title: Physical stability and resistance to peroxidation of a range of liquid-fill hard gelatin capsule products on extreme long-term storage.
abstract: BACKGROUND
  The industrial take-up of liquid-fill hard capsule technology is limited in part by lack of published long-term physical and chemical stability data which demonstrate the robustness of the system.
  
  
  OBJECTIVE
  To assess the effects of extreme long-term storage on liquid-fill capsule product quality and integrity, with respect to both the capsules per se and a standard blister-pack type (foil-film blister).
  
  
  METHODS
  Fourteen sets of stored peroxidation-sensitive liquid-fill hard gelatin capsule product samples, originating ~20 years from the current study, were examined with respect to physical and selected chemical properties, together with microbiological evaluation.
  
  
  CONCLUSIONS
  All sets retained physical integrity of capsules and blister-packs. Capsules were free of leaks, gelatin cross-linking, and microbiological growth. Eight samples met a limit (anisidine value, 20) commonly used as an index of peroxidation for lipid-based products with shelf lives of 2-3 years. Foil-film blister-packs using PVC or PVC-PVdC as the thermoforming film were well-suited packaging components for the liquid-fill capsule format.
  
  
  CONCLUSIONS
  The study confirms the long-term physical robustness of the liquid-fill hard capsule format, together with its manufacturing and banding processes. It also indicates that various peroxidation-sensitive products using the capsule format may be maintained satisfactorily over very prolonged storage periods.
authors: Encap Drug Delivery, Livingston, UK. bbowtle@encapdrugdelivery.com
authors: William
authors: W
authors: Bowtle
authors: Lionel
authors: L
authors: Kanyowa
authors: Mark
authors: M
authors: Mackenzie
authors: Paul
authors: P
authors: Higgins
mesh_terms: D002214:Capsules; D004349:Drug Packaging; D004355:Drug Stability; D004356:Drug Storage; D005780:Gelatin / Q000737:chemistry*; D015227:Lipid Peroxidation; D013997:Time Factors
chemical_list: D002214:Capsules; D005780:Gelatin