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Publication Number
US-11110163-B2
Publication Date
2021-09-07
Expiration Date
Abstract
The invention is directed to an oral vaccine composed of a micronized freeze-dried rotavirus particle suspension with buffering excipients in a non-aqueous liquid. This IVT-06 formulation has imparted heat stability by protecting the virus at temperatures of 30° C. and 40° C. for at least twelve months. Extrapolations from the 12-month stability data indicate a shelf life of more than two years at 30° C., and six months at 50° C. In addition, for ease of administration, the formulated dose has a volume of 0.5 mL.
Core Innovation
The invention relates to an oral, non-aqueous thermo-stable rotavirus vaccine (IVT-06) that is formulated as an immunogenic composition including an attenuated rotavirus, a low-moisture and micronized particle suspension, and an MCT oil vehicle. A lyophilized rotavirus particle suspension is micronized and suspended in MCT oil with buffering excipients to produce the IVT-06 formulation.
The disclosed formulation targets a moisture content of less than or equal to about 1.2%, an approximate uniform particle size of about 5 µm or less, and a buffering environment intended to support pH stability. Arginine and sucrose are used together, and the disclosure identifies a lead formulation including 4% L-arginine with a Hepes buffer and citrate/calcium carbonate buffering improvements.
The invention further relies on achieving a high glass transition temperature (Tg) to enable heat stability of the non-aqueous composition. The disclosure reports accelerated and predicted stability for IVT-06, including protection at 30°C and 40°C for at least 12 months, with extrapolated shelf life greater than 2 years at 30°C and about 6 months at 50°C.
Claims Coverage
The document provides two independent claims centered on an immunogenic rotavirus composition in a non-aqueous MCT-based formulation with low moisture, uniform small particle size, a buffering agent, and specified minimum rotavirus titer; one independent claim additionally requires a glass transition temperature threshold.
Non-aqueous MCT immunogenic rotavirus composition
An immunogenic composition comprising an attenuated strain of a rotavirus at a titer of about 10^5.9 FFU/mL or higher, a buffering agent, and medium-chain triglyceride (MCT).
Arginine-sucrose formulation with low moisture and micronized particle size
An immunogenic composition comprising arginine and sucrose at a ratio of from about 1:1.1-2.5, less than or equal to about 1.2% moisture, and an approximate uniform particle size of about 5 µm or less.
Glass transition temperature enhanced MCT immunogenic rotavirus composition
An immunogenic composition comprising an attenuated strain of a rotavirus at a titer of about 10^5.9 FFU/mL or higher, less than or equal to about 1.2% moisture, an approximate uniform particle size of about 5 µm or less, a buffering agent, and medium-chain triglyceride (MCT), wherein the composition has a glass transition temperature of about 60°C or higher.
Across the independent claims, the core coverage is an immunogenic composition containing an attenuated rotavirus with a minimum titer, combined with low moisture, approximately uniform particles of about 5 µm or less, a buffering agent, and an MCT vehicle; one independent claim further requires a glass transition temperature of about 60°C or higher.
Stated Advantages
Heat stability enabling predicted and accelerated protection of the vaccine, including protection at 30°C and 40°C for at least 12 months.
Extrapolated shelf life greater than 2 years at 30°C.
Extrapolated stability of about 6 months at 50°C.
Retention of rotavirus efficacy without significant loss after storage at elevated temperatures as constrained by the dependent claims.
Buffering performance maintained by a buffering agent to support pH stability including gastric buffering above pH 4.0.
Documented Applications
No documented applications found
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