# US 9,753,021 B2 · Method for the evaluation of the colloidal stability of liquid biopolymer solutions > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 9,753,021 B2 - Document ID: US9753021B2 - Status: Granted - Kind: B2 - Application number: 14/381,697 - Filed: 2013-02-27 - Published: 2015-01-15 - Granted: 2017-09-05 - Earliest claimed: 2012-03-05 - Assignees: Boehringer Ingelheim International GmbH - Applicants: Boehringer Ingelheim International GMBH - Inventors: Patrick Garidel; Thomas Hennes; Torsten Schultz-Fademrecht - Web page: https://patentgrep.com/patent/US9753021B2 ## CPC - G01N 33/15: Medicinal preparations {; Physical properties thereof, e.g. dissolubility} - G01N 15/00: Investigating characteristics of particles; Investigating permeability, pore-volume or surface-area of porous materials - G01N 21/85: Investigating moving fluids or granular solids - G01N 15/075: by optical means - G01N 2201/025: Mechanical control of operations - G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q) ## 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. ## Claims ### Claim 1 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. ### Claim 2 (depends on 1) The method of claim 1, whereby step c) comprises determining the colloidal stability. ### Claim 3 (depends on 1) The method of claim 1, whereby step c) comprises determining the turbidity of said liquid pharmaceutical composition. ### Claim 4 (depends on 3) The method of claim 3, whereby turbidity of said liquid pharmaceutical composition is measured by using a particle counting method such as light obscuration or an imaging method, or alternatively by using photo correlation spectroscopy (PCS). ### Claim 5 (depends on 1) The method of claim 1, whereby step b) is performed for 1 hr to 72 hrs, 1 hr to 48 hrs, 1 hr to 12 hrs, 1 hr to 6 hrs, or 3 hrs to 24 hrs. ### Claim 6 (depends on 1) The method of claim 1, whereby step b) is performed for no longer than 72 hrs, 48 hrs, 24 hrs, 12 hrs, 9 hrs or 6 hrs. ### Claim 7 (depends on 1) The method of claim 1, whereby said liquid pharmaceutical composition contains a protein or a nucleic acid, whereby said nucleic acid is preferably a desoxyribonucleic acid or a ribonucleic acid. ### Claim 8 (depends on 1) The method of claim 1, whereby the liquid pharmaceutical composition comprises a protein. ### Claim 9 (depends on 8) The method of claim 8, whereby the protein is an antibody. ### Claim 10 (depends on 1) The method of claim 1, whereby the container of step a) contains a volume of 20 ml or less, preferably 10 ml, 5 ml, 2 ml, 1 ml, 0.5 ml, 0.2 ml or 0.1 ml or preferably between 0.1 ml to 10 ml. ### Claim 11 (depends on 1) The method of claim 1, whereby the container of step a) is a vial, syringe, carpule or bag. ### Claim 12 (depends on 1) The method of claim 1, whereby step b) includes a translation and rotation movement resulting in an inversal movement. ### Claim 13 (depends on 1) The method of claim 1, whereby the container of step a) is fixed into a kind of cage whereby the cage executes the oloid movement. ### Claim 14 (depends on 1) The method of claim 1, whereby the container of step a) is exactly the final container of the pharmaceutical composition, which is used for the application to a patient, without any other components. ### Claim 15 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. ### Claim 16 (depends on 15) The method of claim 15, whereby the number of liquid pharmaceutical compositions tested in step a) is the same as the number of containers in step a) and/or whereby the number of liquid pharmaceutical compositions tested in step a) is at least 20, 50, 96, 100, 200, 384, 500 or 1000.