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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 2013
Journal Name
Baghdad Science Journal
Comparison of Maximum Likelihood and some Bayes Estimators for Maxwell Distribution based on Non-informative Priors
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In this paper, Bayes estimators of the parameter of Maxwell distribution have been derived along with maximum likelihood estimator. The non-informative priors; Jeffreys and the extension of Jeffreys prior information has been considered under two different loss functions, the squared error loss function and the modified squared error loss function for comparison purpose. A simulation study has been developed in order to gain an insight into the performance on small, moderate and large samples. The performance of these estimators has been explored numerically under different conditions. The efficiency for the estimators was compared according to the mean square error MSE. The results of comparison by MSE show that the efficiency of B

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Publication Date
Tue Jun 01 2010
Journal Name
Al-khwarizmi Engineering Journal
Comparison of the RLS and LMS Algorithms to Remove Power Line Interference Noise from ECG Signal
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    Biomedical signal such as ECG is extremely important in the diagnosis of patients and is commonly recorded with a noise. Many different kinds of noise exist in biomedical environment such as Power Line Interference Noise (PLIN). Adaptive filtering is selected to contend with these defects, the adaptive filters can adjust the filter coefficient with the given filter order. The objectives of this paper are: first an application of the Least Mean Square (LMS) algorithm, Second is an application of the Recursive Least Square (RLS) algorithm to remove the PLIN. The LMS and RLS algorithms of the adaptive filter were proposed to adapt the filter order and the filter coefficients simultaneously, the performance of existing LMS

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Publication Date
Fri Feb 12 2016
Journal Name
International Journal Of Advanced Statistics And Probability
Two fixed point theorems in generalized metric spaces
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<p>In this paper, we prove there exists a coupled fixed point for a set- valued contraction mapping defined on X× X , where X is incomplete ordered G-metric. Also, we prove the existence of a unique fixed point for single valued mapping with respect to implicit condition defined on a complete G- metric.</p>

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Publication Date
Tue Jan 01 2019
Journal Name
Journal Of Global Pharma Technology
Serum levels of cross-linked n-telopeptide of Type i collagen before and after non-surgical periodontal therapy in type 2 diabetic patients with chronic periodontitis
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Background: Diabetes mellitus is a major risk factor for chronic periodontitis (CP) and hyperglycemia has an important role in the enhancement of the severity of the periodontitis. It has been reported that the progression of CP causes shifting of the balance between bone formation and resorption toward osteoclastic resorption, and this will lead to the release of collagenous bone breakdown products into the local tissues and the systemic circulation. Cross-linked N-telopeptide of type I collagen (NTx) is the amino-terminal peptides of type I collagen which is released during the process of bone resorption. This study was conducted to determine the effects of nonsurgical periodontal therapy on serum level of NTx in type 2 diabetic patients

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Publication Date
Sat May 01 2021
Journal Name
Materials Today: Proceedings
WITHDRAWN: Analyzing and measuring the impact of trade openness on the gross domestic product growth of the Iraqi economy after 2003
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Publication Date
Thu Mar 15 2018
Journal Name
Journal Of Baghdad College Of Dentistry
The Surface Hardness Measurement of Stone and Improved Die Stone After the Addition of a Mixture of Chemical Additives with Different Proportion
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Background: Incorporation of chemical additives has long been a technique used to improve properties of the gypsum products. The purpose of this work was to study the effects of adding a combination of gum Arabic and calcium hydroxide to a type III dental stone and type IV improved die stone with different proportion. The effect on water/powder ratio, and surface hardness was determined. Material and method: Both material stone and die stone were blended with two proportion of additives so that each material was mixed twice but with different proportion of gum Arabic (0.1% and 0.2%) and calcium hydroxide (0.5 % and 0.3%). Data for hardness were subjected to two-way analysis of variance. Results: The results revealed that the chemical additi

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Publication Date
Fri Dec 01 2023
Journal Name
Political Sciences Journal
The Future of the Russian- Ukrainian War and the Extent of its Reflection on the Security of Eastern European Countries after 2022
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Wars represent one of the most serious threats to the world order; It is considered a violation of international laws and norms, and humanitarian principles. From this point comes the study of the importance of the topic entitled (The Future of the Russian-Ukrainian war and the extent of its Reflection on the security of Eastern European countries after the year 2022). This study is based on reviewing future possibilities (scenarios) of war. The Russian-Ukrainian war, which was launched by the Russian government led by Russian President Vladimir Putin in February 2022, is still ongoing at the time of writing this research. This chapter includes three possibilities (scenarios). The first possibility deals with the development of the war t

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Publication Date
Sat Jul 13 2024
Journal Name
Al-rafidain Journal Of Medical Sciences ( Issn 2789-3219 )
The Effect of Systemic Proteolytic Enzymes on Postoperative Inflammatory Response and Quality of Life after Surgical Extraction of Impacted Mandibular Third Molar
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Background: The surgical extraction of impacted third molar usually results in postoperative inflammation manifested as pain, facial swelling and trismus which may cause deterioration in the patient’s quality of life. Methods: This randomized controlled study included 56 patients indicated for surgical extraction of IMTM under local anesthesia. These patients were randomly assigned into two groups: a study group that included patients who received Tibrolin® postoperatively and a control group that did not. The predictor variable was whether to use SET or not. Pain measured by the pain numerical rating scale (NRS), facial swelling, and the degree of trismus were the outcome variables. The Arabic version of the Oral Health Impact P

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Publication Date
Sat Jun 25 2022
Journal Name
International Journal Of Drug Delivery Technology
Comparison of Sizes of Zinc Oxide Nanoparticles Extracted from Staphylococcus lugdunensis and Berberis vulgaris Plant Extract Against Some Types of Bacteria and Yeast
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Staphylococcus lugdunensis, isolation between 12.5 to 1.8% routine works may be a possible peroral route of infective endocarditis and found in the oral cavity by examined using saliva. Similar supragingival plaque isolation was observed. The increased bacteria resistance to antibiotics multiple have led to novel methods for resistance bacteria; antimicrobial agents are well known (ZnO NPs) by biological method and are lower toxicity and biology safety ZnNOPs activity by plant extraction and less toxicity as well as bio-safe. The nanoparticle was synthesized by biological method (Green) by barberry (Berberis vulgaris) extract. In this study using (WAD) method using different concentrations between (128, 64, 32, and 16) mg/mL of ZnO

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Publication Date
Sat Jun 25 2022
Journal Name
International Journal Of Drug Delivery Technology
Comparison of Sizes of Zinc Oxide Nanoparticles Extracted from Staphylococcus lugdunensis and Berberis vulgaris Plant Extract Against Some Types of Bacteria and Yeast
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Staphylococcus lugdunensis, isolation between 12.5 to 1.8% routine works may be a possible peroral route of infective endocarditis and found in the oral cavity by examined using saliva. Similar supragingival plaque isolation was observed. The increased bacteria resistance to antibiotics multiple have led to novel methods for resistance bacteria; antimicrobial agents are well known (ZnO NPs) by biological method and are lower toxicity and biology safety ZnNOPs activity by plant extraction and less toxicity as well as bio-safe. The nanoparticle was synthesized by biological method (Green) by barberry (Berberis vulgaris) extract. In this study using (WAD) method using different concentrations between (128, 64, 32, and 16) mg/mL of ZnO NPs, The

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Scopus (5)
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