Claims
- 1. A gel-forming free-flowing powder suitable for use as a vaccine, said powder being obtained by spray-drying or spray freeze-drying an aqueous suspension comprising:
(a) from 0.1 to 0.95% by weight of an aluminum salt or calcium salt adjuvant having an antigen adsorbed therein; (b) from 0.5 to 6% by weight of a saccharide; (c) from 0.1 to 2% by weight of an amino acid or salt thereof; and (d) from 0.02 to 1% by weight of a colloidal substance.
- 2. A powder according to claim 1, wherein the adjuvant is aluminum hydroxide or aluminum phosphate.
- 3. A powder according to claim 1, wherein the adjuvant is aluminum sulfate or calcium phosphate.
- 4. A powder according to claim 1, wherein the antigen is a bacterial or viral antigen.
- 5. A powder according to claim 1, wherein the saccharide is a monosaccharide, disaccharide or sugar alcohol.
- 6. A powder according to claim 1, wherein the saccharide is selected from the group consisting of glucose, xylose, galactose, fructose, D-mannose, sorbose, lactose, maltose, saccharose, trehalose, sucrose, mannitol, sorbitol, xylitol, glycerin, glycerol, erythritol and arabitol.
- 7. A powder according to claim 1, wherein the amino acid is an acidic, neutral or basic amino acid.
- 8. A powder according to claim 1, wherein the amino acid or salt thereof is selected from the group consisting of glycine, alanine, glutamine, arginine, lysine, histidine and monosodium glutamate.
- 9. A powder according to claim 1, wherein the colloidal substance is selected from the group consisting of polysaccharides, hydrogels and proteins.
- 10. A powder according to claim 9, wherein the said substance is selected from the group consisting of dextran, maltodextran, gelatin, agarose and human serum albumin.
- 11. A powder according to claim 1, wherein the aqueous suspension comprises from 0.2 to 0.4% by weight of the adjuvant having antigen adsorbed thereon, from 2 to 4% by weight of the saccharide, from 0.75 to 1.25% by weight of the amino acid or salt thereof and from 0.07 to 0.3% by weight of the colloidal substance.
- 12. A powder according to claim 1, which comprises:
(i) from 7 to 50% by weight of the adjuvant having an antigen adsorbed therein, (ii) from 30 to 80% by weight of the saccharide, (iii) from 7 to 30% by weight of the amino acid or salt thereof, and (iv) from 0.8 to 6% by weight of the colloidal substance.
- 13. A powder according to claim 1, having a mass mean aerodynamic diameter of from 10 to 100 μm and an envelope density of from 0.8 to 1.5 g/cm3.
- 14. A powder according to claim 1, which forms a gel-like suspension without any precipitate after having been added to distilled water (1:500 by weight) and shaken for 3 minutes.
- 15. A process for the preparation of a gel-forming free-flowing powder suitable for use as a vaccine, which process comprises the step of spray-drying or spray freeze-drying an aqueous suspension comprising:
(a) from 0.1 to 0.95% by weight of an aluminum salt or calcium salt adjuvant having an antigen adsorbed therein; (b) from 0.5 to 6% by weight of a saccharide; (c) from 0.1 to 2% by weight of an amino acid or salt thereof; and (d) from 0.02 to 1% by weight of a colloidal substance.
- 16. A process according to claim 15 wherein the aqueous suspension comprises from 0.2 to 0.4% by weight of the adjuvant having antigen adsorbed thereon, from 2 to 4% by weight of the saccharide, from 0.75 to 1.25% by weight of the amino acid or salt thereof and from 0.07 to 0.3% by weight of the colloidal substance.
- 17. A process according to claim 15, wherein the resultant powder forms a gel-like suspension without any precipitate after having been added to distilled water (1:500 by weight) and shaken for 3 minutes.
- 18. A dosage receptacle for a needleless syringe, said receptacle containing an effective amount of a gel-forming free-flowing powder obtained by spray-drying or spray freeze-drying an aqueous suspension comprising:
(a) from 0.1 to 0.95% by weight of an aluminum salt or calcium salt adjuvant having an antigen adsorbed therein; (b) from 0.5 to 6% by weight of a saccharide; (c) from 0.1 to 2% by weight of an amino acid or salt thereof; and (d) from 0.02 to 1% by weight of a colloidal substance.
- 19. A receptacle according to claim 18, wherein the receptacle is selected from the group consisting of capsules, foil pouches, sachets and cassettes.
- 20. A needleless syringe which is loaded with a gel-forming free-flowing powder obtained by spray-drying or spray freeze-drying an aqueous suspension comprising:
(a) from 0.1 to 0.95% by weight of an aluminum salt or calcium salt adjuvant having an antigen adsorbed therein; (b) from 0.5 to 6% by weight of a saccharide; (c) from 0.1 to 2% by weight of an amino acid or salt thereof; and (d) from 0.02 to 1% by weight of a colloidal substance.
- 21. A vaccine composition comprising a pharmaceutically acceptable carrier or diluent and a gel-forming free-flowing powder obtained by spray-drying or spray freeze-drying an aqueous suspension comprising:
(a) from 0.1 to 0.95% by weight of an aluminum salt or calcium salt adjuvant having an antigen adsorbed therein; (b) from 0.5 to 6% by weight of a saccharide; (c) from 0.1 to 2% by weight of an amino acid or salt thereof; and (d) from 0.02 to 1% by weight of a colloidal substance.
