US 11,998,640 B2
Room temperature stable oral calcitonin formulation
James P. Gilligan, Denville, NJ (US); George R. Maurer, Bell Mead, NJ (US); Aniruddha M. Railkar, Ambler, PA (US); Phillip Bauer, Highland Park, IL (US); Thomas A. Daggs, Verona, NJ (US); and Paul P. Shields, North Caldwell, NJ (US)
Assigned to Park Therapeutics, Inc., Monmouth Junction, NJ (US); and Enteris Biopharma, Inc., Boonton, NJ (US)
Filed by PARK THERAPEUTICS, INC., Monmouth Junction, NJ (US); and ENTERIS BIOPHARMA, INC, Boonton, NJ (US)
Filed on Feb. 18, 2022, as Appl. No. 17/675,643.
Application 17/675,643 is a division of application No. 16/267,902, filed on Feb. 5, 2019, granted, now 11,285,113.
Application 16/267,902 is a continuation of application No. PCT/US2017/045229, filed on Aug. 3, 2017.
Claims priority of provisional application 62/371,377, filed on Aug. 5, 2016.
Prior Publication US 2023/0000779 A1, Jan. 5, 2023
Int. Cl. A61K 9/28 (2006.01); A61K 9/20 (2006.01); A61K 38/23 (2006.01); A61P 19/02 (2006.01); A61P 19/10 (2006.01)
CPC A61K 9/2886 (2013.01) [A61K 9/2018 (2013.01); A61K 9/2081 (2013.01); A61K 9/2846 (2013.01); A61K 9/2853 (2013.01); A61K 9/2893 (2013.01); A61K 38/23 (2013.01); A61P 19/02 (2018.01); A61P 19/10 (2018.01); A61K 9/2095 (2013.01)] 20 Claims
 
1. A method for preparing a tablet for oral delivery of calcitonin comprising:
(a) dry blending calcitonin, silicified microcrystalline cellulose, coated citric acid, copovidone, crospovidone, and magnesium stearate;
(b) compressing the blended mixture into a tablet core;
(c) applying a water-soluble barrier layer in an initial spray at a first spray rate sufficient to add approximately 0.25% (w/w) to the tablet core in about 30 minutes at an average product temperature of at least 45° C.; and
(d) applying an enteric coating.