US 12,370,147 B2
Coatable core for a modified release drug formulation
Thomas Buser, Nuglar (CH); Yalcin Cetinkaya-Coskun, Rheinfelden (CH); and Roberto Carlos Bravo González, Rheinfelden (CH)
Assigned to Tillotts Pharma AG, Rheinfelden (CH)
Appl. No. 17/309,557
Filed by Tillotts Pharma AG, Rheinfelden (CH)
PCT Filed Dec. 5, 2019, PCT No. PCT/EP2019/083911
§ 371(c)(1), (2) Date Jun. 4, 2021,
PCT Pub. No. WO2020/115256, PCT Pub. Date Jun. 11, 2020.
Claims priority of application No. 18211145 (EP), filed on Dec. 7, 2018.
Prior Publication US 2022/0016040 A1, Jan. 20, 2022
Int. Cl. A61K 9/20 (2006.01); A61K 9/28 (2006.01); A61K 31/196 (2006.01)
CPC A61K 9/2893 (2013.01) [A61K 9/2054 (2013.01); A61K 31/196 (2013.01)] 12 Claims
 
1. A method of producing a coatable core for a modified release drug formulation for oral administration, the coatable core having a high drug load of at least 70 wt % based on a total weight of the coatable core, wherein the drug is present in the core in an amount of more than 1200 mg, the method comprising:
granulating a composition comprising a drug and at least one binder to form granules;
blending the granules with a pharmacologically acceptable disintegrant and optionally, one or more additional pharmacologically acceptable excipients, to form a compression blend, wherein the disintegrant is present in an amount from about 0.5 wt % to about 5 wt %, based on the total weight of the coatable core; and
compressing the compression blend using an external lubrication compression method, to form a coatable core.