Pharmaceutical formulations
Disclosed herein are an aqueous pharmaceutical formulation comprising cagrilintide and an aqueous formulation comprising semaglutide. The compositions of these two pharmaceutical formulations allow for their presentation in, and administration using, the dual-chamber medical device disclosed herein. Individuals with diseases, such as diabetes and/or obesity and/or related co-morbidities, may benefit from the co-administration of semaglutide and cagrilintide, and/or of the two liquid pharmaceutical formulations disclosed herein, using the medical device disclosed herein.
1 . A medical device comprising a first chamber and a second chamber, wherein the first chamber comprises an aqueous semaglutide formulation and the second chamber comprises an aqueous cagrilintide formulation,
wherein the aqueous semaglutide formulation comprises:
semaglutide;
phosphate, in a concentration of more than 15 mM and less than or equal to 45 mM;
90-99% w/w water; and
a pH of 7.0-8.0, and
wherein the cagrilintide formulation comprises:
cagrilintide;
a buffer which is: glutamic acid/glutamate, in a concentration of about 2-10 mM; or lactic acid/lactate, in a concentration of about 2-35 mM; or acetic acid/acetate, in a concentration of about 2-10 mM;
90-99% w/w water; and
a pH of 3.5-4.5.
2 . The medical device according to claim 1 , wherein the first chamber is a distal chamber and the second chamber is a proximal chamber.
3 . The medical device according to claim 1 , wherein the medical device is configured to be capable of administrating the semaglutide formulation and the cagrilintide formulation subcutaneously in a single injection.
4 . The medical device according to claim 1 , wherein the aqueous semaglutide formulation comprises: semaglutide in a concentration of 0.1-10 mg/ml; and wherein the aqueous cagrilintide formulation comprises cagrilintide in a concentration of 0.1-20 mg/ml.
5 . The medical device according to claim 1 , wherein the aqueous cagrilintide formulation has a pH of about 4.0 and the aqueous semaglutide formulation has a pH of about 7.4.
6 . The medical device according to claim 4 , wherein the aqueous cagrilintide formulation has a pH of about 4.0 and the aqueous semaglutide formulation has a pH of about 7.4.
7 . The medical device according to claim 1 , wherein the aqueous cagrilintide formulation comprises glutamic acid/glutamate buffer in a concentration of about 2-10 mM.
8 . The medical device according to claim 7 , wherein the aqueous cagrilintide formulation comprises glutamic acid/glutamate buffer in a concentration of about 5 mM.
9 . The medical device according to claim 1 , wherein the aqueous cagrilintide formulation further comprises a tonicity agent selected from the group consisting of glycerol, mannitol, propylene glycol, sorbitol, sucrose and trehalose.
10 . The medical device according to claim 9 , wherein the tonicity agent is glycerol at a concentration of 20-31 mg/ml.
11 . The medical device according to claim 9 , wherein the tonicity agent is glycerol at a concentration of about 24 mg/ml.
12 . The medical device according to claim 4 , wherein the aqueous cagrilintide formulation further comprises a tonicity agent selected from the group consisting of glycerol, mannitol, propylene glycol, sorbitol, sucrose and trehalose.
13 . The medical device according to claim 12 , wherein the tonicity agent is glycerol at a concentration of 20-31 mg/ml.
14 . The medical device according to claim 12 , wherein the tonicity agent is glycerol at a concentration of about 24 mg/ml.
15 . The medical device according to claim 1 , wherein the aqueous semaglutide formulation comprises about 30 mM phosphate.
16 . The medical device according to claim 4 , wherein the aqueous semaglutide formulation comprises about 30 mM phosphate.
17 . The medical device according to claim 1 , wherein the aqueous semaglutide formulation further comprises histidine.
18 . The medical device according to claim 17 , wherein histidine is at a concentration of about 10 mM.
19 . The medical device according to claim 4 , wherein the aqueous semaglutide formulation further comprises histidine.
20 . The medical device according to claim 19 , wherein histidine is at a concentration of about 10 mM.
21 . The medical device according to claim 1 , wherein the aqueous semaglutide formulation further comprises a tonicity agent selected from the group consisting of propylene glycol, potassium chloride and sodium chloride.
22 . The medical device according to claim 21 , wherein the tonicity agent is sodium chloride at a concentration of about 6.4 mg/ml.
23 . The medical device according to claim 4 , wherein the aqueous semaglutide formulation further comprises a tonicity agent selected from the group consisting of propylene glycol, potassium chloride and sodium chloride.
24 . The medical device according to claim 23 , wherein the tonicity agent is sodium chloride at a concentration of about 6.4 mg/ml.
25 . The medical device according to claim 4 , wherein the aqueous cagrilintide formulation comprises glutamic acid/glutamate buffer in a concentration of about 5 mM, further comprises a tonicity agent of glycerol at a concentration of about 24 mg/ml and has a pH of about 4.0.
26 . The medical device according to claim 4 , wherein the aqueous semaglutide formulation comprises about 30 mM phosphate, further comprises about 10 mM histidine and a tonicity agent of sodium chloride at a concentration of about 6.4 mg/ml and has a pH of about 7.4.
27 . A medical device comprising a first chamber and a second chamber, wherein the first chamber comprises an aqueous semaglutide formulation and the second chamber comprises an aqueous cagrilintide formulation,
wherein the aqueous semaglutide formulation comprises:
semaglutide;
phosphate, in a concentration of about 30 mM;
histidine, in a concentration of about 10 mM;
sodium chloride, in a concentration of about 6.4 mg/ml; and
has a pH of 7.4, and
wherein the aqueous cagrilintide formulation comprises:
cagrilintide;
a glutamic acid/glutamate buffer, in a concentration of about 5 mM;
glycerol in a concentration of about 24 mg/ml; and
a pH of 4.0.
28 . The medical device according to claim 27 , wherein the first chamber is a distal chamber and the second chamber is a proximal chamber.
29 . The medical device according to claim 27 , wherein the medical device is configured to be capable of administrating the semaglutide formulation and the cagrilintide formulation subcutaneously in a single injection.
30 . The medical device according to claim 27 , wherein the aqueous semaglutide formulation comprises: semaglutide in a concentration of 0.1-10 mg/ml; and wherein the aqueous cagrilintide formulation comprises cagrilintide in a concentration of 0.1-20 mg/ml.