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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Apr 01 2018
Journal Name
Journal Of Economics And Administrative Sciences
Study and Diagnosis of the Poverty Phenomenon in Rural Areas of Iraq Using the Traditional Method (Crisp)
...Show More Authors

Poverty is defined as a low standard of living in the sense that a poor person can not afford a minimum standard of living. The phenomenon of poverty is one of the most serious problems that must be dealt with seriously. This phenomenon has persisted in Iraq for decades because of the harsh economic conditions and unstable security conditions due to the crises it has faced since 2013. This study requires much study and analysis. And rural areas as a special case. In this study, the researcher examined the poverty line as a criterion in estimating the poverty indicators, which include (poverty percentage H, poverty gap PG, poverty intensity PS), based on the continuous social and economic survey data for households in 2014. The ma

... Show More
View Publication Preview PDF
Crossref
Publication Date
Tue Feb 02 2021
Journal Name
Journal Of Engineering Science And Technology
INVESTIGATING THE EFFECT OF INLET APERTURE AND BAFFLE POSITION IN IMPROVING THE EFFICIENCY OF PRIMARY SETTLING TANKS
...Show More Authors

Publication Date
Tue Oct 01 2019
Journal Name
Biochemical & Cellular Archives
PREDICTIVE VALUES OF DHEAS, TT AND IGF1 IN SUCCESSFUL PREGNANCY OUTCOME OF PATIENTS UNDERGOING IVF/ICSI-ET
...Show More Authors

vitrofertilization/intracytoplasmic sperm injection-embryo transfer (IVF/ICSI-ET) for infertile patients. Insulin like growth factor 1 (IGF1), Dehydroepiandrosterone sulfate (DHEAS) and Total Testosterone (TT) may have a role on follicle growth, oocyte quality, embryo quality and subsequent pregnancy in patients undergoing IVF cycles. To explore the possibility of using DHEAS, TT and IGF1 as predictive indicator for successful pregnancy in patients undergoing (IVF/ICSI-ET). A prospective study was performed enrolling (12) non pregnant control group,(7) pregnant control group,(18) non-pregnant PCOS group and (12) pregnant PCOS group. The collection of blood and follicular fluid (FF) samples was done at the day of oocyte aspiration. Electroch

... Show More
Scopus (1)
Scopus
Publication Date
Sat Jan 01 2011
Journal Name
Iraqi J Pharm Sci,
Serum Level Profile and Pharmacokinetic Parameters of Single Oral Dose of Metronidazole in Type II Diabetic Patients
...Show More Authors

Many pathophysiological processes can affect the pharmacokinetic properties of drugs in people with diabetes. The present study was deigned to evaluate the influence of diabetes mellitus (DM) on the pharmacokinetic parameters of metronidazole administered as single oral dose. Twelve healthy volunteers and twelve diabetic patients were enrolled in the present study. On day 1, a single oral dose of metronidazole 500 mg was administered orally to all participants at 9:00 am after a 10-hour fasting. Over the following 48 hours, blood samples were taken at frequent intervals and serum metronidazole concentrations were measured by a high-performance liquid chromatography method for assessment of pharmacokinetics of metronidazole. The data

... Show More
Publication Date
Sun Dec 01 2013
Journal Name
Baghdad Science Journal
The Ecology and geographical distribution for the species of the genus Salvia L. of labiatae in Iraq
...Show More Authors

The study included general survey of some districts of Iraq in order to determinate new distribution areas for 33 species of the genus salvia L. ,new collections obtained , new locations for many species recorded. Observed specimens in most Iraqi herbaria were studies and identified. ,the flowering period were also studied

View Publication Preview PDF
Crossref (1)
Crossref
Publication Date
Wed Dec 30 2020
Journal Name
Al-kindy College Medical Journal
The immediate and late results for balloon angioplasty of native coarctation of aorta in pediatrics age group
...Show More Authors

Background: percutaneous balloon dilation of corotation of aorta is a less invasive and alternative to surgical repair for patients with discrete coaction of aorta and although the used of balloon angioplasty in patients with recurrent postoperative coarctation gained a wide consensus, the use this technique for native coarctation is still controversial in children less one years. 

