Stabilisation of Proteins
AssigneeArecar limited
InventorsJan JEZEK, Charles POTTER
Life of this patent
Estimating the term…
Abstract
A dry composition for use in therapy or diagnosis, obtainable by drying an aqueous composition comprising a protein and one or more displacement buffers, wherein the pH of the aqueous composition is such that the protein is stable, wherein the or each displacement buffer has a pKa that is at least 1 unit greater or less than the pH of the aqueous composition, and wherein the aqueous composition is substantially free of a conventional buffer having a pKa that is within one pH unit of the pH of the aqueous composition.
Claims16
A dry composition for use in therapy, obtainable by drying an aqueous composition comprising a protein and one or more displacement buffers, wherein the pH of the aqueous composition is such that the protein is stable, wherein the or each displacement buffer has a pKa that is at least one unit greater or less than the pH of the aqueous composition, wherein the aqueous composition contains less than about 1 mM of a buffer having a pKa that is within one pH unit of the pH of the aqueous composition and wherein the dry composition is shaped in the form of a particle, needle, implant, pellet or tablet.
8-15. (canceled)
A dry composition for use in therapy or diagnosis, comprising a protein component which is a homogeneous mixture of a protein and one or more displacement buffers which, on reconstitution in water, gives an aqueous composition having a given pH, wherein the or each displacement buffer has a pKa that is at least one unit greater or less than the given pH, and wherein the mixture is substantially free of a buffer having a pKa that is within one pH unit of the given pH, and wherein the dry composition is shaped for use in therapy and is in the form of a particle, needle, implant, pellet or tablet.
19-34. (canceled)
A process for the preparation of a pharmaceutically acceptable composition, comprising;
- (i) mixing a protein with one or more displacement buffers at a pH at which the protein is stable, wherein the or each displacement buffer has a pKa that is at least one unit greater or less than the pH of the aqueous composition, and wherein the aqueous composition contains less than about 1 mM of a buffer having a pKa that is within one pH unit of the pH of the aqueous composition:
- (ii) driving the resultant aqueous composition;
- (iii) combining the resultant dry composition with one or more additives;
- and
- (iv) shaping, the drying composition such that the pharmaceutically acceptable composition is in the form of a particle, needle, implant or tablet.
38-41. (canceled)
Dependencies are inferred from the claim text.