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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 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)|
1. A method of administration of fentanyl to a mammal across the oral mucosa thereof to provide analgesia to said mammal, said method comprising: providing a solid
oral dosage form comprising fentanyl or a pharmaceutically acceptable salt thereof in an amount that is pharmaceutically effective for oral mucosal administration; at least one saliva activated effervescent couple comprising 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, said saliva activated effervescent couple being present in an
amount sufficient to increase absorption of said fentanyl or pharmaceutically acceptable salt thereof across said oral mucosa, and 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; wherein the amount of said at least one effervescent couple is between about 5% by weight and about 80% by weight;
and buccally, sublingually or gingivally administering 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 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.
8. The method of claim 7, wherein said substantially neutral pH is slightly higher than 7.