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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Mar 13 2011
Journal Name
Baghdad Science Journal
Phytoplankton primary production in southern Iraqi marshes after restoration
...Show More Authors

Primary productivity and chlorophyll-a were used in this study to monitor the restoration process of southern Iraqi marshes (Al-Hewaizeh, central marshes, and Al-Hammar). The phytoplankton primary productivity was based on oxygen light/dark bottle method. Two different depths samples were taken monthly from six studied marshes stations (two stations for each marsh) during November 2005 to October 2006, while chlorophyll-a samples taken from surface water. The phytoplankton primary productivity values ranged 9.38 – 249.79 mg C/m3.hr for all marshes, its values for surface water sample ranged 11.71 – 256.24 mg C/m3.hr, while for 1m depth ranged 9.38 – 142.5 mg C/m3.hr. Chlorophyll-a values ranged between (1.1 – 21.26) µg/l indicating

... Show More
View Publication Preview PDF
Crossref (1)
Crossref
Publication Date
Tue Jan 01 2013
Journal Name
International Journal Of Advance Biological Research
SOME BIOCHEMICAL CHANGES AFTER TREATMENT IN IRAQIS ACROMEGALIC PATIENTS
...Show More Authors

Acromegaly is a rare disease produce generalize and serious alteration in the patient with active disease. Many of these patients are also diabetic. Many analytes, hormones, markers are change in these disease. The objective of study is to assess the modification in a number of parameters that changed during the acromegaly as a result of excess in GH and IGF1 levels. The study included 36 patients and 38 healthy controls, paired by sex and age and BMI. Serum concentration of GH and the other parameters including (insulin, glucose, lipid profile, uric acid ) were determined by biochemical method .Compared to controls, acromegalic patients had increased levels of GH, insulin, glucose, triglyceride, very low density lipoprotein(VLDL) (p<0.05)

... Show More
View Publication
Publication Date
Tue Aug 23 2016
Journal Name
International Journal Of Pharmacy And Pharmaceutical Sciences
QUALITATIVE PHYTOCHEMICAL COMPARISON BETWEEN FLAVONOIDS AND PHENOLIC ACIDS CONTENTS OF LEAVES AND FRUITS OF MELIA AZEDARACH (FAMILY: MELIACEAE) CULTIVATED IN IRAQ BY HPLC AND HPTLC
...Show More Authors

<p><strong>Objective: </strong>The aim of our study was to compare between flavonoids and phenolic acids contents of leaves and fruits of <em>Melia azedarach</em> since no phytochemical investigation had done previously in Iraq.</p><p><strong>Methods: </strong>The leaves and fruits of <em>Melia azedarach </em>were extracted by soxhlet using 80% ethanol then the dried extract was suspended in water and fractionated using petroleum ether, chloroform, ethyl acetate, and n-butanol. The n-butanol fraction was hydrolyzed by acid and partitioned with ethyl acetate. The different fractions containing flavonoids and phenolic acids were analyzed by HPLC and HPTLC.</p><

... Show More
View Publication
Scopus (18)
Crossref (10)
Scopus Crossref
Publication Date
Thu Nov 01 2018
Journal Name
Journal Of Economics And Administrative Sciences
Comparison of Multistage and Numerical Discretization Methods for Estimating Parameters in Nonlinear Linear Ordinary Differential Equations Models.
...Show More Authors

Many of the dynamic processes in different sciences are described by models of differential equations. These models explain the change in the behavior of the studied process over time by linking the behavior of the process under study with its derivatives. These models often contain constant and time-varying parameters that vary according to the nature of the process under study in this We will estimate the constant and time-varying parameters in a sequential method in several stages. In the first stage, the state variables and their derivatives are estimated in the method of penalized splines(p- splines) . In the second stage we use pseudo lest square to estimate constant parameters, For the third stage, the rem

... Show More
View Publication Preview PDF
Crossref
Publication Date
Wed Jun 18 2025
Journal Name
Journal Of Baghdad College Of Dentistry
Effect of small cardamom extracts on Mutans streptococci and Candida Albicans in comparison to chlorhexidine gluconate and de-ionized water (In vivo study (
...Show More Authors

Background: Small cardamom or green cardamom is the dried fruit of the tall perennial herbaceous plant, Elettaria cardamomum Maton belonging to the family Zingiberaceae. The major use of small cardamom on world wide is for domestic culinary purpose and in medicine. This study was conducted to test the effect of small cardamom extracts on Mutans streptococci and Candida Albicans in comparison to 0.2% chlorhexidine gluconate and de-ionized water in vivo. Materials and Methods: Mutans streptococci and Candid Albicans were isolated, purified and diagnosed according to morphological characteristic and biochemical test. In this experiments, the effect of control agents and small cardamom extracts as a mouth rinses was tested on the saliva

