Phenylephrine Hydrochloride Compositions and Containers
A ready-to-administer antioxidant free phenylephrine compositions has improved stability and is optionally free of metal chelating agents. Contemplated compositions are preferably packaged into a flexible polymer bag and maintain degradation of the phenylephrine at remarkably low levels, even over extended storage periods.
1 . A ready-to-administer sterile antioxidant free phenylephrine composition comprising:
phenylephrine or salt thereof at a concentration of equal to or less than 100 mcg/mL;
a tonicity agent; and
one or more pH adjusting agents;
wherein the composition has a pH of between 3.0 and 5.0,
wherein no more than 0.5% degradation products are formed from degradation of the phenylephrine upon storage of the phenylephrine composition over a period of at least six months at 25° C., and
wherein the composition is ready-to-administer, antioxidant free and packaged in a 250 mL bag.
2 . The composition of claim 1 , wherein the tonicity agent comprises one or more of sodium chloride, glycerol, thioglycerol, mannitol, lactose, and dextrose.
3 . The composition of claim 2 , wherein the tonicity agent comprises sodium chloride.
4 . The composition of claim 1 , wherein the one or more pH adjusting agents comprise hydrochloric acid, sodium hydroxide, or a combination thereof.
5 . The composition of claim 1 , wherein the 250 mL bag is a flexible polymer bag.
6 . The composition of claim 1 , wherein the 250 mL bag is further packaged in a metallized pouch.
7 . The composition of claim 6 , wherein the metallized pouch further comprises an oxygen scavenger.
8 . The composition of claim 1 , wherein the phenylephrine or salt thereof is provided at a concentration of between 10 and 50 mcg/mL.
9 . The composition of claim 1 , wherein the phenylephrine or salt thereof is provided at a concentration of between 30 and 70 mcg/mL.
10 . The composition of claim 1 , wherein the phenylephrine or salt thereof is provided at a concentration of between 50 and 100 mcg/mL.
11 . A method of making a ready-to-administer sterile antioxidant free phenylephrine composition product comprising:
packaging a composition in a 250 mL bag,
wherein the composition comprises:
phenylephrine or salt thereof at a concentration of equal to or less than 100 mcg/mL;
a tonicity agent; and
one or more pH adjusting agents;
wherein the composition has a pH of between 3.0 and 5.0,
wherein no more than 0.5% degradation products are formed from degradation of the phenylephrine upon storage of the phenylephrine composition over a period of at least six months at 25° C.
12 . The method of claim 11 , wherein the tonicity agent comprises one or more of sodium chloride, glycerol, thioglycerol, mannitol, lactose, and dextrose.
13 . The method of claim 12 , wherein the tonicity agent comprises sodium chloride.
14 . The method of claim 11 , wherein the one or more pH adjusting agents comprise hydrochloric acid, sodium hydroxide, or a combination thereof.
15 . The method of claim 11 , wherein the 250 mL bag is a flexible polymer bag.
16 . The method of claim 11 , wherein the 250 mL bag is further packaged in a metallized pouch.
17 . The method of claim 16 , wherein the metallized pouch further comprises an oxygen scavenger.
18 . The method of claim 11 , wherein the phenylephrine or salt thereof is provided at a concentration of between 10 and 50 mcg/mL.
19 . The method of claim 11 , wherein the phenylephrine or salt thereof is provided at a concentration of between 30 and 70 mcg/mL.
20 . The method of claim 11 , wherein the phenylephrine or salt thereof is provided at a concentration of between 50 and 100 mcg/mL.