 16 2023
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
The Effect of Molecular Imprinting on the Loading and Release of Poorly Water Soluble Drug in Hydrogel Gontact Lenses
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Therapeutic contact lenses TCLs is an approach used to enhance corneal residence time and reduce frequent instillation, which is a problem with eye drops.  The problem with CLs is loading of hydrophobic drugs. In this research the CLs were prepared with molecular imprinting MI to enhance the loading of itraconazole, which is used as antifungal drug for fungal keratitis. CLs using different  concentration of hydroxyethyl methacrylate HEMA and methacrylic acid MAA were prepared with and without MI using PEGDA (25 μL) and AIBN (37 mg) as crosslinker and initiator respectively. All the prepared CLs were clear and have good folding endurance. MICLs had significantly higher drug loading compared to conventional CLs. The release of i

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Publication Date
Mon Sep 01 2014
Journal Name
Al-khwarizmi Engineering Journal
Comparison of Fatigue Life Behavior between Two Different Composite Materials Subjected to Shot Peening at Different Times
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This paper investigated the fatigue life behavior of two composite materials subjected to different times of shot peening (2, 4 and 6 min).The first material prepared from unsaturated polyester with E-glass reinforcement by 33% volume fraction. While, the second one was prepared from unsaturated polyester with aluminum powder by2.5% volume fraction. The experimental results showed that the improvement in endurance limit was obtained (for the first material) at 2, 4 and 6 min shot peening times where the percentage of maximum improvement was 25% at shot peening time of 6 min. While, the endurance limit of the second material decreased at shot peening times of 2, 4 and 6 min where the percentage of maximum reduction was 29 % at shot peenin

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