US 11,883,474 B2
Microbiome protection from oral antibiotics
Michael Kaleko, Rockville, MD (US); and Sheila Connelly, Rockville, MD (US)
Assigned to Theriva Biologics, Inc., Rockville, MD (US)
Filed by Theriva Biologics, Inc., Rockville, MD (US)
Filed on Oct. 26, 2022, as Appl. No. 18/049,791.
Application 18/049,791 is a continuation of application No. 16/313,488, granted, now 11,517,614, previously published as PCT/US2017/039672, filed on Jun. 28, 2017.
Claims priority of provisional application 62/355,599, filed on Jun. 28, 2016.
Prior Publication US 2023/0270830 A1, Aug. 31, 2023
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 38/50 (2006.01); A61K 9/00 (2006.01); A61K 9/48 (2006.01); A61K 9/50 (2006.01); A61K 31/424 (2006.01); A61K 38/14 (2006.01)
CPC A61K 38/50 (2013.01) [A61K 9/0053 (2013.01); A61K 9/4808 (2013.01); A61K 9/4858 (2013.01); A61K 9/4866 (2013.01); A61K 9/4891 (2013.01); A61K 9/5026 (2013.01); A61K 9/5084 (2013.01); A61K 31/424 (2013.01); C12Y 305/02006 (2013.01); A61K 38/14 (2013.01)] 22 Claims
 
1. A method of protecting a subject's gastrointestinal (GI) microbiome from an oral antibiotic, comprising administering a formulation comprising a beta-lactamase capable of deactivating the oral antibiotic to a subject who is undergoing treatment or has recently undergone treatment with the oral antibiotic, wherein:
the formulation comprises an enterically coated capsule comprising an enterically coated pellet, the pellet comprising, relative to a pellet's weight:
about 20% to 25% sucrose sphere;
about 30% to 40% binder excipient;
about 12% to 18% beta-lactamase;
about 1% to 2% buffer salts;
about 0.5% to 3% plasticizer; and
about 15% to 30% EUDRAGIT® (poly(methacrylic acid, methylmethacrylate) coating,
wherein the oral antibiotic is co-formulated with one or more beta-lactamase inhibitors.