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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 Dec 31 2023
Journal Name
Journal Of Pioneering Medical Science
Determination of Coronary Care Unit Nurses' Knowledge Regarding Patient Rehabilitation After Myocardial Infarction
...Show More Authors

Background: Cardiovascular disease (CVD) is the number one cause of death worldwide. Objective: To determine of coronary care unit nurses' knowledge regarding patient rehabilitation after myocardial infarction. Methodology: A cross- sectional study was designed in the Cardiac Care Unit of Al-Diwaniyah Teaching Hospital and the Specialized Center for Cardiac Surgery and Catheterization for the period from (November 7, 2022) to (May 12, 2023). A non-probability (purposive) sample consisting of (75 nurses) working in the above-mentioned study site. To determination of coronary care unit Nurses' knowledge regarding patient rehabilitation after myocardial infarction, the researcher used a tool that consists of two parts: The first part:

... Show More
View Publication
Crossref (2)
Crossref
Publication Date
Mon Jun 30 2014
Journal Name
Al-kindy College Medical Journal
Is Elective Interval Appendicectomy after Successful Initial Conservative Management of Appendicular Mass Necessary?
...Show More Authors

Background The traditional management of appendicular mass is an initial conservative treatment followed by interval appendectomy. Recently interval appendicectomy has been questioned.
Objective: The purpose of this study was to clarify the need and the role of interval appendicectomy after successful initial conservative treatment.
Method: This is a prospective study conducted in a major hospital in Basra from April 2006 to Septemper2010, included 65 patients with appendicular mass which subsequently proved postinflammmatory (phlegmonous) changes of the appendix were treated conservatively.
Results: Routine interval appendicectomy was not performed and needed after successful treatment in the majority of the patients (84.6%). F

... Show More
View Publication Preview PDF
Publication Date
Sun Jun 01 2014
Journal Name
International Journal Of Biological & Pharmaceutical Research
PROMASTIGOTES VIABILITY OF LEISHMANIA MAJOR W.T. ANDL. MAJOR KNOCKOUT LMLCB2 AFTER MYRIOCIN TREATMENT
...Show More Authors

Sphingolipids (SLs) are major structural constituents of eukaryotes, including the kinetoplastid parasite Leishmania. SLs are important for cellular trafficking and signaling and participate in different cell functions, such as, differentiation and cell death (apoptosis). In this study we have investigated the viability of Leishmania major wild type (W.T) and L. major knockout LmLCB2, one of two subunits of serine palmitoyl transferase (SPT) after treatment with myriocin (potent inhibitor of SPT) in order to detect the survival and proliferation of the parasites in vitro. This is to focus on the de novo sphingolipids biosynthesis pathway in both Leishmania wild type which can synthesize SPT and knockout Leishmania which genetically ablated

... Show More
View Publication Preview PDF
Publication Date
Thu Apr 05 2018
Journal Name
Acs Applied Nano Materials
Direct Formation of 2D-MnO<sub><i>x</i></sub> under Conditions of Water Oxidation Catalysis
...Show More Authors

We describe the synthesis and characterization of a novel 2D-MnOx material using a combination of HR-TEM, XAS, XRD, and reactivity measurements. The ease with which the 2D material can be made and the conditions under which it can be made implies that water oxidation catalysts previously described as “birnessite-like” (3D) may be better thought of as 2D materials with very limited layer stacking. The distinction between the materials as being “birnessite-like” and “2D” is important because it impacts on our understanding of the function of these materials in the environment and as catalysts. The 2D-MnOx material is noted to be a substantially stronger chemical oxidant than previously noted for other birnessite-like manganese oxi

... Show More
View Publication
Scopus (11)
Crossref (11)
Scopus Clarivate Crossref
Publication Date
Wed Sep 01 2021
Journal Name
Journal Of Ecological Engineering
Study of The Fermentation Conditions of the Bacillus Cereus Strain ARY73 to Produce Polyhydroxyalkanoate from Glucose
...Show More Authors

