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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 Twenty blood samples were withdrawn from each subject over 144 hours period.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
Sun Mar 15 2020
Journal Name
Journal Of Baghdad College Of Dentistry
Oxidative stress status in hypertensive patients on amlodipine treatment
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Background: Oxidative stress may contribute to the etiology of hypertension in humans. Oxidative stress is an imbalance between reactive oxygen species (ROS) and antioxidant defense mechanisms, causing damage to biological macromolecules and dysregulation of normal metabolism and physiology. Amlodipine as an antihypertensive agent is a long-acting calcium channel blocker that dilates blood vessels and improves blood flow. The aim of this study was to assess the oxidative stress in hypertensive patients on Amlodipine treatment through the assessment of salivary Malondialdehyde (MDA) and superoxide dismutase (SOD) as a marker of oxidative stress.

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Publication Date
Mon Oct 01 2012
Journal Name
Computers & Mathematics With Applications
Boundary element formulations for the numerical solution of two-dimensional diffusion problems with variable coefficients
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Publication Date
Thu Dec 31 2009
Journal Name
The Iraqi Journal Of Veterinary Medicine
Possible beneficial effects of amlodipine, lisinopril, and their Combination on lipid profile in hypertensive patients
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It is well known that monotherapy does not provide therapeutic response in all hypertensive. Somepatients show an excellent response, while in others there is a poor response. Combinationantihypertensive therapy is administered when blood pressure is inadequately controlled bymonotherapy to achieve a balanced and additive antihypertensive effect with minimum adverse effects.Both angiotensin converting enzyme (ACE) inhibitors and dihydropyridine type of calcium antagonistsare well established and widely used in monotherapy. An understanding of differences in themechanism of action of these agents allows a logical approach for the use of these agents as acombination therapy. This study was designed to evaluate the possible beneficial

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Publication Date
Tue Nov 22 2016
Journal Name
Der Pharma Chemica
Evaluation of Commercial Antacid Tablets in Iraq
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Antacids are commonly used drugs which are considered inert and free of pharmacological effect by many patients and physicians. They are weak bases that neutralize the gastric acid and relief pain. These weak bases dissociate to neutralize gastric acid and form neutral salts. The ultimate goal of antacid therapy is to reduce the concentration and a total load of acid in gastric juice to a pH 4 - 5. This in vitro study was promised to study the acid neutralizing capacity (ANC) of six commonly available antacids tablets in the Iraqi market by using back titration method. The highest ANC values were for Rennie (17.131± 0.083 and 16.926± 0.052 mEq) in two different hydrochloric acid (HCl) concentrations 1N and 0.5 N, respectively. The static

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Publication Date
Tue Mar 30 2021
Journal Name
Baghdad Science Journal
Spectrophotometric and Spectrofluorimetric Determination of Terazosin in Tablets by Eosin Y
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Simple, sensitive and accurate two methods were described for the determination of terazosin. The spectrophotometric method (A) is based on measuring the spectral absorption of the ion-pair complex formed between terazosin with eosin Y in the acetate buffer medium pH 3 at 545 nm. Method (B) is based on the quantitative quenching effect of terazosin on the native fluorescence of Eosin Y at the pH 3. The quenching of the fluorescence of Eosin Y was measured at 556 nm after excitation at 345 nm. The two methods obeyed Beer’s law over the concentration ranges of 0.1-8 and 0.05-7 µg/mL for method A and B respectively. Both methods succeeded in the determination of terazosin in its tablets

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Publication Date
Fri Nov 11 2022
Journal Name
Al-nisour Journal For Medical Sciences
Spectrophotometric determination of sulfamethoxazole in pure and pharmaceutical formulations
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New, easy, simple, and fast spectral method for estimation of sulfamethoxazole (SMZ) in pure and pharmaceutical forms. The proposed method is based on the azotization of the drug compound by sodium nitrite in an acidic medium and then coupling with 2,3dimethyl phenol reagent (DMP) in a basic medium to yield an orange-coloured dye which shows λmax at 402 nm. Different affection of the optimization reaction has been completed, following the classical univariate sequence. The concentration of sulfamethoxazole about (1-15) μg. mL-1 with molar absorptivity of (14943.461) L.mol1 .cm-1 that obeyed Beer’s law. The detection and quantification limits were (0.852, 2.583) μg. mL-1 respectively, while the value of Sandell’s sensitivity (

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Publication Date
Sun Oct 26 2025
Journal Name
Journal Of Baghdad College Of Dentistry
Sonographic evaluation of masseter muscle thickness in bruxist and non-bruxist subjects
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Background: Masseter muscle is a jaw closing muscle of the mandible involved in Para functional habits; which include lip and cheek chewing, fingernail biting, and teeth clenching or bruxism which can be classified as awake or sleep bruxism. Patients with sleep bruxism are three to four times more likely to experience jaw pain and limitation of movement than people who do not experience sleep bruxism. The aim of this study is to measure the thickness of the masseter muscle in bruxist subjects and compare it with non-bruxist subjects by using sonography. Materials and Method: Forty Iraqi subjects with age ranged (20-40) divided into two groups according to the presence of bruxism. Clinical examination was made and masseter muscle thickness

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Publication Date
Wed Feb 07 2024
Journal Name
Egyptian Journal Of Chemistry
Spectrophotometric Estimation of Methyldopa Drug in pure and pharmaceutical formulations
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Publication Date
Sat Dec 01 2012
Journal Name
Al Mustansiriyah Journal Of Pharmaceutical Sciences
Formulation and In Vitro Evaluation of Mucoadhesive Antimicrobial Vaginal Tablets of Ciprofloxacin Hydrochloride
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Ciprofloxacin is a broad spectrum fluoroquinolone, effective in the treatment of a wide range of infections, including genitourinary tract infections.In this study, bioadhesive vaginal tablets of ciprofloxacin hydrochloride were prepared by direct compression method using a combination of bioadhesivepolymers carbopol 934P(Cp), carboxymethylcellulose (CMC) and sodium alginate (SA) in different ratios.The prepared tablet formulations were characterized by measuring their swelling capacity, surface pH, bioadhesive properties, and in-vitro drug dissolution. It was found that the bioadhesive force was directly proportional to carbopol 934P content in different formulae and was further enhanced by the inclusion of carboxymethylcellulose.

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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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