Packaging-Induced Interactions and Degradation

Part of the Biotechnology: Pharmaceutical Aspects book series (PHARMASP, volume XII)


Forced degradation studies are typically used to determine the potential degradation products that may form during formal stability studies that are conducted on drug substances and drug products. Occasionally, impurities are detected in stability studies that were not observed in the forced degradation studies. Such observations can result from poorly designed forced degradation studies (of the drug substance and/or drug product) that failed to generate all of the relevant degradation products. Potential interaction of the drug with packaging or shipping materials may not be effectively captured unless studies are designed to look for these potential interactions. Migration of materials into drug substance or product may result in simple contamination. However, migratory species may also be reactive and form new drug-related impurities. Several examples are shared to highlight drug substance and drug product interactions with packaging components that fit into the above categories.


Drug Substance Packaging Material Forced Degradation Study Packaging Component Outer Laminate 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.


  1. Balough M, Lennon JD, Hendricker AD, Feinberg TN (2007) LC-GC 25(8):710–717Google Scholar
  2. Fliszar KA, Walker D, Allain L (2006) PDA J Pharm Sci Tech 60(6):337–342Google Scholar
  3. Jaminet F (1968) Inst Pharm Prod Probl Pharm 23(7):375–391Google Scholar
  4. Jenke DR (2002) PDA J Pharm Sci Tech 56(6):332–371Google Scholar
  5. Maus RG, Li M, Clement CM, Kinzer JA (2007) Gas phase transfer of polymer cross-linking agents and by-products to solid oral pharmaceuticals. J Pharm Biomed Anal 45(3):400–406CrossRefPubMedGoogle Scholar
  6. Nassar MN, Nesarikar VV, Lozano R (2005) Degradation of a lyophilized formulation of BMS-204352: identification of degradants and role of elastomeric closures. Pharm Dev Technol 10(2):227–232PubMedGoogle Scholar
  7. Pellerin F et al. (1991) Interactions and migrations among plastic materials and drugs. Analytical approach. Matieres Plast Usage Pharm, 2nd edn. Ed. Med. Int., Cachan, pp. 273–301Google Scholar
  8. Qin X-Z, Ip DP, Chang KH-C, Dradransky PM, Brooks MA, Sakuma T (1994) Pharmaceutical application of LC-MS. 1 – characterization of a famotidine degradate in a package screening study by LC-APCI MS. J Pharm Biomed Anal 12(2):221–233CrossRefPubMedGoogle Scholar
  9. Takacsi N (1989) Orsz Gyogysz Intez 26(5):157–159Google Scholar

Copyright information

© American Association of Pharmaceutical Scientists 2010

Authors and Affiliations

  1. 1.Eli Lilly and CompanyIndianapolisUSA

Personalised recommendations