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Claims for Patent: RE38385

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Claims for Patent: RE38385

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)
Application Number:09/939,688
Patent 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 amorphous 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 at 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 in 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 method of rendering a purified biologically active material storage-stable at 20.degree. C., which material is unstable in aqueous solution at 20.degree. C., comprising the steps of: (1) dissolving to form an aqueous solution of (a) a quantity of a purified biologically active material, which material is unstable in aqueous solution at 20.degree. C., which 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 (b) a quantity of a carrier substance that is water-soluble or water-swellable; (2) evaporating liquid water from said aqueous solution, thereby forming a quantity of a composition; and (3) determining whether said composition formed by said step of evaporating exists in a glassy state at or above 20.degree. C..Iaddend..Iadd.

18. A method of rendering a purified biologically active material storage-stable at 20.degree. C., which material is unstable in aqueous solution at 20.degree. C., comprising the steps of: (1) dissolving to form an aqueous solution of (a) a quantity of a purified biologically active material, which material is unstable in aqueous solution at 20.degree. C., which 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 (b) a quantity of a carrier substance that is water-soluble or water-swellable; (2) evaporating liquid water from said aqueous solution, thereby forming a quantity of a composition; (3) determining whether said composition formed by said step of evaporating has a glass transition temperature at or above 20.degree. C..Iaddend..Iadd.

19. The method of any of claims 17 and 18 further comprising the steps of: recovering said purified biologically active material without any substantial storage; and comparing activity of the recovered purified biologically active material to activity of said purified biologically active material prior to storage..Iaddend..Iadd.

20. The method of any one of claims 17 and 18 wherein said purified biologically active material is not an enzyme..Iaddend..Iadd.

21. The method of any one of claims 17 and 18 wherein said purified biologically active material is a peptide or protein other than an enzyme..Iaddend..Iadd.

22. The method of any one of claims 17 and 18 wherein said purified biologically active material is a hormone other than an enzyme..Iaddend..Iadd.

23. The method of any one of claims 17 and 18 wherein said purified biologically active material is a blood clotting factor other than an enzyme..Iaddend..Iadd.

24. The method of any one of claims 17 and 18 wherein said purified biologically active material comprises a member selected from the group consisting of immunoglobulin, an enzyme cofactor, a nucleoside, a nucleotide, a dinucleotide, a dimer of a nucleoside, a dimer of a nucleotide, an oligomer of a nucleoside, and an oligomer of a nucleotide..Iaddend..Iadd.

25. The method of any one of claims 17 and 18 wherein said purified biologically active material comprises a hormone..Iaddend..Iadd.

26. The method of any one of claims 17 and 18 wherein said purified biologically active material comprises a transport protein..Iaddend..Iadd.

27. The method of any one of claims 17 and 18 wherein said purified biologically active material comprises a blood clotting factor..Iaddend..Iadd.

28. The method of any one of claims 17 and 18 wherein said purified biologically active material comprises a peptide..Iaddend..Iadd.

29. The method of any one of claims 17 and 18 wherein said purified biologically active material comprises an enzyme..Iaddend..Iadd.

30. The method of any one of claims 17 and 18 wherein said purified biologically active material comprises a pharmacologically active protein..Iaddend..Iadd.

31. The method of any one of claims 17 and 18 wherein said purified biologically active material comprises a dehydrogenase..Iaddend..Iadd.

32. The method of any one of claims 17 and 18 wherein said purified biologically active material comprises a restriction enzyme..Iaddend..Iadd.

33. The method of any one of claims 17 and 18 wherein said purified biologically active material comprises an oxidase enzyme..Iaddend..Iadd.

34. The method of any one of claims 17 and 18 wherein said purified biologically active material comprises a reductase enzyme..Iaddend..Iadd.

35. The method of any one of claims 17 and 18 wherein said purified biologically active material comprises a restriction endonuclease..Iaddend..Iadd.

36. The method of any one of claims 17 and 18 wherein said purified biologically active material comprises a member selected from the group consisting of ascorbate oxidase, cytochrome C reductase, Glycerol-3-phosphate reductase, alpha-glucosidase, and LDH..Iaddend..Iadd.

37. The method of any one of claims 17 and 18 wherein said carrier substance comprises a member selected from the group consisting of polydextrose, inulin, stachyose, dextran, sorbose, polyacrylamide, GPS, palatinit, and maltotriose..Iaddend..Iadd.

