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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Wed Apr 02 2025
Journal Name
University Of Thi-qar Journal
Production of Thermostable Bioflocculant from Bacillus subtilis and Optimization of Flocculation Conditions
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Bacteria strain H7, which produces flocculating substances, was isolated from the soil of corn field at the College of Agriculture in Abu-Ghrib/Iraq, and identified as Bacillus subtilis by its biochemical /physiological characteristics. The biochemical analysis of the partially purified bioflocculant revealed that it was a proteoglycan composed of 93.2 % carbohydrate and 6.1 % protein. The effects of bioflocculant dosage, temperature, pH, and different salts on the flocculation activity were evaluated. The maximum flocculation activity was observed at an optimum bioflocculant dosage of 0.2 mL /10 mL (49.6%). The bioflocculant had strong thermal stability within the range of 30-80 °C, and the flocculating activity was over 50 %. The biofloc

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Publication Date
Sat Jun 30 2001
Journal Name
Iraqi Journal Of Chemical And Petroleum Engineering
Optimizing Viscous Flow in Pipes Through Improved Flow Conditions and Chemical Injections
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Publication Date
Mon May 06 2024
Journal Name
Journal Of Pakistan Association Of Dermatologists
Assessment of tumor necrosis factor alpha and interleukinـ10 in obese psoriatic patients before and after using apremilast
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Background Psoriasis is one of the most prevalent chronic inflammatory skin conditions; its prevalence ranges from 1 to 3%. Tumor necrosis factor-alpha (TNF-α), a cytokine that enhances inflammation, is overexpressed in synovium and skin plaques in psoriasis. TNF-α plays a critical role in the pathogenesis of psoriasis. IL-10 is the most crucial cytokine for reducing excessive immune responses and decreasing pro-inflammatory reactions in all autoimmune disorders.   Objective To evaluate the effect of Apremilast on ILـ10, TNFـα, and BMI in obese psoriatic patients.   Methods Thirty patients included in this investigative study to measure the concentrations of TNFـα, ILـ10 and BMI, before and after receiving Apremilast. TNFـα and

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Publication Date
Mon Jun 15 2020
Journal Name
Journal Of Baghdad College Of Dentistry
Evaluation of dental enamel color after fixed orthodontic therapy using two types of protectors to prevent white spot lesions (A prospective clinical study)
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Background: The aim of this study is to evaluate the color change ∆E of the dental enamel following treatment with 2 kinds of protector (icon infiltrant, clinpro varnish) before fixed orthodontic treatment to avoid the possible white spot lesions. Materials and Methods: Fifty four subjects treated with fixed appliances were divided into 3 groups: the 1st group was control, while the 2nd and 3rd groups were treated with icon infiltrant and clinpro varnish before bonding procedure, respectively. Color parameters (L,a,b) were recorded for the middle and gingival thirds before and after bonding procedure to get the ∆E of each group. Results: One-way ANOVA test showed a non-significant difference in ∆E between the 3 groups a

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Publication Date
Tue Jun 10 2025
Journal Name
Journal Of Baghdad College Of Dentistry
Cephalometric Study of Iraqi Adult Subjects with Cl I and Cl III Skeletal Relationships and Their Effects on Masseter Muscle Thickness by Using Ultrasonography
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Background: Masseter muscle is one of the most obvious muscles of mastication and considered as one indicator of jaw muscle activity. It has a major influence on the transverse growth of the midface and the vertical growth of the mandible. This study undertaken to determine the role of cephalometric analysis for discrimination between Cl I and Cl III skeletal relationships, determine the role of ultrasonography in determination of masseter muscle thickness, compare masseter muscle thickness between Cl I and Cl III skeletal relationships, and determine the effect of gender on masseter muscle thickness. Material and Method: The sample of the current study consisted of 70 Iraqi subjects 40 males and 30 females with age ranging 18-25 years. The

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Publication Date
Tue Jun 01 2021
Journal Name
Baghdad Science Journal
On Blow-up Solutions of A Parabolic System Coupled in Both Equations and Boundary Conditions
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This paper is concerned with the blow-up solutions of a system of two reaction-diffusion equations coupled in both equations and boundary conditions. In order to understand how the reaction terms and the boundary terms affect the blow-up properties, the lower and upper blow-up rate estimates are derived. Moreover, the blow-up set under some restricted assumptions is studied.

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Publication Date
Thu Aug 25 2022
Journal Name
Special Education
Speech Act of Persuasion in two Political Speeches American and British.
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BN Rashid…, Special Education, 2022

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Publication Date
Mon Oct 01 2012
Journal Name
The Iraqi Journal Of Agricultural Science
EVALUATION AND PERFORMANCE COMPARISON OF MOLD BOARD AND DISC PLOW IN SOILS OF CENTRAL IRAQ
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The experiment was conducted to evaluate and performance comparison for moldboard and disk plows in central of Iraq in 2011. Three factor were used in this study included Two types of plows included moldboard and disk plows which represented main plot , three forward speeds of the tillage was second factor included 1.85, 3.75 and 5.62 km / h which represented sup plot , and three levels of soil moisture was third factor included 21 , 18 and 14 % to determined data actual plow depth , Practical productivity, Volume of disturbed soil, Field efficiency , Slippage percentage in silt clay loam soil with depth 22 cm were studied in the experiment Split – split plot design under randomized complete block design with three replications using

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Publication Date
Tue Oct 01 2024
Journal Name
Journal Of Obstetrics Gynecology And Cancer Research
Comparison of Levels of Activin A and Follistatin in Ectopic Pregnancies and Missed Abortions Patients
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Scopus
Publication Date
Fri Jan 05 2018
Journal Name
International Journal Of Science And Research (ijsr)
Comparative Study of Some Antibiotic Resistance, Extended Spectrum ß-Lactamases (ESBLs), Metallo ß-Lactamases (MBLs) Produced in Pseudomonas aeruginosa Isolated from Clinical and Food Samples
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A total number of 33 isolates of Pseudomoans aeruginosa were collected from different clinical samples, such as: burn, wound and urine from patients attending Al-Yarmouk teaching hospital and some private clinical laboratories in Baghdad city through the period from October to December 2016. On the other hand, 21 isolates of P. aeruginosa were collected from 38 different food samples; such as: vegetables and fruits, from different local markets in Baghdad city during the period from November to December 2016. All isolates were identified by using different bacteriological and biochemical assays and confirmed by Vitek-2 identification system. The antimicrobial susceptibility test for clinical and food isolates towards 17 antimicrobial a

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