Patent ID: 8226978
Filing Date: 2012-07-24
Classification: A61J,A61K,A61M,A61P,G07C,G07F,H01Q

Abstract:
1. A dosage form for oral transmucosal administration to a subject, comprising: from about 5 to about 100 micrograms (mcg) of sufentanil and a bioadhesive material, wherein; (i) said bioadhesive material provides for adherence of the dosage form to the oral mucosa of said subject during the period of drug delivery; (ii) said dosage form has a volume of less than 30 microliters or a mass of less than 30 mg; and (iii) after administration of said dosage form to said subject, said dosage form 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 dosage form provides a dose-normalized mean C max of 1.59-2.75 pg/mL per mcg dosed; and said dosage form provides a T max with a coefficient of variation of less than 40%.