Claims for Patent: 8,753,611

Summary for Patent: 8,753,611

Title:	Sublingual buccal effervescent
Abstract:	A pharmaceutical dosage form adapted to supply a medicament to the oral cavity for buccal, sublingual or gingival absorption of the medicament which contains an orally administrable medicament in combination with an effervescent for use in promoting absorption of the medicament in the oral cavity. The use of an additional pH adjusting substance in combination with the effervescent for promoting the absorption drugs is also disclosed.
Inventor(s):	Eichman; Jonathan D. (Ann Arbor, MI), Hontz; John (Plymouth, MN), Khankari; Rajendra K. (Maple Grove, MN), Pather; Sathasivan Indiran (Plymouth, MN), Robinson; Joseph R. (Madison, WI)
Assignee:	Cephalon, Inc. (Frazer, PA)
Application Number:	13/099,003
Patent Claims:	1. A method of administering at least one systemically distributable pharmaceutical agent across the oral mucosa comprising: a) providing a solid oral dosage form including: (1) an orally administerable medicament that is present in an amount that is pharmaceutically effective for buccal mucosal, gingival, or sublingual mucosal administration; (2) at least one pH adjusting substance, which is a base selected from sodium carbonate, potassium carbonate, magnesium carbonate, disodium hydrogen phosphate, sodium dihydrogen phosphate, dipotassium hydrogen phosphate, and potassium dihydrogen phosphate; and (3) at least one saliva activated effervescent couple in an amount sufficient to increase absorption of said orally administerable medicament across the oral mucosa, wherein said effervescent couple comprises an acid selected from citric, tartaric, malic, fumaric, adipic and succinic acid, and a base selected from sodium bicarbonate, sodium carbonate, potassium bicarbonate, potassium carbonate, and magnesium carbonate; wherein said orally administerable medicament is not substantially encompassed by or dispersed in a material that prevents absorption of said medicament across the oral mucosa; b) placing said solid oral dosage form in the mouth of a patient so that saliva in said patient's mouth activates said at least one effervescent couple in said tablet; and c) holding said solid oral dosage form and dissolving the contents of said solid oral dosage form in the mouth of a patient whereby said at least one effervescent couple promotes absorption of said orally administerable medicament across the oral mucosa. 2. The method of administering at least one systemically distributable pharmaceutical agent according to claim 1 wherein said step c) includes holding said solid oral dosage form and dissolving the contents of said solid oral dosage form in said mouth adjacent a cheek for buccal administration. 3. The method of administering at least one systemically distributable pharmaceutical agent according to claim 1 wherein said step c) includes holding said solid oral dosage form and dissolving the contents of said solid oral dosage form in said mouth beneath the tongue for sublingual administration. 4. The method of administering at least one systemically distributable pharmaceutical agent according to claim 1 wherein said step c) includes holding said solid oral dosage form and dissolving the contents of said solid oral dosage form in said mouth between the upper lip and gum for gingival administration. 5. The method of administering at least one systemically distributable pharmaceutical agent according to claim 1, wherein said solid oral dosage form further includes a bioadhesive, wherein said bioadhesive increases the contact time between said solid oral dosage form and the oral mucosa. 6. The method of administering at least one systemically distributable pharmaceutical agent according to claim 1, wherein said solid oral dosage form further includes glidants, lubricants, binders, sweeteners, flavoring and coloring components. 7. The method of administering at least one systemically distributable pharmaceutical agent according to claim 1, wherein said orally administerable medicament is selected from the group consisting of analgesics, anti-inflammatories, antipyretics, antibiotics, antimicrobials, laxatives, anorexics, antihistamines, antiasthmatics, antidiuretics, antiflatuents, anti-emetics, antimigraine agents, antispasmodics, sedatives, antihyperactives, antihypertensives, tranquilizers, decongestants, and beta blockers. 8. The method of administering at least one systemically distributable pharmaceutical agent according to claim 1, wherein said orally administerable medicament is selected from the group consisting of peptides, proteins and oligonucleotides. 9. The method of administering at least one systemically distributable pharmaceutical agent according to claim 1, wherein said at least one effervescent couple is present in an amount between about 5% by weight and 95% by weight. 10. The method of administering at least one systemically distributable pharmaceutical agent according to claim 1, wherein said at least one effervescent couple is present in an amount between about 30% by weight and 80% by weight. 11. The method of administering at least one systemically distributable pharmaceutical agent according to claim 1, wherein said at least one effervescent couple is present in an amount sufficient to evolve a gas in an amount between about 5 cm to about 30 cm.