|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; Walib (Crystal, MN)|
|Assignee:||Cephalon, Inc. (Frazer, PA)|
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 comprising a food acid and a bicarbonate in an amount of about 15 to about 60% by weight of
said tablet; a pH adjusting substance comprising a carbonate in an amount of about 0.5 to about 25% by weight of said tablet, wherein said pH adjusting substance is different from the food acid and the bicarbonate in the 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 claim 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.
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.