Polyhydroxyalkanoates (PHAs) have gained much attention as biodegradable polymers, many efforts are being made to minimize the cost of PHAs by finding cheap carbon source depending on the type of microorganism and fermentation conditions. The aims of this study were to evaluate the effects of different glucose concentrations and other important conditions on the PHA production by Bacillus cereus isolated from soil. Polyhydroxyalkanoates PHAs accumulated by soil microorganisms were examined by screening the isolated bacteria using Sudan B Black and Nile Blue staining process. A Gram positive strain was identified using the 16s rRNA gene, deposited in the NCBI GenBank sequence database. Different growth conditions (favorite glucose concentrat

... Show More
View Publication
Scopus (25)
Crossref (28)
Scopus Clarivate Crossref
Publication Date
Mon Mar 13 2017
Journal Name
Journal Of Baghdad College Of Dentistry
Testing Different Properties of A Light-Cured Denture Base Material After Addition of Silicon Oxide Nanofiller (An in Vitro Study)
...Show More Authors

ABSTRACT Background: Improving the properties of heat- cured and self-cured acrylic resin have been studied by many researchers. However, little studies concerned with visible light cured resin (VLCR) improved through addition of nanofiller are available. The purpose of this study was to evaluate some properties of (VLCR) after addition of SiO2 nanofiller. Materials and Methods: SiO2 nanofiller were added to (VLCR) tray material after being dissolved in tetrahydrofuran (THF) solvent. According to the pilot study 2% SiO2 nanofiller addition exhibited better properties than the other percentages (1%, 3%). The main study conducted involved (100) specimens divided into 5 groups according to the test included. (20) Specimens were selecte

... Show More
View Publication Preview PDF
Crossref (3)
Crossref
Publication Date
Tue Jan 20 2026
Journal Name
Journal Of Baghdad College Of Dentistry
The association of crevicular albumin level with the severity of periodontal destruction in chronic periodontitis patients after initial periodontal treatment
...Show More Authors

Background: Gingival crevice fluid (GCF) is a mixture of substances derived from serum, leukocytes, and structural cells of periodontium and oral bacteria. These substances possess a great potential for serving as indicators of periodontal disease and healing after therapy the main purpose of this study was to find if there is a difference in albumin concentration between healthy and diseased periodontal tissues and to compare between diseased group according to pocket depth Materials and methods: total sample composed of 60 pockets found in 35 patients all of them had no history of any systemic disease, The samples were divided in to three main group that include two diseased groups divided according to the depth of the periodontal pocket

... Show More
View Publication Preview PDF
Publication Date
Tue Aug 26 2025
Journal Name
Journal Of Contemporary Medical Sciences
Psychosexual Consequences that Iraqi Women Suffer after Emergency Hysterectomy
...Show More Authors

Publication Date
Tue Aug 26 2025
Journal Name
Journal Of Contemporary Medical Sciences
Psychosexual Consequences that Iraqi Women Suffer after Emergency Hysterectomy
...Show More Authors

Preview PDF
Publication Date
Fri Sep 30 2022
Journal Name
Journal Of Economics And Administrative Sciences
Comparison of Some Methods for Estimating the Survival Function and Failure Rate for the Exponentiated Expanded Power Function Distribution
...Show More Authors

       We have presented the distribution of the exponentiated expanded power function (EEPF) with four parameters, where this distribution was created by the exponentiated expanded method created by the scientist Gupta to expand the exponential distribution by adding a new shape parameter to the cumulative function of the distribution, resulting in a new distribution, and this method is characterized by obtaining a distribution that belongs for the exponential family. We also obtained a function of survival rate and failure rate for this distribution, where some mathematical properties were derived, then we used the method of maximum likelihood (ML) and method least squares developed  (LSD) to estimate the parameters an

... Show More
View Publication
Crossref