title: Preparation and stability evaluation of extemporaneous oral suspension of valsartan using commercially available tablets.
abstract: 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.
authors.affiliation: Department of Pharmacy, Faculty of Medicine & Health Sciences, An-Najah National University, Nablus, Palestine. anzaid@najah.edu
authors.forename: Abdel Naser
authors.initials: AN
authors.lastname: Zaid
authors.affiliation: Department of Pharmacy, An-Najah National University, Nablus, Palestine
authors.forename: Mohyeddin
authors.initials: M
authors.lastname: Assali
authors.affiliation: Pharmacare Ltd., Beitunia, Ramallah, Palestine
authors.forename: Aiman
authors.initials: A
authors.lastname: Qaddomi
authors.affiliation: Pharmacare Ltd., Beitunia, Ramallah, Palestine
authors.forename: Mashhour
authors.initials: M
authors.lastname: Ghanem
authors.affiliation: Pharmacare Ltd., Beitunia, Ramallah, Palestine
authors.forename: Yara Abu
authors.initials: YA
authors.lastname: Zaaror
mesh_terms: D000284:Administration, Oral; D047228:Angiotensin II Type 1 Receptor Blockers / Q000008:administration & dosage / Q000737:chemistry*; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D004339:Drug Compounding; D054796:Drug Dosage Calculations; D004355:Drug Stability; D007700:Kinetics; D012995:Solubility; D013535:Suspensions; D013607:Tablets; D013777:Tetrazoles / Q000008:administration & dosage / Q000737:chemistry*; D014633:Valine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000737:chemistry; D000068756:Valsartan
chemical_list: D047228:Angiotensin II Type 1 Receptor Blockers; D013535:Suspensions; D013607:Tablets; D013777:Tetrazoles; D000068756:Valsartan; D014633:Valine