... Show More
View Publication Preview PDF
Publication Date
Mon Sep 16 2019
Journal Name
Ibn Al-haitham Journal For Pure And Applied Sciences
Colorimetric Determination of Meprobamate after a simple derivatization
...Show More Authors

     A sensitive and environmentally benign spectrometric method was developed for quantifying Meprobamate (MEP). The analyzed MEP was derivatized into a colored complex and determined spectrometrically. The colorimetric analytical parameters were optimized and validated. Low limit of detection (LOD) was achieved down to 1.88×10-6 mol/l while the limit of quantification (LOQ) was extended over the range of 1.97×10-6 - 1.35×10-3 mol/l. The high precision has been denoted by the 1.54% value of the coefficient of variation. The recovery was 96.07%, while the RSD (n=3) was 1.05 - 1.19%. The apparent molar absorptivity (Ɛ) obtained within 1154.7 - 1691.9 L.mol-1.cm

... Show More
View Publication Preview PDF
Crossref (1)
Crossref
Publication Date
Thu Nov 08 2018
Journal Name
Iraqi National Journal Of Nursing Specialties
Effect of using two packing Technic on Hardness of two dental acrylic resin
...Show More Authors

Objective: the aim of this study is to invest age and determine the effect of using (2) packing
technique (conventional and new tension technique) on hardness of (2) types of heat cure acrylic
resin which are (Ivoclar and Qual dental type).
Methodology : this study was intended the using of two types of heat cure acrylic (IVoclar and
Qual dental type) which are used in construction of complete denture which packed in two different
packing technique (conventional and new tension technique) and accomplished by using a total of
(40) specimens in diameter of ( 2mm thickness, 2 cm length and 1 cm width) . This specimens were
sectioned and subdivide into (4) group each (10) specimens for one group , then signed as (A, Al B

... Show More
View Publication Preview PDF
Publication Date
Wed Aug 31 2022
Journal Name
Al-kindy College Medical Journal
Automated breast ultrasound: A comparison study with handheld ultrasound in detection and characterization of lesions in mammographically dense breast
...Show More Authors

Background: Although mammography is a powerful screening tool in detection of early breast cancer, it is imperfect, particularly for women with dense breast, which have a higher risk to develop cancer and decrease the sensitivity of mammogram, Automated breast ultrasound is a recently introduced ultrasonography technique, developed with the purpose to standardize breast ultrasonography and overcome some limitations of handheld ultrasound, this study aims to evaluate the diagnostic efficacy of Automated breast ultrasound and compare it with handheld ultrasound in the detection and characterization of breast lesions in women with dense breasts. Objectives: To evaluate the diagnostic efficacy of Automated breast ultrasound and compare

... Show More
Crossref
Publication Date
Wed Jun 18 2025
Journal Name
Journal Of Baghdad College Of Dentistry
Antibacterial effect of cardamom and black tea aqueous extract on mutans streptococci in comparison to chlorhexidine (in vitro study)
...Show More Authors

Background: Antimicrobial agents have been considered as having potential for the prevention of dental caries. This study aimed to test the effect of different concentrations of cardamom and black tea extracts on the sensitivity and growth of salivary mutans streptococci in comparison to chlorhexidine gluconate (0.2%) in vitro. Materials and methods: In this study. Mutans streptococci were isolated from saliva of 34 healthy people (aged between 22-40yrs). The bacteria was isolated, purifiedand diagnosed according to morphologicalcharacteristic and biochemical tests. Aqueous extracts of cardamom and black tea were prepared. Different concentrations of extracts were prepared and estimated in gm/ 100ml deionized water. The agar diffusion techn

... Show More
View Publication Preview PDF
Publication Date
Wed Aug 31 2022
Journal Name
Al-kindy College Medical Journal
Automated breast ultrasound: A comparison study with handheld ultrasound in detection and characterization of lesions in mammographically dense breast
...Show More Authors

Background: Although mammography is a powerful screening tool in detection of early breast cancer, it is imperfect, particularly for women with dense breast, which have a higher risk to develop cancer and decrease the sensitivity of mammogram, Automated breast ultrasound is a recently introduced ultrasonography technique, developed with the purpose to standardize breast ultrasonography and overcome some limitations of handheld ultrasound, this study aims to evaluate the diagnostic efficacy of Automated breast ultrasound and compare it with handheld ultrasound in the detection and characterization of breast lesions in women with dense breasts.

Objectives:<

... Show More
View Publication Preview PDF
Crossref