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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Fri Mar 01 2019
Journal Name
Al-khwarizmi Engineering Journal
Comparison Study of Electromyography Using Wavelet and Neural Network
...Show More Authors

In this paper we present a method to analyze five types with fifteen wavelet families for eighteen different EMG signals. A comparison study is also given to show performance of various families after modifying the results with back propagation Neural Network. This is actually will help the researchers with the first step of EMG analysis. Huge sets of results (more than 100 sets) are proposed and then classified to be discussed and reach the final.

View Publication Preview PDF
Publication Date
Tue Mar 19 2024
Journal Name
Baghdad Science Journal
Comparison of physical characteristics of mass and luminosity function of disk systems in barred and unbarred spiral galaxies
...Show More Authors

إحدى أهم الطرق لتقصي توزيع المجرات عبر الزمن الكوني هي دالة اللمعان LF بدلالة كتلة القرص الباريوني ψS(Mb)، القدر . لقد درسنا تقديرًا لكثافة كتلة الباريون في عينة من المجرات الحلزونية القضيبية وغير القضيبية من الادبيات السابقة، والتي تتضمن فعليًا، لكل صنف من الاجرام السماوية ذات المحتوى الباريون المرئي، جزءًا لا يتجزأ من ناتج دالة الضيائية (LF) ونسبة الكتلة إلى الضوء. استخدمت تقنية الانحدار المتعدد لحزمة الب

... Show More
View Publication
Scopus (1)
Crossref (1)
Scopus Clarivate Crossref
Publication Date
Sun Jun 25 2023
Journal Name
Tikrit Journal Of Pure Science
Chemical comparison and Trichomes types of Salvia species growing in Anbar Governorate – Iraq
...Show More Authors

The trichomes and chemical composition of three species of the genus Salvia wild-grown (Salvia lanigera, Salvia spinosa) and cultured (Salvia officinalis) were studied in the Anbar governate, the chemical components of the stem and leaves were studied by Gas chromatography–mass spectrometry(GC-MS), in addition to studying the trichomes of the epidermis in the stem and leaves (upper and lower epidermis) by Light microscope. Important differences appeared to us in the chemical study, where it was found that some compounds were found in species without others, which gives them taxonomic importance, also, the trichomes were important in distinguishing the studied species, the species S. spinosa was distinguished by the presence of gla

... Show More
View Publication
Crossref
Publication Date
Sat Dec 24 2022
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Comparison of Phenolic Contents and Antioxidant Activities for Black and White Desert Truffles Spread in Syria
...Show More Authors

Desert truffle is considered as a type of Syrian wild fungi that spreads heavily, and it occupies important rank in folk medicine, where its aqueous extract is used for the treatment of some eye and skin illnesses, and people prefer the use of black truffle. This work interested in studying of the most available species; Terfezia claveryi (black) and Tirmania pinoyi (white). The extracts of the two species of truffle were prepared by maceration with water, methanol, and ethanol 70%. Their total phenolic contents (TPC) and total flavonoid contents (TFC) were analyzed using Folin-ciocalteu and Aluminum chloride methods respectively, and their antioxidant activities was tested using 2,2-diphenyl-1-picrylhydrazyl (DPPH) and

... Show More
View Publication Preview PDF
Scopus (4)
Crossref (2)
Scopus Crossref
Publication Date
Sun Feb 10 2019
Journal Name
Journal Of The College Of Education For Women
Denotation of Stanza and couplet between the two sonnets
...Show More Authors

The stanza in the sonnet has been defined as a set of poetic lines followed after proem
and be the same meter as that of proem in complete stanza, but in rhyme scheme different
from that meter. The couplet is defined as set of poetic lines that followed the stanza and be as
the same meter as that of stanza, but with different rhyme scheme. This definition is approved
by all specialized in field of Andalus literature and it was also proven to them that this
construction emptied of indications. This meter has endeavored to prove that that there were a
difference in denotation for meaning between the stanza and couplet. Thus, the sonneteers
have outweighed the sonnet of the blind "Tutaili" to their sonnets as they felt

... Show More
View Publication Preview PDF
Publication Date
Mon Mar 08 2021
Journal Name
Baghdad Science Journal
Performance quality of single and ?two stage solar concentrators
...Show More Authors

The performance of single and two stage solar concentrator were studied ' " The ratio of the primary to the secondary mirrors diameter is taking to be 0.5, depending on the theoretical calculation for the accumulated energy by the concentrator with ratio between 0.0 to 0.9. The design of the systems were designed and examined by using a ray-tracing program. The efficiency of the single and the two stage concentrators are calculated and compared with and without cooling systems.

