US 12,337,024 B2
Larazotide formulations
Balasingham Radhakrishnan, Raleigh, NC (US); Jay P. Madan, Raleigh, NC (US); and Gary F. Musso, Raleigh, NC (US)
Assigned to Interlude Biopharma Co., Miami, FL (US)
Appl. No. 17/635,441
Filed by Interlude Biopharma Co., Miami, FL (US)
PCT Filed Aug. 14, 2020, PCT No. PCT/US2020/046272
§ 371(c)(1), (2) Date Feb. 15, 2022,
PCT Pub. No. WO2021/034629, PCT Pub. Date Feb. 25, 2021.
Claims priority of provisional application 63/009,768, filed on Apr. 14, 2020.
Claims priority of provisional application 62/888,052, filed on Aug. 16, 2019.
Prior Publication US 2022/0331392 A1, Oct. 20, 2022
Int. Cl. A61K 38/08 (2019.01); A61K 9/16 (2006.01); A61K 9/28 (2006.01); A61P 1/04 (2006.01)
CPC A61K 38/08 (2013.01) [A61K 9/1635 (2013.01); A61K 9/1652 (2013.01); A61K 9/282 (2013.01); A61K 9/2846 (2013.01); A61K 9/2893 (2013.01); A61P 1/04 (2018.01)] 17 Claims
OG exemplary drawing
 
1. An oral composition comprising an effective amount of a peptide that is larazotide or a larazotide derivative, or salt thereof, contained within a biodegradable or erodible polymer matrix comprising microcrystalline cellulose that provides for sustained release of the peptide in simulated intestinal fluid having a pH of 7.0 for at least about 120 minutes;
wherein the composition further comprises an enteric coating that is resistant to dissolution in simulated gastric fluid or simulated intestinal fluid having a pH of 5.5 or less, wherein the composition provides for less than about 25% release of the peptide after two hours in said simulated gastric fluid or simulated intestinal fluid.