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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Mar 04 2012
Journal Name
Baghdad Science Journal
Biochemical and Kinetic Studies on Alkaline Phosphatase and other Biochemical Features in Sera of Patients with type 2 Diabetes
...Show More Authors

Background :Alkaline phosphatase (ALP) was a widely used marker for skeletal and hepatobiliary disorders, but its activity was also increased in atherosclerosis and peripheral vascular disease. Several study has showed that ALP activity was increased in the sera of diabetic patients. The current study was conducted to evaluate ALP activity in type 2 diabetic patients and optimum conditions for enzyme activity in their sera.Methods: This study was carried out at in AL-Yarmok hospital(diabetic center) between February /2009 and April /2009. Fifty two patients with type 2 diabetes have been enrolled. Besides BMI, WHR, serum fasting blood glucose, ALP, HbA1C,uric acid and lipid profile levels have been performed .The relationship bet

... Show More
View Publication Preview PDF
Crossref (1)
Crossref
Publication Date
Sun Dec 27 2020
Journal Name
Journal Of Accounting And Financial Studies ( Jafs )
Limitation of liability and reinsurance and its role in increasing production insurance: بحث أستطلاعي في شركة التامين العراقية العامة
...Show More Authors

The liability limit liability limit and reinsurance re factors insurance are important in influencing the achievement of company's competitive goals and achieve success and excellence in the market and because the limit of liability and reinsurance aimed to increase output with the stability of inputs leading to increased insurance business and increase profits. The study was based on two variables presidents interact with each other to form the intellectual and philosophical framework has two ( the limit of liability and reinsurance ) . The study was launched from a problem expressed by a number of targeted questions answered from the elucidation of theoretical philosophy and intellectual goals of these variables and highlight the impor

... Show More
View Publication Preview PDF
Publication Date
Sat Feb 01 2020
Journal Name
Journal Of Green Engineering
Water distribution and interference of wetting front in stratified soil under a continues and an intermittent subsurface drip irrigation
...Show More Authors

Scopus (8)
Scopus
Publication Date
Wed Mar 10 2021
Journal Name
Baghdad Science Journal
EFFECT OF SALINE WATER AND POTASH FERTILIZER ON PROLINE CONTENT AND WATER POTENTAL IN PISUM SATIVUM L. (VAR.SENADOR CAMBADOS)
...Show More Authors

Filed experiment was conducted to test the effect of saline water and potassium fertilizers rate on proline and water potential of Pisum sativum L. (Var.Senador Cambados ) leaves . Treatments of the experiment included two levels of water salinity( 2, 7 dSm-1) as a main plot and fertilizer rates as a sub plot. Results indicated that irrigation of plant with saline water 7 dSm-1 and fertilization 150 kg/donum increased proline accumulation and water potential 0.31 mmol/g,-17.00 bar at 9 AM morning and 0.62 mmol/g , -21.00 bar at 3 PM afternoon ,Irrigating plant with a 2 dSm-1 and fertilization 300 kg/donum decreased proline accumulation and water potential of leaves 0.22 mmol/g, -16.00 bar at 9 A

... Show More
View Publication Preview PDF
Crossref
Publication Date
Sat Feb 07 2026
Journal Name
Journal Of Baghdad College Of Dentistry
Immunohistochemical evaluation of FHIT and WWOX expression in normal oral mucosa, oral epithelial dysplasia and oral squamous cell carcinoma
...Show More Authors

Background: Oral squamous cell carcinoma is the most prevalent malignant neoplasm of the oral cavity which results from accumulated genetic and epigenetic alterations. It is not always inexorable and may be reversible if early intervention in the process can occur to prevent further genetic mutation and disease progression. The FHIT gene is a tumor suppressor gene located in FRA3B region which is the most active common fragile site, where DNA damage leading to aberrant transcripts and translocations frequently occur. The WWOX is a tumor suppressor gene that plays a central role in tumor suppression through transcriptional repression and apoptosis, with its apoptotic function the more prominent of the two. This study aimed to evaluate and co

... Show More
View Publication Preview PDF
Publication Date
Thu Sep 05 2024
Journal Name
Journal Of Ecohumanism
Early Warning System Means and Tools in the African Union and the Organization of American States: An Analytical Study
...Show More Authors

