Beta-lactamase formulations and uses thereof
AssigneeTheriva Biologics, Inc.
InventorsAndrew Bristol, Michael Kaleko, Sheila Connelly
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Abstract
The present invention provides, in part, formulations comprising a beta-lactamase. Particularly, modified-release formulations comprising a beta-lactamase are provided which release a substantial amount of the beta-lactamase in the intestines. Therapeutic uses of the beta-lactamase formulations are also provided.
Claims16
A method of treating or preventing a Clostridium difficile infection (CDI) and/or a Clostridium difficile-associated disease in the gastrointestinal tract, comprising administering a modified-release formulation to a patient in need thereof, wherein the formulation comprises at least one modified-release pellet, and wherein each modified-release pellet comprises:
- about 10-20% by weight of a beta-lactamase which comprises an amino acid sequence having at least 95% sequence identity to SEQ ID NO:1, 3 or 6;
- about 20-30% by weight sucrose sphere;
- about 30-40% by weight hydroxypropylcellulose;
- about 15-25% by weight an enteric polymer;
- about 1.5-2.5% by weight triethyl citrate;
- about 0.5-15% by weight glyceryl monostearate;
- about 0.1-10% by weight polysorbate-80;
- and
- about 1-2% by weight of buffer salt.
A method of treating or preventing a Clostridium difficile infection (CDI) and/or a Clostridium difficile-associated disease in the gastrointestinal tract, comprising administering a modified-release formulation to a patient in need thereof, wherein the formulation comprises at least one modified-release pellet, and wherein each modified-release pellet comprises:
- about 16% by weight of a beta-lactamase;
- about 23% by weight sucrose sphere;
- about 35% by weight hydroxypropylcellulose;
- about 21% by weight an enteric polymer;
- about 2% by weight triethyl citrate;
- about 1% by weight glyceryl monostearate;
- about 0.5% by weight polysorbate-80;
- and
- about 2% by weight of buffer salt;
- wherein the beta-lactamase comprises an amino acid sequence having the sequence of SEQ ID NO:
- 1 with an asparagine at Ambler position 276.
Dependencies are inferred from the claim text.