38. The method of any one of claims 17 and 18 wherein said carrier substance comprises a carbohydrate..Iaddend..Iadd.

39. The method of any one of claims 17 and 18 wherein said carrier substance comprises a sugar..Iaddend..Iadd.

40. The method of any one of claims 17 and 18 wherein said carrier substance comprises a polysaccharide..Iaddend..Iadd.

41. The method of any one of claims 17 and 18 wherein said carrier substance comprises a disaccharide..Iaddend..Iadd.

42. The method of any one of claims 17 and 18 wherein said step of determining comprises determining whether said composition exists in a glassy state at between 20.degree. C. and 150.degree. C..Iaddend..Iadd.

43. The method of any one of claims 17 and 18 wherein said step of determining comprises determining whether said composition exists in a glassy state at between 25.degree. C. and 150.degree. C..Iaddend..Iadd.

44. The method of any one of claims 17 and 18 wherein said step of determining comprises determining whether said composition exists in a glassy state at between 43.degree. C. and 70.degree. C..Iaddend..Iadd.

45. The method of any one of claims 17 and 18 wherein said step of determining comprises determining whether said composition exists in a glassy state at between 55.degree. C. and 70.degree. C..Iaddend..Iadd.

46. A method of rendering a purified biologically active material storage-stable at 20.degree. C., which material is unstable in aqueous solution at 20.degree. C., comprising the steps of: (1) dissolving to form an aqueous solution of (a) a purified biologically active material which is unstable in aqueous solution at 20.degree. C. and which 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 (b) a carrier substance that is water-soluble or water-swellable; (2) evaporating liquid water from said solution, thereby converting said solution into a glassy state composition, wherein said glassy state composition exists when at 20.degree. C.; wherein said evaporating is done without heating; and wherein said carrier substance comprises a member of the group consisting of inulin, polydextrose, stachyose, dextran, sorbose, polyacrylamide, GPS, and palatinit..Iaddend..Iadd.

47. A glassy state composition which is storage-stable at 20.degree. C., comprising: (1) a carrier substance which is water-soluble or water-swellable; (2) at least one material to be stored which is dissolved in said carrier substance; wherein said composition including said carrier substance has the property of being in a glassy state and being storage stable 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. and 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 carrier substance comprises a member of the group consisting of inulin, polydextrose, stachyose, dextran, sorbose, polyacrylamide, GPS, and palatinit..Iaddend..Iadd.

48. A method of forming a glassy state composition which is storage-stable at 20.degree. C., comprising the steps of: (1) dissolving to form an aqueous solution of (a) at least one material to be stored and (b) a carrier substance which is water-soluble or water-swellable; (2) evaporating water from said solution, thereby forming said glassy state composition; wherein said glassy state composition including said carrier substance has the property of being in said glassy state and being storage stable 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. and is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleoside 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 carrier substance comprises a member of the group consisting of inulin, polydextrose, stachyose, dextran, sorbose, polyacrylamide, GPS, and palatinit..Iaddend..Iadd.

49. A glassy state composition which is storage-stable at 20.degree. C., comprising: (1) a carrier substance which is water-soluble or water-swellable; (2) at least one material to be stored which is dissolved in said carrier substance; wherein said glassy state composition including said carrier substance has the property of being in a glassy state and being storage stable when at 20.degree. C.; wherein said glassy state composition contains no more than 4% by weight water; and wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20.degree. C. and is selected from the group consisting of a hormone, immunoglobulin, a transport protein, a blood clotting factor, an enzyme cofactor, an oxidase enzyme, a reductase enzyme, a dehydrogenase, a restriction enzyme, a nucleoside, a nucleotide, a dinucleotide, a dimer of a nucleoside, an oligonucleotide, and an oligomer of a nucleoside..Iaddend..Iadd.

50. A method of forming a composition which is storage-stable at 20.degree. C., comprising the steps of: (1) dissolving to form an aqueous solution of (a) at least one material to be stored and (b) a carrier substance which is water-soluble or water-swellable; (2) evaporating water from said solution, thereby forming said glassy state composition; wherein said glassy state composition including said carrier substance has the property of being in a glassy state and being storage stable when at 20.degree. C.; wherein said glassy state composition contains no more than 4% by weight water; and wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution at 20.degree. C. and is selected from the group consisting of a hormone, immunoglobulin, a transport protein, a blood clotting factor, an enzyme cofactor, an oxidase enzyme, a reductase enzyme, a dehydrogenase, a restriction enzyme, a nucleoside, a nucleotide, a dinucleotide, a dimer of a nucleoside, an oligonucleotide, and an oligomer of a nucleoside..Iaddend..Iadd.

