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 Twenty two blood samples were withdrawn from each volunteer over 24 hours period.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 31 2017
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Effect of Temperature on the Stability and Release Profile of Ibuprofen Microcapsules
...Show More Authors

The stability and releasing profile of 2:1 core: wall ratio ibuprofen microcapsules prepared by aqueous coacervation (gelatin and acacia polymers coat) and an organic coacervation methods (ethyl cellulose and sodium alginate polymers coat) in weight equivalent to 300mg drug, were studied using different storage temperatures 40°C, 50°C ,60°C and refrigerator temperature 4°C in an opened and closed container for three months (releasing profile) and four months (stability study).It was found that, these ibuprofen microcapsules were stable with expiration dates of 4.1 and 3.1 years for aqueous and an organic method respectively.Aqueous prepared ibuprofen microcapsules were found more stable than those microcapsules prepared by or

... Show More
View Publication Preview PDF
Crossref
Publication Date
Sun Jan 01 2017
Journal Name
Journal Of The College Of Languages (jcl)
Numbness of the Mind Paradigm in Haruki Murakami’s After the Quake and Iraq’s After the Quake
...Show More Authors

Haruki Murakami (1949-present) is a contemporary Japanese writer whose works have been translated into fifty languages and won him plenty of Japanese and international awards. His short stories are well constructed in a weird realistic manner and are mixed with elements of surrealism. His novels and short stories fall under the genre of magical realism. One of the major revolving themes that Murakami wrote about was the haunting feeling of emptiness and disconnectedness in a world which seems to care much for materialism and self-interests.

    The paper explores two of Murakami’s short stories in his book After the Quake (2000) and the relevance of their themes and characters to Iraq after the q

... Show More
View Publication Preview PDF
Publication Date
Tue Sep 08 2020
Journal Name
Baghdad Science Journal
A Comparison Between Two Shape Parameters Estimators for (Burr-XII) Distribution
...Show More Authors

This paper deals with defining Burr-XII, and how to obtain its p.d.f., and CDF, since this distribution is one of failure distribution which is compound distribution from two failure models which are Gamma model and weibull model. Some equipment may have many important parts and the probability distributions representing which may be of different types, so found that Burr by its different compound formulas is the best model to be studied, and estimated its parameter to compute the mean time to failure rate. Here Burr-XII rather than other models is consider  because it is used to model a wide variety of phenomena including crop prices, household income, option market price distributions, risk and travel time. It has two shape-parame

... Show More
View Publication Preview PDF
Scopus (2)
Scopus Clarivate Crossref
Publication Date
Mon Nov 10 2025
Journal Name
Journal Of Baghdad College Of Dentistry
Comparison of enamel color alteration between bonded and free unbonded surfaces of maxillary anterior teeth after fixed orthodontic therapy (A prospective clinical study)
...Show More Authors

Background: The purpose of this study is to compare the color changes between the bonded middle third and the unbonded gingival and incisal thirds, fallowing fixed orthodontic treatment Material and method: The color parameter l, a, b has been recorded for each thirds in upper anterior teeth by mean of easy shad device. The has been calculated for gingival, middle and incisal thirds for the upper anterior teeth in 34 patient, 17 males and 17femals, those subject undergone fixed orthodontic treatment Results: The in middle bonded third is highly significant higher than that in incise and gingival thirds p<0.01 because the middle third isn’t expose to oral fluid and dental brushing since it covered by the bracket. Also there

... Show More
View Publication Preview PDF
Publication Date
Wed Nov 01 2017
Journal Name
Journal Of Economics And Administrative Sciences
Analytical Study Compared Between Poisson and Poisson Hierarchical Model and Applied in Healthy Field
...Show More Authors

Through this research, We have tried to evaluate the health programs and their effectiveness in improving the health situation through a study of the health institutions reality in Baghdad to identify the main reasons that affect the increase in maternal mortality by using two regression models, "Poisson's Regression Model" and "Hierarchical Poisson's Regression Model". And the study of that indicator (deaths) was through a comparison between the estimation methods of the used models. The "Maximum Likelihood" method was used to estimate the "Poisson's Regression Model"; whereas the "Full Maximum Likelihood" method were used for the "Hierarchical Poisson's Regression Model

