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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 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
Wed Mar 29 2017
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Development of Modified Release Nicotine Tablet Formulation for Treatment of Ulcerative Colitis
...Show More Authors

One of the therapeutic effects of nicotine  is used as  a protective against developing ulcerative colitis . ulcerative colitis is an inflammatory disease of the bowel affecting the superficial lining mucosa in the rectum and large intestine. In this study nicotine tablets were formulated as modified release tablets targeted to the colon. All formulas were studied for drug release , effect of diluent, retardant concentration, avicel grade,and compression force, the selected formula was then further studied for drug release in 3 different pH ( coated tablets) .The kinetic study revealed acceptable shelf life  . Finally the selected formula was given to 6 patients in a pre-liminary clinical study which showed that nicotine c

... Show More
View Publication Preview PDF
Crossref
Publication Date
Sun Mar 26 2017
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Spectrophotometric Determination of Nitrofurantoin Drug in its Pharmaceutical Formulations Using MBTH as a Coupling Reagent
...Show More Authors

A direct, sensitive and efficient spectrophotometric method for the determination of nitrofurantoin
drug (NIT) in pure as well as in dosage form (capsules) was described. The suggested method was
based on reduction NIT drug using Zn/HCl and then coupling with 3-methyl-2-benzothiazolinone
hydrazone hydrochloride (MBTH) in the presence of ammonium ceric sulfate. Spectrophotometric
measurement was established by recording the absorbance of the green colored product at 610 nm.
Using the optimized reaction conditions, beer’s law was obeyed in the range of 0.5-30 μg/mL, with
good correlation coefficient of 0.9998 and limits of detection and quantitation of 0.163 and 0.544
μg/mL, respectively. The accuracy and

... Show More
View Publication Preview PDF
Crossref (3)
Crossref
Publication Date
Sun Sep 06 2009
Journal Name
Baghdad Science Journal
Effect of food on growth and fecundity Brine Shrimp Artemia spp. laboratory Conditions
...Show More Authors

This in order to test the effect of food on growth and fecundity, two kinds of food have been used the algae Scendesmus quadricaudae and fresh water shrimp powder. For two generations, growth and productivity have been followed up. The fresh water shrimp has been noticed as a food better than algae, because it caused recording, for the two generation higher length rate for the weeks of experiment. The individuals length rate at the end of the forth week reached 9.35 and 9.48 mm for the first generation and second generation respectively. The average length weekly increase rate for the first and second generations individuals feeding on dried shrimp was higher through the first and second week compared to what was recorded when feeding alga

... Show More
View Publication Preview PDF
Crossref
Publication Date
Sun Jun 30 2013
Journal Name
Al-khwarizmi Engineering Journal
Efficiency Prediction and Performance Characterization of Photovoltaic Solar Panel at Baghdad Climate Conditions
...Show More Authors

The performance of a solar cell under sun radiation is necessary to describe the electrical parameters of the cell. The Prova 200 solar panel analyzer is used for the professional testing of four solar cells at Baghdad climate conditions. Voltage -current characteristics of different area solar cells operated under solar irradiation for testing their quality and determining the optimal operational parameters for maximum electrical output were obtained. A correlation is developed between solar cell efficiency h and the corresponding solar cell parameters; solar irradiance G, maximum power Pmax, and production date P. The average absolute error of the proposed correlation is 5.5% for 40 data points. The results also show th

... Show More
View Publication Preview PDF
Publication Date
Wed Jan 01 2025
Journal Name
Medical Journal Of Babylon
Optimum Conditions for Pyomelanin Production and Characterization from Local Isolates of Pseudomonas aeruginosa
...Show More Authors

Nowadays, there is increased interest in the biosynthesis of microbial melanin related to their numerous biological functions and applications in many fields, especially in medical fields, including immune-modulating, antimicrobial antibiotic, antiviral antivenin, anticancer, antitumor activity, and anti-biofilm activity. Pyomelanin is a hydrophobic macromolecule that is typically dark brown or black in color, formed by the oxidative polymerization of phenolic or indolic compounds. Pyomelanin is reported to be safe for consumption, thus providing a crucial strategy for biocontrol of biofilm. Furthermore, natural pyomelanin is known as a potent antioxidant, photoprotective, and free radical scavenging. Objective: This study focuses on the

... Show More
View Publication
Scopus 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 (5)
Crossref (2)
Scopus Crossref
Publication Date
Sat Jun 01 2019
Journal Name
Journal Of Global Pharma Technology
Synthesis & Characterization of Chitosan Schiff Base Hydrogel for Controlled Drug Release
...Show More Authors

Chitosan-schiff base with three different ratios of para-Dimethyl aminobenzaldehyde& chitosan Schiff base hydrogels have been prepared for controlled drug release study. The synthesized chitosan Schiff base and chitosan Schiff base hydrogel were characterized by FT-IR, UV-Visible, SEM, analysis. Swelling properties of the hydrogel were investigated at three different media pH (2, 7, 10). The swelling degree varied with the pH, amount of crosslinking agent glutaraldehyde and with the amount of paraDimethylaminobenzaldehyde for the hydrogels. All hydrogels were used for controlled drug release system. Aspirin was used as model drug, in three different buffer solution (2, 7, 10) as release media. The rate of release of drugs in the pH2 is more

... Show More
Publication Date
Fri Jan 01 2016
Journal Name
International Journal Of Applied Pharmaceutics
Preparation of ferrous sulfate microcapsules as a sustained release dosage forms
...Show More Authors

Scopus (6)
Scopus
Publication Date
Thu Apr 01 2021
Journal Name
Annals Of The Romanian Society For Cell Biology
Evaluation of Nesfatin – 1 and Other Biochemical Markers in diabetic Neuropathy Iraqi patients before and after treatment with tegretol
...Show More Authors

Diabetic neuropathy is a form of nerve damage that can occur in people who have diabetes. High blood sugar (glucose) induced nerve damage in every part of the body. The nerves in the legs and feet were the most frequently affected. The extent to which a diabetic patient's body is impaired is calculated by the degree of nervosa harm.The purpose of this present study is estimation BMI,IL-10 , nesfatin-1 and HS-CRP in Iraqi DN patients before and after treatment via tegretol as well as it is the first study sheds light on the relationship between Nesfatin -1 and other parameters ( BMI,IL-10 and HS-CRP) also predication of Nesfatin-1 as a newly biomarker in patients with diabetic neuropathy. The present study consist of from 30 cohort G1 as hea

... Show More
Preview PDF