Objective: to evaluate the immediate and late result of balloon dilation of native coarctation of aorta in infant and children.

Type of the study: A prospective study. 

Subjects & Methods: The study was done on forty-five patients who were referred for cardiac catheterization and balloon

... Show More
View Publication Preview PDF
Crossref
Publication Date
Mon Jul 20 2020
Journal Name
Biochemical And Cellular Archive
DETERMINATION OF POLYMORPHISM OF GLUTATHIONE S TRANSFERASE (GST) IN THE IRAQI (DIABETIC AND NON-DIABETIC) ACROMEGALIC PATIENTS
...Show More Authors

In Iraqi patients with acromegaly the present investigation included 40 control group and 70 patients with acromegaly divided 35 patients with Diabetic while another 35 patients without Diabetic, with ages between (29-72) years for the identification of GST activity polymorphisms by present and absent GSTM1, GSTT1, and PCR-RFLP, enzymatic digestions were carried out using BsmAI (Biolabs. England, UK) for GSTP1b and AciI (Biolabs, England, UK) for GSTP1c.the association GSTActivity with GST genotype were investigated in a cohort of Iraq acromegaly patients comparing with the healthy control group. The results show a non-significant change in GSTP1b gene in both groups, while show high significantly in GSTP1c in diabetic and non-diabetic acro

... Show More
Preview PDF
Publication Date
Thu Oct 01 2015
Journal Name
Al-academy
Artistic and intellectual embodiment of the stream of consciousness approach in the film novelist: نهاد حامد ماجد
...Show More Authors

In the midst of the public narrative film , we discussed the issue of dealing with the current narrative more specialized which its future dimension form shift and twist on the level of construction narrative film in some of its diverse and renewable trends in its two ways theoretical and practical and non-give important implications for the modes of operation of the renewable narrative structures and the fact that the cinema is an arts which always open to ideas in neighboring fields and this come naturally as a result of the continuing intellectual and knowledge sharing between cinema and other science . our current research has already begun to address the issue in a stream of consciousness narrative structure film based on all that t

... Show More
View Publication Preview PDF
Crossref
Publication Date
Sun Dec 03 2017
Journal Name
Iosr Journal Of Pharmacy And Biological Sciences
Relationship between Lipid Peroxidation and Integrity of Sperm Plasma Membrane in a Sample of Iraqi Infertile Men
...Show More Authors

The current study aims to investigate the relationship between lipid peroxidation, represented by seminal malondialdehyde (MDA) level, and integrity of sperm plasma membrane, represented by the hypo-osmotic swelling (HOS) test score, in infertile men. One hundred and twenty Iraqi men (20 fertile and 100 infertile) shared in this study during their attendance to the High Institute for Infertility Diagnosis and Assisted Reproductive Technologies/Al- Nahrain University. The mean age of the fertile men was (30.46±0.78) years while the mean age of infertile men was (32.58±0.64) years with the duration of infertility (5.36±0.33) years. Semen samples were collected and the parameters of seminal fluid analysis were assessed; also, the HOS

... Show More
Publication Date
Fri Nov 01 2019
Journal Name
Journal Of Physics: Conference Series
The Bifurcation analysis of Prey-Predator Model in The Presence of Stage Structured with Harvesting and Toxicity
...Show More Authors
Abstract<p>For a mathematical model the local bifurcation like pitchfork, transcritical and saddle node occurrence condition is defined in this paper. With the existing of toxicity and harvesting in predator and prey it consist of stage-structured. Near the positive equilibrium point of mathematical model on the Hopf bifurcation with particular emphasis it established. Near the equilibrium point E<sub>0</sub> the transcritical bifurcation occurs it is described with analysis. And it shown that at equilibrium points E<sub>1</sub> and E<sub>2</sub> happened the occurrence of saddle-node bifurcation. At each point the pitch fork bifurcation occurrence is not happened. </p> ... Show More
View Publication
Crossref (1)
Crossref