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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Aug 01 2020
Journal Name
Research Journal Of Pharmacy And Technology
Evaluation of in vivo and in vitro protective effects of quercetin on lipopolysaccharide-induced inflammation and cytotoxicology
...Show More Authors

Quercetin, one of the flavonoids family member, can be found in many vegetables, fruits, and beverages with a noticeable nutritional pharmacological properties. This study was aimed to evaluate the ability of quercetin to inhibit lipopolysaccharide (LPS) that induced lethal toxicity in vivo, and to elucidate the importance of the quercetin as an antitumor agent in breast cancer cell line MCF-7.In vivo experiments included the effect of hesperidin and LPS on the liver and spleen of male mice. In the liver, the antioxidant activity was measured by estimating the concentration of glutathione (GSH), and catalase (CAT), while in the spleen, the concentration of cytokines was measured including IL-33 and TNF-α. In vitro experiments included MTT

... Show More
Publication Date
Tue Dec 01 2020
Journal Name
Baghdad Science Journal
Conductivity Study of DTAB in Water and Ethanol-Water Mixture in the Presence and Absence of ZnSO4
...Show More Authors

The physicochemical behaviour of dodecyltrimethylammonium bromide (DTAB) in water and ethanol-water mixture in the presence and absence of ZnSO4 were studied by measuring the conductivity at 298.15 K. The pre-micellar (S1) and post-micellar slopes (S2) were obtained and calculated the degree of dissociation (α) and the critical micelle concentration (cmc). With an increase in ethanol content, the cmc and α of DTAB increased whereas, in the presence of ZnSO4, the cmc and α decreased. By using cmc and α, thermodynamic properties as the standard free energy of micellization ( ) were evaluated. With an increase in ethanol content, the negative values of  are decreased indicating less spont

... Show More
View Publication Preview PDF
Scopus (3)
Crossref (3)
Scopus Clarivate Crossref
Publication Date
Wed Dec 30 2015
Journal Name
College Of Islamic Sciences
Views of Amadi and Gorgani In the metaphor in their books budget and mediation
...Show More Authors

The research revolves around the views of Al-Amadi and Al-Jurjani in the metaphors in their books, balancing Abu Tammam and Al-Bohtari, and mediation between Mutanabi and his opponents. And others whose poems were cited. One of the most important things we have reached is: the critics release the term metaphor to take sometimes and mean to take the meaning or steal it, and analyzed the evidence of metaphor as a rhetorical art in the light of what he heard about the former Arab poets, rejected the unusual metaphor out of use, and reclaimed the familiar metaphor. The research after submitted to the topics are: the first: Al-Amadi and his budget book, the second: Al-Jurjani and his book of mediation, and the third is divided into three dema

... Show More
View Publication Preview PDF
Publication Date
Wed Sep 01 2021
Journal Name
Civil Engineering Journal
Measuring of Subjective and Objective Aesthetics in Planning and Urban Design
...Show More Authors

The article includes the concept of aesthetics through what has been dealt with in the literature by philosophers and researchers who have addressed this concept in an attempt to derive indicators of aesthetics. The article adopted a descriptive and analytical methodology by reviewing recent literature on the concept of aesthetics and its relation to urban planning and design issues. Many subjective and objective aesthetics indicators have been identified, some of which are classified under real aesthetics, and some under fake aesthetics. The indicators were applied to the Kufa Mosque complex and Sahla Mosque complex as a comparative case study. It was found that the indicators of real aesthetics have a higher weight in determining

... Show More
View Publication
Scopus (11)
Crossref (1)
Scopus Clarivate Crossref
Publication Date
Sun Sep 06 2009
Journal Name
Baghdad Science Journal
Estimation of cellular immune response by evaluation of some cytokines in immunopathogenesis of chronic hepatitis B and C pre- and post- treated Iraqi patients (in vivo and in vitro)
...Show More Authors

Two groups of chronic hepatitis B and C virus patients were divided into Pre-treated patients (25 CHB patients with positive HBs Ag for more than 6 months and 40 CHC patients), and post-treated patients [12 CHB patients (4, 6, and 2 were treated with lamivudine, IFN-? and combination of LMV + IFN-? respectively), and 27 patients for CHC (3, 13 and 11 patients were treated with Ribavirin, IFN-? and combination therapy (RBV+ IFN-?) respectively].These patients were followed up for 6 months. By using ELISA technique, levels of IL-6, IL-10, IFN-? and TNF-? were measured in vivo and in vitro (supernatant of PBMCs stimulated with PHA) and compared with healthy control. The mean level of IL-6, IL-10 and TNF-? in CHB patients showed significant dif

