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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Thu Jan 03 2002
Journal Name
Iraqi Journal Of Architecture And Planning
The technological indicators of the relationship between structure and form in contemporary interior space
...Show More Authors

Publication Date
Sat Nov 10 2018
Journal Name
Iraqi National Journal Of Nursing Specialties
Effect of Maternal Age on the Mother and Neonatal health in Baghdad Maternity Hospitals
...Show More Authors

Objectives: to compare health of mothers and neonatal among age groups, to find out the correlation between
age groups and mother and neonatal health.
Methodology: A descriptive study was carried out at delivery rooms of three teaching hospitals in Baghdad city
from Feb. 28th through May. 28th
, 2013. A purposive (non-probability) sample of 300 laboring women was selected
from delivery rooms categorized into three groups, group 1 (≤19) years, group 2 their age between (20-35) years
old and group 3 their age (≥35) years. The data were collected through the use of constructing questionnaire, an
interview technique with mothers and reviewing their medical records as means of data collection; The
questionnaire con

... Show More
View Publication Preview PDF
Publication Date
Sat Oct 29 2022
Journal Name
Current Trends In Geotechnical Engineering And Construction
Automatic Co-registration of UAV-Based Photogrammetry and Terrestrial Laser Scanning in Urban Areas
...Show More Authors

View Publication
Scopus (3)
Scopus Crossref
Publication Date
Wed May 01 2019
Journal Name
Reports Of Practical Oncology & Radiotherapy
Estimation of tumor and local tissue dose in gold nanoparticles radiotherapy for prostate cancer
...Show More Authors

The objective of this research was to estimate the dose distribution delivered by radioactive gold nanoparticles (198 AuNPs or 199 AuNPs) to the tumor inside the human prostate as well as to normal tissues surrounding the tumor using the Monte-Carlo N-Particle code (MCNP-6.1. 1 code). Background Radioactive gold nanoparticles are emerging as promising agents for cancer therapy and are being investigated to treat prostate cancer in animals. In order to use them as a new therapeutic modality to treat human prostate cancer, accurate radiation dosimetry simulations are required to estimate the energy deposition in the tumor and surrounding tissue and to establish the course of therapy for the patient. Materials and methods A simple geometrical

... Show More
View Publication
Scopus (15)
Crossref (14)
Scopus Clarivate Crossref
Publication Date
Wed Mar 10 2021
Journal Name
Baghdad Science Journal
Embryonic Development of Eye Lens in Mosquito fish Gambusia affinis (Baird and Girard, 1853)
...Show More Authors

The embryonic development of the Mosquito fish(Gambusia affinis) eye lens was investigated using light microscopy .The results indicated that the embryonic development of the lens does not correspond to that of the non spherical lenses of terrestrial vertebrates .This study showed that a very small cavity in the lens vesicle appears during development ,but it differs from that of the mammalian lens. The most important aspect in this study is that ,the posterior edge of the simple cuboidal epithelium which covers the anterior half of the surface of the lens is situated well beyond the equatorial region of the lens .As a result , the germinal and transitional zones became closer to the posterior pole rather than the anterior pole of the le

... Show More
View Publication Preview PDF
Crossref
Publication Date
Sun Mar 13 2011
Journal Name
Baghdad Science Journal
Determination and evaluation of principal minerals in Negella sativa by atomic absorption technical methods
...Show More Authors

Determination and evaluation of principal minerals in Negella sativa by atomic absorption technical methods were showed, using wet ashing method. This work was done on Negella sativa because of wide using of this plant in many formulations ( in food or medicine ).two types of atomic absorptions were used : first, flame atomic absorption spectroscopy, for minerals of high concentrations such as, Na, Mg, K, Fe, Ca, Li, Ni, Zn, Mn, Cu. Second, flameless atomic absorption spectroscopy, for minerals of low concentrations such as, Al, Si, V, B, Pb, Co, Cd, Cr ,Si, Hg, Sn .The results showed the existence of many minerals in Negella sativa useful to human sanity with acceptable dietary allowance. On other side, the presence of harmful m

... Show More
View Publication Preview PDF
Crossref
Publication Date
Tue Jul 25 2017
Journal Name
J. Entomol. Zool. Studies
Histological and histochemical observations of the small Intestine in the indigenous Gazelle (Gazella subgutturosa)
...Show More Authors

LO Hamza, NA Al-Mansor, J. Entomol. Zool. Studies, 2017 - Cited by 14

View Publication
Publication Date
Sun Mar 01 2009
Journal Name
Baghdad Science Journal
The Relationship Between Hyperglycemia and the Rheumatoid Factor in the Serum of Diabetic Patients
...Show More Authors

This study was conducted to determine the relationship between two most common diseases in Iraqis patients , which are Diabetic mellitus (DM) and Rheumatoid Arthritis (RA); seeking rheumatoid factor in hyperglycemic sera. The results revealed that ; 62.5% of hyperglycemic (HG) patients had positive rheumatoid factor (RF) . No difference in number between both gender of HG patients (20 males and 20 females ) , RF reaction was nearly similar in males and females of HG patients ( 12 &13 respectively ) . Only 40% out of patient controls had positive RF . None of the apparently healthy subjects had positive RF .

View Publication Preview PDF
Crossref
Publication Date
Fri Jun 15 2018
Journal Name
Journal Of Baghdad College Of Dentistry
Evaluation of serum levels Superoxide dismutase in women with polycystic ovarian syndrome and gingivitis
...Show More Authors

Background: Polycystic ovary syndrome (PCOS) is the most common endocrine abnormality in women, there is an increasing evidence for an oxidative stress in PCOS that induce genomic and mitochondrial deoxyribonucleic acid damage that leads directly to reduced fertility. The objectives of this study are to assess and compare the periodontal health status by measuring clinical periodontal parameters (PLI, GI and BOP)as well as serum levels of superoxide dismutase at gingivitis ,gingivitis with PCOS and healthy periodontium groups, then correlate between clinical and biochemical parameters. Materials and Methods: 60 females with an age range between (25-40) years old had been tested and divided into3 groups ,the control group consists of (20) f

... Show More
View Publication
Crossref
Publication Date
Sun Sep 03 2017
Journal Name
Baghdad Science Journal
Measurement and purification of Alanine aminotransferase (ALT) enzyme activity in patients with celiac disease
...Show More Authors

Celiac disease (CD) is the most common genetically - based disease in correlation with food intolerance. The aim of this study is to measure the activity of ALT enzyme and purify enzyme from sera women with celiac disease. Alanine aminotransferase (ALT) activity has been assayed in (30) women serum samples with celiac disease, age range between (20-40) year and (30) serum of healthy women as control group, age range between (22-38) year. In the present study, the mean value of ALT activity was significantly higher in patients with celiac disease than healthy group (p<0.01). The ALT enzyme was partial purified from sera women with celiac disease by dialysis, gel filtration using Sephadex G- 50 and ion exchange chr

... Show More
View Publication Preview PDF
Scopus (5)
Scopus Crossref