FORMULATIONS FOR VIROSOMES
This disclosure provides virosome formulations, in particular, liquid pharmaceutical formulations comprising virosomes.
1 . A liquid composition comprising:
a) virosomes;
b) a KH 2 PO 4 /Na 2 HPO 4 buffer, wherein the phosphate concentration is between 15 mM and 30 mM;
c) a salt, wherein the salt concentration is higher than 60 mM; and
d) trehalose, wherein the trehalose concentration is between 2% (w/w) and 10% (w/w),
wherein said composition has a pH between 6.5 and 8.
2 . The composition according to claim 1 , wherein said composition has a pH between 7 and 7.8.
3 . The composition according to claim 1 , wherein said composition
has a pH of 7.5; and
comprises trehalose at a concentration between 3% (w/w) and 5% (w/w).
4 . The composition of claim 1 , further comprising:
a salt at a concentration between 60 mM and 85 mM.
5 . The composition according to claim 4 , wherein said salt is NaCl.
6 . A method of preserving a virosome, wherein the method comprises:
preparing the composition according to claim 1 .
7 . The method according to claim 6 , further comprising:
storing said composition at a temperature between 2° C. and 8° C.
8 . The method according to claim 6 , further comprising:
storing said composition at a temperature between −80° C. and −65° C.
9 . The method according to claim 6 , further comprising:
storing said composition at a temperature between −15° C. and −30° C.
10 . The composition of claim 2 , wherein the salt is at a concentration between 60 mM and 85 mM.
11 . The composition of claim 10 , wherein the salt is NaCl.
12 . The composition of claim 3 , wherein the salt is at a concentration between 60 mM and 85 mM.
13 . The composition of claim 12 , wherein the salt is NaCl.
14 . A method of preserving a virosome, wherein the method comprises:
preparing the composition of claim 2 so as to preserve the virosome.
15 . The method according to claim 14 , further comprising:
storing the composition at a temperature between 2° C. and 8° C.
16 . The method according to claim 14 , further comprising:
storing the composition at a temperature between −80° C. and −65° C.
17 . The method according to claim 14 , further comprising:
storing the composition at a temperature between −15° C. and −30° C.
18 . A method of preserving a virosome, wherein the method comprises:
preparing the composition of claim 3 so as to preserve the virosome.
19 . A method of preserving a virosome, wherein the method comprises:
preparing the composition of claim 4 so as to preserve the virosome.
20 . A method of preserving a virosome, wherein the method comprises:
preparing the composition of claim 5 so as to preserve the virosome.