... Show More
View Publication Preview PDF
Crossref
Publication Date
Tue Aug 03 2021
Journal Name
Key Engineering Materials
A Comparison Study between Asymmetrical Castellated Steel Beams Encased by Reactive Powder Concrete with Laced Reinforcement
...Show More Authors

The main objectives of this study are to study the enhancement of the load-carrying capacity of Asymmetrical castellated beams with encasement the beams by Reactive Powder Concrete (RPC) and lacing reinforcement, the effect of the gap between top and bottom parts of Asymmetrical castellated steel beam at web post, and serviceability of the confined Asymmetrical castellated steel. This study presents two concentrated loads test results for four specimens Asymmetrical castellated beams section encasement by Reactive powder concrete (RPC) with laced reinforcement. The encasement of the Asymmetrical castellated steel beam consists of, flanges unstiffened element height was filled with RPC for each side and laced reinforced which are use

... Show More
View Publication
Scopus (3)
Crossref (3)
Scopus Crossref
Publication Date
Tue Sep 08 2020
Journal Name
Baghdad Science Journal
A comparison among Different Methods for Estimating Regression Parameters with Autocorrelation Problem under Exponentially Distributed Error
...Show More Authors

Multiple linear regressions are concerned with studying and analyzing the relationship between the dependent variable and a set of explanatory variables. From this relationship the values of variables are predicted. In this paper the multiple linear regression model and three covariates were studied in the presence of the problem of auto-correlation of errors when the random error distributed the distribution of exponential. Three methods were compared (general least squares, M robust, and Laplace robust method). We have employed the simulation studies and calculated the statistical standard mean squares error with sample sizes (15, 30, 60, 100). Further we applied the best method on the real experiment data representing the varieties of

... Show More
View Publication Preview PDF
Scopus Clarivate Crossref
Publication Date
Thu Nov 17 2022
Journal Name
Aip Conference Proceedings
Principles of using project management tools and techniques of mitigate components causing delays and disruption in public and private construction projects in Iraq
...Show More Authors

Delays and disruption are a common issue in both community and personal building programs The problem exists all throughout the world, but it is particularly prevalent in Iraq, where millions of dollars are squandered each time as a outcome. Delays and interruptions may have serious consequences not just for Iraq's construction plans, but also for the country's economic and social status. While numerous studies have been conducted to investigate the factors driving delays and disruption in Iraqi construction projects, slight consideration has been given to by what means project management implements and approaches have affected the occurrence of project delays and disruption. After analyzing the crucial reasons for delays and instability in

... Show More
Crossref
Publication Date
Thu Apr 25 2019
Journal Name
Iraqi Journal Of Market Research And Consumer Protection
MEASUREMENT OF CHEMICAL AND PHYSICAL PROPERTIES IN SOME MINERAL WATER SAMPLES FILLED IN THE MARKETS OF THE PROVINCE OF NAJAF AND COMPARE WITH THE IRAQI AND INTERNATIONAL RATIOS.: MEASUREMENT OF CHEMICAL AND PHYSICAL PROPERTIES IN SOME MINERAL WATER SAMPLES FILLED IN THE MARKETS OF THE PROVINCE OF NAJAF AND COMPARE WITH THE IRAQI AND INTERNATIONAL RATIOS.
...Show More Authors

In this research, a selection of some mineral water was selected on the basis of being the most marketed by the owners of shops in Najaf province, with six types, where daily samples of this water were taken by 50 ml for two months from (1/11/2018 -1/1/2019). The following ions concentrations were measured (Br-, Cl-, F-, NO3-, SO42-, Na+, K+, Ca2+, Mg2+), pH and the electrical conductivity were measured and the results were compared with the allowable rates according to the international organizations. It was noted that they conform to international and Iraqi standards.

View Publication Preview PDF
Publication Date
Tue Jul 01 2014
Journal Name
Ieee Transactions On Circuits And Systems I: Regular Papers
Crosstalk-Aware Multiple Error Detection Scheme Based on Two-Dimensional Parities for Energy Efficient Network on Chip
...Show More Authors

Achieving reliable operation under the influence of deep-submicrometer noise sources including crosstalk noise at low voltage operation is a major challenge for network on chip links. In this paper, we propose a coding scheme that simultaneously addresses crosstalk effects on signal delay and detects up to seven random errors through wire duplication and simple parity checks calculated over the rows and columns of the two-dimensional data. This high error detection capability enables the reduction of operating voltage on the wire leading to energy saving. The results show that the proposed scheme reduces the energy consumption up to 53% as compared to other schemes at iso-reliability performance despite the increase in the overhead number o

... Show More
View Publication
Scopus (25)
Crossref (19)
Scopus Clarivate Crossref