Oral transmucosal delivery

• US 6,488,953 B2
• Filed: 06/01/2001
• Issued: 12/03/2002
• Est. Priority Date: 12/01/1998
• Status: Expired due to Term

• Current Assignee: Controlled Therapeutics (Scotland) Ltd.
• Original Assignee: Controlled Therapeutics (Scotland) Ltd.
• Inventors: Halliday, Janet Anne, Robertson, Steven
• Primary Examiner(s): AZPURU, CARLOS A
• Application Number:
  US09/872,759
• Publication Number:
  US 20020037491A1
• Time in Patent Office: 550 Days
• Field of Search: 424/434, 424/435
• US Class Current: 424/434
• CPC Class Codes: A61K 9/006 Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
• CPC Class Codes: A61K 9/2027 obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
• CPC Class Codes: A61P 15/10 for impotence
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/08 Antiepileptics; Anticonvulsants
• CPC Class Codes: A61P 25/16 Anti-Parkinson drugs
• CPC Class Codes: A61P 31/04 Antibacterial agents

Abstract

An autoadhesive oral transmucosal delivery device contains a pharmaceutically active agent which is delivered via mucosal tissues in the mouth. The device comprises a dry hydrogel polymer which autoadheres to the moist mucosal surface for a time sufficient for release of active agent to occur before becoming detached.

Claims

1. An autoadhesive oral transmucosal delivery device which comprises;

a body formed of a hydrogel capable of absorbing water to achieve a water-content whereat the device autoadheres to an oral mucosal surface;

the hydrogel body being formed of a cross-linked polyurethane;

the hydrogel body comprising a pharmaceutically active agent which is released while the body is adhered to the mucosal surface;

the hydrogel body subsequently detaching from the mucosal surface.

2. A device according to claim 1 wherein the hydrogel contains less than 2 wt % water.

3. A device according to claim 2 wherein the hydrogel contains less than 1 wt % water.

4. A device according to any preceding claim wherein said autoadhering water-content is below 50 wt %.

5. A device according to any preceding claim wherein said autoadhering water-content is above 25 wt %.

6. A device according to any preceding claim wherein said autoadhering water-content is in the range 35 to 45 wt %.

7. A device according to any preceding claim having a rate of water uptake sufficient to allow the device to autoadhere to mucosal membranes in less than 15 minutes.

8. A device according to any preceding claim having an adherence period in the range 2 to 3 hours before the device detaches.

9. A device according to any preceding claim in the form of a strip of smallest dimension in the range 5 to 15 mm and longest dimension in the range 10 to 25 mm.

10. A device according to any preceding claim having a thickness in the range 0.5 to 5 mm.

11. A device according to any preceding claim which further comprises a co-solute effective to increase the maximum loading of active agent in the hydrogel.

12. A device according to claim 11 wherein the co-solute is selected from sodium chloride, potassium chloride, sodium saccharin and benzoic acid.

13. A device according to any preceding claim which comprises a mixture of at least two active agents.

14. A device according to any preceding claim wherein the active agent is a protein.

15. A device according to any of claims 1 to 13 wherein the active agent is apomorphine.

16. A device according to any of claims 1 to 13 wherein the active agent is benzodiazepine.

17. A device according to any of claims 1 to 13 wherein the active agent is an antimicrobial.

18. A device according to any preceding claim having a coating comprising a further pharmaceutically active agent.

19. A device according to claim 18 wherein the further active agent compound in the coating is apomorphine.