Thermostable quick-dissolving thin film
Inventors
DEBACQ, Christophe • LOVALENTI, Phillip • Nguyen, Van • PLAPIED, Laurence • STRODIOT, Laurent • WUERFEL, Austin
Assignees
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Publication Number
US-12214087-B2
Publication Date
2025-02-04
Expiration Date
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.
Core Innovation
The invention relates to a quick-dissolving thin film comprising a virus and an excipient mix. The excipient mix comprises one or more water-soluble polymer(s), trehalose, a metal ion, a carboxylate, and a buffering agent. The quick-dissolving thin film is thermostable and is formulated as a thin film intended to quickly dissolve.
The problem addressed is maintaining the biological activity of a virus in a quick-dissolving thin film while providing thermostability suitable for use over time at elevated temperatures. The disclosed approach targets preserved viral titer over time at 20–30°C and at 40°C for weeks.
The disclosed film excludes any animal derived product or gelatin and uses an excipient combination intended to support thermostability together with rapid dissolution. Documented formulations include water-soluble polymers such as PVA, and trehalose, together with metal ions such as Zn2+, carboxylates such as citric acid, and buffering agents such as phosphate buffer or histidine base.
Claims Coverage
The provided independent claim presents three inventive features: a virus-containing quick-dissolving thin film with a defined excipient mix, thermostability, and exclusion of animal-derived product or gelatin.
Virus-containing quick-dissolving thin film with defined excipient mix
A quick-dissolving thin film comprising a virus and an excipient mix including one or more water-soluble polymer(s), trehalose, a metal ion, a carboxylate, and a buffering agent.
Thermostable quick-dissolving thin film
The quick-dissolving thin film is thermostable.
Exclusion of animal-derived product or gelatin
The quick-dissolving thin film does not comprise any animal derived product or gelatin.
Coverage centers on a thermostable quick-dissolving thin film containing a virus formulated with an excipient mix of water-soluble polymer(s), trehalose, a metal ion, a carboxylate, and a buffering agent, while excluding animal derived product or gelatin.
Stated Advantages
Thermostability while providing a quick-dissolving thin film.
Does not comprise any animal derived product or gelatin.
Documented Applications
Therapeutic and preventive use against infectious disease, including rotavirus oral thin film (OTF) use context.
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