Disasters, crises and wars are a serious and unforeseen threat. The capacity of the early warning system to monitor such crises is therefore crucial. The ability to make quick decisions in a short time is necessary to prevent crises from occurring. Here, the role and effectiveness of the early warning system emerges through its ability to monitor, record and analyze signals. It can also be evidenced by its ability to immediately convey these indicators to the concerned authorities to take measures that ensure these conflicts and disasters do not worsen. The system’s ability to detect disasters and crises, identify the crisis and its type, and use the scientific method and common sense to deal with it is something that contributes to findi

... Show More
Scopus (1)
Scopus Crossref
Publication Date
Sat Apr 01 2023
Journal Name
Baghdad Science Journal
Physiological and Hormonal Effects of Titanium Dioxide Nanoparticles on Thyroid Function and the Impact on Bodyweight in Male Rats
...Show More Authors

Fifty-four Sprague-Dawley albino adult male rats were classified into three main groups each of 18 rats treated for a particular duration (1,2, and 4) weeks respectively. Each group was subdivided into three subgroups each of six rats treated as follows; group (1) serve as normal control, group (2, and 3) intra-peritoneal treated with TiO2NPs (50,200) mg/kg respectively, body *weight of all rats was measured before and after the experiment, then rats were dissected at the end of each experiment and the weights of the thyroid was measured. The result showed a highly significant decrease (p<0.01) in thyroid gland weight, a highly significant increase (p<0.01) in body weights and TSH, while a highly significant decrease (p&

... Show More
View Publication Preview PDF
Scopus (7)
Crossref (1)
Scopus Crossref
Publication Date
Wed May 12 2021
Journal Name
Annals Of The Romanian Society For Cell Biology
Determining Grades and Standard Levels for the Most Important Physical and Motor Abilities of Sepak Takraw Juniors in Iraq
...Show More Authors

(Sepak takraw) is a game that mixes football and volleyball, it is played on a court similar to a badminton court, in which players have the right to play the ball with any part of the body except the arm and hand. The object of the game is to return the ball to the opponent's court and score a point. Since it is a newly emerging game, all aspects related to it must be studied and covered in order to reach the highest levels, and it is known that each game or sporting activity has its own physical and motor capabilities, which is important to determine the level of technical performance, as the game's abilities contribute to mastering the skills. The importance of research in determining standard levels of physical and motor abilities for y

... Show More
View Publication Preview PDF
Publication Date
Mon Jun 08 2020
Journal Name
Research Journal Of Chemistry And Environment
High Performance Liquid Chromatographic and Areaunder Curve spectrophotometric Methods forEstimation of Cefixime in Pure and MarketedFormulation: A Comparative Study
...Show More Authors

Cefixime is an antibiotic useful for treating a variety ofmicroorganism infections. In the present work, tworapid, specific, inexpensive and nontoxic methods wereproposed for cefixime determination. Area under curvespectrophotometric and HPLC methods were depictedfor the micro quantification of Cefixime in highly pureand local market formulation. The area under curve(first technique) used in calculation of the cefiximepeak using a UV-visible spectrophotometer.The HPLC (2nd technique) was depended on thepurification of Cefixime by a C18 separating column250mm (length of column) × 4.6 mm (diameter)andusing methanol 50% (organic modifier) and deionizedwater 50% as a mobile phase. The isocratic flow withrate of 1 mL/min was applied, the temper

... Show More
Publication Date
Mon May 16 2022
Journal Name
International Journal Of Biomaterials
Histopathological and Biochemical Comparative Study of Copper Oxide Nanoparticles and Copper Sulphate Toxicity in Male Albino Mice Reproductive System
...Show More Authors

Copper (Cu) is an essential trace element for the efficient functioning of living organisms. Cu can enter the body in different ways, and when it surpasses the range of biological tolerance, it can have negative consequences. The use of different nanoparticles, especially metal oxide nanoparticles, is increasingly being expanded in the fields of industry and biomedical materials. However, the impact of these nanoparticles on human health is still not completely elucidated. This comparative study was conducted to evaluate the impacts of copper oxide nanoparticles (CuO NPs) and copper sulphate (CuSO4 0.5 (H2O)) on infertility and reproductive function in male albino mice BALB/c. Body weight, the weight of male reproductive organs, mal

... Show More
View Publication
Scopus (27)
Crossref (22)
Scopus Clarivate Crossref