- 22. A method of vaccinating a subject, which method comprises the step of administering to the said subject an effective amount of a gel-forming free-flowing powder obtained by spray-drying or spray freeze-drying an aqueous suspension comprising:
(a) from 0.1 to 0.95% by weight of an aluminum salt or calcium salt adjuvant having an antigen adsorbed therein; (b) from 0.5 to 6% by weight of a saccharide; (c) from 0.1 to 2% by weight of an amino acid or salt thereof; and (d) from 0.02 to 1% by weight of a colloidal substance.
- 23. A method according to claim 22, wherein the powder is administered by a needleless syringe.
- 24. A method according to claim 22, wherein the powder is formulated with a pharmaceutically acceptable carrier or diluent.
- 25. A method according to claim 24, wherein the formulation is administered subcutaneously or intramuscularly.
- 26. A gel-forming free-flowing powder suitable for use as a vaccine, which powder comprises:
(i) from 5 to 60% by weight of an aluminum salt or calcium salt adjuvant having an antigen adsorbed thereon; (ii) from 25 to 90% by weight of a saccharide; (iii) from 4.5 to 40% by weight of an amino acid or salt thereof; and (iv) from 0.5 to 10% by weight of a colloidal substance.
- 27. A powder according to claim 26, which comprises:
(i) from 7 to 50% by weight of the adjuvant having an antigen adsorbed therein, (ii) from 30 to 80% by weight of the saccharide, (iii) from 7 to 30% by weight of the amino acid or salt thereof, and (iv) from 0.8 to 6% by weight of the colloidal substance.
- 28. A powder according to claim 26, which forms a gel-like suspension without any precipitate after having been added to distilled water (1:500 by weight) and shaken for 3 minutes.
- 29. A powder suitable for use as a vaccine, said powder being obtained by spray freeze-drying an aqueous suspension comprising an aluminum salt or calcium salt adjuvant having an antigen adsorbed therein.
- 30. A powder according to claim 29, wherein the adjuvant is aluminum hydroxide, aluminum phosphate, aluminum sulfate or calcium phosphate.
- 31. A powder according to claim 29, wherein the antigen is a bacterial or viral antigen.
- 32. A powder according to claim 29, wherein the aqueous suspension comprises less than 10% by weight of the adjuvant having antigen adsorbed thereon.
- 33. A powder according to claim 29, having a mass mean aerodynamic diameter of from 1 to 100 μm and an envelope density of from 0.8 to 1.5 g/cm3.
- 34. A powder according to claim 29, wherein the suspension further comprises an amorphous sugar, a crystalline sugar and optionally a polymer and/or an amino acid or a salt thereof.
- 35. A powder according to claim 29, which forms a gel-like suspension without any precipitate after having been added to distilled water (1:500 by weight) and shaken for 3 minutes.
- 36. A process for the preparation of a powder suitable for use as a vaccine, which process comprises the step of spray freeze-drying an aqueous suspension comprising an aluminum salt or calcium salt adjuvant having an antigen adsorbed therein.
- 37. A process according to claim 36, wherein the adjuvant is aluminum hydroxide, aluminum phosphate, aluminum sulfate or calcium phosphate.
- 38. A process according to claim 36, wherein the antigen is a bacterial or viral antigen.
- 39. A process according to claim 36, wherein the aqueous suspension comprises less than 10% by weight of the adjuvant having antigen adsorbed thereon.
- 40. A process according to claim 36, wherein the suspension further comprises an amorphous sugar, a crystalline sugar and optionally a polymer and/or an amino acid or a salt thereof.
- 41. A process according to claim 36, wherein the resultant spray freeze-dried powder forms a gel-like suspension without any precipitate after having been added to distilled water (1:500 by weight) and shaken for 3 minutes.
- 43. A dosage receptacle for a needleless syringe, said receptacle containing an effective amount of a powder obtained by spray freeze-drying an aqueous suspension comprising an aluminum salt or calcium salt adjuvant having an antigen adsorbed therein.
- 44. A receptacle according to claim 43, wherein the receptacle is selected from the group consisting of capsules, foil pouches, sachets and cassettes.
- 45. A needleless syringe which is loaded with a powder obtained by spray freeze-drying an aqueous suspension comprising an aluminum salt or calcium salt adjuvant having an antigen adsorbed therein.
- 46. A vaccine composition comprising a pharmaceutically acceptable carrier or diluent and a powder obtained by spray freeze-drying an aqueous suspension comprising an aluminum salt or calcium salt adjuvant having an antigen adsorbed therein.
- 47. A method of vaccinating a subject, which method comprises administering to the said subject an effective amount of a powder obtained by spray freeze-drying an aqueous suspension comprising an aluminum salt or calcium salt adjuvant having an antigen adsorbed therein.
- 48. A method according to claim 47, wherein the powder is administered by a needleless syringe.
- 49. A method according to claim 47, wherein the powder is formulated with a pharmaceutically acceptable carrier or diluent.
- 50. A method according to claim 49, wherein the formulation is administered subcutaneously or intramuscularly.
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application is related to U.S. provisional application serial No. 60/210,581, filed Jun. 8, 2000, from which priority is claimed pursuant to 35 U.S.C. §119(e)(1) and which application is incorporated herein by reference in its entirety.
Provisional Applications (1)
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Number |
Date |
Country |
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60210581 |
Jun 2000 |
US |