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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Fri Nov 29 2019
Journal Name
Iraqi Journal Of Physics
A comparison study of the Structural and magnetic properties of pure Ni metal and NiZnMn ferrite
...Show More Authors

The magnetic properties of a pure Nickel metal and Nickel-Zinc-Manganese ferrites having the chemical formula Ni0.1(Zn0.4Mn0.6)0.9Fe2O4 were studied. The phase formation and crystal structure was studied by using x-ray diffraction which confirmed the formation of pure single spinel cubic phase with space group (Fd3m) in the ferrite. The samples microstructure was studied with scanning electron microstructure and EDX. The magnetic properties of the ferrite and nickel metal were characterized by using a laboratory setup with a magnetic field in the range from 0-500 G. The ferrite showed perfect soft spinel phase behavior while the nickel sample showed higher magnetic loss an

... Show More
View Publication Preview PDF
Crossref
Publication Date
Mon Jun 16 2025
Journal Name
Journal Of Baghdad College Of Dentistry
Effects of time delay and tension system application after final flask closure on the vertical displacement of acrylic and porcelain teeth in maxillary complete dentures
...Show More Authors

Background: The displacement of artificial teeth during complete denture construction presents major processing errors in the occlusal vertical dimension which were verified at the previous trial denture stage. The aim of this study was to assess the effect of delay in processing after final flask closure and tension application on the vertical acrylic and porcelain teeth displacement of complete dentures constructed from heat cured acrylic and the results were compared with the conventional processing method. Materials and methods: forty samples of identical maxillary complete dentures were constructed from heat polymerized acrylic resin. These samples were subdivided into the following experimental subgroups in which each subgroup contai

... Show More
View Publication Preview PDF
Publication Date
Mon Jan 01 2018
Journal Name
Jordan Journal Of Biological Sciences
Expression of biotransformation and antioxidant genes in the liver of albino mice after exposure to aflatoxin B1 and an antioxidant sourced from turmeric (Curcuma longa)
...Show More Authors

The present investigation aims to determine the effects of aflatoxin B1 (AFB1) on biotransformation and antioxidant genes and the protective effects of curcumin, present in turmeric (Curcuma longa) powder (TMP). Specifically, the study included four groups of albino mice were fed for 30 days on diet Group I: Control, Group II: animals fed on the conventional basal diet supplemented with 0.5% food grade TMP that supplied 74 mg/kg total curcuminoids. Group III contained animals reared on conventional basal diet supplemented with 1.0 ppm AFB1 supplied by ground aflatoxin culture material (760 ppm AFB1). Finally, Group IV comprised of albino mice fed with basal diet supplemented with 1.0 ppm AFB1 and 0.5% TMP that supplied 74 mg/kg of the

... Show More
Publication Date
Mon Jul 24 2023
Journal Name
Research Journal Of Pharmacy And Technology
Comparison of the effects of Methotrexate and Etanercept on RANKL and OPG as Bone Metabolism Biomarkers in patients with Rheumatoid Arthritis
...Show More Authors

Rheumatoid arthritis is an autoimmune diseasecharacterized by chronic inflammationthat affects joints and cartilage. Bone complications such asRA-relatedosteoporosis are one of the most extra-articular manifestations. Many inflammatory mediators are released during RA disease pathophysiology; these mediators stimulate osteoclast genesis of bone by direct effects on RANKL and OPG. The study aimedto measure RANKL, OPG in RA patients treated with Etanercept only and other groups treated with Methotrexate onlyat baseline and after three months to evaluate bone state. An observational case-control prospective study was done on 30 RA patients who received MTX, 30 RA patients who received ETN, and 30 healthy,age-matched control groups. The

... Show More
View Publication
Scopus (1)
Scopus Crossref
Publication Date
Mon Nov 07 2022
Journal Name
Environmental Monitoring And Assessment
Comparison of Climate Change Impact upon Water Productivity of Winter Wheat in Northern and Southern Regions of Iraq 
...Show More Authors
Abstract<p>Maximizing the water productivity for any agricultural system is considered an adaptation to the potential climate change crisis. It is required, especially in arid and semi-arid environments in Iraq. Therefore, this study assessed the potential impact of climate change on the different environments in the Qadissiya and Nineveh provinces. The ensemble of six GCM models employed for the regional climate model of the HCLIM-ALADIN in high-resolution 10*10 km<sup>2</sup> and Aqua-Crop was used to examine the response of water productivity and yield of winter wheat. With and without CO<sub>2 </sub>concentration changing under different water regimes in the near term (2020-2040</p> ... Show More
Crossref
Publication Date
Wed Jul 01 2020
Journal Name
Journal Of Controlled Release
Breast intraductal nanoformulations for treating ductal carcinoma in situ I: Exploring metal-ion complexation to slow ciclopirox release, enhance mammary persistence and efficacy
...Show More Authors

