Claims
- 1. A quick dissolving oral mucosal drug delivery device, comprising a mucosal surface-coat-forming inner layer disposed between two moisture barrier coating layers; wherein the mucosal surface-coat-forming inner layer comprises a water-soluble hydrocolloid and an active agent; and wherein the two moisture barrier coating layers comprise a non-crosslinked polymer and a moisture barrier modifier.
- 2. The drug delivery device of claim 1, wherein the mucosal surface-coat-forming inner layer further comprises a plasticizer.
- 3. The drug delivery device of claim 1, wherein the mucosal surface-coat-forming inner layer further comprises a detackifier.
- 4. The drug delivery device of claim 1, wherein the mucosal surface-coat-forming inner layer further comprises at least one member selected from the group consisting of taste modifying agents, emulsifying agents, buffering agents, coloring agents and preservatives.
- 5. The drug delivery device of claim 1, wherein the moisture barrier coating layers further comprise at least one member selected from the group consisting of flavoring agents and anti-oxidants.
- 6. The drug delivery device of claim 1, wherein the mucosal surface-coat-forming inner layer has a thickness i n the range of 1-50 mil.
- 7. The drug delivery device of claim 1, wherein the moisture barrier coating layers have a thickness in the range of 1 to 25 μm each.
- 8. The drug delivery device of claim 1, wherein the device dissolves or disintegrates in the oral cavity within 1-600 seconds.
- 9. The drug delivery device of claim 1, wherein the active agent is selected from the group consisting of a therapeutic agent, a dietary supplement and a hygiene aid.
- 10. The drug delivery device of claim 1, wherein the active agent is sildenafil citrate.
- 11. The drug delivery device of claim 1, wherein the active agent is selected from the group consisting of nicotine, hydromorphone, oxybutynine and estradiol.
- 12. The drug delivery device of claim 1, wherein the active agent is selected from the group consisting of famotidine, granisetron, hydrocortisone, loratadine, vinpocetine, buprenorphine, domperidone and loperamide.
- 13. A quick dissolving oral mucosal drug delivery device, comprising a mucosal surface-coat-forming inner layer disposed between two moisture barrier coating layers; wherein the mucosal surface-coat-forming inner layer comprises a water-soluble hydrocolloid, at least one active agent, at least one plasticizer and at least one detackifier; and wherein the two moisture barrier coating layers comprise at least one water soluble or dispersible film former and at least one moisture barrier modifier.
- 14. The drug delivery device of claim 13, wherein the mucosal surface-coat-forming inner layer further comprises at least one member selected from the group consisting of taste modifying agents, emulsifying agents, buffering agents, coloring agents and preservatives.
- 15. The drug delivery device of claim 13, wherein the moisture barrier coating layers further comprise at least one member selected from the group consisting of flavoring agents and anti-oxidants.
- 16. A method of making a quick dissolving oral mucosal drug delivery device, comprising:
(a) dissolving a hydrocolloid in a solvent to form a substantially homogeneous preparation; (b) adding to (a), an active agent and at least one reagent selected from the group consisting of an emulsifier, a plasticizer, a taste modifier, a water soluble inert filler, a coloring agent, a preservative, a permeation enhancer, a stabilizer and a buffering agent to form a coatable or extrudable mixture; (c) forming a mucosal surface-coat-forming inner layer from the mixture of (b); and, (d) applying moisture barrier coating layers to the mucosal surface-coat-forming inner layer of (c).
- 17. A method for administering an active agent to a subject comprising:
(a) applying a quick dissolving oral mucosal drug delivery device to an oral mucosal surface of the subject; wherein the quick dissolving oral mucosal drug delivery device comprises a mucosal surface-coat-forming inner layer disposed between two moisture barrier coating layers; wherein the mucosal surface-coat-forming inner layer comprises a water-soluble hydrocolloid, at least one active agent, at least one plasticizer and at least one detackifier; and wherein the two moisture barrier coating layers comprise at least one water soluble or dispersible film former and at least one moisture barrier modifier.
- 18. A quick dissolving oral mucosal drug delivery device, comprising a mucosal surface-coat-forming inner layer encapsulated within a moisture barrier coating layer; wherein the mucosal surface-coat-forming inner layer comprises a water-soluble hydrocolloid and an active agent; and wherein the moisture barrier coating layer comprises a non-crosslinked polymer and a moisture barrier modifier.
- 19. The drug delivery device of claim 18, wherein the moisture barrier coating layers further comprise at least one member selected from the group consisting of flavoring agents and anti-oxidants.
- 20. The drug delivery device of claim 18, wherein the moisture barrier coating layers have a thickness in the range of 1 to 25 μm each.
- 21. The drug delivery device of claim 18, wherein the device dissolves or disintegrates in the oral cavity within 1-600 seconds.
- 22. A quick dissolving oral mucosal drug delivery device, comprising a mucosal surface-coat-forming inner layer encapsulated by a moisture barrier coating layer; wherein the mucosal surface-coat-forming inner layer comprises a water-soluble hydrocolloid, at least one active agent, at least one plasticizer and at least one detackifier; and wherein the moisture barrier coating layer comprises at least one water soluble or dispersible film former and at least one moisture barrier modifier.
- 23. The drug delivery device of claim 22, wherein the moisture barrier coating layer further comprises at least one member selected from the group consisting of flavoring agents and anti-oxidants.
Parent Case Info
[0001] This application claims priority from U.S. Provisional Application Serial No. 60/303,324, filed Jul. 6, 2001; the disclosure of which is incorporated herein by reference as if set forth herein in its entirety.
Provisional Applications (1)
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Number |
Date |
Country |
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60303324 |
Jul 2001 |
US |