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Details for Patent: RE39497

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Details for Patent: RE39497

Title:Storage of materials
Abstract: A material or mixture of materials which is not itself storage stable is rendered storage stable by incorporation into a water-soluble or swellable glassy or rubbery composition which can then be stored at ambient temperature. Recovery is by adding aqueous solution to the composition.
Inventor(s): Franks; Felix (Cambridge, GB), Hatley; Ross H. M. (Cambridge, GB)
Assignee: Nektar Therapeutics (San Carlos, CA)
Filing Date:Aug 28, 2001
Application Number:09/939,689
Claims:1. A composition which is storage stable at 20.degree. C. comprising: i) a carrier substance which is water-soluble or water-swellable and is in a glassy amorpous state; ii) at least one material to be stored, which is unstable in aqueous solution at room temperature of 20.degree. C. dissolved in said amorphous carrier substance, said composition existing in a glassy state at 20.degree. C..].

.[.2. A composition according to claim 1 wherein the material to be stored is selected from proteins, peptides, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzyme cofactors, and derivatives of any of the foregoing having one or more additional moieties bound thereto..].

.[.3. A composition according to claim 1 having a water content not exceeding 4% by weight..].

.[.4. A composition according to claim 1 wherein the composition displays a glass transition temperature of at least 30.degree. C..].

.[.5. A composition according to claim 1 wherein carrier substance is selected from carbohydrates and derivatives thereof which are polyhydroxy compounds..].

.[.6. A composition according to claim 5 wherein the carrier substance is a sugar polymer containing sugar residues linked through ether bridges to bifunctional groups other than carbohydrate..].

.[.7. A composition according to claim 1 wherein the carrier substance is a synthetic polymer..].

.[.8. A composition according to claim 1 wherein said material to be stored comprises a material which is unstable when alone in aqueous solution at room temperature..].

.[.9. A composition according to claim 1 wherein said material to be stored comprises a plurality of materials..].

.[.10. A composition according to claim 9 wherein said material to be stored comprises a plurality of materials which react together in aqueous solution..].

.[.11. A composition according to claim 1 which can be stored without refrigeration for at least 1 week..].

.[.12. A method of rendering a material storage stable a 20.degree. C., which material is unstable in aqueous solution at room temperature of 20.degree. C., comprising dissolving the material in a carrier substance which is water-soluble or water-swellable, or to a solution thereof, so that the material is dissolved in said carrier substance, and forming the resulting mixture into a glassy amorphous state, said mixture existing in said glassy state at 20.degree. C..].

.[.13. A method according to claim 12 wherein forming the said mixture into an amorphous state is effected by evaporation under subatmospheric pressure..].

.[.14. A method according to claim 13 wherein evaporation is commenced at a temperature of 20 to 40.degree. C. and subsequently continued at a temperature of 40 to 70.degree. C..].

.[.15. A method according to claim 13 wherein the subatmospheric pressure is not greater than 90% of atmospheric..].

.[.16. In a method of storing a material, which material is unstable in aqueous solution at 20.degree. C., the improvement comprising dissolving the material in a carrier substance which is water-soluble or water-swellable, or in a solution thereof, so that the material is dissolved in said carrier substance, forming the resulting mixture into a glassy amorphous state and storing the mixture in said glassy amorphous state without refrigeration for at least one week..].

.Iadd.17. A composition which is storage-stable at 20.degree. C., comprising: (1) a carrier substance which is water-soluble or water-swellable and is in a glassy state; (2) at least one material to be stored which is dissolved in said carrier substance; wherein said composition exists in a glassy state at 20.degree. C.; wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20.degree. C.; wherein said purified biologically active material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto; wherein said composition contains no more than 4 percent by weight of water; and wherein said biological active material is not rennin..Iaddend.

.Iadd.18. A composition which is storage-stable at 20.degree. C., comprising: (1) a carrier substance which is water-soluble or water-swellable and (2) at least one material to be stored which is dissolved in said carrier substance; wherein said composition has the property that it exists in a glassy state when at 20.degree. C.; wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20.degree. C.; wherein said biologically active material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said with proviso that when said at least one material comprises an enzyme, said enzyme comprises an enzyme selected from restriction enzymes, dehydrogenase enzymes, oxidase enzymes, and reductase enzymes..Iaddend.

.Iadd.19. A composition which is storage-stable at 20.degree. C., comprising: (1) a carrier substance which is water-soluble or water-swellable and (2) at least one material to be stored which is dissolved in said carrier substance; wherein said composition has the property that it exists in a glassy state when at 20.degree. C; wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20.degree. C; wherein said biologically active material is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto; and wherein said biologically active material is not freeze stable; and with proviso that when said at least one material comprises an enzyme, said enzyme comprises an enzyme selected from dehydrogenase enzymes, restriction enzymes, oxidase enzymes, and reductase enzymes..Iaddend.
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