View Publication
Scopus (17)
Crossref (17)
Scopus Clarivate Crossref
Publication Date
Sun Dec 01 2019
Journal Name
Baghdad Science Journal
Thermodynamic Investigation of Partially Purified Paraoxonase in the Sera of Healthy Pregnant Women Compared to Women with Pregnancy Complication
...Show More Authors

The thermodynamic constanting of “crude and partially purified” Paraxonase(PON) was evaluated in the sera of “healthy and ectopic” pregnant women in order to characterize the reaction of PON with diethyl para-nitro phenyl phosphate as substrate.This study was performed on (17) women with ectopic pregnancy (EP) whose age between (25-55) years  and (25) normal pregnant women with  a mean age of (25 -55) years as  a control group . Samples were collected from the Medical City, AL-Yarmook and Fatema AL-Zahraa hospitals during the period from Sep.2011 to April 2012.The study included the evaluation  of “paraxonase activity, specific activity and total protein” in the (crude and partially purified) sera of EP pa

... Show More
View Publication Preview PDF
Scopus Clarivate Crossref
Publication Date
Sun Aug 20 2017
Journal Name
Ibn Al-haitham Journal For Pure And Applied Sciences
Study on the Physiological Function of a - Tocopherol, Vitamin (E) on Lipoproteins Levels in Serum of Apparantly Healthy Individuals
...Show More Authors

The  role  of  free  radicals  generation  and  Lipid  Peroxidation

during the course of ischemic heart disease is well establshed as a basic for Pthogenesis and subsequent tissue damage consequenes . In an attempt to shed a light on the possible relationship between lipid peroxidation and some antioxidant.

The effect of vitamine E  (as a potent antioxidant free radical scavenger) . On the serum levels of the Lipoproteins, (HDLc) High Density Lipoprotein , (LDLc) Low Density Lipoprotein and (VLDLc) very Low Density Lipoprotein in healthy donors.

The  study  includes  (50) healthy  donors  from  males  and  females  ,

... Show More
View Publication Preview PDF
Publication Date
Mon Jul 25 2022
Journal Name
2022 Ieee 20th International Conference On Industrial Informatics (indin)
Robust Continuous Sliding Mode Controller for Uncertain Canonical Brunovsky Systems Using Reduced Order Extended State Observer
...Show More Authors

A reduced-order extended state observer (RESO) based a continuous sliding mode control (SMC) is proposed in this paper for the tracking problem of high order Brunovsky systems with the existence of external perturbations and system uncertainties. For this purpose, a composite control is constituted by two consecutive steps. First, the reduced-order ESO (RESO) technique is designed to estimate unknown system states and total disturbance without estimating an available state. Second, the continuous SMC law is designed based on the estimations supplied by the RESO estimator in order to govern the nominal system part. More importantly, the robustness performance is well achieved by compensating not only the lumped disturbance, but also its esti

... Show More
View Publication
Scopus (4)
Crossref (1)
Scopus Clarivate Crossref
Publication Date
Sun Dec 31 2023
Journal Name
Biomedical And Pharmacology Journal
Extraction, Isolation and Structure Elucidation of Two Phenolic Acids from Aerial Parts of Celery and Coriander
...Show More Authors

Celery and coriander are vastly applied in modern medicine and traditionally because various medicinal and nutritional benefits depend on their medicinal characteristics. The study aimed to detect, isolate and compare extracts contents of phenolic acids (caffeic and p-coumaric acids) in ethyl acetate fraction of fresh and dry aerial parts of coriander (Coriandrum sativum L.) and celery (Apium graveolens L.) of the Apiaceae family. The extraction of these constituents was carried out by maceration method using 70% ethanol and fractionation was done by using petroleum ether, and ethyl acetate. The existence of caffeic and p-coumaric acids in aerial part extracts of two plants was identified by thin-layer chromatography (TLC) and high-

... Show More
View Publication
Scopus (1)
Scopus Crossref