Solid dose delivery vehicle and methods of making same

• US 20040052825A1
• Filed: 08/29/2003
• Published: 03/18/2004
• Est. Priority Date: 12/02/1994
• Status: Active Grant

• 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
• Granted Patent: US 7,056,495 B2
• Time in Patent Office: Days
• US Class Current: 424/400
• 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 method for making an amorphous or non-crystalline solid dose delivery vehicle, the vehicle comprising a hydrophobic material and a polyol,

said method comprising the steps of dissolving or suspending the polyol and hydrophobic material in an organic/aqueous solvent, removing the solvent and forming the vehicle.

2. The method according to claim 1, wherein said hydrophobic material is a bioactive agent.

3. The method according to claim 2, wherein said bioactive agent is selected from the group consisting of steroids and corticosteroids.

4. The method according to claim 1, wherein said polyol is a carbohydrate.

5. The method according to claim 4, wherein said carbohydrate is selected from the group consisting of monosaccharides, disaccharides, trisaccharides and oligosaccharides.

6. The method according to claim 4, wherein said carbohydrate is selected from the group consisting of glucose;

maltose;

lactose;

maltulose;

iso-maltulose;

lactulose;

mono-reducing glycosides of polyhydroxy compounds selected from sugar alcohols, other straight chain polyalcohols, raffinose, stachyose, melezitose, dextran, sucrose and sugar alcohols thereof;

maltitol, lacitotol, iso-maltulose, palatinit and 2D-glucopyranosyl-1, 6-mannitol.

7. The method according to claim 4, wherein said carbohydrate is trehalose.

8. The method according to claim 1, wherein the solid dose delivery vehicle is amorphous.

9. The method according to claim 1, wherein the solvent is removed by a drying process.

10. The method according to claim 9, wherein the drying process is spray drying.

11. The method according to claim 1, wherein the solid dose delivery vehicle is in the form of powder.

12. The method according to claim 11, wherein the powder is a particulate size of 0.1 to 10 μ

m.