Valsartan

saedkh's picture

Formulation and Bioequivalence of Two Valsartan Tablets After a Single Oral Administration

Journal Title, Volume, Page: 
Sci Pharm. Mar 2011; 79(1): 123–135. Published online Nov 20, 2010. doi: 10.3797/scipharm.1009-01
Year of Publication: 
2010
Authors: 
Abdel Naser Zaid
Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, Palestine
Rita Cortesi
Department of Pharmaceutical Sciences, University of Ferrara, ViaFossato di Mortara, 17–19, 44100. Ferrara, Italy
Aiman Qaddomi
Pharmacare Ltd. Beitunia, P.O. Box: 677, Ramallah, Palestine
Saed Khammash
Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, Palestine
Current Affiliation: 
Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, Palestine
Preferred Abstract (Original): 

The aim of this study is to assess the quality of Valzan® tablet (160 mg, valsartan immediate release test formulation) by comparing its pharmacokinetic parameters with Diovan® tablet (160 mg, valsartan reference formulation). Valzan® tablets were prepared according to a dry granulation method (roll compaction). To assess the bioequivalence of Valzan® tablets a randomized, two-way, crossover, bioequivalence study was performed in 24 healthy male volunteers. The selected volunteers were divided into two groups of 12 subjects. One group was treated with the reference formulation (Diovan®) and the other one with the generic Valzan®, with a cross-over after the drug washout period of 14 days. Blood samples were collected at fixed time intervals and valsartan concentrations were determined by a validated HPLC assay method. The pharmacokinetic parameters AUC0–48, AUC0–∞, Cmax, Tmax, Ke and T1/2 were determined for both the tablets and were compared statistically to evaluate the bioequivalence between the two brands of valsartan, using the statistical model recommended by the FDA. The analysis of variance (ANOVA) did not show any significant difference between the two formulations and 90% confidence intervals (CI) fell within the acceptable range for bioequivalence. Based on this statistical evaluation it was concluded that the test tablets (Valzan®) is well formulated, since it exhibits pharmacokinetic profile comparable to the reference brand Diovan®.

2384's picture

Tablet Formulation and Development of a Validated Stability Indicating HPLC Method for Quantification of Valsartan and Hydrochlorthiazide Combination

Journal Title, Volume, Page: 
International Journal of Pharmacy & Pharmaceutical Sciences;Jul2012, Vol. 4 Issue 3,
Year of Publication: 
2012
Authors: 
Abdel Naser Zaid
An-Najah National University, Nablus, Palestine
Current Affiliation: 
Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, Palestine
Nidal Jaradat
An-Najah National University, Nablus, Palestine
Raqi Shubitah
An-Najah National University, Nablus, Palestine
Murad Abualhasan
An-Najah National University, Nablus, Palestine
Muman Malkieh
Jerusalem Pharmaceuticals Co., Al Bireh, Ramallah, Palestine
Maher Kharoaf
Jerusalem Pharmaceuticals Co., Al Bireh, Ramallah, Palestine
Preferred Abstract (Original): 

This study was aimed to develop valsartan/ hydrochlorothiazide tablet formulation and to develop a stability indicating HPLC method for their analysis in raw materials and in its final dosage form according to the ICH guidelines. Film coating tablets containing valsartan and hydrochlorothiazide were developed. A gradient HPLC method was performed; the flow rate was 1.5 ml/min, injected volume 20μL, the mobile phases consist of two solvent: Solvent A (0.20 M ammonium acetate, adjusted to pH 5.6 with glacial acetic acid) and Solvent B (acetonitrile) and UV detection was carried out at 265nm. Valsartan and hydrochlorothiazide and their combined dosage form were exposed to thermal, oxidative, acid-base hydrolytic stress conditions, the stressed samples were analyzed. The method was validated with respect to linearity, precision, accuracy, system suitability, and robustness. The used method is specific for the estimation of valsartan and hydrochlorothiazide in presence of their degradation products and impurities. The method was linear over the range of 2.5–32μg/mL and 17.5-224μg/mL for valsartan and hydrochlorothiazide respectively. The mean recoveries were 100±2% for valsartan and hydrochlorothiazide respectively. The percentage of relative standard deviation (%RSD) was found to be less than critical value. Our developed analytical method is a stability indicating, economical and easy method which is useful in the quality control of valsartan and hydrochlorothiazide in tablet dosage forms.

