title: Stability of propranolol in extemporaneously compounded suspensions.
abstract: BACKGROUND
  Propranolol is a drug of choice for many diseases occurring in neonates and infants, an age group for which oral suspensions are required almost exclusively. Many adult and elderly patients for whom propranolol is prescribed are also unable to swallow solid dosage forms. In Canada, propranolol is not commercially available in a liquid dosage form, and existing recipes for extemporaneously compounded suspensions of propranolol (1 mg/mL) are limited by concerns regarding diabetes mellitus in certain subpopulations, the need for a more concentrated suspension for patients taking larger doses, and the tediousness of compounding.
  
  
  OBJECTIVE
  To evaluate the stability of propranolol suspensions in a sugar-free, commercially available vehicle after storage at room temperature and under refrigeration for up to 120 days.
  
  
  METHODS
  Suspensions of propranolol (2 and 5 mg/mL) were prepared in the sugar-free vehicle (Ora-Blend SF), placed in 100-mL amber plastic prescription bottles, and stored at 25°C and 4°C. Samples were collected from each bottle once weekly for 120 days, stored frozen, and analyzed by a validated, stability-indicating high-performance liquid chromatography - ultraviolet detection method. A suspension was considered stable if it maintained at least 90% of its initial concentration of propranolol. Physical compatibility was evaluated in terms of colour, taste, precipitation, and pH.
  
  
  RESULTS
  Propranolol suspensions 2 mg/mL and 5 mg/mL stored at 25°C maintained at least 94.7% of their initial concentration for 120 days, and suspensions stored at 4°C maintained at least 93.9% of their initial concentration for 120 days. There were no notable changes in pH, and all samples remained physically unchanged except for a slight change in colour, around day 70, of suspensions stored at room temperature.
  
  
  CONCLUSIONS
  Propranolol suspensions (2 mg/mL and 5 mg/mL) prepared in Ora-Blend SF and stored in plastic prescription bottles at either 25°C or 4°C are expected to remain stable for 120 days.
authors.affiliation: , BS(Pharm), PharmD, FASHP, FCCP, FCSHP, is Professor, Faculty of Pharmaceutical Sciences and Distinguished University Scholar, The University of British Columbia, and Clinical Pharmacy Specialist, Department of Pharmacy, Children's and Women's Health Centre of British Columbia, Vancouver, British Columbia. She is also the Editor of the CJHP .
authors.forename: Mary H H
authors.initials: MH
authors.lastname: Ensom
authors.forename: Jennifer
authors.initials: J
authors.lastname: Kendrick
authors.forename: Susan
authors.initials: S
authors.lastname: Rudolph
authors.forename: Diane
authors.initials: D
authors.lastname: Decarie
keywords: propranolol; stability; suspension