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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Sat Jan 01 2022
Journal Name
Iop Conference Series: Earth And Environmental Science
Natural Convection in Annulus Between Two Concentric Cylinders Partially Filled with Metal Foam Distributed with New Suggested Design
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Abstract<p>The investigation of natural convection in an annular space between two concentric cylinders partially filled with metal foam is introduced numerically. The metal foam is inserted with a new suggested design that includes the distribution of metal foam in the annular space, not only in the redial direction, but also with the angular direction. Temperatures of inner and outer cylinders are maintained at constant value in which inner cylinder temperature is higher than the outer one. Naiver Stokes equation with Boussinesq approximation is used for fluid regime while Brinkman-Forchheimer Darcy model used for metal foam. In addition, the local thermal equilibrium condition in the energy e</p> ... Show More
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Publication Date
Tue Apr 11 2023
Journal Name
College Of Islamic Sciences
Collision in the dispute between the two imams Shafi’i and Abu Hanifa by Sheikh Mansour bin Muhammad bin Abd al-Jabbar al-Marwazi al-Samani Abi al-Muzaffar (d. 498 AH) from the issue (If one of the Muslim spouses apostatized and one of the infidel spouses
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The science of jurisprudence is one of the legal sciences that scholars have been interested in since the first centuries of Islam, and they wrote many books about it, and the science of manuscripts is considered one of the scientific achievements in which many scholars emerged, including Imam Al-Samaani, so I chose this manuscript related to Istism to clarify its concept and meaning for all people, The student (Ali Ahmed Abdel-Aziz Sheikh Hamad) preceded me in the investigation of part of the book, and it was facilitated for me, by the grace of God Almighty, to investigate the issue (if one of the Muslim spouses apostatized and one of the infidel spouses converted to Islam until the end of the issue of if the two spouses were taken capt

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Publication Date
Tue Mar 27 2018
Journal Name
Mustansiria Dental Journal
The Effect of Modified Carisolv Gel on Surface Roughness of two Different Types of Ceramic Materials Using Light Polarizing Microscope
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This in vitro study evaluated the influence of chemomechanical caries removal solution on the surface topography of metal-ceramic feldspar porcelain (MAJOR ceramic) and All-ceramic feldspar porcelain (Vita Alpha) using light polarizing microscope. Forty specimens of MAJOR ceramic and forty specimens of Vita Alpha ceramic of (12mm diameter & 3mm height) were prepared .All specimens were polished with silicon polishing burs, cleaned, autoglazed and stored in 37°C before exposure to Carisolv. Thirty specimens of each material randomly exposed to Carisolv gel for 5, 10 and 20 minutes respectively, other ten specimens were not, to act as control group. All specimens were subjected to surface roughness test by profilometer and evalua

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Publication Date
Sat Jan 24 2026
Journal Name
Journal Of Baghdad College Of Dentistry
Evaluation of the Efficiency of Three Different Obturation Techniques to Obturate the Isthmus Area of Roots Canals Prepared by Two Different Instrumentation Techniques (An In Vitro Study)
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Background: The isthmus is a difficult area in the root canal complex to manage. The research aimed to evaluate the efficiency of three different obturation techniques (lateral condensation, EandQ (thermoplasticized gutta percha system) and Soft Core (thermoplasticized core carrier gutta percha system)) to obturate the isthmus area of roots prepared by two different instrumentation techniques (rotary ProTaper universal and ProTaper Next systems). Material and method: Sixty freshly extracted teeth were randomly divided into two main groups (A and B) of 30 teeth each. Group A was prepared by rotary ProTaper Universal whereas group B was prepared by ProTaper Next system. Each main group was then randomly subdivided into three subgroups of 10 t

