Solid dose delivery vehicle and methods of making same

• US 7,056,495 B2
• Filed: 08/29/2003
• Issued: 06/06/2006
• 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:
  US10/652,212
• Publication Number:
  US 20040052825A1
• Time in Patent Office: 1,012 Days
• Field of Search: 424/45, 424/46, 424/78.04, 424/451, 424/464, 424/489, 424/423, 424/427, 424/430, 424/434, 424/436, 424/449
• US Class Current: 424/45
• 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;

wherein said hydrophobic material is a bioactive agent;

wherein the solvent is removed by spray drying; and

wherein the polyol is a carbohydrate selected from the group consisting of glucose, maltose, lactose, maltulose, iso-maltulose, lactulose or mono-reducing glycosides of sugar alcohols, straight chain polyalcohols, raffinose, stachyose, melezitose, dextran, sucrose, sucrose sugar alcohols, maltitol, lactitol, iso-maltulose, palatinit and 2D-glucopyranosyl-1,6 mannitol.

2. The method according to claim 1, wherein said bioactive agent is selected from the group consisting of steroids and corticosteroids.

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

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

5. The method according to claim 4, wherein the powder is a particulate size of 0.1 to 10 μ

m.

6. The method according to claim 1, wherein polyol and materials are suspended or dissolved in a mixture of different solvents.

7. The method according to claim 1, wherein the vehicle is in the form of a solid solution.

8. 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;

wherein said hydrophobic material is a bioactive agent;

wherein the solvent is removed by spray drying; and

wherein the polyol is trehalose.