title: Stability of celecoxib oral suspension.
abstract: BACKGROUND
  Celecoxib is a selective cyclo-oxygenase 2 inhibitor that relieves pain without affecting platelet function, causing gastrointestinal toxic effects, or increasing the risk of bleeding.
  
  
  OBJECTIVE
  To develop a suspension formulation for oral celecoxib and to determine its physical and chemical stability when packaged in amber polyvinyl chloride (PVC) bottles and stored with refrigeration (5°C) and at room temperature (23°C).
  
  
  METHODS
  The contents of celecoxib capsules were used to prepare a single suspension, with Ora-Blend used as the suspending and flavouring agent. The suspension (10 mg/mL) was then packaged in amber PVC bottles and stored at either 5°C or 23°C. Samples were collected on days 0, 7, 14, 21, 27, 56, and 93. Chemical stability was determined using a validated stability-indicating high-performance liquid chromatography method. At each sampling time, the suspensions were checked visually for changes in appearance (i.e., colour, layering, caking, and ease of resuspension), odour, and pH.
  
  
  RESULTS
  All of the suspensions were stable for at least 93 days, regardless of storage conditions. There were no apparent changes in physical appearance, nor were there any substantial changes in odour or pH.
  
  
  CONCLUSIONS
  Suspensions of celecoxib (10 mg/mL in Ora-Blend) packaged in amber PVC bottles were stable for up to 93 days when stored at 5°C or 23°C. A 3-month expiry date has been established for this oral suspension on the basis of physical compatibility and chemical stability.
authors.affiliation: , MSc(Chem), BSC(Pharm), is Product Development Pharmacist, Department of Pharmaceutical Sciences, The Ottawa Hospital (Civic Campus), Ottawa, Ontario.
authors.forename: Ronald F
authors.initials: RF
authors.lastname: Donnelly
authors.forename: Elena
authors.initials: E
authors.lastname: Pascuet
authors.forename: Carmen
authors.initials: C
authors.lastname: Ma
authors.forename: Régis
authors.initials: R
authors.lastname: Vaillancourt