|Title:||Generally linear effervescent oral fentanyl dosage form and methods of administering|
|Abstract:||Fentanyl containing dosage forms and methods using same are described. These dosage forms include substantially less fentanyl by weight than know oral formulation and have advantages in terms of cost and side effects. These dosage forms are intended for oral administration of fentanyl across the oral mucosa.|
|Inventor(s):||Moe; Derek (Maple Grove, MN), Agarwal; Vikas (Plymouth, MN), Habib; Walid (Maple Grove, MN)|
|Assignee:||Cima Labs, Inc. (Eden Prairie, MN)|
1. A tablet comprising: an amount of fentanyl free base or an equivalent amount of salt thereof selected from the group consisting of about 100 micrograms, about 200 micrograms, about
300 micrograms, about 400 micrograms, about 600 micrograms, and about 800 micrograms, calculated as fentanyl free base an effervescent agent which includes a food acid and a bicarbonate in an amount of about 15 to about 60% by weight of said tablet,
wherein said acid and said bicarbonate are present in said tablet in stoichiometrically equivalent amounts; a pH adjusting substance which is a carbonate in an amount of about 0.5 to about 25% by weight of said tablet, wherein said pH adjusting
substance is in addition to the components of said effervescent agent; a starch glycolate in an amount of about 0.25 to about 20% by weight of said tablet; mannitol in an amount of about 10 to about 80% by weight of said tablet; said tablet being
suitable for delivery of said fentanyl across the oral mucosa of a patient by buccal administration and having a dwell time that is less than about 30 minutes.
2. The tablet of claim 1, wherein said starch glycolate is present in an amount of from about 0.5 to about 15% by weight.
3. The tablet of 2, wherein said starch glycolate is present in an amount of from about 0.5 to about 10% by weight.
4. The tablet of claim 1, where in said tablet does not include cross-linked PVP.
5. The tablet of claim 1, wherein said mannitol is spray dried mannitol.
6. The tablet of claim 1, wherein said fentanyl free base or an equivalent amount of salt thereof is fentanyl citrate.
7. The tablet of claim 1 further comprising an F1 package, said tablet being packaged in said F1 package.