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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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
Mon Aug 14 2017
Journal Name
Ibn Al-haitham Journal For Pure And Applied Sciences
Plant Phenology And Itsrelation TO The Cool Semi-Arid Conditions OF Sana'a
...Show More Authors

In the cool semi-arid highland areas of Sana'a, a plant
phonological study of forty two species revealed that there was one
major outburst of plant emergence corresponding with the first period
of the heavy rainfall which take place during March-April. The second
period of heavy rainfall which takes place during July-August shows
moderate effect on emergence and growth.
Plant Species included annuals, biennials and perennials. Perennials
showed
the
following
growth
forms
hemicryptophytes,
chamaephytes, phanerophytes, and cryptophytes. Most plants where
herbaceous and a few where woody
Different Individuals of the same species could behave as annuals,
biennials or perennials. In areas where

... Show More
View Publication Preview PDF
Publication Date
Tue Apr 18 2017
Journal Name
Transactions Of The Asabe
Effect of Drying Conditions on Triticale Seed Germination and Rice Weevil Infestation
...Show More Authors

The combination of high protein content and a soft seed coat makes the wheat-rye hybrid Triticale (Triticosecale) vulnerable to attack by rice weevils. Drying triticale grain to moisture contents safe for storage can prevent infestation by rice weevils, but if grain is being stored for seed, high drying temperatures can affect seed germination. Grain can be effectively dried at low temperatures, but low-temperature drying is difficult in hot, humid regions such as the Gulf Coast. This study nvestigated the effects of drying temperatures from 35°C to 45°C on triticale seed germination and found no statistical differences between the germination rates of the seed at any of the drying temperatures and the germination rates of controls. Final

... Show More
View Publication
Scopus (5)
Crossref (4)
Scopus Clarivate Crossref
Publication Date
Sun Dec 31 2000
Journal Name
Iraqi Journal Of Chemical And Petroleum Engineering
Preparation of Zeolite 4A and Studying the Operating Conditions of the Agglomeration in the Inclined Rotary Disk
...Show More Authors

View Publication Preview PDF
Publication Date
Tue Jun 10 2025
Journal Name
Journal Of Baghdad College Of Dentistry
Comparison of regional bond strength of post space of fiber-reinforced post luted with two types of cements at different testing times
...Show More Authors

Back ground: This in vitro study was carried out to investigate the effect of post space regions (coronal, middle and apical), Time and the mode of polymerization (dual, self-cured) of the cements used on the bond strength between translucent fiber post and root dentin by using push-out test. Materials and Methods: Forty eight extracted mandibular first premolars (single root) were instrumented with ProTaper Universal system files (for hand use) and obturated with gutta percha for ProTaper and AH26® root canal sealer following the manufacturer instructions, after 24 hours post space was prepared using FRC postec® plus drills no.3 creating 8 mm depth post space. The prepared samples were randomly divided into two main groups (24 samples ea

... Show More
View Publication Preview PDF
Publication Date
Wed Dec 01 2021
Journal Name
Journal Of Economics And Administrative Sciences
Expatriate Workers and Its Repercussions on the Economy and Labor Market in Iraq After 2003
...Show More Authors

The demand for expatriate labor to Iraq increased after 2003 as a result of the openness that Iraq experienced, but this expatriate labor, which was requested at an increasing rate, has had economic, social, and political effects on the Iraqi economy in general, and the Iraqi labor market in particular. This is due to the high rates of unemployment, as most of these expatriate workers cause competition to local labor, and thus cause repercussions on the Iraqi economy as a whole, except for those expatriate workers coming with companies working in the oil sector. Iraq's GDP

View Publication Preview PDF
Crossref
Publication Date
Tue Jan 01 2013
Journal Name
International Journal Of Contemporary Mathematical Sciences
Equivalent between the Criterion and the Three Open Set's Conditions in Disk-Cyclicity
...Show More Authors

A vector in a separable infinite dimensional Hilbert space is called disk-cyclic for bounded operator if the orbit α : 0, α∈;|∝| 1is dense in. The useful tool used to discover codisk-cyclic operation is called the disk-cyclic Criterion. In this paper we will show that some equivalent conditions of the

View Publication
Crossref
Publication Date
Wed May 12 2021
Journal Name
Indian Journal Of Forensic Medicine & Toxicology
The Relationship of Healthy Rationalist Pundit Thinking to the Spiking and Block Performance of Volleyball For Junior Players
...Show More Authors

View Publication
Crossref
Publication Date
Fri Oct 20 2023
Journal Name
Ibn Al-haitham Journal For Pure And Applied Sciences
A Comparative Correlation between the Oral Microbiome of Diabetes Mellitus and Healthy Individuals and their Relation with Some Demographic Parameters
...Show More Authors

  Diabetes Mellitus (DM) is a chronic disease distributed worldwide and dominantly related to different types of diseases especially microbial infections, this study aimed to find the relationship between DM mouth microbiome and some demographic factors. Sixty saliva specimens and bacterial oral swabs were collected from randomly selected DM patients, including 29 females and 31 males enrolled in this study, which was obtained from the Al-Mustansiriya University national diabetes center in Baghdad, and other 40 apparently healthy people specimens and swabs were collected from 25 females and 15 males as a control group for the period starting November / 2021 to February / 2022. The results revealed that the most prevalent bacterial gener

... Show More
View Publication Preview PDF
Crossref
Publication Date
Wed Aug 30 2017
Journal Name
Ibn Al-haitham Journal For Pure And Applied Sciences
Some Immunological and Cytological Aspects .of The Breast and Uterus Can.cer Patients After Radiotherapy
...Show More Authors

The- role of radiotherapy in immunological and  cytological function of  patients.  with  carcino.ma  of  breast 'tDd   uterus  were  investigared: Using n:>sette forming T lYJi'lphl)Cytes, white  blood  cell's and lymphocytes  count  and  distributiQn  of  micronuclei  as  parameters . After  irradiation . the number  of  peripheral   blood  lymphocytes and vvhite blood  cells  was  reduced  . The  percentage of ro:sette Jorming  T

ly mphocytes   were· alsu  decreased   while  NBT  percentage  Of poly

morpho  nudcocyte

... Show More
View Publication Preview PDF
Publication Date
Sat Jul 01 2023
Journal Name
Journal Of Analytical Chemistry
A Spectrophotometric Method for Tetracycline Determination in its Bulk Powder and Pharmaceutical Formulations Using Flow Injection and Batch Procedures: a Comparative Study
...Show More Authors

A reliable and environmental analytical method was developed for the direct determination of tetracycline using flow injection analysis (FIA) and batch procedures with spectrophotometric detection. The developed method is based on the reaction between a chromogenic reagent (vanadium (III) solution) and tetracycline at room temperature and in a neutral medium, resulting in the formation of an intense brown product that shows maximum absorption at 395 nm. The analytical conditions were improved by the application of experimental design. The proposed method was successfully used to analyze samples of commercial medications and verified throughout the concentration ranges of 25–250 and 3–25 µg/mL for both FIA and batch procedures, respecti

... Show More
View Publication
Scopus (4)
Crossref (3)
Scopus Clarivate Crossref