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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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 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
Wed Dec 05 2018
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Spectrophotometric Determination of Chlordiazepoxide in Pharmaceutical Formulations via Oxidative Coupling Reaction with Phenothiazine
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Abstract

A sensitive, precise and reliable indirect spectrophotometric method for the determination of chlordiazepoxide (CDE) in pure and pharmaceutical dosage forms is described. The method is based on oxidative coupling reaction between amino group resulting from acidic decomposition of CDE with phenothiazine in the presence of sodium periodate to produce an intense green soluble dye that is stable and shows a maximum absorption at 602 nm. The calibration plot indicates that Beer’s law is obeyed over the concentration range of 0.1?50 µg/mL, with a molar absorptivity of 1×104 L/mol cm and correlation coefficient of 0.9994.All the conditions that affecting on the stability and sensitivity of the fo

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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 Aug 01 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
Sat Dec 01 2018
Journal Name
Political Sciences Journal
power and chinese Abilities development after cold war
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Abstract: This research deals with the developing of power and different abilities (military, security, economy, technology and scientific excellence) The research shows that the excellence of the Chinese economy and its development , had a positive reflection on the other powers and abilities , it means it is a base of development in all fields. The development in power and Chinese military abilities had a clear effect on Chinese strategic creed , and that what the research deals with in some details. The research also deals with developing Chinese nuclear abilities. The research doesn't ignore the security eye that indicates to the protection of the state sovereignty, concentrating on the unity and safety Chinese lands. The res

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Publication Date
Fri Jan 01 2021
Journal Name
Conference: 4th International Conference On Innovative Studies Of Contemporary Sciences
An anatomical and chemical comparison study of Epipremnum aureum cultivated in soil and soilless
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The present study took up the different ways to cultivate the species Epipremnum aureum by two habitat water and soil and comber the anatomical features of the root, stem, and leaf. The results showed amazing significant anatomical features to the ecosystem. The root and stem anatomy showing decrease in all characters that studied but the leaf anatomy showing increase of palisade, spongy tissue thickness, midrib thickness, number of vessels in the xylem also the long and width of stomata of the soilless plants than soil ones. The upper epidermis empty from the stomata for the two treatment and the stoma diffuse in the lower epidermis, the type of it paracytic type. Also the total of flavonoids in the plant that were growth in soil reached 1

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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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