... Show More
View Publication Preview PDF
Crossref
Publication Date
Mon Nov 10 2025
Journal Name
Journal Of Baghdad College Of Dentistry
Accuracy of spiral computed tomography in evaluation of maxillary sinus septa among dentate and edentulous Iraqi subjects (Comparative study)
...Show More Authors

Background: Presence of maxillary sinus septa has been known to be a complicating factor for sinus elevation procedure and implant placement in posterior maxilla. The maxillary sinuses septa are thin walls of cortical bone inside the sinus. They vary in number, location, and height. This study aimed to discover the accuracy of Spiral Computed Tomographic Scan in evaluation the maxillary sinus septa (prevalence, location, height) in subjects with dentate, partially edentulous and completely edentulous maxilla. Material and method: This study included (267) subjects ranged from (20-70 years), (132) male and (135) female divided into three groups, (97) fully dentate group, (102) partially edentulous group and (68) completely edentulous group w

... Show More
View Publication Preview PDF
Publication Date
Sat Oct 28 2023
Journal Name
Baghdad Science Journal
Indirect Flow Injection Spectrophotometric and Chromatographic Methods for the Determination of Mebendazole in Pharmaceutical Formulations
...Show More Authors

Chromatographic and spectrophotometric methods for the estimation of mebendazole in
pharmaceutical products were developed. The flow injection method was based on the oxidation of
mebendazole by a known excess of sodium hypochlorite at pH=9.5. The excess sodium hypochlorite is then
reacted with chloranilic acid (CAA) to bleach out its color. The absorbance of the excess CAA was recorded
at 530 nm. The method is fast, simple, selective, and sensitive. The chromatographic method was carried out
on a Varian C18 column. The mobile phase was a mixture of acetonitrile (ACN), methanol (MeOH), water
and triethylamine (TEA), (56% ACN, 20% MeOH, 23.5% H2O, 0.5% TEA, v/v), adjusted to pH = 3.0 with
1.0 M hy

... Show More
View Publication Preview PDF
Scopus (3)
Crossref (2)
Scopus Crossref
Publication Date
Wed Sep 24 2025
Journal Name
Tropical Journal Of Pharmaceutical Research
Antibacterial-enhancing efficacy of aloe vera and honey in salicylic acid topical formulations against acne
...Show More Authors

Purpose: To compare the antibacterial-enhancing efficacy of aloe vera and honey in salicylic acid topical formulations against acne. Method: Six formulations containing 5 % salicylic acid were developed as creams and gels as follows: Formulations S, V and H were creams containing salicylic acid alone (S), salicylic acid with 28 % aloe vera (V), and salicylic acid with 10 % honey (H). Formulations J, M, and B were gels containing salicylic acid alone (J), salicylic acid with aloe vera 20 % (M) and salicylic acid with 12 % honey (B). Each formula was evaluated for colour, odour, pH, viscosity, spreadability, and stability under different temperatures (25, 30, and 60oC) and times (1 hour, 1 day, and 1 week). Furthermore, antibacterial

... Show More
View Publication Preview PDF
Scopus Crossref
Publication Date
Tue Jan 01 2019
Journal Name
Indian Journal Of Public Health Research &amp; Development
Spectrophotometric Determination of Nifedipine in Pharmaceutical Tablets Using Batch and Flow Injection Method Via Diazotization Coupling Reaction
...Show More Authors

View Publication
Scopus (2)
Crossref (1)
Scopus Crossref
Publication Date
Sat Oct 01 2016
Journal Name
Journal Of Economics And Administrative Sciences
ORGANIZATIONAL VALUES AND ITS IMPACT ON STRATEGIC PERFORMANCE A field study a comparison between Two Universities of Baghdad & Al-Nahrain
...Show More Authors

 

ABSTRACT

     The researcher seeks to shed light on the relationship analysis and the impact between organizational values in all its dimensions (Administration Management, Mission, relationship management, environmental management) and strategic performance (financial perspective, customer perspective, the perspective of internal processes, learning and development) in the presidency of Two Universities of Baghdad & Al-Nahrain, it has been formulating three hypotheses for this purpose.

      The main research problem has been the following question: Is there a relationship and the impact of bet

... Show More
View Publication
Crossref