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|Title:||Effervescent oral opiate dosage forms and methods of administering opiates|
|Abstract:||Opiate containing dosage forms and methods using same are described. These dosage forms include substantially less opiates by weight than known oral formulations. These dosage forms are intended for oral administration across the oral mucosa.|
|Inventor(s):||Moe; Derek (Maple Grove, MN)|
|Assignee:||Cima Labs, Inc. (Eden Prairie, MN)|
1. A dosage form comprising about 20 to about 200,000 micrograms of an opiate, about 15 to about 60% w/w of an effervescent material, wherein said effervescent material comprises an
acid source and a source of a reactive base, and wherein said acid source and said base source are present in said dosage form in stoichiometrically equivalent amounts; about 0.5 to about 25% w/w of a pH adjusting substance, wherein said pH adjusting
substance is in addition to the components of said effervescent material, a filler, wherein said filler is mannitol; and a starch glycolate, wherein said dosage form is configured for the delivery of said opiate across the oral mucosa as a consequence
of buccal, gingival or sublingual administration.
2. The dosage form of claim 1, wherein said pH adjusting substance provides a localized pH of 3 to 10.
3. The dosage form of claim 2, wherein said pH adjusting substance can change the localized pH by at least 0.5 pH units.
4. The dosage form at claim 3 wherein said pH adjusting substance can change the localized pH by at least 1.0 pH units.
5. The dosage form of claim 1, wherein said pH adjusting substance is a carbonate or bicarbonate.
6. The dosage form of claim 1, wherein said starch glycolate is provided in an amount of about 0.5 to about 15% w/w.
7. The dosage form of claim 1 having a mean dwell time in the mouth of a patient of about 5 to about 30 minutes when administered by buccal, gingival or sublingual routes.
8. The dosage form of claim 1 further comprising a binder, a sweetener, a coloring component, a flavor, a glidant, a lubricant, a preservative, a filler and a disintegrant.
9. The dosage form of claim 1 packed in an F1 or F2 blister package.
10. The dosage form according to claim 1 wherein said pH adjusting substance is present in an amount of about 5% to about 15% w/w.
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