51. A glassy state composition which is storage-stable at 20.degree. C., comprising: (1) a carrier substance which is water-soluble or water-swellable; (2) at least one material to be stored which is dissolved in said carrier substance; wherein said composition including said carrier substance has the property of being in a glassy state and being storage stable 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. and 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 at least one material comprises a second biologically active material; and wherein the first and second biologically active materials react with one another when in aqueous solution with one another..Iaddend..Iadd.

52. A method of forming a glassy state composition which is storage-stable at 20.degree. C., comprising the steps of: (1) dissolving to from an aqueous solution of (a) at least one material to be stored and (b) a carrier substance which is water-soluble or water-swellable; (2) evaporating water from said solution, thereby forming said glassy state composition; wherein said glassy state composition including said carrier substance has the property of being in a glassy state and being storage stable when at 20.degree. C.; wherein said at least one material comprises a first purified biologically active material that is unstable in aqueous solution at 20.degree. C. and 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 at least one material comprises a second biologically active material, and the first and second biologically active materials react with one another when in aqueous solution with one another..Iaddend..Iadd.

53. A method of forming a glassy state composition which is storage-stable at 20.degree. C., comprising the steps of: (1) dissolving to form an aqueous solution of (a) at least one material to be stored and (b) a carrier substance which is water-soluble or water-swellable; (2) evaporating water from said solution, thereby forming said glassy state composition; wherein said glassy state composition including said carrier substance has the property of being in a glassy state and being storage stable 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 at least one 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 glassy state composition contains no more than 4 percent by weight of water; and shaping said glassy state composition into a shape..Iaddend..Iadd.

54. The method of claim 53 wherein said shape is a tablet form..Iaddend..Iadd.

55. The method of claim 54 wherein said at least one material is not an enzyme..Iaddend..Iadd.

56. A method of rendering a purified biologically active material storage-stable at 20.degree. C. and pharmacologically using said material, which material is unstable in aqueous solution at 20.degree. C., comprising the steps of: (1) dissolving to form an aqueous solution of (a) a purified biologically active material (i) which is unstable in aqueous solution at 20.degree. C. and which is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto and (ii) which is not an enzyme and (b) a carrier substance that is water-soluble or water-swellable; (2) forming said solution into a glassy state composition by evaporating liquid water, wherein said glassy state composition exists when at 20.degree. C.; and (3) administering said purified biologically active material stored in said glassy state composition; wherein said carrier substance comprises a member selected from the group consisting of inulin, polydextrose, stachyose, dextran, sorbose, polyacrylamide, GPS, and palatinit..Iaddend..Iadd.

57. A method of rendering a purified biologically active material storage-stable at 20.degree. C. and pharmacologically using said material, which material is unstable in aqueous solution at 20.degree. C., comprising the steps of: (1) dissolving to form an aqueous solution of (a) a purified biologically active material (i) which is unstable in aqueous solution at 20.degree. C. and which is selected from the group consisting of peptides, proteins, nucleosides, nucleotides, dimers or oligomers of nucleosides or nucleotides, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto and (ii) which is not an enzyme and (b) a carrier substance that is water-soluble or water-swellable; (2) forming said solution into a glassy state composition by evaporating liquid water, wherein said glassy state composition exists when at 20.degree. C.; and (3) administering said purified biologically active material stored in said glassy state composition; wherein said glassy state composition contains no more than 4% by weight water..Iaddend..Iadd.

58. A process of forming a composition which is storage-stable at 20.degree. C., said composition comprising the steps of: (1) dissolving to form an aqueous solution (a) a carrier substance which is water-soluble or water-swellable and (b) at least one material to be stored; (2) evaporating liquid water from said solution to convert said solution into a composition in a glassy state; wherein said composition has the properties that it is storage-stable and exists in said glassy state when at 20.degree. C.; wherein said composition contains no more than 4 percent by weight of water; wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution when at 20.degree. C.; wherein said at least one 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 step of evaporating comprises heating the combined carrier substance and purified biologically active material to a temperature not exceeding 80.degree. C. while maintaining subatmospheric pressure on the combined carrier substance and purified biologically active material..Iaddend..Iadd.

