Thermostable quick-dissolving thin film
OwnerChristophe Debacq, Phillip Lovalenti +4inventors
InventorsChristophe Debacq, Phillip Lovalenti, Van Nguyen, Laurence Plapied, Laurent Strodiot, Austin Wuerfel
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Abstract
The present invention relates to thermostable quick-dissolving thin films comprising a biological moiety and an excipient mix which are suitable for the formulation of biological moieties such as viral vaccines, to methods for manufacturing such thermostable quick-dissolving thin films, and to their use in therapy. The excipient mix comprises one or more water-soluble polymer(s), a sugar selected from sucrose, trehalose and a combination thereof, a metal ion, a carboxylate, and a buffering agent.
Claims20
A quick-dissolving thin film comprising a virus and an excipient mix, wherein said excipient mix comprises
- one or more water-soluble polymer(s),
- trehalose,
- a metal ion,
- a carboxylate, and
- a buffering agent,
- wherein said quick-dissolving thin film is thermostable, and
- wherein said quick-dissolving thin film does not comprise any animal derived product or gelatin.
A method for preparing a thermostable quick-dissolving thin film comprising:
- a) preparing an aqueous solution comprising or consisting of
- a virus,
- one or more water-soluble polymer(s),
- trehalose,
- a metal ion,
- a carboxylate, and
- one or more buffering agents,
- wherein said aqueous solution does not comprise any animal derived product or gelatin,
- b) adjusting the pH of the aqueous solution to a value comprised between 5 and 9,
- c) applying the aqueous solution on a drying surface,
- d) drying the aqueous solution to obtain a thin film, and
- e) removing the dried thin film from the drying surface,
- thereby obtaining said thermostable quick-dissolving thin film.
Dependencies are inferred from the claim text.