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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 13 2024
Journal Name
Journal Of Optics
Analysis of laser induced breakdown spectra for distinguish between healthy and carious teeth
...Show More Authors

Dielectric barrier discharges (DBD) can be described as the presence of contact with the discharge of one or more insulating layers located between two cylindrical or flat electrodes connected to an AC/pulse dc power supply. In this work, the properties of the plasma generated by dielectric barrier discharge (DBD) system without and with a glass insulator were studied. The plasma was generated at a constant voltage of 4 kV and fixed distance between the electrodes of 5 mm, and with a variable flow rate of argon gas (0.5, 1, 1.5, 2 and 2.5) L/min. The emission spectra of the DBD plasmas at different flow rates of argon gas have been recorded. Boltzmann plot method was used to calculate the plasma electron temperature (Te), and Stark broadeni

... Show More
View Publication
Scopus (1)
Crossref (1)
Scopus Clarivate Crossref
Publication Date
Fri Feb 01 2019
Journal Name
Journal Of Economics And Administrative Sciences
Comparison of estimations methods of the entropy function to the random coefficients for two models: the general regression and swamy of the panel data
...Show More Authors

In this study, we focused on the random coefficient estimation of the general regression and Swamy models of panel data. By using this type of data, the data give a better chance of obtaining a better method and better indicators. Entropy's methods have been used to estimate random coefficients for the general regression and Swamy of the panel data which were presented in two ways: the first represents the maximum dual Entropy and the second is general maximum Entropy in which a comparison between them have been done by using simulation to choose the optimal methods.

The results have been compared by using mean squares error and mean absolute percentage error to different cases in term of correlation valu

... Show More
View Publication Preview PDF
Crossref
Publication Date
Mon Apr 01 2024
Journal Name
The Egyptian Journal Of Hospital Medicine
Prevalence of Subclinical Cases of HBsAg and IgM-HCV Positivity among Healthy Iraqi Individuals
...Show More Authors

View Publication
Crossref
Publication Date
Sat Dec 01 2018
Journal Name
Political Sciences Journal
Iraq after war and strategy of reconstruction : Analytical study in reality and future horizon
...Show More Authors

Abstract (Iraq post – war reconstruction strategy: analytical study in fact and future prospects.) There search aims at identifying the causes of internal instability in Iraq from the political ,economic , social and security aspects , to diagnose the imbalance and to work towards finding real solutions to this . The study also aims at identifying the reconstruction proposals to completely eliminate the organizationof the terrorist advocate, as well as to know. theproblem of research lies in the ability of Iraqi political elites to achieve internal stability and to employ reconstruction proposals at all levels . The hypothesis of the research lies in the equation that the process of building stability (political – economic)and (socia

... Show More
View Publication Preview PDF
Crossref
Publication Date
Sat Jun 30 2007
Journal Name
Al-kindy College Medical Journal
Pyogenic Discitis in Female after Delivery and Pelvic Surgery
...Show More Authors

Background: Pyogenic discitis most frequently occurs
after home delivery, hemorridectomy, and dilatation and
curettage. Discitis is generally due to blood borne bacterial
invasion of the disc from adjacent end-plate via
communicating vessels. Infective discitis remains an
uncommon, but potentially serious cause for back pain.
Delayed diagnosis can occur and a high index of suspicion
may occur.
Methods: The study included 30 patients suffering from
localized low back pain with limitation of movement.
Diagnosis was made by history, physical examination and
investigation mainly E.S.R and MRI.
Results: 50.3% of patient with discitis had a history of
vaginal delivery, 15% had a history of hemorridectomy

... Show More
View Publication Preview PDF
Publication Date
Wed Aug 01 2018
Journal Name
Journal Of Economics And Administrative Sciences
Privatization Thesis and its trends in Iraq after 2003
...Show More Authors

The concept of privatization is built on the basis of the transfer of assets and services of the public sector to the private sector this concept has appeared in the eighties of the last century whene the high oil prices took place and recession solution swept the world Which called for the freedom of the market and left the room for the private sector to take the initiatine in economic activity.         Both the IMF have   adopted this thesis in their programs of the structural adjustment in light of external and internal factors helped to Create the conditions to accept thesis that under the pretext of achieving a number of economic goals.