View Publication Preview PDF
Publication Date
Tue May 23 2023
Journal Name
Journal Of Engineering
EXPERIMENTAL AND THEORETICAL STUDY OF TWO-PHASE HEAT PIPE
...Show More Authors

In this study, thermal characteristics of a two-phase closed heat pipe were investigated experimentally and theoretically. A two-phase closed heat pipe (copper container, Fluorocarbon FC-72 (C6F14) working fluid) was fabricated to examine its performance under the effect of input heat flux range of 250–1253 W/m2 , 70% fill charge ratio and various tilt angles. The temperature distribution along the heat pipe, input heat to evaporator section, and output heat from condenser were monitored. A comprehensive mathematical model was developed to investigate the steadystate heat transfer performance of a two-phase closed heat pipe. A steady state analytical model, is presented to determine important parameters on the design of two-phase close

... Show More
View Publication Preview PDF
Crossref
Publication Date
Wed Jul 01 2020
Journal Name
Journal Of Engineering
One and Two-Dimensional Hydraulic Simulation of a Reach in Al-Gharraf River
...Show More Authors

       

One and two-dimensional hydraulic models simulations are important to specify the hydraulic characteristics of unsteady flow in Al-Gharraf River in order to define the locations that facing problems and suggesting the necessary treatments. The reach in the present study is 58200m long and lies between Kut and Hai Cities. Both numerical models were simulated using HEC-RAS software, 5.0.4, with flow rates ranging from 100 to 350 m3/s. Multi-scenarios of gates openings of Hai Regulator were applied. While the openings of Al-Gharraf Head Regulator were ranged between 60cm to fully opened. The suitable manning roughness for the unsteady state was

... Show More
View Publication Preview PDF
Crossref (8)
Crossref
Publication Date
Sat Dec 30 2023
Journal Name
Iraqi Journal Of Pharmaceutical Sciences( P-issn 1683 - 3597 E-issn 2521 - 3512)
Isolation, Identification, and Quantification of Two Compounds from Cassia glauca Cultivated in Iraq
...Show More Authors

The Cassia glauca Lam. is the tree that belongs to the Fabaceae family and is native to India has many uses in indigenous systems of medicine, folk medicine, and traditional Brazilian medicine. Has many pharmacological activities such as anti-diabetic, antibacterial, antifungal, antioxidant, anti-hemolytic, anticancer, cardio-protective, and Hepato-protection.  The aim of study is to Isolation, identification, and quantification of some compounds from aerial parts of Cassia glauca since no phytochemical investigation had previously been done in Iraq for this plant. The aerial parts were defatted in n. hexane for 48 hours. The defatted materials were extracted in 85% ethanol using the hot method (soxhlet), then the extract was fra

... Show More
Scopus (4)
Scopus Crossref
Publication Date
Thu Dec 03 2015
Journal Name
Al- Kindy College Medical Journal
Proximal palmar mini-incision carpal tunnel release technique
...Show More Authors

Background: Carpal tunnel syndrome is the most common entrapment neuropathy in humans today. For patients in whom conservative treatment fails, surgical decompression is indicated. Various surgical techniques are becoming increasingly popular. Due to the rapid postoperative recovery shown after endoscopic operations, proximal palmar mini-incision for carpal tunnel release is a comparative alternative. Methods: Ninety four patients [113 hands] with a carpal tunnel syndrome underwent carpal tunnel release through a 1-cm longitudinal incision made just over the distal flexor crease. The self- administered Boston Questionnaire was used to assess the severity of patients’ symptoms and their functional status, both before and after the surgical

... Show More
View Publication Preview PDF