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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Oct 01 2017
Journal Name
مجلة القادسية للعلوم الرياضية
The impact of leverage in two different environments on the development of weapons and arms explosion strength on some physiological indicators and the accuracy of the performance of the service and crushing volleyball skills
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ھدف البحث الـــــى : ١ -إعداد تدریبات القوة الارتدادیة في وسطین متباینین على بعض المؤشرات الفسیولوجیة لتطویر القوة الانفجاریة ودقة مھارتي الأرسال والضرب الساحق بالكرة الطائرة . ٢ -التعرف على تأثیر تدریبات القوة الارتدادیة في وسطین متباینین على بعض المؤشرات الفسیولوجیة لتطویر القوة الانفجاریة.. ٣ -التعرف على تأثیر تدریبات القوة الارتدادیة في وسطین متباینین على دقة مھارتي الأرسال والضرب الساحق بالكرة الطائرة

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Publication Date
Sat Dec 15 2018
Journal Name
Journal Of Baghdad College Of Dentistry
Development of Sinusitis After Sinus Floor Elevation Surgery: A Systematic Review
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Background: Maxillary sinusitis can arise after sinus floor elevation surgery and should be treated immediately to prevent further complications which included dental implants failure, graft lost, and oro-antral fistula. This is the first systematic review to assess the incidence, causes, and treatment of sinusitis after sinus lift surgery. Materials and methods: An electronic search included MEDLINE (PUBMED) data base site was carried out for articles involving development of sinusitis after sinus lift surgery from September 1997 up to April, 8, 2017. The search was done and reviewed by two independent authors. Results: The total results of electronic search were (182) abstracts and articles, the extracted articles which involved develo

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Publication Date
Wed Feb 27 2019
Journal Name
Political Sciences Journal
Effects of Neighboring Countries on the Iraqi Parliament Performance after 2003
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Publication Date
Thu Jan 16 2020
Journal Name
Indian Journal Of Forensic Medicine & Toxicology
Effect of Addition of Composite Polyamide Micro Particles and Silicone Dioxide NanoParticle on Some Mechanical Properties of Room Temperature Vulcanized Maxillofacial Silicone Elastomer Before and after Artificial Aging
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Background: The most common reason for re-making a maxillofacial prosthesis is the degradation of the mechanical properties of the silicone. Aim of this study: To assess some mechanical properties of VST-50F maxillofacial silicone reinforced with a composite of silicon dioxide nanoparticle and polyamide-6 microparticle before and after artificial aging. Material and Method: Preparing 240 samples tested for tear strength, tensile strength and elongation percentage, hardness, and roughness before and after aging. The Silicon dioxide was added in concentrations of 1% by weight and Polyamide-6 in the concentration of 0.25% and 0.5% by weight to the VST-50F RTV maxillofacial silicone. The one-way ANOVA and post hoc tests were used for inferentia

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Publication Date
Mon Jan 08 2024
Journal Name
Al-rafidain Journal Of Medical Sciences ( Issn 2789-3219 )
Recurrence Rate of Pleomorphic Adenoma in Minor Salivary Glands After Surgical Excision: A Retrospective Clinical Study
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Background: Pleomorphic adenoma of the minor salivary gland is a rare benign tumor. It commonly occurs in the hard and soft palates. Treatment by surgical excision achieved success in improving the patient’s health. Objective: To evaluate the recurrence rate after surgical treatment of pleomorphic adenoma in minor salivary glands. Methods: This retrospective study included patients who attended the Maxillofacial Surgery Unit in Ghazi Al-Hariri Hospital, Baghdad, from 2019 to 2021, complaining of soft tissue lumps involving the soft and hard palate, buccal mucosa, and upper lip. After the provisional diagnosis of these lesions, a total surgical excision of the tumor with a safe margin of 1 mm was performed, and the biopsy was sent for hist