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Publication Date
Sat Dec 28 2024
Journal Name
Dental Hypotheses
Assessment of Color Change of Artificial White Spot Lesions after Sandblasting with Bioactive Glass, Resin Infiltration, or Microabrasion Followed by Color Stability Test by pH Cycling: An in Vitro Study
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Introduction: This study aimed to assess the color change of human teeth with artificial enamel white spot lesions (WSLs) after sandblasting with bioactive glass, resin infiltration, and microabrasion and to test color stability after pH cycling. Methods: Fifty extracted human mandibular first molars were randomly assigned into five groups: Sound, WSLs (untreated), and WSLs sandblasted with bioactive glass (Sylc), WSLs treated by resin infiltration (ICON), and WSLs treated by microabrasion (Opalustre), respectively. All specimens underwent a pH cycling procedure. The color parameters for each specimen were assessed using an Easyshade dental spectrophotometer at different time stages then the color changes (ΔE) were calculated. Results: The

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Publication Date
Wed Jul 01 2015
Journal Name
Journal Of The Faculty Of The Medicine Baghdad
Do low back pain changes correlate with sagittal lumbar alignment changes after total hip replacement arthroplasty?
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Abstract Background: The hip joint and lumbar spine are both anatomically and functionally closely related as had shown by many authors. So the abnormality in one area can affect the other e.g. hip joint osteoarthritis can cause lumbar sagittal malalignment and backache. Objectives: is to see if there is significant improvement in backache after total hip replacement? And which degree of backache improvement is associated with significant changes in lumbar lordosis? Methods and patients: a prospective open trial study was performed on 30 patients who had severe hip osteoarthritis and chronic low back pain. Total hip replacement was performed to all patients. Backache and lumbar lordosis were measured by visual analogue scale and Cobb’s a

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Publication Date
Sun Dec 03 2017
Journal Name
Baghdad Science Journal
Comparison among Populations of Mosquitoes Culex quinquefasciatus Say by using Geometric Morphometric Technique from Different Regions of Iraq
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The geometric morphometric technique was used to study the variables in the shape and size wings of different populations of mosquitoes Culex quinquefasciatus from different Iraqi provinces Babylon, Baghdad and Wasit. The results showed that the average of centroid size were 366, 387.5 and 407.4 Micron in Babylon, Baghdad and Kut, respectively. The statistical analysis showed that there were no significant differences in the average of centroid size of all specimens and they belong to the same species.

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Publication Date
Tue Mar 01 2011
Journal Name
Journal Of Accounting And Financial Studies ( Jafs )
The effect of differentiation strategy on achieve competitive advantage: survey comparison between the companies maintenance service
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Is to obtain competitive advantage legitimate objective pursued by all organizations to achieve, because they live today in environments of rapid change and dynamic in order to meet the demands of the customer changing as well as intense competition between the organizations, which requires them to get the location of competitive markets in order to do this will remain to do the building and strengthening competitive advantage to be able to achieve, but that this feature is not easy and is not only through the identification and use of a successful strategy for a competitive standard and then manage it successfully. Hence the research problem of determining the sources of differentiation strategy and its impact on the dimensions of compe

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Publication Date
Sat Feb 01 2020
Journal Name
Iop Conference Series: Materials Science And Engineering
Revealing the potentials of 3D modelling techniques; a comparison study towards data fusion from hybrid sensors
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Abstract<p>The vast advantages of 3D modelling industry have urged competitors to improve capturing techniques and processing pipelines towards minimizing labour requirements, saving time and reducing project risk. When it comes to digital 3D documentary and conserving projects, laser scanning and photogrammetry are compared to choose between the two. Since both techniques have pros and cons, this paper approaches the potential issues of individual techniques in terms of time, budget, accuracy, density, methodology and ease to use. Terrestrial laser scanner and close-range photogrammetry are tested to document a unique invaluable artefact (Lady of Hatra) located in Iraq for future data fusion sc</p> ... Show More
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Publication Date
Sat Mar 01 2008
Journal Name
Iraqi Journal Of Physics
Comparison between Different Data Image Compression Techniques Applied on SAR Images
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In this paper, image compression technique is presented based on the Zonal transform method. The DCT, Walsh, and Hadamard transform techniques are also implements. These different transforms are applied on SAR images using Different block size. The effects of implementing these different transforms are investigated. The main shortcoming associated with this radar imagery system is the presence of the speckle noise, which affected the compression results.

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