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|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 administerable 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):||Pather; Sathasivan Indiran (Plymouth, MN), Khankari; Rajendra K. (Maple Grove, MN), Eichman; Jonathan D. (Ann Arbor, MI), Robinson; Joseph R. (Madison, WI), Hontz; John (Plymouth, MN)|
|Assignee:||Cima Labs Inc. (Minneapolis, MN)|
1. A method of administration of fentanyl to a mammal across the oral mucosa thereof, said method comprising: providing a solid oral dosage form comprising fentanyl or a
pharmaceutically acceptable salt thereof and at least one saliva activated effervescent agent in an amount sufficient to increase absorption of said fentanyl or pharmaceutically acceptable salt thereof across said oral mucosa, at least one pH adjusting
substance, and wherein said amount of said at least one effervescent agent is between about 5% by weight and about 80% by weight; and buccally, sublingually or gingivally administrating said solid oral dosage form to said mammal.
2. The method of claim 1, wherein said fentanyl or pharmaceutically acceptable salt thereof is administered via a buccal route.
3. The method of claim 1, wherein said fentanyl or a pharmaceutically acceptable salt thereof is administered via a sublingual route.
4. The method of claim 1, wherein said fentanyl or a pharmaceutically acceptable salt thereof is administered via a gingival route.
5. The method of claim 1, wherein said mammal is a human.
6. The method of claim 1, wherein said dosage form is a tablet.
7. The method of claim 1, wherein said pH adjusting substance is a base.
8. The method of claim 1, wherein the amount of said pH adjusting substance is selected to provide a substantially neutral pH at a site of said absorption through said oral mucosa.
9. The method of claim 8, wherein said substantially neutral pH is slightly higher than 7.