Method for the evaluation of the colloidal stability of liquid biopolymer solutions
AssigneeBoehringer Ingelheim International GmbH
InventorsPatrick Garidel, Thomas Hennes, Torsten Schultz-Fademrecht
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Abstract
The invention concerns the field of biomolecule formulation screening and stability testing. It concerns a method for the evaluation of the colloidal stability of liquid biopolymer solutions. The present invention describes a method for determining the stability of a liquid pharmaceutical composition comprising: a) providing a liquid pharmaceutical composition in a container, b) shaking said container on a shaker, whereby the shaker performs an oloid movement, c) determining the stability of said liquid pharmaceutical composition.
Claims16
A method for determining the stability of a liquid pharmaceutical composition comprising:
- a) providing a liquid pharmaceutical composition in a container,
- b) moving the said container in an oloid movement in three dimensions (x, y and z), wherein the oloid movement results in an increased turbidity of the liquid pharmaceutical composition, and wherein the increased turbidity is higher than a turbidity that would be produced by horizontal shaking of the container for a same amount of time, and
- c) determining the stability of said liquid pharmaceutical composition.
A method of selecting a stable pharmaceutical composition comprising:
- a) providing a number of liquid pharmaceutical compositions in a number of containers,
- b) moving one or more of the said containers in an oloid movement in three dimensions (x, y and z), wherein the oloid movement results in an increased turbidity of the liquid pharmaceutical compositions in the one or more of the said containers, and wherein the increased turbidity is higher than a turbidity that would be produced by horizontal shaking of the container for a same amount of time,
- c) determining the stability of said liquid pharmaceutical compositions after shaking, and
- d) selecting a stable liquid pharmaceutical composition.
Dependencies are inferred from the claim text.