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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
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
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
Tue Jun 20 2023
Journal Name
Baghdad Science Journal
Comparison between Modified Weighted Pareto Distribution and Many other Distributions
...Show More Authors

 

In 2020 one of the researchers in this paper, in his first research, tried to find out the Modified Weighted Pareto Distribution of Type I by using the Azzalini method for weighted distributions, which contain three parameters, two of them for scale while the third for shape.This research compared the distribution with two other distributions from the same family; the Standard Pareto Distribution of Type I and the Generalized Pareto Distribution by using the Maximum likelihood estimator which was derived by the researchers for Modified Weighted Pareto Distribution of Type I, then the Mont Carlo method was used–that is one of the simulation manners for generating random samples data in different sizes ( n= 10,30,50), and in di

... Show More
View Publication Preview PDF
Scopus (2)
Crossref (2)
Scopus Crossref
Publication Date
Tue Dec 30 2025
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
Tue Sep 01 2015
Journal Name
Ama, Agricultural Mechanization In Asia, Africa And Latin America
Effect of three honeycomb interplant distances on yield and it components of two cultivars of bean
...Show More Authors

A factorial experiment (2× 3) in randomized complete block design (RCBD) with three replications was conducted to examine the effect of honeycomb selection method using three interplant distances on yield and its components of two cultivars of bean, Bronco and Strike. Interplant distances used were 75× 65 cm, 90× 78 cm, and 105× 91 cm (row× plant) represent short (high plant density), intermediate (intermediate plant density), and wide (low plant density) distance, respectively. Parameters used for selection were number of days from planting to the initiation of first flower, number of nodes formed prior to first flower, and number of main branches. Results showed significant superiority of the Bronco cultivar represented in the number

... Show More
Scopus
Publication Date
Tue Dec 30 2025
Journal Name
Journal Of Baghdad College Of Dentistry
Effect of small cardamom extracts on Mutans streptococci in comparison to chlorhexidine gluconate and de-ionized water (In vitro study (
...Show More Authors

Background: Herbs are being widely explored to discover alternatives to synthetic antibacterial agents.Small Cardamom often referred to as queen of spices because of its very pleasant aroma and taste, have a history as old as human race. Most people use cardamom as a spice and are largely unaware of its numerous health benefits. The purpose of this study was to evaluate the effect of different concentrations of water and alcoholic cardamom extracts on sensitivities, growth, and adherence of Mutans streptococci in vitro. Materials and Methods: In this study, saliva was collected from ten volunteers (College students 18-22 years). Agar well technique was used to study the sensitivities of Mutans streptococci to different concentrations of s

... Show More
View Publication Preview PDF
Publication Date
Wed Dec 14 2016
Journal Name
Journal Of Baghdad College Of Dentistry
Effect of Black Cardamom Extracts on Mutans Streptococci in Comparison to Chlorhexidine Gluconate and De-ionized Water (In Vitro Study)
...Show More Authors

Background: Spices and herbs have been used by many cultures to enhance the flavor and aroma of food and for their medicinal value. Black cardamom is one of these spices widely used in cooking because of its unique taste and powerful flavor. The aim of study was to test the effect of black cardamom on Mutans Streptococci in comparison to chlorhexidine gluconate (0.2%) and de-ionized water. Materials and methods: Dried fruits of black cardamom were extracted by using alcohol (70% ethanol). Saliva was collected from seven volunteers. Agar well technique with different concentrations of black cardamom extracts was used to test the sensitivities of Mutans Streptococci, as well black cardamom extracts effect on viable counts of Mutans Streptococ

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