M_abualhasan's picture

Tablet Formulation and Development of a Validated Stability Indicating HPLC Method for Quantification of Valsartan and Hydrochlorthiazide Combination

Journal Title, Volume, Page: 
SOURCE International Journal of Pharmacy & Pharmaceutical Sciences;Jul2012, Vol. 4 Issue 3, p284
Year of Publication: 
2012
Authors: 
MAHER KHAROAF
Jerusalem Pharmaceuticals Co., Al Bireh, Ramallah, Palestine
Muman Malkieh
Jerusalem Pharmaceuticals Co., Al Bireh, Ramallah, Palestine
Murad Abualhasan
An-Najah National University, Nablus, Palestine
Current Affiliation: 
Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, Palestine
Raqi Shubitah
An-Najah National University, Nablus, Palestine
Nidal Jaradat
An-Najah National University, Nablus, Palestine
Abdel Naser Zaid
An-Najah National University, Nablus, Palestine
Preferred Abstract (Original): 
This study was aimed to develop valsartan/ hydrochlorothiazide tablet formulation and to develop a stability indicating HPLC method for their analysis in raw materials and in its final dosage form according to the ICH guidelines. Film coating tablets containing valsartan and hydrochlorothiazide were developed. A gradient HPLC method was performed; the flow rate was 1.5 ml/min, injected volume 20μL, the mobile phases consist of two solvent: Solvent A (0.20 M ammonium acetate, adjusted to pH 5.6 with glacial acetic acid) and Solvent B (acetonitrile) and UV detection was carried out at 265nm. Valsartan and hydrochlorothiazide and their combined dosage form were exposed to thermal, oxidative, acid-base hydrolytic stress conditions, the stressed samples were analyzed. The method was validated with respect to linearity, precision, accuracy, system suitability, and robustness. The used method is specific for the estimation of valsartan and hydrochlorothiazide in presence of their degradation products and impurities. The method was linear over the range of 2.5–32μg/mL and 17.5-224μg/mL for valsartan and hydrochlorothiazide respectively. The mean recoveries were 100±2% for valsartan and hydrochlorothiazide respectively. The percentage of relative standard deviation (%RSD) was found to be less than critical value. Our developed analytical method is a stability indicating, economical and easy method which is useful in the quality control of valsartan and hydrochlorothiazide in tablet dosage forms.
2384's picture

Formulation and Bioequivalence of Two Valsartan Tablets after a Single Oral Administration

Journal Title, Volume, Page: 
Sci. Pharm. 2011; 79: 123–135
Year of Publication: 
2011
Authors: 
Abdel Naser ZAID
Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, Palestine
Current Affiliation: 
Department of Pharmacy, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, Palestine
Rita CORTESI
Department of Pharmaceutical Sciences, University of Ferrara, ViaFossato di Mortara, 17–19, 44100. Ferrara, Italy
Aiman QADDOMI
Pharmacare Ltd. Beitunia, P.O. Box: 677, Ramallah, Palestine
Saed KHAMMASH
College of Pharmacy, An-Najah National University, P.O. Box: 7, Nablus, Palestine
Preferred Abstract (Original): 

The aim of this study is to assess the quality of Valzan® tablet (160 mg, valsartan immediate release test formulation) by comparing its pharmacokinetic parameters with Diovan® tablet (160 mg, valsartan reference formulation). Valzan® tablets were prepared according to a dry granulation method (roll compaction). To assess the bioequivalence of Valzan® tablets a randomized, two-way, crossover, bioequivalence study was performed in 24 healthy male volunteers. The selected volunteers were divided into two groups of 12 subjects. One group was treated with the reference formulation (Diovan®) and the other one with the generic Valzan®, with a cross-over after the drug washout period of 14 days. Blood samples were collected at fixed time intervals and valsartan concentrations were determined by a validated HPLC assay method. The pharmacokinetic parameters AUC0–48, AUC0–∞, Cmax, Tmax, Ke and T1/2 were determined for both the tablets and were compared statistically to evaluate the bioequivalence between the two brands of valsartan, using the statistical model recommended by the FDA. The analysis of variance (ANOVA) did not show any significant difference between the two formulations and 90% confidence intervals (CI) fell within the acceptable range for bioequivalence. Based on this statistical evaluation it was concluded that the test tablets (Valzan®) is well formulated, since it exhibits pharmacokinetic profile comparable to the reference brand Diovan®.

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