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US 12,691,077 B2Granted
Alkaline phosphatase formulations and uses thereof
AssigneeTheriva Biologics, Inc.
InventorsMichael Kaleko, Ray Stapleton, Andrew Bristol, Steven Hubert, Cristina Freire
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Abstract
The present invention provides, in part, formulations comprising an alkaline phosphatase. Particularly, modified-release formulations comprising an alkaline phosphatase are provided, which release a substantial amount of the alkaline phosphatase in the intestines. Therapeutic uses of the alkaline phosphatase formulations are also provided.
Claims19
A modified-release formulation comprising at least one modified-release pellet comprising an alkaline phosphatase (AP)-based agent contained in a capsule, wherein the modified-release formulation comprises:
- about 5-15% by weight AP-based agent;
- about 35-45% by weight sucrose sphere;
- about 15-25% by weight hydroxypropylcellulose;
- about 0.1-1% by weight of buffer salt;
- about 20-30% by weight enteric polymer;
- and
- about 1-10% by weight coating system additive, wherein the coating system additive is a mixture of glyceryl monostearate, polysorbate-80, and triethyl citrate, wherein the formulation maintains at least 80% AP-based agent activity when stored at 2-8° C. for at least 6 months.
4 more elements
Dependencies are inferred from the claim text.