Bioadhesive drug formulations for oral transmucosal delivery
First Claim
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1. A bioadhesive tablet for sublingual administration to a subject, comprising:
- (a) from about 2.5 to about 100 micrograms of sufentanil, expressed as the base; and
(b) a bioadhesive material, wherein said bioadhesive material is present at 2-30% by weight and provides for adherence to the oral mucosa of said subject, and said tablet has a volume of from about 0.1 microliters to about 50 microliters, wherein after administration of said tablet to said subject, said tablet provides a minimal saliva response and minimal swallowing of sufentanil; and
at least 55% of drug delivery of sufentanil occurs via the oral transmucosal route.
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Accused Products
Abstract
Bioadhesive drug formulations that adhere to an oral mucosal membrane of a subject are provided together with single dose applicators and devices for delivering the drug formulations to the oral mucosa, and methods for using the same.
228 Citations
26 Claims
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1. A bioadhesive tablet for sublingual administration to a subject, comprising:
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(a) from about 2.5 to about 100 micrograms of sufentanil, expressed as the base; and (b) a bioadhesive material, wherein said bioadhesive material is present at 2-30% by weight and provides for adherence to the oral mucosa of said subject, and said tablet has a volume of from about 0.1 microliters to about 50 microliters, wherein after administration of said tablet to said subject, said tablet provides a minimal saliva response and minimal swallowing of sufentanil; and
at least 55% of drug delivery of sufentanil occurs via the oral transmucosal route. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26)
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Specification