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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Tue Dec 01 2015
Journal Name
Journal Of Economics And Administrative Sciences
Cognitive Bias and Organizational Inertia are Two Functions of Strategic Change An Experimental Study in Amman Stock Market
...Show More Authors

The research aims at considering the reality of cognitive bias and organizational inertia as determinants of strategic change in a sample of companies listed in Amman Stock Market. To achieve objectives of the research, a model consisting of two independent variables has been designed, namely:

(1) The cognitive bias resulting from (escalating commitment, analogy, previous assumptions, representative generalization, command and control, convergent thinking), and (2) Organizational inertia due to (Icarus discrepancy, power distribution, rooted organizational culture), and a dependent variable, strategic change in (leadership patterns, strategy, the organization per se). 

From the model two main hypotheses were derived;

... Show More
View Publication Preview PDF
Crossref
Publication Date
Thu Jun 30 2016
Journal Name
Journal Of Madenat Al-elem University College
Histopathological changes induced after oral administration of acetamiprid in kidneys of male albino mice
...Show More Authors

View Publication
Publication Date
Mon May 18 2026
Journal Name
Journal Of Baghdad College Of Dentistry
Retentive forces, tensile strength and deflection fatigue of Acetal thermoplastic clasp material in comparison with cobalt-chromium alloy
...Show More Authors

Background: Nowadays there is an increasing of the emphasis on aesthetic, dentist have been concerned about providing aesthetics and functional removable partial dentures to their patients and this was make the mission more difficult because of the goal now is achieving optimal aesthetic of the denture - while maintaining retentive, stable, and conservative to the health of supporting tooth and supporting tissue. The traditional use of metal clasp like cobalt-chromium, gold, stainless-steel and titanium hampers esthetics because of its obvious display conflicts with patient’s prosthetic confidentiality. Acetal resin (poly oxy methylene) may be used as alternative denture clasp material. This material was promoted primarily on the basis of

... Show More
View Publication Preview PDF
Publication Date
Fri Oct 01 2021
Journal Name
Ace Journal Of Clinical Chemistry And Laboratory Medicine
Comparison Between of Five Drugs Anti‐Virus for COVID‐19th in Chemicals Properties and Pharmacological Effectiveness: A Review
...Show More Authors

The corona virus epidemic outbreak has urged an extreme worldwide effort for re‐purposing obtainable approved medications for its treatment. In this review, we're focusing on the chemicals properties andpharmacologicaleffectiveness of medicationsofsmallmolecule that are presently being evaluated in clinical trials for the management of corona virus (COVID‐19). The current review sheds light on a number of drugs that have been diagnosed to treat COVID‐19 and their biological effects.

Publication Date
Fri Oct 30 2020
Journal Name
Journal Of Economics And Administrative Sciences
Comparison between method penalized quasi- likelihood and Marginal quasi-likelihood in estimating parameters of the multilevel binary model
...Show More Authors

Multilevel models are among the most important models widely used in the application and analysis of data that are characterized by the fact that observations take a hierarchical form, In our research we examined the multilevel logistic regression model (intercept random and slope random model) , here the importance of the research highlights that the usual regression models calculate the total variance of the model and its inability to read variance and variations between levels ,however in the case of multi-level regression models, the calculation of  the total variance is inaccurate and therefore these models calculate the variations for each level of the model, Where the research aims to estimate the parameters of this m

... Show More
View Publication Preview PDF
Crossref
Publication Date
Fri Mar 31 2017
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
A Modified Organic Method for Preparation of Ibuprofen Microcapsules As a Sustained Release Solid Dosage Form
...Show More Authors

ABSTRACT:
Microencapsulation is used to modify and retard drug release as well as to overcome the unpleasant effect
(gastrointestinal disturbances) which are associated with repeated and overdose of ibuprofen per day.
So that, a newly developed method of microencapsulation was utilized (a modified organic method) through a
modification of aqueous colloidal polymer dispersion method using ethylcellulose and sodium alginate coating materials to
prepare a sustained release ibuprofen microcapsules.
The effect of core : wall ratio on the percent yield and encapsulation efficiency of prepared microcapsules was low, whereas
, the release of drug from prepared microcapsules was affected by core: wall ratio ,proportion of coa

... Show More
View Publication Preview PDF
Crossref
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
Sat Jul 03 2021
Journal Name
Periodicals Of Engineering And Natural Sciences (pen)
Comparison between VG-levy and Kernel function estimation with application
...Show More Authors

View Publication
Scopus Crossref
Publication Date
Sat Jan 01 2005
Journal Name
Iraqi Journal Of Science
Comparison between Zernike moment and central moments for matching problem
...Show More Authors

Moment invariants have wide applications in image recognition since they were proposed.

Publication Date
Wed Sep 30 2020
Journal Name
Iraqi Journal Of Chemical And Petroleum Engineering
Performance Comparison between Recycled Single Stage and Double Stage Hydrocyclones
...Show More Authors

   This research presents a comparison of performance between recycled single stage and double stage hydrocyclones in separating water from water/kerosene emulsion. The comparison included several factors such as: inlet flow rate (3,5,7,9, and 11 L/min), water feed concentration (5% and 15% by volume), and split ratio (0.1 and 0.9). The comparison extended to include the recycle operation; once and twice recycles. The results showed that increasing flow rate as well as the split ratio enhancing the separation efficiency for the two modes of operation. On the contrary, reducing the feed concentration gave high efficiencies for the modes. The operation with two cycles was more efficient than one cycle. The maximum obtained effici

... Show More
View Publication Preview PDF
Crossref (1)
Crossref