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Publication Date
Mon Jan 08 2024
Journal Name
Al-rafidain Journal Of Medical Sciences ( Issn 2789-3219 )
Recurrence Rate of Pleomorphic Adenoma in Minor Salivary Glands After Surgical Excision: A Retrospective Clinical Study
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Background: Pleomorphic adenoma of the minor salivary gland is a rare benign tumor. It commonly occurs in the hard and soft palates. Treatment by surgical excision achieved success in improving the patient’s health. Objective: To evaluate the recurrence rate after surgical treatment of pleomorphic adenoma in minor salivary glands. Methods: This retrospective study included patients who attended the Maxillofacial Surgery Unit in Ghazi Al-Hariri Hospital, Baghdad, from 2019 to 2021, complaining of soft tissue lumps involving the soft and hard palate, buccal mucosa, and upper lip. After the provisional diagnosis of these lesions, a total surgical excision of the tumor with a safe margin of 1 mm was performed, and the biopsy was sent

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Publication Date
Tue Mar 26 2024
Journal Name
Scientific Reports
An in vitro assessment of the residual dentin after using three minimally invasive caries removal techniques
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Abstract<p>To evaluate the efficiency and effectiveness of three minimally invasive (MI) techniques in removing deep dentin carious lesions. Forty extracted carious molars were treated by conventional rotary excavation (control), chemomechanical caries removal agent (Brix 3000), ultrasonic abrasion (WOODPECKER, GUILIN, China); and Er, Cr: YSGG laser ablation (BIOLASE San Clemente, CA, USA). The assessments include; the excavation time, DIAGNOdent pen, Raman spectroscopy, Vickers microhardness, and scanning electron microscope combined with energy dispersive X-ray spectroscopy (SEM–EDX). The rotary method recorded the shortest excavation time (p < 0.001), Brix 3000 gel was the slowest. DIAGNOdent pen va</p> ... Show More
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Publication Date
Thu Jul 07 2022
Journal Name
Iraqi Journal Of Market Research And Consumer Protection
COMPARISON BETEEEN THE CONSUMPTION OF RED MEAT AND WHITE MEAT FOR ASAMPLE OF CITIZENS OF THE CITY OF BAGHDAD/ AN EXPLORATORY STUDY : COMPARISON BETEEEN THE CONSUMPTION OF RED MEAT AND WHITE MEAT FOR ASAMPLE OF CITIZENS OF THE CITY OF BAGHDAD/ AN EXPLORATORY STUDY
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Three hundred Iraqi people participated in demographic and attitudes study about red and white meat consumption. The mean age of the participants was 50 SD ± 11 years (mean 30-72); 51% were females and 49% males, mostly in forties who lived ≥ 5 years in Baghdad. The results showed that 80% of individuals prefer red meat. A 90% of people prefer fresh meat compared to frozen and processed meat. A 60% of people buy meat from popular markets. Nearly 87% of respondents believe the improving of livestock sector is essential and 80% of people confirmed there are obstacles to development this sector. An 80% of participates thought the reasons of the high prices of local fresh meat is the lack of plann

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Publication Date
Mon May 29 2023
Journal Name
Rawal Medical Journal
Comparison of functional and radiological outcomes of lower third closed tibia fractures treated by nail VS plate osteosynthesis
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Objective: To determine the functional and radiological outcomes of lower third tibia closed fractures fixed by nail or plate osteosynthesis. Methodology: This randomized controlled trial included 20 patients presenting with closed fracture lower third tibia in Al-Kindy teaching hospital, Baghdad, Iraq. The patients were divided as every other one into two equal groups; group I had fractures fixed by 3.5 mm locked plate and group II by intramedullary locking nail. We followed all patients for 24 weeks to assess surgical complications, fracture union, alignment and functional outcome based on Knee society score (KSS). Results: The mean union time in both groups was 10.2 ± 1.48 and 9.3 ± 1.77 weeks, respectively (p = 0.003). Mean KSS in bot

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Publication Date
Thu Nov 21 2024
Journal Name
F1000research
Comparison of the severity of urinary tract infections between Metformin and SGL2 Inhibitors among Iraqi Type 2 Diabetics.
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Background Many antidiabetic medications with distinct modes of action are available, The sodium glucose cotransporter-2 (SGLT-2) inhibitors are among the most recent oral antihyperglycemic medications. The American Diabetes Association recommends metformin, a biguanide medication, as the first option for oral control of type 2 diabetes because it has demonstrated promise in this regard. Aim of the study To evaluate and compare the effects of metformin and SGLT-2 inhibitors on general urine parameters in T2DM patients from Iraq. Method a prospective cohort study where 101 adult patients of both sexes aged under 70 years and newly diagnosed with T2DM, patients were divided into two groups, Metformin group (n=52), where metformin was p

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