Preferred Language
Articles
/
bijps-404
Bioequivalence and Pharmacokinetics of Two Formulations of Amlodipine Tablets in Healthy Subjects
...Show More Authors

The bioequivalence of a single dose tablet containing 5 mg amlodipine as a test product in comparison to Norvasc® 5 mg tablet (Pfizer USA) as the reference product was studied. Both products were administered to twenty eight healthy male adult subjects applying  a fasting, single-dose, two-treatment, two-period, two-sequence, randomized crossover design with two weeks washout period between dosing. Twenty blood samples were withdrawn from each subject over 144 hours period. Amlodipine concentrations were determined in plasma by a validated HPLC-MS/MS method. From the plasma concentration-time data of each individual, the pharmacokinetic parameters; Cmax, Tmax, AUC0-t, AUC0-Â¥, Cmax/AUC0-Â¥, lZ, T0.5, MRT, Cl/F and Vd/F; were calculated applying non-compartmental analysis. The average values of the above parameters  for the test formula were 1.99 ng/ml, 8.3 hours, 82.87 ng.hr/ml, 95.23 ng.hr/ml, 0.0219 hr-1, 0.018 hr-1, 38.5 hr, 56.2 hr, 60.9 l/hr and 3483 liters, respectively. The average values of these parameter for the reference formula were 1.92 ng/ml, 7.9 hours, 76.3 ng.hr/ml, 89.31 ng.hr/ml, 0.0225hr-1, 0.019  hr-1, 36.7 hr, 59.9 hr, 69.5 l/hr, and 3983.4 liters, respectively. The pharmacokinetic parameters mentioned above were statistically analyzed by ANOVA test. Ln-transformed values of the pharmacokinetic parameters used for bioequivalence testing; Cmax, AUC0-t and AUC0-Â¥ ; were also statistically analyzed by ANOVA, 90% Confidence Interval (CI) and Schuirmann’s two one-sided t-tests. For the Tmax, parametric and nonparametric tests were applied. Based on FDA criteria on bioequivalence, the results of the above statistical tests demonstrated bioequivalence of the two products.

Keywords: Amlodipine, Pharmacokinetic, Bioequivalence , HPLC/MS/MS.

Crossref
View Publication Preview PDF
Quick 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 (4)
Crossref (2)
Scopus Crossref
Publication Date
Sun Dec 06 2009
Journal Name
Baghdad Science Journal
Study of the Porosity of Certain pharmaceutical Tablets using Mercury Intrusion Porosimeter
...Show More Authors

Porosity and pore structure are important characteristics of pharmaceutical tablets, since they influence the physical properties, such as mechanical strength, density and disintegration time. This paper is an attempt to investigate the pore structure of four different paracetamol tablets based on mercury porosimetry. The intrusion volumes of mercury were used to calculate the pore diameter, pore volume and pore size distribution. The result obtained indicate that the variation of the pore volume in the tablets followed the sequence:- S.D.I. Iraq? Pharmacare,Dubai-U.A.E.? Bron and Burk(UK) London?Lark Laboratories(India), while the variation of surface area followed the sequence:- S.D.I. Iraq? Lark Laboratories(India)? Pharmacare,Dubai-U.A

... Show More
View Publication Preview PDF
Crossref (1)
Crossref
Publication Date
Tue Aug 15 2023
Journal Name
Al-academy
The aesthetics of the sculptural formulations of swords in the Al-Kafeel Museum of Treasures and Manuscripts
...Show More Authors

The research included (the aesthetics of the sculptural formulations of swords in the Al-Kafeel Museum) four chapters. Al-Kafeel Museum.)
Within the time period: (1240 AH / (1824 and 1825) AD - 1312 AH / (1894 and 1895) AD). The second: the types of Islamic swords. The third chapter included (research procedures), and the analysis of samples from the sample (3) as a model according to the descriptive approach, and the fourth chapter dealt with (results, conclusions, recommendations, and proposals). As well as recommendations, proposals and sources.

