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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Sun Dec 30 2012
Journal Name
Iraqi Journal Of Chemical And Petroleum Engineering
Production of Biodiesel Fuel from Oleic Acid and Comparison of its Properties with Petroleum Diesel
...Show More Authors

Biodiesel define as the mono-alkyl esters of vegetable oil and animal fats is an alternative diesel fuel that is steadily gaining attention because the combustion of fossil fuels such as coal, oil and natural gas has been identify as a major cause of the increase in the concentration of carbon dioxide in the earth’s atmosphere and causing global warming.
The present work concerns with estimating the physical properties experimentally such as kinematic viscosity, density, flash point and carbon residue of biodiesel that produced by the esterification reaction of methanol and oleic acid with homogeneous catalysts H2SO4 in a lab-scale packed reactive distillation column using the best operating conditions of methanol to oleic acid 8:1,

... Show More
View Publication
Publication Date
Sat May 01 2010
Journal Name
Journal Of Baghdad College Of Dentistry
Comparison of microleakage Restorative Dentistry Comparison of microleakage in three different retrograde cavity preparations with Mineral Trioxide Aggregate as filling material
...Show More Authors

Background: The apical seal is the single most important factor in determining the success of surgical endodontics, the aim of this study was to compare the sealing ability of Mineral Trioxide Aggregate in three different cavity designs. Materials and Methods: Thirty extracted human single-rooted teeth were divided into three groups of ten teeth per group, a retrograde cavity preparation was carried out using a low speed handpiece and round bur with parallel walls in the first group, ultrasonic retrotip and unit in the second group and a low speed handpiece with a carbide inverted cone bur with undercuts in the third group, all the cavities were filled with MTA. microleakage was measured by dye penetration technique using methylene blue. Re

... Show More
Preview PDF
Publication Date
Tue Dec 01 2020
Journal Name
Journal Of Economics And Administrative Sciences
Select the optimal project by using two methods of analytic hierarchy and goal programming
...Show More Authors

      The aim of this research is to solve a real problem in the Department of Economy and Investment in the Martyrs establishment, which is the selection of the optimal project through specific criteria by experts in the same department using a combined mathematical model for the two methods of analytic hierarchy process and goal programming, where a mathematical model for goal programming was built that takes into consideration the priorities of the goal criteria by the decision-maker to reach the best solution that meets all the objectives, whose importance was determined by the hierarchical analysis process. The most important result of this research is the selection of the second pro

... Show More
View Publication Preview PDF
Crossref
Publication Date
Wed Jul 04 2018
Journal Name
Civil Engineering Journal
Behavior of Reinforced Reactive Powder Concrete Two-Way Slabs under Static and Repeated Load
...Show More Authors

This paper studies the behavior of reinforced Reactive Powder Concrete (RPC) two-way slabs under static and repeated load. The experimental program included testing six simply supported RPC two-way slabs of 1000 mm length, 1000 mm width, and 70 mm thickness. All the tested specimens were identical in their material properties, and reinforcement details except their steel fibers content. They were cast in three pairs, each one had a different steel fibers ratio (0.5 %, 1 %, and 1.5 %) respectively. In each pair, one specimen was tested under static load and the other under five cycles of repeated load (loading-unloading). Static test results revealed that increasing steel fibres volume fraction from 0.5 % to 1 % and from 1% to 1.5%,

... Show More
View Publication
Crossref (12)
Crossref
Publication Date
Sat Jan 01 2011
Journal Name
Journal Of Engineering
TWO-PARAMETER GAMMA DISTRIBUTION AND LOG NORMAL DISTRIBUTION FOR DERIVATION OF SYNTHETIC UNIT HYDROGRAPH
...Show More Authors

Most available methods for unit hydrographs (SUH) derivation involve manual, subjective fitting of
a hydrograph through a few data points. The use of probability distributions for the derivation of synthetic
hydrographs had received much attention because of its similarity with unit hydrograph properties. In this
paper, the use of two flexible probability distributions is presented. For each distribution the unknown
parameters were derived in terms of the time to peak(tp), and the peak discharge(Qp). A simple Matlab
program is prepared for calculating these parameters and their validity was checked using comparison
with field data. Application to field data shows that the gamma and lognormal distributions had fit well.<

