Solid dose delivery vehicle and methods of making same

• US 6,893,657 B2
• Filed: 02/27/2003
• Issued: 05/17/2005
• 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:
  US10/376,136
• Publication Number:
  US 20030147961A1
• Time in Patent Office: 810 Days
• Field of Search: 424/451, 424/464, 424/489, 424/45, 424/46, 424/78.04, 424/423, 424/427, 424/430, 424/434, 424/436, 424/449
• US Class Current: 424/451
• 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 therapeutic dried composition in solid dose form suitable for oral delivery, comprising a stabilizing polyol and immunogenic agent wherein the composition provides a quick release or flooding dose of the immunogenic agent after administration.

2. The composition, according to claim 1, wherein the composition is freeze-dried.

3. The composition, according to claim 1, wherein the immunogenic agent is selected from the group consisting of live and attenuated viruses, nucleotide vectors encoding antigens, bacteria and antigens.

4. The composition, according to claim 1, wherein the immunogenic agent is an antigen selected from the group consisting of diptheria, tetanus, pertussis, botulinum, cholera, Dengue, hepatitis A, C and B, haemophilus influenzae b, herpes virus, Hylobacterium pylori, influenza, Japanese encephalitis, meningococci A, B and C, measles, mumps, papilloma virus, pneumococci, polio, rubella, rotavirus, respiratory syncytial virus, Shigella, tuberculosis, yellow fever and combinations thereof.

5. The composition, according to claim 1, further comprising an amount of adjuvant effective to enhance an immune response to the immunogenic agent.

6. The composition, according to claim 5, wherein the adjuvant is selected from the group consisting of aluminium salts, squalene mixtures (SAF-1), muramyl peptide, saponin derivatives, mycobacterium cell wall preparations, monophosphoryl lipid A, mycolic acid derivtives, nonionic block copolymer surfacants, Quil A, cholera toxin B subunit, polyphosphazene, immunostimulating complexes and mitogenic components of Freund'"'"'s adjuvant.

7. The composition, according to claim 1, wherein the stabilizing polyol is selected from the group consisting of monosaccharides, disaccharides, trisaccharides, oligosaccharides.