Small-volume oral transmucosal dosage forms

Abstract

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.

1 - 170 . (canceled) 
     
     
         171 . A dosage form for oral transmucosal administration to a subject, comprising: an opioid active drug, wherein said dosage form is bioadhesive and has a volume of less than 15 microliters or a mass of less than 15 mg. 
     
     
         172 . The dosage form of  claim 171 , wherein the drug is a congener of sufentanil. 
     
     
         173 . The dosage form of  claim 172 , wherein the congerners of sufentanil is alfentanil, lofentanil, carfentanil, remifentanil, trefentanil or mirfentanil 
     
     
         174 . The dosage form of  claim 171 , wherein the dosage form has a volume of less than 10 microliters or a mass of less than 10 mg. 
     
     
         175 . The dosage form of  claim 171 , wherein the dosage form has a volume of less than 5 microliters or a mass of less than 5 mg. 
     
     
         176 . The dosage form of  claim 171 , wherein after administration of the dosage form to the subject, at least 50% of the drug delivery of the opioid active drug occurs via the oral transmucosal route. 
     
     
         177 . The dosage form of  claim 176 , wherein after administration of the dosage form to the subject, at least 55% of the drug delivery of the opioid active drug occurs via the oral transmucosal route. 
     
     
         178 . The dosage form of  claim 176 , wherein after administration of the dosage form to the subject, at least 60% of the drug delivery of the opioid active drug occurs via the oral transmucosal route. 
     
     
         179 . The dosage form of  claim 171 , wherein the transmucosal administration is to the sublingual membrane. 
     
     
         180 . The dosage form of  claim 179 , wherein the administration is to the buccal membrane. 
     
     
         181 . The dosage form of  claim 171 , wherein a single oral transmucosal administration of the dosage form to the subject results in a bioavailability of greater than 65%. 
     
     
         182 . The dosage form of  claim 181 , wherein a single oral transmucosal administration of the dosage form to the subject results in a bioavailability of greater than 75%. 
     
     
         183 . The dosage form of  claim 182 , wherein a single oral transmucosal administration of the dosage form to the subject results in a bioavailability of greater than 80%. 
     
     
         184 . A drug delivery device comprising the dosage form of  claim 171 . 
     
     
         185 . A method of treating pain in a subject, comprising administering a dosage form to the oral mucosa of a subject, wherein said dosage form is bioadhesive and comprises an opioid active drug, wherein said dosage form is bioadhesive and has a volume of less than 15 microliters or a mass of less than 15 mg. 
     
     
         186 . The method of  claim 185 , wherein the opioid active drug is a congener of sufentanil. 
     
     
         187 . The dosage form of  claim 186 , wherein the congerners of sufentanil is alfentanil, lofentanil, carfentanil, remifentanil, trefentanil or mirfentanil. 
     
     
         188 . The method of  claim 185 , wherein the dosage form has a volume of less than 10 microliters or a mass of less than 10 mg. 
     
     
         189 . The method of  claim 185 , wherein the dosage form has a volume of less than 5 microliters or a mass of less than 5 mg. 
     
     
         190 . The method of  claim 185 , wherein after administration of the dosage form to the subject, at least 50% of the drug delivery of the opioid active drug occurs via the oral transmucosal route. 
     
     
         191 . The method of  claim 185 , wherein after administration of the dosage form to the subject, at least 55% of the drug delivery of the opioid active drug occurs via the oral transmucosal route. 
     
     
         192 . The method of  claim 185 , wherein after administration of the dosage form to the subject, at least 60% of the drug delivery of the opioid active drug occurs via the oral transmucosal route. 
     
     
         193 . The method of  claim 185 , wherein the transmucosal administration is to the sublingual membrane. 
     
     
         194 . The method of  claim 193 , wherein the administration is to the buccal membrane. 
     
     
         195 . The method of  claim 185 , wherein a single oral transmucosal administration of the dosage form to the subject results in a bioavailability of greater than 65%.