tetano
Editor, Senior Moderator
Int J Pharm. 2015 Feb 6. pii: S0378-5173(15)00105-2. doi: 10.1016/j.ijpharm.2015.01.053. [Epub ahead of print]
[h=1]Stability of collapse lyophilized influenza vaccine formulations.[/h] Anamur C[SUP]1[/SUP], Winter G[SUP]1[/SUP], Engert J[SUP]2[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] A clear limitation of many liquid vaccines is the obligatory cold-chain distribution system. Therefore, distribution of a dried vaccine formulation may be beneficial in terms of vaccine stability, handling and transport. Collapse freeze-drying is a process which utilizes fairly aggressive but at the same time economic lyophilization cycles where the formulation is dried above its glass transition temperature. In this study, we used collapse freeze-drying for a thermosensitive model influenza vaccine (Pandemrix[SUP]?[/SUP]). The dried lyophilizates were further cryo-milled to engineer powder particles in the size range of approximately 20-80μm which is applicable for epidermal powder immunization. Vaccine potency and stability were neither affected by high temperature input during collapse lyophilization nor over a storage period of six months. Furthermore, cryo-milled vaccine lyophilizates showed good storage stability of up to three months at high storage temperature (40?C). This technique can provide a powerful tool for the worldwide distribution of vaccine and for new application technologies such as engineered powder immunization.
Copyright ? 2015. Published by Elsevier B.V.
[h=4]KEYWORDS:[/h] Collapse lyophilization; Cryo-milling; Influenza vaccine; Powder immunization; Vaccination
PMID: 25660049 [PubMed - as supplied by publisher]
[h=1]Stability of collapse lyophilized influenza vaccine formulations.[/h] Anamur C[SUP]1[/SUP], Winter G[SUP]1[/SUP], Engert J[SUP]2[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] A clear limitation of many liquid vaccines is the obligatory cold-chain distribution system. Therefore, distribution of a dried vaccine formulation may be beneficial in terms of vaccine stability, handling and transport. Collapse freeze-drying is a process which utilizes fairly aggressive but at the same time economic lyophilization cycles where the formulation is dried above its glass transition temperature. In this study, we used collapse freeze-drying for a thermosensitive model influenza vaccine (Pandemrix[SUP]?[/SUP]). The dried lyophilizates were further cryo-milled to engineer powder particles in the size range of approximately 20-80μm which is applicable for epidermal powder immunization. Vaccine potency and stability were neither affected by high temperature input during collapse lyophilization nor over a storage period of six months. Furthermore, cryo-milled vaccine lyophilizates showed good storage stability of up to three months at high storage temperature (40?C). This technique can provide a powerful tool for the worldwide distribution of vaccine and for new application technologies such as engineered powder immunization.
Copyright ? 2015. Published by Elsevier B.V.
[h=4]KEYWORDS:[/h] Collapse lyophilization; Cryo-milling; Influenza vaccine; Powder immunization; Vaccination
PMID: 25660049 [PubMed - as supplied by publisher]