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Bioequivalence and Pharmacokinetics of Two Formulations of Amlodipine Tablets in Healthy Subjects
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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 Twenty blood samples were withdrawn from each subject over 144 hours period.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.

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Publication Date
Sat Sep 01 2018
Journal Name
Journal Of Pharmaceutical Sciences And Research
Preparation and characterization of oro-dispersible tablets of bromhexine hydrochloride
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Publication Date
Fri Jun 15 2018
Journal Name
Journal Of Baghdad College Of Dentistry
Relation of Gonial Angle Index to osteoporosis and age using CBCT in female subjects
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Publication Date
Fri Jun 15 2018
Journal Name
Journal Of Baghdad College Of Dentistry
Relation of Gonial Angle Index to osteoporosis and age using CBCT in female subjects
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background: osteoporosis is a metabolic bone disease that affects women more than men, it is characterized by generalizes reduction of bone mineral density (BMD) leaving a fragile weak bone that is liable to fracture, gonial angle index (GAI) is one of the radio-morphometric indices, it has been controversial whether it is related to bone mineral density or ageing or none of them. The aim of study is to evaluate the role of cone beam computed tomography (CBCT) as a screening tool for diagnosis of osteoporosis and age effect in females using gonial angle index. Material and method: 60 females were divided into 3 groups according to age and (BMD) status into: Group1 (non-osteoporosis 20-30 years), Group2 (non-osteoporosis 50years and above),

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Publication Date
Sat Apr 01 2023
Journal Name
Baghdad Science Journal
Spectrophotometric Determination of Salbutamol Sulphate and Isoxsuprine Hydrochloride in Pharmaceutical Formulations
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A simple, sensitive and accurate spectrophotometric method has been developed for the determination of salbutamol sulphate (SAB) and isoxsuprine hydrochloride (ISX) in pure and pharmaceutical dosage. The method involved oxidation of (SAB) and (ISX) with a known excess of N-bromosuccinamid in acidic medium, and subsequent occupation of unreacted oxidant in decolorization of Evans blue dye (EB). This, in the presence of SAB or ISX was rectilinear over the ranges 1.0-12.0, 1.0-11.0 µg/mL, with molar absorptivity 4.21×104 and 2.58×104 l.mol-1.cm-1 respectively. The developed method had been successfully applied for the determination of the studied drugs in their pharmaceutical dosage resulting i

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Publication Date
Sun Aug 13 2017
Journal Name
Ibn Al-haitham Journal For Pure And Applied Sciences
Spectrophotometric Determination of Rantidine-HCl in Pharmaceutical Formulations
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Spectrophotometric  methods  were  developed   for    the determination of rantidine-HCl in pharmaceutical tablets. These methods were based on the reaction of DDQ and p-chloranil with rantidine-HCl, resulting in the formation of an orange-red and purple colored products which are quantified spectrophotometrically at 460 and 540nm in DDQ and p-chloranil, respectively. A graph of absorbance versus concentration show that Beer’s law is obeyed in a concentration ranges of 20-160 and (30-120)g/ml with molar absorptivities of 2.631 x 103 and 1.052 x 103l .mol-1-cm-1 for DDQ and  p-chloranil, respectively. The optimum conditions for  color development  are described and 

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Publication Date
Fri Apr 04 2025
Journal Name
Journal Of Baghdad College Of Dentistry
The frontal sinus dimensions in mouth and nasal breathers in Iraqi adult subjects
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Background: The frontal sinus area can be used as a diagnostic aid to recognize mouth breather subjects. The aims of this study were to determine the gender difference in each group, to compare the frontal sinus area between mouth breather and nasal breather group, and to verify the presence of correlation between the frontal sinus area and the cephalometric skeletal measurements used in this study. Materials and Methods: Cephalometric radiographs were taken for 60 adults (30 mouth breathers and 30 nasal breathers) age range (18-25), for each group 15 males and 15 females, in the orthodontic clinic in the college of Dentistry at Baghdad University. The control group (nasal breather) with skeletal class I and ANB angle ranged between 2-4º,

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Publication Date
Tue Mar 28 2017
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Formulation and Optimization of Oral Fast Dissolving Prochloperazine Maleate Tablets
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Prochloperazine maleate (PCM) is one of the most prescribed phenothiazine. The purpose of the present research was to develop fast dissolving tablets of PCM with β-cyclodextrin inclusion complex. Tablets prepared  by wet granulation with sublimation and by using  different superdisintegrants type [ low-hydroxypropylcellulose LH21 (L-HPC LH21), carboxymethylcellulose calcium (ECG505), crospovidone (CP)], and different type of subliming agents (urea and ammonium bicarbonate (AB)). Tablets evaluated for its % friability, disintegration time, wetting time, hardness, content uniformity, weight variation, in vitro dissolution studies. For further enhancement of disintegration and dissolution, PCM orodispersible tablet were formula

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Publication Date
Tue Sep 01 2020
Journal Name
Meta Gene
Genetic polymorphisms frequency of vitamin D receptor gene rs7975232 and rs731236 in Iraqi thalassemic patients and healthy controls compared to Arabian healthy populations
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Publication Date
Sun Jun 21 2020
Journal Name
Iraqi Journal Of Pharmaceutical Sciences ( P-issn 1683 - 3597 E-issn 2521 - 3512)
Preparation, in vitro and ex-vivo Evaluation of Mirtazapine Nanosuspension and Nanoparticles Incorporated in Orodispersible Tablets
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          The objective of the present investigation was to enhance the solubility of practically insoluble mirtazapine by preparing nanosuspension, prepared by using solvent anti solvent technology. Mirtazapine is practically insoluble in water which act as antidepressant .It was prepared as nano particles in order to improve its solubility and dissolution rate. Twenty formulas were prepared and different stabilizing agents were used with different concentrations such as poly vinyl pyrrolidone (PVPK-90), poly vinyl alcohol (PVA), poloxamer 188 and poloxamer 407. The ratios of drug to stabilizers used to prepare the nanoparticles were 1: 1 and 1:2. The prepared nanoparticles were evaluated for

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Publication Date
Wed Jan 01 2020
Journal Name
Annals Of Tropical Medicine And Public Health
Volumetric assessment of maxillary sinus in cleft lip and palate patients in comparison to normal subjects
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