... Show More
View Publication Preview PDF
Crossref (1)
Crossref
Publication Date
Thu Sep 15 2022
Journal Name
Journal Of Baghdad College Of Dentistry
The push out bond strength of bioceramic seal-er(Total Fill) after warm and cold obturation tech-niques An in vitro comparative
...Show More Authors

Background: The goal of a root canal treatment is three dimensional obturation with a complete seal of the root canal system. The aim of this study was to evaluate and compare the effect of two warm obturation techniques, warm vertical compaction (WVC) and, carrier based obturation technique Gutta Core (GC), versus two cold obturation techniques, cold lateral compaction (CLC) and, single cone (SC) on push-out bond strength of bioceramic sealer (Total Fill) at three different root levels. Materials and Methods: Forty extracted maxillary first molars teeth with a straight round palatal root canal and mature apices were selected for this study. After sectioning the palatal roots to 11 mm from the root apex, the canals were prepared wit

... Show More
Preview PDF
Crossref (5)
Crossref
Publication Date
Thu Sep 15 2022
Journal Name
Journal Of Baghdad College Of Dentistry
The push out bond strength of bioceramic seal-er(Total Fill) after warm and cold obturation tech-niques An in vitro comparative
...Show More Authors

Background: The goal of a root canal treatment is three dimensional obturation with a complete seal of the root canal system. The aim of this study was to evaluate and compare the effect of two warm obturation techniques, warm vertical compaction (WVC) and, carrier based obturation technique Gutta Core (GC), versus two cold obturation techniques, cold lateral compaction (CLC) and, single cone (SC) on push-out bond strength of bioceramic sealer (Total Fill) at three different root levels. Materials and Methods: Forty extracted maxillary first molars teeth with a straight round palatal root canal and mature apices were selected for this study. After sectioning the palatal roots to 11 mm from the root apex, the canals were

... Show More
View Publication Preview PDF
Scopus (6)
Crossref (5)
Scopus Crossref
Publication Date
Wed Jan 01 2020
Journal Name
Dental Research Journal
Impact of a mixture of nanofiller and intrinsic pigment on tear strength and hardness of two types of maxillofacial silicone elastomers
...Show More Authors

Background: The ideal maxillofacial prosthesis should have fine and thin boundaries that bindwith the surrounding facial structures and possess high tear strength.This study aims to determinethe best percentages of nanofiller (TiO2) and intrinsic pigment (silicone functional intrinsic) thatcould be mixed in as additives to improve the tear strength of Cosmesil M511 andVST50F siliconeelastomers with the least effect on their hardness.Materials and Methods: In this in vitro experimental study, a total of 80 samples, 40 for eachelastomer, were fabricated. Each elastomer sample was split into two equal groups to test for tearstrength and Shore A hardness. Each group consisted of 20 samples, including 10 control sampleswithout additives and 10 e

... Show More
View Publication
Scopus (3)
Crossref (2)
Scopus Crossref
Publication Date
Wed Feb 01 2023
Journal Name
Petroleum Science And Technology
Lithofacies and electrofacies models for Mishrif Formation in West Qurna oilfield, Southern Iraq by deterministic and stochastic methods (comparison and analyzing)
...Show More Authors

View Publication
Scopus (14)
Crossref (12)
Scopus Clarivate Crossref
Publication Date
Wed Mar 10 2021
Journal Name
Baghdad Science Journal
Effect of spraying fertilizer paper and aqueous extract of licorice in the content of the fruits of two varieties of sweet peppers total Azaúbh solids and vitamin
...Show More Authors

Studied the effect of foliar fertilizers Alaongrin results showed that spraying fertilizer Alaongrin and Fertilizers and Ministry of Agriculture and rack licorice extract every three weeks after thirty days from planting seedlings

View Publication Preview PDF