Excipients for stabilising viral particles, polypeptides or biological material
A sterile pharmaceutically acceptable aqueous solution, which solution is provided in a sealed container and comprises: a pharmaceutically acceptable aqueous solvent; viral particles or a physiologically active polypeptide; an excipient selected from a polyethyleneimine; a compound of formula (I) or a physiologically acceptable salt or ester thereof; or a compound of formula (II) or a physiologically acceptable salt or ester thereof; and optionally, one or more sugars.
1. A method for the preparation of a ready-to-use, storage-stable aqueous solution which is provided in a sealed container and which contains live viral particles, which method comprises:
(a) providing a solution comprising:
water or physiological saline, which is optionally buffered with a physiologically acceptable buffer;
live viral particles from Adenoviridae, Orthomyxoviridae, Paramyxoviridae, Parvoviridae, Picornaviridae, Poxviridae, Flaviviridae or Herpesviridae;
an excipient which is an N,N-di(C 1-6 alkyl)-glycine or N,N,N-tri(C 1-6 alkyl)-glycine, or a physiologically acceptable salt or ester thereof;
a sulfone compound of formula (IIC):
wherein R a and R b independently represent C 1-6 alkyl; and
optionally one or more sugars; and
(b) sealing the aqueous solution of step (a) in a container, thereby preparing said ready-to-use, storage stable aqueous solution containing live viral particles.
2. The method according to claim 1 , in which the viral particles are from an adenovirus, vaccinia virus, influenza virus or measles virus.
3. The method according to claim 1 , in which the excipient is N,N-dimethylglycine or N,N,N-trimethylglycine, or a physiologically acceptable salt or ester thereof.
4. The method according to claim 3 , in which the excipient is N,N-dimethylglycine or a physiologically acceptable salt or ester thereof.
5. The method according to claim 1 , in which the solution comprises sucrose or mannitol.
6. The method according to claim 5 , in which the solution comprises sucrose and raffinose.
7. The method according to claim 1 , in which the sulfone compound of formula (IIC) is methylsulfonylmethane.
8. The method according to claim 1 , in which the solution is isotonic.
9. The method according to claim 1 , in which the solution is provided in a sealed container under nitrogen.
10. The method according to claim 1 , in which the sealed contained is a sealed vial, ampoule, syringe, cartridge, flexible bag or glass bottle.
11. The method according to claim 1 , in which the solution is passed through a sterilising filter in step (a).
12. A ready-to-use, storage-stable aqueous solution containing live viral particles from Adenoviridae, Orthomyxoviridae, Paramyxoviridae, Parvoviridae, Picornaviridae, Poxviridae, Flaviviridae or Herpesviridae which is provided in a sealed container, said live viral particle containing aqueous solution being obtainable by a method as defined in claim 1 .
13. The aqueous solution according to claim 12 , in which the solution of the method comprises sucrose or mannitol.
14. The aqueous solution according to claim 12 , in which the solution of the method comprises a sulfone of formula (IIC) which is methylsulfonylmethane.
15. The method according to claim 1 , in which the solution comprises sucrose.
16. The method according to claim 1 , in which the solution comprises mannitol.
17. The method according to claim 1 , in which the solution comprises sucrose and mannitol.