In Iraq in spite of

... Show More
View Publication Preview PDF
Crossref
Publication Date
Mon Mar 28 2022
Journal Name
Politeia-journal Of Political Theory Political Philosophy And Sociology Of Politics
State-building and Ethnic Pluralism in Iraq after 2003
...Show More Authors

The research article deals with the process of building or rebuilding the state in Iraq after 2003 in its various dimensions, in light of the vision and foundational procedures that were developed and supervised by the United States in cooperation with the new leaders of Iraq based on the mechanism of sectarianethnic representation, and diagnosing the imbalances that arose out of that vision and the accompanying procedures, which led to the emergence of new variables in the political process, especially in the post-ISIS* phase, which produced important challenges to the political system and the Iraqi state. The political dynamics and balances emerging after ISIS* represented at the same time opportunities and risks in the process of

... Show More
View Publication Preview PDF
Clarivate Crossref
Publication Date
Thu Jan 30 2014
Journal Name
Al-kindy College Medical Journal
Normal bowel habites in a sample of healthy Iraqi population
...Show More Authors

Background: Clinicians and investigators consider the normal range of bowel habit and frequency as between 3 to 21 motions per week . Stool frequency out side the normal range may be unusual but may not be abnormal in the sense of a disease . And according to the consistency, the normal stool ranges from porridge like to hard and pellety .Objectives: To establish a basic data about the bowel habits (consistency and frequency) in a sample of healthy Iraqi population; in addition to learn about their definition of constipation and diarrhea.Methods: Prospective study from Jan 2000- Jun 2000 at Al-Yarmouk teaching hospital, Baghdad. Questionnaires were distributed to 950 healthy persons of different age group .The questionnaire included: Det

... Show More
View Publication Preview PDF
Publication Date
Mon Jun 30 2014
Journal Name
Al-kindy College Medical Journal
Normal bowel habits in a sample of healthy Iraqi population
...Show More Authors

Clinicians and investigators consider the normal range of bowel habit and frequency as between 3 to 21 motions per week. Stool frequency outside the normal range may be unusual but may not be abnormal in the sense of a disease, and according to the consistency, the normal stool ranges from porridge like to hard and pellety.
Objectives: To establish a basic data about the bowel habits (consistency and frequency) in a sample of healthy Iraqi population; in addition to learn about their definition of constipation and diarrhea.
Methods: Prospective study from Jan 2000- Jun 2000 at Al-Yarmouk teaching hospital, Baghdad. Questionnaires were distributed to 950 healthy persons of different age group .The questionnaire included: Detailed hi

... Show More
View Publication Preview PDF
Publication Date
Wed Sep 20 2023
Journal Name
Chalcogenide Letters
Calculation of the localized and extended energy states density for Ge60Se40-xTex alloy prepared by melting point method
...Show More Authors

The DC electrical conductivity properties of Ge60Se40-xTex alloy with x = 0, 5, 10, 15 and 20). The samples were formed in the form of discs with the thickness of 0.25–0.30 cm and the diameter of 1.5 cm. Samples were pressed under a pressure of 6 tons per cm2 , using a ton hydraulic press. They were prepared after being pressed using a ton hydraulic press using a hydraulic press. Melting point technology use to preper the samples. Continuous electrical conductivity properties were recorded from room temperature to 475 K. Experimental data indicates that glass containing 15% Te has the highest electrical conductivity allowing maximum current through the sample compared to Lu with other samples. Therefore, it is found that the DC co

... Show More
View Publication
Scopus (1)
Crossref (1)
Scopus Clarivate Crossref