Solid dose delivery vehicle and methods of making same

• US 6,811,792 B2
• Filed: 10/25/2002
• Issued: 11/02/2004
• Est. Priority Date: 12/02/1994
• Status: Expired due to Fees

• Current Assignee: Quadrant Drug Delivery Limited (Vectura Group Ltd.)
• Original Assignee: Quadrant Drug Delivery Limited (Vectura Group Ltd.)
• Inventors: Colaco, Camilo, Roser, Bruce J., Blair, Julian, Kampinga, Jaap
• Primary Examiner(s): AZPURU, CARLOS A
• Application Number:
  US10/280,468
• Publication Number:
  US 20030054040A1
• Time in Patent Office: 739 Days
• Field of Search: 424/423, 424/443, 424/449, 424/502
• US Class Current: 424/423
• CPC Class Codes: A61K 9/0021 Intradermal administration, e.g. through microneedle arrays, needleless injectors mechanical aspects A61M
• CPC Class Codes: A61K 9/145 with organic compounds
• CPC Class Codes: A61K 9/1623 Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
• CPC Class Codes: Y02A 50/30 Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

The present invention encompasses a solid dose delivery vehicle for ballistic administration of a bioactive material to subcutaneous and intradermal tissue, the delivery vehicle being sized and shaped for penetrating the epidermis. The delivery vehicle further comprises a stabilizing polyol glass loaded with the bioactive material and capable of releasing the bioactive material in situ. The present invention further includes methods of making and using the solid dose delivery vehicle of the invention.

Claims

1. A solid dose delivery vehicle suitable for administration by ballistic delivery, comprising a solid solution of bioactive material in a stabilizing polyol glass continuous phase.

2. The solid dose delivery vehicle as claimed in claim 1, wherein the vehicle is in the form of uniform microspheres of narrow size distribution suitable for administration to the basal layers of the epidermis.

4. The solid dose delivery vehicle as claimed in claim 1, wherein the bioactive material is a prophylactic for use as a vaccine.

5. The solid dose delivery vehicle as claimed in claim 1, wherein the bioactive material is DNA.

6. The solid dose delivery vehicle as claimed in claim 1, wherein the bioactive material comprises an antigen and an adjuvant.

7. The solid dose delivery vehicle as claimed in claim 1, wherein the polyol is selected from the group consisting of disaccharides, trisaccharides and oligosaccharides.

8. The solid dose delivery vehicle as claimed in claim 1, wherein the polyol is trehalose.

3. A solid dose delivery vehicle suitable for administration by ballistic delivery, comprising a stabilizing polyol and a bioactive agent, loaded onto a vehicle.

9. A vaccine composition comprising a solid dose delivery vehicle suitable for administration by ballistic delivery, comprising a solid solution of bioactive material in a stabilizing polyol glass continuous phase and wherein the bioactive material is a DNA plasmid encoding an immunogen.

10. The vaccine composition as claimed in claim 9, further comprising an amount of an adjuvant sufficient to enhance the immune response to the immunogen.

11. A device for ballistic delivery, comprising a solid dose delivery vehicle suitable for administration by ballistic delivery, comprising a solid solution of bioactive material in a stabilizing polyol glass continuous phase.

12. A device for subdermal delivery of a therapeutic agent, wherein the device includes a solid dose delivery vehicle comprising a therapeutically effective amount of said therapeutic agent and polyol.

13. The device according to claim 12, wherein the polyol is a stabilizing polyol.

14. The device according to claim 12, wherein the polyol is selected from the group consisting of disaccharides, trisaccharides and oligosaccharide.