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US 12,746,340 B2Granted
Formulations, methods, and pre-filled multi-dose injection devices without cloud point
AssigneeW. L. Gore & Associates, Inc.
InventorsEdward C. Gunzel, Thomas W. Patapoff
Life of this patent
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Abstract
The present disclosure is directed to pre-filled multi-dose injection devices and related therapeutic formulations and methods that lack a cloud point. The therapeutic formulation may be a transparent solution, and preservatives may remain within the aqueous phase without being phase separated to retain antimicrobial effectiveness.
Claims20
A pre-filled multi-dose injectable device comprising:
- a stopper;
- a barrel;
- a solid lubricant on at least one of the stopper and the barrel, the pre-filled multi-dose injectable device being free or substantially free of a liquid lubricant;
- and
- at least one formulated therapeutic comprising:
- an active pharmacological agent selected from small interfering RNAs (siRNAs), small interfering DNAs (siDNAs), messenger RNAs (mRNAs), aptamers, and/or a combination thereof;
- and
- at least one phenolic or benzyl alcohol preservative;
- wherein the at least one formulated therapeutic is free or substantially free of a surfactant, wherein the surfactant comprises at least one of polysorbate 20, polysorbate 40, polysorbate 60, polysorbate 80, or a combination thereof, and exhibits a turbidity increase of less than 30 nephelometric turbidity units (NTU) upon warming from 5° C. to 30° C.
6 more elements
Dependencies are inferred from the claim text.