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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Sat Apr 19 2025
Journal Name
Journal Of Baghdad College Of Dentistry
Computed tomographic localization of infraorbital foramen position and correlation with the age and gender of Iraqi subjects
...Show More Authors

Background: The Infraorbital foramen is an anatomical structure with an important location in the maxilla, position of foramen in maxillofacial area is necessary in clinical situation requiring regional nerve blocks that are performed in children undergoing facial surgeries to avoid injury to corresponding nerve. The aim of study was to determine the position of the Infraorbital foramen and to correlate Infraorbital foramen position with age and gender using computed tomography. Subjects, Materials, and Methods: The sample consist of prospective study for 50 Iraqi subjects (21 male and 29 female) with age ranged from (5-17) years. The examination was performed on Multi – Slice Spiral Tomography scanner in Al-Karakh General Hospital. Using

... Show More
View Publication Preview PDF
Publication Date
Tue Jul 13 2021
Journal Name
Journal Of Craniofacial Surgery
Comparison of Two Botulinum Toxin Injection Methods for Treatment of Excessive Gingival Display
...Show More Authors

Background: Hyperfunction of the muscles of the upper lip is considered as the most common cause of excessive gingival display (EGD). The aim of this study was to demonstrate the effectiveness of botulinum toxin (BT) injection as a conservative treatment for EGD due to muscular hyperfunction and to compare the outcome of 2 injection methods. Material and methods: This study included 40 participants who were randomly assigned into 2 groups of 20 each, The first group received 2.5IU BT injection at 1 point per side (2-points group), while the second group received a total of 5 IU of BT at 2 points per side (4-points group). The outcome variables were the reduction in the central and lateral gingival display expressed as the difference between

... Show More
View Publication
Scopus (2)
Crossref (3)
Scopus Clarivate Crossref
Publication Date
Thu May 17 2018
Journal Name
Ibn Al-haitham Journal For Pure And Applied Sciences
Swelling Behavior and Drug Release of Interpenetrating Network Composed of PVA and Chitosan
...Show More Authors

     PVA and chitosan biodegradable, non-toxic, biocompatible polymers convenient for use in drug release.

In this study polyvinyl alcohol (PVA) and chitosan (CS) hydrogels crosslinked with glutaraldehyde (GA) with different ratio morphology and structure characterization interpenetrating polymer network (IPN).They were investigated by Fourier transmission infrared spectroscopy (FTIR), scanning electron microscope (SEM), UV-Visible spectrophotometer,swelling of hydrogel and drug release were studied by changing crosslinking ratio and PH.

 

View Publication Preview PDF
Crossref (2)
Crossref
Publication Date
Fri Sep 27 2019
Journal Name
Journal Of Baghdad College Of Dentistry
Salivary vitamin E and uric acid in patients with OLP and healthy individuals
...Show More Authors

Background: Oral Lichen planus (OLP) is a T-cell mediated chronic inflammatory oral mucosal disease of unknown etiology. Recent studies have reported an increased oxidative stress and lipid peroxidation in such patients. This suggests that reactive oxygen species may have a role in the pathogenesis of lichen planus. Oxidative stress in OLP release molecules consisting of granzymes resulting in local tissue damage in the effectors. Antioxidants that can defend against oxidative stress in the body cells include enzymes, as well as non- enzymatic antioxidants, such as melatonin, uric acid, vitamin A and E. Purpose: To study the level of salivary vitamin E and uric acid as antioxidant agents in patients with OLP and compared with healthy con

... Show More
View Publication Preview PDF
Scopus (2)
Crossref (2)
Scopus Crossref
Publication Date
Sun Mar 13 2011
Journal Name
Baghdad Science Journal
Comparison study between two different Environment areas regarding diarrhea causes.
...Show More Authors

This study Achieved to search form the infections by Cholera and Diarrhea in two different areas from the side of Cultural, Social, Economical and Environmental field in Baghdad governorate, during a period from 3/10 – 3/12/2007.these were in Obiady city and Palestine street. This study included groups of patients who went to the Kindy Hospital lab. The researcher use a sample of (300) persons of different ages with range (150) persons in each city from the study city, in this study show a great different in the percentage of infection by parasites, helminthes, viruses, bacteria and vibrio cholera in the two city according to age groups, reach upper percentage by infection in age (1-10) years in Obiady city with percent (57.5 %) wh

