Preparation and Stability Evaluation of Extemporaneous Oral Suspension of Valsartan Using Commercially Available Tablets

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Journal Title, Volume, Page: 
International journal of pharmaceutical compounding, 18, 169-174
Year of Publication: 
2014
Authors: 
Abdel Naser Zaid
Department of Pharmacy of An-Najah National University and is a member of faculty of Medicine & Health Sciences, Nablus, Palestine
Current Affiliation: 
Department of Pharmacy of An-Najah National University and is a member of faculty of Medicine & Health Sciences, Nablus, Palestine
Mohyeddin Assali
Department of Pharmacy of An-Najah National University and is a member of faculty of Medicine & Health Sciences, Nablus, Palestine
Current Affiliation: 
Department of Pharmacy of An-Najah National University and is a member of faculty of Medicine & Health Sciences, Nablus, Palestine
Aiman Qaddomi
Pharmacare Ltd. Beitunia, Ramallah, Palestine
Current Affiliation: 
Pharmacare Ltd. Beitunia, Ramallah, Palestine
Mashhour Ghanem
Pharmacare Ltd. Beitunia, Ramallah, Palestine
Current Affiliation: 
Pharmacare Ltd. Beitunia, Ramallah, Palestine
Yara Abu Zaaror
Pharmacare Ltd. Beitunia, Ramallah, Palestine
Current Affiliation: 
Pharmacare Ltd. Beitunia, Ramallah, Palestine
Preferred Abstract (Original): 

The aim of this study was to develop an extemporaneous valsartan suspension (80 mg valsartan/ 5 mL) starting from commercial tablets (80-mg/ tablet). A high-performance liquid chromatographic system was used for the analysis and quantification of valsartan in the samples studied. Samples of valsartan suspension for analysis were prepared as reported by the validated high-performance liquid chromatographic method and the dissolution tests were performed according to the U.S. Food and Drug Administration’s method. The high-performance liquid chromatographic assay indicated that the 80-mg/5-mL valsartan suspension was stable for 30 days when stored at long-term and accelerated storage conditions. Valsartan release profile showed that approximately 85% of valsartan dissolved after 10 minutes and, accordingly, the calculation of similarity factor was not necessary. It is possible for the pharmacist to crush valsartan 80-mg tablets and prepare a suspension which has dosage flexibility that can be calculated according to  body-surface area, kidney, and liver functions, without affecting the chemical stability of the active ingredient nor its dissolution profile and also have a cost-effective dosage form.

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