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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Sun Dec 01 2013
Journal Name
Baghdad Science Journal
Studying the possibility of confection of hepatitis C and hepatitis G viruses in Iraqi patients
...Show More Authors

The aim of this study was spot light to the possibility of confection between hepatitis C&G viruses in Iraqi patients. The groups was studied included two groups as follow: 1- first group: its (Infected group) the patients of this group have Anti-HCV abs in their serum by using Indirect ELISA technique. 2- second group: its (Control group) the persons of this group have no Anti-HCV abs in their serum by using indirect ELISA technique. The result of this study was observed there was two patients from the first group have Anti-HGVabs in their serum with infection percent 2.70%, also the same result was found in the second group wich mean there was two persons have Anti-HGVabs in their serum with infection percent 8.33% .So when we comparin

... Show More
View Publication Preview PDF
Crossref
Publication Date
Wed Sep 15 2021
Journal Name
Journal Of Baghdad College Of Dentistry
The estimation of the viable count of mutans streptococcus in waterpipe smokers and cigarette smokers
...Show More Authors

Background: Waterpipe and cigarette are two products of tobacco consumption, tobacco use has detrimental effects on the oral cavity, numerous studies around the world have reported a significant relationship between smoking and increase dental caries and viable count of cariogenic bacteria, Materials and Methods: unstimulated saliva was collected from 84 subjects and divided equally into three groups waterpipe smokers, cigarette smokers, and non-smokers all of the participants are adult male aged between 25-60 years, dental caries was measured by use DMFT index, while S.mutans and S.sobrinus were isolated by using a selective medium SB 20M (Sugar bacitracin-20 modified) agar Results: this present study showed a significant (p≤0.01)

... Show More
View Publication Preview PDF
Scopus (5)
Crossref (1)
Scopus Crossref
Publication Date
Tue Feb 05 2019
Journal Name
Journal Of The College Of Education For Women
Employment of Literay Tradition In the Polemic Poems of Jarir , Al-Farazdaq and Al-Akhtal
...Show More Authors

The present study is an academic attempt to show how the threeUmayyad poets ; Jarir ,
Al-Farazdaq and Al-Akhtal have skillfully employed old conventions and traditions in their
poetry to serve a dual purpose of making their ideas striking , memorable and compelling and
of reaching eminence as poets.
The primary aim of the poets has been to amuse , convince and influence the readers or
listeners of their poetry . as it were, a mirror image of the social , religious and historical
beliefs , values and customs which prevailed throughout the ages before the emergence.

View Publication Preview PDF
Publication Date
Wed Sep 30 2015
Journal Name
College Of Islamic Sciences
Preservation of the mind and its development Makassedi study in the light of prayers Almathur
...Show More Authors

A great abbey in the Shari'a, and is therefore destined to be preserved in many texts and by methods
There are many prayers in the Qur'an and Sunnah to encourage them
They have a clear relationship with the preservation of the purposes of the Sharia in general, and with a purpose
Save the mind in particular, but the scholars - the mercy of God - when they declare that the costs of Sharia
Due to the preservation of my intentions in the creature, they limit their words to orders and intentions, and are not exposed
In particular,
If they were included in the texts of the Shariah and Tawjiyatiya,
To be related to the preservation of the purposes of the law, which confirms the words of the former leaders, and light the li

... Show More
View Publication Preview PDF
Publication Date
Sat Feb 09 2019
Journal Name
Journal Of The College Of Education For Women
The Spatial Poetics and the "Murder of the Real"in Paul Auster's City of Glass*
...Show More Authors

Paul Auster's City of Glass is here singled out as representative of the writer's The New
York Trilogy. All throughout his novelistic career, Auster has been working on a pseudothesis
that adheres to a certain aesthetic of disappearance. The study engages this Austerian
aesthetic apropos of certain theoretical stretches such as the Emersonian "Not Me", the
Thoreauvian "interval" or "nowhere", the Deleuzian "nomadic trajectory", the Derridian
"grammè" or "specter", and the Baudrillardian "disappearance". The city of the novel's titling
is here seen as the trope of all that which has already disappeared, and hence it is seen as the
space (mise en scène) where the perfect crime of the murder of the real is to be thoro

... Show More
View Publication Preview PDF
Publication Date
Thu Mar 22 2018
Journal Name
Journal Of Biodiversity And Environmental Sciences
Survey and taxonomical study of ants that collected from indoor in different regions of Iraq
...Show More Authors

Publication Date
Tue Jan 01 2019
Journal Name
Energy Procedia
Calculation of Salinity and Soil Moisture indices in south of Iraq - Using Satellite Image Data
...Show More Authors

A band rationing method is applied to calculate the salinity index (SI) and Normalized Multi-Band Drought Index (NMDI) as pre-processing to take Agriculture decision in these areas is presented. To separate the land from other features that exist in the scene, the classical classification method (Maximum likelihood classification) is used by classified the study area to multi classes (Healthy vegetation (HV), Grasslands (GL), Water (W), Urban (U), Bare Soil (BS)). A Landsat 8 satellite image of an area in the south of Iraq are used, where the land cover is classified according to indicator ranges for each (SI) and (NMDI).

View Publication
Scopus (10)
Crossref (5)
Scopus Clarivate Crossref
Publication Date
Sun Oct 06 2024
Journal Name
International Journal Of Advances In Engineering And Management (ijaem)
The makers of sedition in light of Chapters (Al-Baqarah and Yusuf)/An objective study
...Show More Authors

The makers of strife exist in every era and time. They differ in how these temptations are created and the methods used in doing so. In our modern era, they are more; This is due to the presence of information technology and its easy availability at their fingertips, as well as the spread of social networking sites, which are rapidly spreading among ignorant groups and groups that are deficient in their use. Which led the makers of sedition to exploit these matters and create various temptations and spread them among peoples and societies. Today, we cannot predict the future of humanity in light of this huge amount of temptation. What the Holy Qur’an mentioned about the types of temptations in its noble verses and their embodiment in seve

... Show More
Preview PDF
Publication Date
Sat Aug 25 2018
Journal Name
Oriental Journal Of Chemistry
Estimation of preptin in serum of Thyroid Dysfunction Patients and its Relationship with other Parameters
...Show More Authors

The research includes a clinical study of Preptin with other parameters. The normal value of preptin in hypothyroidism (2638.4±280.0) in female while (2960.4±256.6) in male, in hyperthyroidism (589.0±90.1) in male, while in female (993.2±103.9), diabetes (2465.6±282.4) in female, in male (2085.5±282.8), in diabetes & hypothyroidism (3314.3±177.3) in male,(3179.4±265.7) in female, but control group in female (427.8±60.4), in male (384.7±62.4) at age (20-45) years they were divided into five groups: group one (G1) consisted of 30 hypothyroidism. The two group (G2) consisted of 30 patients with hyperthyroidism. And three group (G3) consisted of 30 healthy group, four group (G4) consisted of 30 patient with diabetes, and five group (G

... Show More
Scopus (1)
Crossref (1)
Scopus Clarivate Crossref
Publication Date
Sun Jan 01 2017
Journal Name
Journal Of Clinical And Diagnostic Research
Treatment of Fistula-In-Ano with Tight (Cutting) Seton: Analysis of Outcomes and Efficacy Assessment
...Show More Authors

View Publication Preview PDF
Scopus (5)
Crossref (3)
Scopus Crossref