US 12,303,507 B2
Pharmaceutical composition of single dosage form for treating or preventing hypertension and hyperlipidemia
Ji Yeon Kim, Seoul (KR); and Bo Hoon Kim, Yongin-si (KR)
Assigned to DAEWOONG PHARMACEUTICAL CO., LTD., Hwaseong-si (KR)
Appl. No. 17/431,464
Filed by Daewoong Pharmaceutical Co., Ltd., Hwaseong-si (KR)
PCT Filed Feb. 26, 2020, PCT No. PCT/KR2020/002772
§ 371(c)(1), (2) Date Aug. 17, 2021,
PCT Pub. No. WO2020/175922, PCT Pub. Date Sep. 3, 2020.
Claims priority of application No. 10-2019-0022739 (KR), filed on Feb. 26, 2019.
Prior Publication US 2022/0133720 A1, May 5, 2022
Int. Cl. A61K 31/505 (2006.01); A61K 9/20 (2006.01); A61K 9/24 (2006.01); A61K 9/28 (2006.01); A61K 31/4178 (2006.01); A61K 31/4422 (2006.01)
CPC A61K 31/505 (2013.01) [A61K 9/2009 (2013.01); A61K 9/2077 (2013.01); A61K 9/209 (2013.01); A61K 9/284 (2013.01); A61K 31/4178 (2013.01); A61K 31/4422 (2013.01)] 11 Claims
 
1. A pharmaceutical composition of a single dosage form, comprising: a compartment comprising olmesartan medoxomil and amlodipine or a salt thereof; and a compartment comprising rosuvastatin or a salt thereof, wherein the pharmaceutical composition has a dosage form of a bilayer tablet comprising a layer containing olmesartan medoxomil and amlodipine or a salt thereof and a layer containing rosuvastatin or a salt thereof, wherein the compartment comprising olmesartan medoxomil and amlodipine or a salt thereof contains dibasic calcium phosphate dihydrate in an amount of 1 to 30 parts by weight based on total 100 parts by weight of the compartment comprising olmesartan medoxomil and amlodipine or a salt thereof;
wherein the compartment comprising olmesartan medoxomil and amlodipine or a salt thereof comprises pregelatinized starch, croscarmellose sodium, and crospovidone as disintegrants, wherein the disintegrants are in amounts of 4 to 40 parts by weight, 1 to 10 parts by weight, and 1 to 20 parts by weight, respectively, based on 100 parts by weight of the compartment,
wherein the compartment comprising rosuvastatin or a salt thereof comprises crospovidone and croscarmellose sodium as disintegrants, wherein the disintegrants are each in an amount of 1 to 10 parts by weight based on total 100 parts by weight of the compartment.