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 Twenty blood samples were withdrawn from each subject over 144 hours period.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
Thu Apr 20 2023
Journal Name
Ibn Al-haitham Journal For Pure And Applied Sciences
A Comparative Biochemical Study Between Patient’s Obese and Healthy
...Show More Authors

Objectives: Obesity rates have increased globally with increase in the incidence of comorbidities especially type 2 diabetes mellitus. A cross-sectional study was conducted on healthy obese adults to estimate: (i) comparisons of anthropometric indicators, lipid profile, and glycemic profile in obese compared with non-obese, and (ii) the association of anthropometrics and lipid profile with glycemic profile in obese adults. Methods: The study includes 120 individual with aged ranged (25 – 55) years were enrolled in this study. They were divided into two groups: group one (G1) consist of 90 patients with a body mass index (BMI) of more than 25 kg/m2. Group two (G2) of 30 healthy adults as a co

... Show More
View Publication Preview PDF
Crossref
Publication Date
Thu May 09 2024
Journal Name
Al-rafidain Journal Of Medical Sciences ( Issn 2789-3219 )
Formulation and Evaluation of Immediate-Release Oral Tablets Containing Magnesium Aluminum Silicate-Loaded Simvastatin
...Show More Authors

Background: Simvastatin (SIM) is a lipid-lowering agent to prevent disorders caused by clogged blood vessels. Because of its low solubility, it has low bioavailability. The adsorption technique is effective in improving drug solubility and dissolution rate. Objective: To use magnesium aluminum silicate (MAS) as an adsorbent in combination with Soluplus® as a hydrophilic polymer to formulate SIM as immediate-release tablets (IRTs). Methods: We used the solvent evaporation method to make MAS-loaded SIM in the presence of Soluplus®, making sure that the ratio of SIM to MAS to SOLU was 1:6:3. We then used this mixture to make IRTs. Using the direct compression method, we made all of the SIM-IRT formulas. We used diluents like Avicel

... Show More
View Publication Preview PDF
Scopus 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
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 (7)
Scopus Clarivate Crossref
Publication Date
Fri Jul 14 2017
Journal Name
Tenside Surfactant
Oil-Water Interfacial Tensions of Silica Nanoparticle-Surfactant Formulations
...Show More Authors

The implementation of nanotechnology in all industries is one of most significant research fields. Nanoparticles have shown a promising application in subsurface fields. On the other hand, various surfactants have been used in the oil industry to reduce oil/water interfacial tension and also widely used to stabilize the nano-suspensions. The primary objective of this study was to investigate the improvements of surfactants ability in term of interfacial tension (γ) reduction utilizing addition of silicon dioxide nanoparticles at different temperatures and salinity. The pendant drop technique has been used to measure γ and electrical conductivity has been used to measure the critical micelle concentration (CMC). The synergistic effects of

... Show More
Scopus (43)
Crossref (47)
Scopus Clarivate 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 Aug 09 2017
Journal Name
Ibn Al-haitham Journal For Pure And Applied Sciences
Relationship Between Lipid Peroxidation and Vitamine (E) ,  -Tocooherol Supplementation in Sera of Apparntly Healthy Individuals
...Show More Authors

  In an attempt to shed a light on the possible relationship between lipid peroxidation and some antioxidant.         The effect of vitamine E (as a potent antioxidant free radical scavenger) on the serum levels of Total cholesterol (TC) and Triacylglycerols (TG) was studied and the lipid peroxidation marker (MDA) was measured.       The study includes (50) healthy donors from males and females who had given vitamine E at a rate of (400IU) daily for one month and were divided into two groups. 1. Group (A) : included (25) males donors (20-40) years old, before and after giving vitamine E. 2. Group (B) : included (25) females donors (20-40) years old , before and af

... Show More
View Publication Preview PDF
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
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
Wed Dec 05 2018
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Spectrophotometric Determination of Chlordiazepoxide in Pharmaceutical Formulations via Oxidative Coupling Reaction with Phenothiazine
...Show More Authors

Abstract

A sensitive, precise and reliable indirect spectrophotometric method for the determination of chlordiazepoxide (CDE) in pure and pharmaceutical dosage forms is described. The method is based on oxidative coupling reaction between amino group resulting from acidic decomposition of CDE with phenothiazine in the presence of sodium periodate to produce an intense green soluble dye that is stable and shows a maximum absorption at 602 nm. The calibration plot indicates that Beer’s law is obeyed over the concentration range of 0.1?50 µg/mL, with a molar absorptivity of 1×104 L/mol cm and correlation coefficient of 0.9994.All the conditions that affecting on the stability and sensitivity of the fo

... Show More
View Publication Preview PDF
Scopus (2)
Scopus Crossref