Preferred Language
Articles
/
bijps-367
Bioequivalence and Pharmacokinetics Comparison of Two Formulations of Extended-Release Pentoxifylline Tablets in Healthy Subjects after Fasting and Fed Conditions
...Show More Authors

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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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.

Crossref
View Publication Preview PDF
Quick Preview PDF
Publication Date
Sat Dec 17 2022
Journal Name
Iraqi Journal Of Laser
PDF Biosensing technique for detection of H.pylori bacteria: Israa M.L. SaQari*, Layla M.H. Al-ameri
...Show More Authors

Abstract :H.pylori is an important cause of gastric duodenal disease, including gastric ulcers, Mucosa-associated lymphoid tissue (MALT), and gastric carcinoma. biosensors are becoming the most extensively studied discipline because the easy, rapid, low-cost, highly sensitive, and highly selective biosensors contribute to advances in next-generation medicines such as individualized medicine and ultrasensitive point-of-care detection of markers for diseases.  Five of ten patients diagnosed with H.pylori ranging in age from 15–85 participated in this research. who [gastritis, duodenitis, duodenal ulcer (DU), and peptic ulcer (PU)] Suspected H.pylori colonies w

... Show More
View Publication Preview PDF
Publication Date
Mon Mar 27 2017
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Synthesis of New B-adrenoceptor Blocking Agent Including 1,3,4 Thiadiazole with Expected Adrenoceptor Blocking Activity
...Show More Authors

β-Adrenergic blocking agents, mostly comprising of β-amino alcohols, are of pharmaceutical significance and have received major attention due to their utility in the management of cardiovascular disorders including hypertension, angina pectoris, cardiac arrhythmias and other disorders related to the sympathetic nervous system. Most compounds available for clinical use belong to the aryloxypropanolamine series, which is considered the second generation of β-blocking agents. The present study includes the synthesis of compounds with an N-substituted oxypropanolamine moiety attached to the 1, 3, 4-thiadiazole derivatives. According to this information, eight compounds were synthesized and characterized by IR spectra and elemental m

... Show More
View Publication Preview PDF
Crossref (1)
Crossref
Publication Date
Tue Sep 01 2020
Journal Name
Optik
Synthesis of Ag2O films by pulsed laser deposited on porous silicon as gas sensor application
...Show More Authors

View Publication
Scopus (45)
Crossref (39)
Scopus Clarivate Crossref
Publication Date
Sun Jan 01 2023
Journal Name
International Conference On Scientific Research & Innovation (icsri 2022)
Investigating the capability of MCM-41 nanoparticle for COD removal from Iraqi petroleum refinery wastewater
...Show More Authors

View Publication Preview PDF
Scopus (8)
Crossref (5)
Scopus Crossref
Publication Date
Mon Nov 01 2021
Journal Name
Journal Of Engineering
Stability Improvement of The Iraqi Super Grid (400kV) using High Voltage Direct Current (HVDC) Transmission
...Show More Authors

This research analyzes the level of the short circuit effect of the Iraqi super network and decides the suitable location for the High Voltage Direct Current (HVDC) connections in order to obtain the best short circuit reduction of the total currents of the buses in the network. The proposed method depends on choosing the transmission lines for Alternating current (AC) system that suffers from high Short Circuit Levels (SCLs) in order to reduce its impact on the transmission system and on the lines adjacent to it and this after replacing the alternating current (AC) line by direct current (DC) line. In this paper, Power System Simulator for Engineering (PSS/E) is used to model two types of HVDC lines in an effective regi

... Show More
View Publication Preview PDF
Crossref (1)
Crossref
Publication Date
Thu Feb 28 2019
Journal Name
Journal Of Engineering
Numerical Simulation of Unsaturated Soil Water from a Trickle Irrigation System for Sandy Loam Soils
...Show More Authors

