Hydrogel particle formation

• US 20050191361A1
• Filed: 04/11/2005
• Published: 09/01/2005
• Est. Priority Date: 08/03/2001
• Status: Abandoned Application

• Current Assignee: Powderject Research Limited (Pfizer Inc.)
• Original Assignee: Powderject Research Limited (Pfizer Inc.)
• Inventors: Maa, Yuh-Fun, O'Connor, Barbara Horsey, Prestrelski, Steven Joseph, Burkoth, Terry Lee, Muddle, Andrew, Hafner, Roderick
• Application Number:
  US11/102,705
• Publication Number:
  US 20050191361A1
• Time in Patent Office: Days
• US Class Current: 424/489
• CPC Class Codes: A61K 9/0021 Intradermal administration, e.g. through microneedle arrays, needleless injectors mechanical aspects A61M
• CPC Class Codes: A61K 9/006 Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
• CPC Class Codes: A61K 9/1652 Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin homeopathic globules A61K9/1623
• CPC Class Codes: A61K 9/19 lyophilised , i.e. freeze-dried, solutions or dispersions lyophilised products with subsequent particle size reduction A61K9/14; granules or pellets made by lyphilisation A61K9/1682; solid oral dosage forms made by lyophilisation A61K9/2095; lyophilisation additives A61K47/00
• CPC Class Codes: C12N 15/895 using biolistic methods

Abstract

New compositions formed from the combination of an active substance with a hydrogel carrier moiety are provided. The compositions are suitable for use in high-velocity transdermal particle injection techniques. Methods of providing the new compositions are also provided. In addition, methods for administering pharmacologically active agent to a subject are provided. These methods are useful for delivering drugs, biopharmaceuticals, vaccines and diagnostics agents.

Claims

1-38. -38. (canceled)

39. A method for transdermal or transmucosal delivery of a pharmacologically active agent to a subject in need thereof, comprising delivering a particulate pharmaceutical composition comprising a hydrogel and the pharmacologically active agent into a target skin or mucosal site using a needleless syringe device.

40. The method of claim 39, wherein the hydrogel is agarose, dextran, cellulose, chitin, starch, polyvinylpyrrolidone or polyvinyl alcohol.

41. The method of claim 40, wherein the hydrogel is agarose and the particles of the medicament further comprise dextran as an excipient.

42. The method of claim 39, wherein the active agent is a peptide.

43. The method of claim 39, wherein the active agent is a vaccine.

44. The method of claim 39, wherein the active agent is a gene construct.

45. The method of claim 44, wherein the gene construct comprises a sequence coding for an antigen operably linked to a promoter.

46. The method of claim 39, wherein the mean mass aerodynamic diameter of the particles is from 10 to 100 μ

m.

47. The method of claim 39, wherein the envelope density of the particles is from 0.8 to 1.5 g/cm³.

48. The method of claim 39, wherein the active agent is present in the particulate pharmaceutical composition in an amount ranging from about 0.1 to 85 wt % of the composition.

49. The method of claim 39, wherein the pharmaceutical composition is formed using a freeze-drying step.

50. The method of claim 39, wherein the pharmaceutical composition is formed using a spray-drying step.

51. The method of claim 39, wherein the pharmaceutical composition is delivered by the needleless syringe device at a velocity of from 100 to 2000 m/sec.

52. A method for delivering a pharmacologically active agent to a subject in need thereof, comprising:

(a) preparing a particulate pharmaceutical composition comprising a hydrogel and a pharmacologically active agent;

(b) accelerating said particulate pharmaceutical composition to a high velocity; and

(c) delivering said accelerated particles into a target skin or mucosal site.

53. The method of claim 52, wherein the hydrogel is agarose, dextran, cellulose, chitin, starch, polyvinylpyrrolidone or polyvinyl alcohol.

54. The method of claim 52, wherein the active agent is a peptide.

55. The method of claim 52, wherein the active agent is a vaccine.

56. The method of claim 52, wherein the mean mass aerodynamic diameter of the particles is from 10 to 100 μ

m.

57. The method of claim 52, wherein the envelope density of the particles is from 0.8 to 1.5 g/cm³.

58. The method of claim 52, wherein the particulate pharmaceutical composition is accelerated to a velocity of from 100 to 2000 m/sec.