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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Mon Sep 30 2002
Journal Name
Iraqi Journal Of Chemical And Petroleum Engineering
Effect of using Two Binders on the Agglomeration of Zeolite Type 4A
...Show More Authors

View Publication Preview PDF
Publication Date
Fri Nov 15 2024
Journal Name
Iraqi Journal Of Science
Comparison of the Physical Trace of Global Luminosity Emission at Multiwavelength and Star Formation Rates of Luminous Infrared Galaxies Using Extragalactic Distance Scale Techniques
...Show More Authors

This paper aims to study the rate of star formation (SFR) in luminous infrared galaxies at different wavelengths using distance measurement techniques (dl, dm) and to know which methods are the most accurate to determine the rate of star formation as we present through this research the results of the statistical analysis (descriptive statistics) for a sample of luminous infrared galaxies. The data used in this research were collected from the NASA Extragalactic Database (NED) and HYPERLEDA, then used to calculate the star formation rate and indicate the accuracy of the distance methods used (dl, dm). Two methods were tested on Hα, OII, FIR, radio continuum at 1.4 GHz, FUV, NUV, and total (FUV + FIR). The results showed that the dl

... Show More
View Publication
Scopus Crossref
Publication Date
Tue Oct 01 2024
Journal Name
Journal Of The Faculty Of Medicine Baghdad
Comparison of ََQuality of Life and Treatment Satisfaction among Sample of Iraqi Patients Using Anticoagulant Therapy (Warfarin or Non-Vitamin K Antagonist Oral Anticoagulants)
...Show More Authors

Background: Oral anticoagulation medication, warfarin and non-vitamin k antagonist oral anticoagulants  (NOAC) may require long term use which may affect patients’ satisfaction with their treatment and their quality of life (QOL). Objective: To compare the quality of life and treatment satisfaction among groups of patients using different anticoagulant therapies (warfarin and NOAC). Patients and methods: A cross-sectional study was performed at Ibn Al-Bitar Hospital for cardiac surgery in Baghdad in the period between December 2022 to May 2023. The study population included a convenient sample of patients receiving either warfarin or non-vitamin k antagonist oral anticoagulants treatment. The Arabic version of the short form 12

... Show More
View Publication
Scopus Crossref
Publication Date
Sun May 24 2026
Journal Name
Journal Of Baghdad College Of Dentistry
An Evaluation of Some Mechanical Properties of Autopolymerizing Acrylic Resin with the Modified One after Changing the Curing Environment: (In vitro Study)
...Show More Authors

Background: Studying and investigating the transverse strength(Ts), impact strength(Is), hardness (Hr) and surface roughness(Ra) of conventional and modified autopolymerizing acrylic resin with different weight percentages of biopolymer kraftlignin, after curing in different water temperatures; 40°C and 80°C. Material and Methods: Standard acrylic specimens were fabricated according to ADA specification No.12 for transverse strength, ISO 179 was used for impact testing, Shore D for hardness and profilometerfor surface roughness. The material lignin first dispersed in the monomer, then the powder PMMA is immediately added. Ligninadded in different weight percentages. Then cured using pressure pot (Ivomet) in two temperatures;40°C a

... Show More
View Publication Preview PDF
Publication Date
Sun Jan 01 2023
Journal Name
Iraqi Journal Of Hematology
Comparison of circulating matrix metalloproteinase-2 levels in untreated acute myeloid leukemia patients with remission status
...Show More Authors

The study aimed to evaluate the level of MMP‑2 in acute myeloid leukemia (AML) patients in comparison with that in remission status, and healthy subjects, and to find its correlation with hematologic parameters. This study included sixty newly diagnosed AML patients. Remission status was assessed after induction chemotherapy. The overall survival (OS) was determined after 6 months. The plasma MMP‑2 level was measured at diagnosis by enzyme immunoassay. Twenty‑eight healthy individuals were recruited as a control group. Plasma MMP‑2 was higher in AML patients than in healthy individuals (P = 0.005). The level of MMP‑2 was much higher in the M5 subtype than in the other subtypes (P = 0.0001). There was no statistically significant d

... Show More
View Publication
Scopus (2)
Crossref (2)
Scopus Clarivate Crossref
Publication Date
Tue Jun 01 2021
Journal Name
International Medical Journal
Visibility of mandibular canal on CBCT cross-sectional images in comparison with panoramic radiograph: Retrospective study
...Show More Authors

Scopus (3)
Scopus
Publication Date
Wed Oct 01 2008
Journal Name
Saudi Medical Journal
Topical therapy of acne vulgaris using 2% tea lotion in comparison with 5% zinc sulphate solution.
...Show More Authors

KE Sharquie, AA Noaimi, MM Al-Salih, Saudi Medical Journal, 2008 - Cited by 56

View Publication
Publication Date
Wed Oct 01 2008
Journal Name
Journal
Topical therapy of acne vulgaris using 2% tea lotion in comparison with 5% zinc sulphate solution
...Show More Authors

S Khalifa E, N Adil A, AS Mazin M…, 2008

View Publication
Scopus (42)
Scopus
Publication Date
Sun Dec 01 2019
Journal Name
Baghdad Science Journal
Comparison of Some Suggested Estimators Based on Differencing Technique in the Partial Linear Model Using Simulation
...Show More Authors

In this paper new methods were presented based on technique of differences which is the difference- based modified jackknifed generalized ridge regression estimator(DMJGR) and difference-based generalized  jackknifed ridge regression estimator(DGJR), in estimating the parameters of linear part of the partially linear model. As for the nonlinear part represented by the nonparametric function, it was estimated using Nadaraya Watson smoother. The partially linear model was compared using these proposed methods with other estimators based on differencing technique through the MSE comparison criterion in simulation study.

View Publication Preview PDF
Crossref (1)
Scopus Clarivate Crossref
Publication Date
Sun Jan 01 2023
Journal Name
Brazilian Dental Science
Effect of adhesive primer application on shear bond strength of self-adhesive cement to tooth structure and two different CAD/CAM milled blocks
...Show More Authors

View Publication
Scopus (4)
Crossref (1)
Scopus Crossref