Trickle irrigation is a system for supplying filtered water and fertilizer directly into the soil and water and it is allowed to dissipate under low pressure in an exact predetermined pattern. An equation to estimate the wetted area of unsaturated soil with water uptake by roots is simulated numerically using the HYDRUS-2D/3D software. In this paper, two soil types, which were different in saturated hydraulic conductivity were used with two types of crops tomato and corn, different values of emitter discharge and initial volumetric soil moisture content were assumed. It was assumed that the water uptake by roots was presented as a continuous sink function and it was introduced into Richard's equation in the unsaturated z

... Show More
View Publication Preview PDF
Crossref (1)
Crossref
Publication Date
Mon Apr 01 2019
Journal Name
Journal Of Engineering
Removal of Methyl Orange from Aqueous Solutions by Adsorption Using Corn Leaves as Adsorbent Material
...Show More Authors

A comparative study was done on the adsorption of methyl orange dye (MO) using non-activated and activated corn leaves with hydrochloric acid as an adsorbent material. Scanning electron microscopy (SEM) and Fourier Transform Infrared spectroscopy (FTIR) were utilized to specify the properties of adsorbent material. The effect of several variables (pH, initial dye concentration, temperature, amount of adsorbent and contact time) on the removal efficiency was studied and the results indicated that the adsorption efficiency increases with the increase in the concentration of dye, adsorbent dosage and contact time, while inversely proportional to the increase in pH and temperature for both the treated and untreated corn leav

... Show More
View Publication Preview PDF
Crossref (19)
Crossref
Publication Date
Sun Mar 01 2015
Journal Name
Sust Journal Of Engineering And Computer Science (jecs)
Virtual failure influence of Roseires dam on Khartoum city using HEC-RAS Hydraulic simulation modeling
...Show More Authors

Dam break is series phenomenon that can result in fatal consequences and loss of properties. Unfortunately, the observed consequences can only be available after the dam breaks. Therefore, it is important to anticipate what will happen prior to dam break to issue suitable warning and locate the possible risk areas. This study attempts to simulate the case of dam break in Blue Nile at Roseires dam and see its consequences downstream. Roseires dam lies at a distance of 630 km south of Khartoum, Sennar dam lies at about 260 km downstream of Roseires dam. In this study hydraulic model is developed based of Hydraulic Engineering Centre (HEC), River Analysis System (RAS), and HEC- RAS. The HEC-RAS based model is calibrated and validated usi

... Show More
Publication Date
Mon Jun 28 2021
Journal Name
Journal Of Engineering
Effective quality control of a municipal wastewater treatment plant using Geographic information systems: A Review
...Show More Authors

Inefficient wastewater disposal and wastewater discharge problems in water bodies have led to increasing pollution in water bodies.  Pollutants in the river contribute to increasing the biological oxygen demand (BOD), total suspended solids (SS), total dissolved solids (TDS), chemical oxygen demand (COD), and toxic metals render this water unsuitable for consumption and even pose a significant risk to human health. Over the last few years, water conservation has been the subject of growing awareness and concern throughout the world, so this research focused on review studies of researches that studied the importance of water quality of wastewater treated disposal in water bodies and modern technology to management w

... Show More
View Publication Preview PDF
Crossref (2)
Crossref
Publication Date
Tue Mar 12 2019
Journal Name
Lubricants
Absorption Wavebands for Discriminating Oxidation Time of Engine Oil as Detected by FT-IR Spectroscopy
...Show More Authors

Fourier Transform-Infrared (FT-IR) spectroscopy was used to analyze gasoline engine oil (SAE 5W20) samples that were exposed to seven different oxidation times (0 h, 24 h, 48 h, 72 h, 96 h, 120 h, and 144 h) to determine the best wavenumbers and wavenumber ranges for the discrimination of the oxidation times. The thermal oxidation process generated oil samples with varying total base number (TBN) levels. Each wavenumber (400–3900 cm−1) and wavenumber ranges identified from the literature and this study were statistically analyzed to determine which wavenumbers and wavenumber ranges could discriminate among all oxidation times. Linear regression was used with the best wavenumbers and wavenumber ranges to predict oxidation time.

... Show More
View Publication Preview PDF
Scopus (20)
Crossref (19)
Scopus Clarivate Crossref