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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 09 2018
Journal Name
Journal Of Education In Black Sea Region
Discriminatory and Racist Discourse in American TV Channels: The Image of Arab Immigrants
...Show More Authors

The present study examines critically the discursive representation of Arab immigrants in selected American news channels. To achieve the aim of this study, twenty news subtitles have been exacted from ABC and NBC channels. The selected news subtitles have been analyzed within van Dijk’s (2000) critical discourse analysis framework. Ten discourse categories have been examined to uncover the image of Arab immigrants in the American news channels. The image of Arab immigrants has been examined in terms of five ideological assumptions including "us vs. them", "ingroup vs. outgroup", "victims vs. agents", "positive self-presentation vs. negative other-presentation", and "threat vs. non-threat". Analysis of data reveals that Arab immig

... Show More
View Publication Preview PDF
Crossref (1)
Crossref
Publication Date
Sun Sep 04 2016
Journal Name
Baghdad Science Journal
Surface-Subface Geochemical and Mineralogical Study of Gypcrete in Alexandria Area Central Iraq
...Show More Authors

Gypsiferous soil deposits (Gypcrete) are weakly consolidate earthy mixture of secondary gypsum, sand and clay. It is formed in arid and semi- arid area with annual precipitation rainfall less than 400mm. These sediments occur in surface and subsurface in region of little rainfall and rapid evaporation. This research deals with the study of gypcrete in Alexandria to improve the mineralogical and geochemical properties of the gypcrete. The gypcrete soil is used as raw material to produce the plaster for building purposes. Three samples of gypcrete were chemically and geochemically analyzed. The common mineral is howed in 0-0.5m Gypsum followed by Calcite in 0-1m and Quartz in 1-1.5m due to leaching and infiltration by rainfall as well as it

... Show More
View Publication Preview PDF
Crossref
Publication Date
Wed Jun 08 2022
Journal Name
International Journal Of Health Sciences
Isolation and identification of Aspergillus fumigatus from feline respiratory infection in Baghdad province
...Show More Authors

Aspergillus fumigatus considered to be the most important species to cause respiratory infection cases in both humans and animals especially in cats in the last decades. In this study, we focused on the isolation and identification of Aspergillus fumigates by collecting 40 samples in deferent veterinary clinics and stray cats in Baghdad city, during the period (October 2021 to January 2022), all samples were cultured on Sabouraud dextrose agar and malt extract agar. The isolates identified by the laboratory methods, it’s depend on macroscopic and microscopic appearance. The results showed that (40) swaps taken from the pharynx of infected cats, included: Aspergillus fumigatus 16 (40%), Aspergillus spp. 7 (17.5%), Aspergillus niger

... Show More
View Publication
Crossref (2)
Crossref
Publication Date
Sun Sep 01 2013
Journal Name
Baghdad Science Journal
A sensitive spectrophotometric determination of tadalafil in pharmaceutical preparations and industrial wastewater samples
...Show More Authors

A simple, accurate, precise, rapid, economical and a high sensitive spectrophotometric method has been developed for the determination of tadalafil in pharmaceutical preparations and industrial wastewater samples, which shows a maximum absorbance at 204 nm in 1:1 ethanol-water. Beer's law was obeyed in the range of 1-7?g/ mL ,with molar absorptivity and Sandell ? s sensitivity of 0.783x105l/mol.cm and 4.97 ng/cm2respectively, relative standard deviation of the method was less than 1.7%, and accuracy (average recovery %) was 100 ± 0. 13. The limits of detection and quantitation are 0.18 and 0.54 µg .ml-1, respectively. The method was successfully applied to the determination of tadalafil in some pharmaceutical formulations

... Show More
View Publication Preview PDF
Crossref (2)
Crossref
Publication Date
Wed Dec 11 2019
Journal Name
Journal Of The College Of Education For Women
Turkish Policy Towards Africa in the Era of the Justice and Development Party
...Show More Authors

