Small-volume oral transmucosal dosage forms

摘要

Small-volume oral transmucosal dosage forms or NanoTabs® comprising a predetermined amount of a pharmaceutically active drug are provided. Exemplary applications include use of the NanoTabs® to administer a drug for the treatment of acute, post-operative or breakthrough pain.

主权项

1. A method of treating pain in a subject, comprising administering a single dose of sufentanil to the oral mucosa of a subject, wherein the single dose is provided as a small volume solid tablet, and said solid tablet comprises:
from about 0.25 micrograms (mcg) to 200 micrograms sufentanil, wherein; a) said solid tablet is bioadhesive and adheres to the oral mucosa of said subject, b) said solid tablet is a substantially homogeneous composition and has a volume of less than 30 microliters (mei); and c) after administration of said solid tablet to said subject, said solid tablet provides a minimal saliva response and minimal swallowing of sufentanil; at least 55% of drug delivery of sufentanil occurs via the oral transmucosal route; said solid tablet provides a dose-normalized Cmax of about 2.72+/−0.84 pg/mL per mcg dosed.