... Show More
View Publication Preview PDF
Crossref
Publication Date
Thu Jun 29 2017
Journal Name
College Of Islamic Sciences
Imam Yahya bin Saeed Al-Ansari and his jurisprudential views on fasting issues
...Show More Authors

In The Name of Allah Most Gracious Most Merciful

 

The reason for choosing this topic was:

 

First: It is my great love for the Prophet Muhammad, may God’s prayers and peace be upon him, his family, his companions, his followers, the followers of their followers, and the scholars after them until the Day of Judgment.

 


Secondly: Showing a great jurisprudential figure who has contributed by speaking about important jurisprudential issues in the life of this nation, and bringing out this immortal book to put it in the hands of scholars, so I chose a figure from the followers (may God be pleased with them all).

 


Third: The study of the jurisprudence of the companions

... Show More
View Publication Preview PDF
Publication Date
Wed Jun 30 2010
Journal Name
Al-kindy College Medical Journal
Hypomagnesemia in Iraqi Diabetic Patients and Healthy Controls: An Exploratory study
...Show More Authors

Background: Diabetes mellitus has been suggested
to be the most common metabolic disorder
associated with magnesium deficiency, and because
available data suggest that adverse outcomes are
associated with hypomagnesemia, it is prudent that
routine surveillance for hypomagnesemia be done
and the condition be treated whenever possible.
Aim of the study:To explore the serum Mg
concentrations of diabetic patients and healthy
controls in our locality.
Mehtods: One hundred and forty four diabetic
patients (22 with type I and 122 with type II diabetes
mellitus) recruited from the outpatient diabetes clinic
at the Specialized Center For Endocrine DiseasesBaghdad (62 patients), National Diabetes Center-Al

... Show More
View Publication Preview PDF
Publication Date
Wed Mar 15 2023
Journal Name
Journal Of Medicinal And Chemical Sciences
Simple Spectrophotometric Method for Determination of Drug Lisinopril in Pure Form and Pharmaceutical Formulations
...Show More Authors

Scopus (2)
Scopus
Publication Date
Sun Aug 13 2017
Journal Name
Ibn Al-haitham Journal For Pure And Applied Sciences
Spectrophotometric Determination of Rantidine-HCl in Pharmaceutical Formulations
...Show More Authors

Spectrophotometric  methods  were  developed   for    the determination of rantidine-HCl in pharmaceutical tablets. These methods were based on the reaction of DDQ and p-chloranil with rantidine-HCl, resulting in the formation of an orange-red and purple colored products which are quantified spectrophotometrically at 460 and 540nm in DDQ and p-chloranil, respectively. A graph of absorbance versus concentration show that Beer’s law is obeyed in a concentration ranges of 20-160 and (30-120)g/ml with molar absorptivities of 2.631 x 103 and 1.052 x 103l .mol-1-cm-1 for DDQ and  p-chloranil, respectively. The optimum conditions for  color development  are described and 

... Show More
View Publication Preview PDF
Publication Date
Sun Jan 01 2017
Journal Name
Journal Of The College Of Languages (jcl)
Numbness of the Mind Paradigm in Haruki Murakami’s After the Quake and Iraq’s After the Quake
...Show More Authors

Haruki Murakami (1949-present) is a contemporary Japanese writer whose works have been translated into fifty languages and won him plenty of Japanese and international awards. His short stories are well constructed in a weird realistic manner and are mixed with elements of surrealism. His novels and short stories fall under the genre of magical realism. One of the major revolving themes that Murakami wrote about was the haunting feeling of emptiness and disconnectedness in a world which seems to care much for materialism and self-interests.

    The paper explores two of Murakami’s short stories in his book After the Quake (2000) and the relevance of their themes and characters to Iraq after the q

... Show More
View Publication Preview PDF