59. The process of claim 58 wherein said step of evaporating comprises heating the combination to at least 30.degree. C. and not exceeding 80.degree. C..Iaddend..Iadd.

60. A process of forming a composition which is storage-stable at 20.degree. C., said composition comprising the steps of: (1) dissolving to form an aqueous solution (a) a carrier substance which is water-soluble or water-swellable and (b) at least one material to be stored; (2) evaporating liquid water from said solution to convert said solution into a composition in a glassy state; wherein said composition has the properties that it is storage-stable and exists in said glassy state when at 20.degree. C.; wherein said composition contains no more than 4 percent by weight of water; wherein said at least one material comprises a purified biologically active material that is unstable in aqueous solution when at 20.degree. C.; wherein said at least one 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 step of evaporating comprises heating the combined carrier substance and purified biologically active material to a temperature not exceeding 80.degree. C.; 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..Iadd.

61. The process of claim 60 wherein said carrier substance comprises a water soluble or water swellable synthetic polymer..Iaddend..Iadd.

62. The process of claim 60 wherein said purified biologically active material is not an enzyme..Iaddend..Iadd.

63. The process of claim 60 wherein said purified biologically active material comprises a hormone..Iaddend..Iadd.

64. The process of claim 60 wherein said purified biologically active material comprises immunoglobulin..Iaddend..Iadd.

65. The process of claim 60 wherein said purified biologically active material comprises a blood clotting factor..Iaddend..Iadd.

66. The process of claim 60 wherein said purified biologically active material comprises a pharmacologically active protein..Iaddend..Iadd.

67. A glassy state 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 amorphous carrier substance; 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 has the properties that it is storage stable and exists in a glassy state when at 20.degree. C.; wherein a weight ratio of said purified biologically active material to said carrier substance is between about 2:1 and about 1:1; 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; wherein said composition contains no more than four weight percent water..Iaddend..Iadd.

68. A method of rendering a material storage stable at 20.degree. C. which material is unstable in aqueous solution at room temperature of 20.degree. C., comprising the steps of: (1) dissolving to form an aqueous solution (a) said material and (b) a carrier substance which is water-soluble or water-swellable; (2) evaporating liquid water from said solution thereby converting said solution into a glassy state composition; wherein said 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; wherein said composition has the property that it is storage stable and exists in said glassy state when at 20.degree. C.; and wherein a weight ratio of said purified biologically active material to said carrier substance is between about 1:2 and about 1:1; with proviso that when said at least one material comprises an enzyme, said enzyme comprises an enzyme selected from restriction enzymes, oxidase enzymes, and reductase enzymes; wherein said composition contains no more than 4 weight percent water..Iaddend..Iadd.

69. A composition which is storage-stable at 20.degree. C., comprising: (1) a carrier substance which is water-soluble or water-swellable; (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, 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 biologically active material is not an enzyme..Iaddend..Iadd.

70. 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, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto; wherein said biologically active material is not an enzyme; and wherein said carrier substance does not comprise maltotriose..Iaddend..Iadd.

71. A method of forming a composition which is storage-stable at 20.degree. C., comprising the steps of: (1) dissolving to form an aqueous solution (a) a carrier substance which is water-soluble or water-swellable and (b) at last one material to be stored; forming said solution into a glassy state composition by evaporating liquid water; 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, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto; wherein said biologically active material is not an enzyme; and wherein said carrier substance does not comprise maltotriose..Iaddend..Iadd.

72. 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 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..Iadd.

73. 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; wherein said composition contains no more than 4 percent by weight of water; 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..Iadd.

74. 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; wherein said carrier substance does not comprise maltotriose; 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..Iadd.

75. A method of forming a composition which is storage-stable at 20.degree. C., comprising the steps of: (1) dissolving to form an aqueous solution (a) a carrier substance which is water-soluble or water-swellable and (b) at least one material to be stored; forming said solution into a glassy state composition by evaporating liquid water; 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 nucleotide, enzymes, enzyme cofactors and derivatives of any of the foregoing, said derivatives having one or more additional moieties bound thereto; wherein said carrier substance does not comprise maltotriose; 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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