Turkish policy towards Africa witnessed important developments over time that began before the Ottoman era and then developed during the Ottoman era when the Ottoman state played an important role in maintaining security by confronting Portuguese interventions in North Africa and sending military aid. Thus, the Ottoman state was able to develop its policy towards Africa for important considerations based mainly on the employment of the religious factor and the spread of Islam for the African acceptance of the Ottomans in the African territories and thus, achieve economic, strategic and political motives. Later, these relations declined in the Republican era due to the weak political and economic potential of Turkey on the one hand and th

... Show More
View Publication Preview PDF
Publication Date
Tue Feb 05 2019
Journal Name
Journal Of The College Of Education For Women
Rashid Street and its impact in the political twenties of the last century
...Show More Authors

Rasheed Street has had great importance by the nature of what was seen as being of vital events of a key facility in the Iraqi capital Baghdad since ancient times until now .
And such as cultural and historical memory-rich street for Iraq, pulsating nerve since the beginning of the last century thanks to the commercial and intellectual stature, as well as being a tourist landmark frequented alleys most of the tourists coming to Iraq , which counted for them a source of tourist attraction, given the religious diversity of fungal who excelled by the street, as we find in exchange for his Church of the Virgin Mary, the time which was built in the middle of the Caliphs Mosque towering minarets and promised that the oldest and largest of t

... Show More
View Publication Preview PDF
Publication Date
Fri Sep 27 2019
Journal Name
Journal Of Baghdad College Of Dentistry
Clinical Assessment and Cytomorphometric Analysis of Buccal Mucosal Cells in Behçet’s Disease Patients
...Show More Authors

Background: Behçet’s disease (BD) is a disorder of systemic inflammatory condition. Its important features are represented by recurrent oral, genital ulcerations and eye lesions. Aims. The purpose of the current study was to evaluate and compare cytological changes using morphometric analysis of the exfoliated buccal mucosal cells in Behçet’s disease patients and healthy controls, and to evaluate the clinical characteristics of Behçet’s disease. Methods. Twenty five Behçet’s disease patients have been compared to 25 healthy volunteers as a control group. Papanicolaou stain was used for staining the smears taken from buccal epithelial cells to be analyzed cytomorphometrically. The image analysis software has been used to

... Show More
View Publication
Scopus (1)
Scopus Crossref
Publication Date
Wed Jun 01 2011
Journal Name
Journal Of Madenat Alelem College
Morphological description and Histological structure of the liver in Passer domesticus (House sparrow)
...Show More Authors

This study showed that liver of Passer domesticus bilobed the right lobe is cardiac shape while the left is elliptical and the liver colour is brown. It is occupying most of anterior and middle parts of abdominal cavity. The liver is surrounded by Glison capsule which is represented by a thin layer of connective tissue with septum extend peripherally in liver tissue. The liver tissue is formed from polyhedral hepatocyte arrange as irregular hepatic cord surrounded the central vein. Each cell contains one or two nucleus with one or more nucleolus. The blood sinusoid appeared between the liver cells .The hepatic cord arranged radially around the central vein. The portal area is clear and surrounded by connective tissue. Gallbladder is almost

... Show More
Publication Date
Thu Jul 20 2023
Journal Name
Ibn Al-haitham Journal For Pure And Applied Sciences
Morphological Description and Histological Study of Thyroid Gland in Felis catus (Linnaeus,1758)
...Show More Authors

The results of the current study showed that the thyroid gland in an adult domestic cat (Felis catus) is located in the neck area on both sides of the trachea at rings 1–5. The gland consists of two lobes (right and left), and it is surrounded by a capsule of connective tissue consisting of two outer and inner layers, and a layer of fatty tissue overlaps with the outer layer of the capsule. In addition, the results of this study found that the histological structure of the thyroid gland is composed of several follicles that appear in different sizes and shapes. The follicles are lined with simple cuboidal epithelial tissue and sometimes appear lined with high and low simple cuboidal epithelial tissue. The gland is histologically c

... Show More
Preview PDF
Crossref
Publication Date
Wed Jan 01 2020
Journal Name
Biochemical And Cellular Archives
Histological and histochemical study of the duodenum in the Caucasian Squirrel, Sciurus Anomalus
...Show More Authors

Scopus