View Publication Preview PDF
Crossref
Publication Date
Wed Jan 01 2020
Journal Name
Journal Of Southwest Jiaotong University
A Recognition System for Subjects' Signature Using the Spatial Distribution of Signature Body
...Show More Authors

This investigation proposed an identification system of offline signature by utilizing rotation compensation depending on the features that were saved in the database. The proposed system contains five principle stages, they are: (1) data acquisition, (2) signature data file loading, (3) signature preprocessing, (4) feature extraction, and (5) feature matching. The feature extraction includes determination of the center point coordinates, and the angle for rotation compensation (θ), implementation of rotation compensation, determination of discriminating features and statistical condition. During this work seven essential collections of features are utilized to acquire the characteristics: (i) density (D), (ii) average (A), (iii) s

... Show More
View Publication Preview PDF
Crossref (1)
Crossref
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
Thu Jan 01 2015
Journal Name
International Journal Of Pharmacy And Pharmaceutical Sciences
Study the sustain release effect of different polymers used in the formulation of aspirin-rosuvastatin tablets
...Show More Authors

Scopus (4)
Scopus
Publication Date
Thu Nov 01 2012
Journal Name
Journal Of The Faculty Of Medicine Baghdad
A Comparative Study of the Effects of Age and Smoking on Nail Growth Rate in Healthy Individuals
...Show More Authors

GA Al Omran, AA Noaimi, Z Al Madfai, H Al Hamamy, Journal of the Faculty of Medicine Baghdad, 2012

View Publication
Publication Date
Sat Apr 01 2017
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
In Vitro Release Study on Capsules and Tablets Containing Enteric - Coated Granules Prepared by Wet Granulation
...Show More Authors

Wet granulation method was used instead of conventional pan coating  or fluidized –bed coating technique to prepare enteric-coated diclofenac sodium granules, using ethanolic solution of EudragitTM L100 as coating, binding and granulating agent .Addition of PEG400 or di-n-butyl phthalate as a plasticizer was found to improve the enteric property of the coat.

Part of the resulted granules was filled in hard gelatin capsules (size 0), while the other part was compressed into tablets with and without disintegrant.

The release profile of these two dosage forms in 0.1N HCl (pH 1.2)for 2 hours, and in phosphate buffer (pH 6.8) for 45 minutes as well as the release kinetic were compared with that of the en

... Show More
View Publication Preview PDF
Crossref
Publication Date
Wed Sep 01 2021
Journal Name
Baghdad Science Journal
Determination of Sulfacetamide Sodium in Pure and Their Pharmaceutical Formulations by Using Cloud Point Extraction Method
...Show More Authors

      In this study, simple, low cost, precise and speed spectrophotometric methods development for evaluation of sulfacetamide sodium are described. The primary approach contains conversion of sulfacetamide sodium to diazonium salt followed by a reaction with p-cresol as a reagent in the alkaline media.  The colored product has an orange colour with absorbance at λmax 450 nm. At the concentration range of (5.0-100 µg.mL-1), the Beer̆ s Low is obeyed with correlation coefficient (R2= 0.9996), limit of detection as 0.2142 µg.mL-1, limit of quantification as 0.707 µg.mL-1 and molar absorptivity as 1488.249 L.mol-1.cm-1. The other approach, cloud point extraction w

... Show More
View Publication Preview PDF
Scopus (8)
Scopus Clarivate Crossref
Publication Date
Mon Mar 13 2017
Journal Name
Journal Of Baghdad College Of Dentistry
Periodontal Health Status and Assessment of Osteocalcin levels in Saliva of Diabetic Patients and Systemically Healthy Persons (Comparative study)
...Show More Authors

ABSTRACT Background: Diabetes and periodontitis are complicated prolonged disorders through a recognized two-way association. There is elongated-conventional mark that hyperglycaemia in diabetes is affected on immune-inflammatory response and disturb the action of osteoclast and in balance bone turnover, which might rise the person vulnerability to the progress of prolonged periodontitis. Osteocalcin is one of the greatest plentiful matrix proteins originate in bones and produced absolutely there. Small osteocalcin crumbles are noticed in regions of bone remodeling and are in fact degradation products of the bone matrix, that is released outside cells into the Gingival Crevicular Fluid (GCF) and saliva after destruction of periodontal tissu

... Show More
View Publication Preview PDF
Crossref