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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Feb 24 2020
Journal Name
Sustainability
State-of-the Art-Powerhouse, Dam Structure, and Turbine Operation and Vibrations
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Dam and powerhouse operation sustainability is a major concern from the hydraulic engineering perspective. Powerhouse operation is one of the main sources of vibrations in the dam structure and hydropower plant; thus, the evaluation of turbine performance at different water pressures is important for determining the sustainability of the dam body. Draft tube turbines run under high pressure and suffer from connection problems, such as vibrations and pressure fluctuation. Reducing the pressure fluctuation and minimizing the principal stress caused by undesired components of water in the draft tube turbine are ongoing problems that must be resolved. Here, we conducted a comprehensive review of studies performed on dams, powerhouses, a

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Publication Date
Sun Jun 01 2014
Journal Name
Baghdad Science Journal
Preparation and Identification of some new Pyrazolopyrin derivatives and their Polymerizations study
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Preparation and Identification of some new Pyrazolopyrin derivatives and their Polymerizations study

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Publication Date
Wed Mar 10 2021
Journal Name
Baghdad Science Journal
Preparation and Evaluation of PolyVinyl Alcohol Derivative as Antimicrobial and Antifungal Agents
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Polyvinal alcohol was Cynoethylated , complex compound with Iodin in presence of Cu++ ions were preparated and their ultra violet (U.V) and infra red( IR) spectra were investigated. The prepared derivative and complexes were evaluated as antibacterial and antifungal agents following the standard dilution method. MIC(minimum inhibitory concentration) for each polymer using ten types of gram + ve and gram _ ve bacteria were determinated in addition to three types of fungi. The results obtainded showed that MIC, s were around 0.0011 × 103 molar for different polymetric derivatives tried.

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Publication Date
Thu Apr 02 2020
Journal Name
1st International Conference In Physical Science And Advance Materials
Structural and Morphological Characteristics of Organic and Inorganic Blend Heterojunction NiPcTs/Cd
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In the present study NiPcTs, CdS thin films, and Blends of NiPcTs:CdS were prepared with 1:2 content mixing ratio of NiPcTs to CdS solutions. Cadmium chloride and thiourea were used as the essential materials for deposition CdS thin films while using organic powder of NiPcTs to deposit NiPcTs nanostructure films. The spin-coating technique was employed to fabricate the NiPcTs , CdS films and NiPcTs-CdS blend. Structural properties of films have been investigated via X-Ray diffraction(XRD),and show that thin films of NiPcTs, and CdS have monoclinic and polycrystalline hexagonal structure respectively while the blend has two polycrystalline structure with cubic and hexagonal phases. Atomic force microscope (AFM) confirmed that the surf

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Publication Date
Sun Jun 21 2020
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Knowledge, Use and Recommendation of Iraqi Pharmacist Toward Complementary and Alternative Medicine
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Over the past few decades, the global usage and applications of different kinds of complementary and alternative medicine are greatly exaggerated among the general population, this requires improving the knowledge of all health care provider including pharmacists toward proper and safe use of different complementary and alternative medicine modalities. The current study aims to assess the Iraqi pharmacists' knowledge, use, and recommendation toward complementary and alternative medicine A cross-sectional pilot survey was done on a convenient sample of Iraqi pharmacists. Data were collected using a pretested 

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Publication Date
Sun Jul 30 2023
Journal Name
Iraqi Journal Of Science
Generalization of Gamma and Beta Functions with Certain Properties and Statistical Application
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     This work is devoted to define new generalized gamma and beta functions involving the recently suggested seven-parameter Mittag-Leffler function, followed by a review of all related special cases. In addition, necessary investigations are affirmed for the new generalized beta function, including, Mellin transform, differential formulas, integral representations, and essential summation relations. Furthermore, crucial statistical application has been realized for the new generalized beta function.  

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Publication Date
Wed Jun 01 2022
Journal Name
Eurasian Chemical Communications
Characterization and synthesis of some new Schiff bases and their potential applications
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In this present work, [4,4`-(biphenyl-4,4`-diylbis(azan-1-yl-1-ylidene))bis(methan-1-yl-1-ylidene)bis(2-methoxyphenl)(A1),4,4`-(biphenyl-4,4`-diylbis(azan-1-yl-1-ylidene))bis(methan-1-yl-1-ylidene)diphenol(A2),1,1`-(biphenyl-4,4`-diylbis(azan-1-yl-1-ylidene))bis(methan-1-yl-1-ylidene) dinaphthalen-2-ol (A3)]C.S was prepared in 3.5% NaCl. Corrosion prevention at (293-323) K has been studied by using electrochemical measurements. It shows that the utilized inhibitors are of mixed type based on the polarization curves. The results indicated that the inhibition efficiency changes were used with a change according to the functional groups on the benzene ring and through the electrochemical technique. Temperature increases with corrosion current

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Publication Date
Tue Jun 14 2016
Journal Name
Applied Organometallic Chemistry
Synthesis and antioxidant activities of Schiff bases and their complexes: a review
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Schiff bases, named after Hugo Schiff, are aldehyde- or ketone-like compounds in which the carbonyl group is replaced by imine or azomethine group. They are widely used for industrial purposes and also have a broad range of applications as antioxidants. An overview of antioxidant applications of Schiff bases and their complexes is discussed in this review. A brief history of the synthesis and reactivity of Schiff bases and their complexes is presented. Factors of antioxidants are illustrated and discussed. Copyright © 2016 John Wiley & Sons, Ltd.

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Publication Date
Mon Apr 04 2022
Journal Name
Communications In Mathematical Biology And Neuroscience
Stability and bifurcation of a prey-predator system incorporating fear and refuge
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It is proposed and studied a prey-predator system with a Holling type II functional response that merges predation fear with a predator-dependent prey's refuge. Understanding the impact of fear and refuge on the system's dynamic behavior is one of the objectives. All conceivable steady-states are investigated for their stability. The persistence condition of the system has been established. Local bifurcation analysis is performed in the Sotomayor sense. Extensive numerical simulation with varied parameters was used to explore the system's global dynamics. A limit cycle and a point attractor are the two types of attractors in the system. It's also interesting to note that the system exhibits bi-stability between these 2 types of attractors.

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Publication Date
Fri Apr 01 2022
Journal Name
Baghdad Science Journal
Body mass index and shortened telomere length in middle-aged female and male RUNNING HEAD: Middle-aged and shortened telomere length
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Obesity is a risk factor associated with age-related disorders that accelerate aging, and it increases the risk of metabolic diseases. Therefore, this study was conducted to investigate the association of leukocyte telomere length (LTL) with the presence of higher body weight in middle-aged females and males. The study subjects comprised 160 (80 control and 80 higher body mass index BMI groups) with ranging ages of 30-50 years included and stratified for BMI. The physio-biochemical analysis was measured using enzymatic determination. Mean telomere length was determined by using the southern blotting technique. The association analysis revealed a significant variance (P < 0.01) in biochemical parameters between higher BMI grou

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