Transoral dosage forms comprising sufentanil and naloxone

Abstract

The invention pertains to methods that include administering to a subject a transoral dosage form comprising a pharmaceutical carrier and sufentanil, and maintaining a mean pH ranging from about 3.5 to about 5.5 during a dosing period after administration of the transoral dosage form as determined using an in vitro donor media test. Related dosage forms are also disclosed. Also disclosed are transoral dosage forms and related methods, wherein a transoral dosage form may comprise: (1) about 5 to about 1000 micrograms of sufentanil; (2) about 50 micrograms to about 100 milligrams of naloxone; and (3) acidifying material in an amount sufficient to provide a mean pH ranging from about 3.5 to about 5.5 during a dosing period after administration of the transoral dosage form as determined using an in vitro donor media test; wherein the dosing period begins no earlier than about 1 minute after administration of the transoral dosage form, and ends no later than about 120 minutes after administration of the transoral dosage form.

1 .- 15 . (canceled) 
     
     
         16 . A transoral dosage form comprising:
 sufentanil citrate; and   acidifying material in an amount sufficient to provide a mean pH ranging from about 3.5 to about 5.5 during a dosing period after administration of the transoral dosage form as determined using an in vitro donor media test;   wherein the dosing period begins no earlier than about 1 minute after administration of the transoral dosage form, and ends no later than about 120 minutes after administration of the transoral dosage form.   
     
     
         17 . (canceled) 
     
     
         18 . The transoral dosage form of  claim 16 , wherein the acidifying material comprises an acid or a buffer. 
     
     
         19 . The transoral dosage form of  claim 16 , wherein the buffer comprises one or more of ascorbic acid, acetic acid, citric acid, D-gluconic acid, dimethylglutaric acid, DL-lactic acid, L-malic acid, fumaric acid, galactaric acid, L-lactic acid, L-tartaric acid, or succinic acid, in each case an acid being paired with the acid's corresponding conjugate base. 
     
     
         20 . The transoral dosage form of  claim 19 , wherein the dosing period begins no earlier than about 2 minutes after administration of the transoral dosage form, and ends no later than about 60 minutes after administration of the transoral dosage form. 
     
     
         21 . The transoral dosage form of  claim 20 , wherein the dosing period begins no earlier than about 2 minutes after administration of the transoral dosage form, and ends no later than about 30 minutes after administration of the transoral dosage form. 
     
     
         22 . The transoral dosage form of  claim 16 , wherein the dosing period begins no earlier than about 3 minutes after administration of the transoral dosage form, and ends no later than about 60 minutes after administration of the transoral dosage form. 
     
     
         23 . The transoral dosage form of  claim 22 , wherein the dosing period begins no earlier than about 4 minutes after administration of the transoral dosage form, and ends no later than about 60 minutes after administration of the transoral dosage form. 
     
     
         24 . The transoral dosage form of  claim 23 , wherein the dosing period begins no earlier than about 5 minutes after administration of the transoral dosage form, and ends no later than about 60 minutes after administration of the transoral dosage form. 
     
     
         25 . The transoral dosage form of  claim 16 , wherein the transoral dosage form comprises a transoral dosage form having a fixed drug releasing area. 
     
     
         26 . The transoral dosage form of  claim 16 , wherein the transoral dosage form comprises a transoral dosage form having a variable drug releasing area. 
     
     
         27 . The transoral dosage form of  claim 16 , wherein the transoral dosage form comprises a gel dosage form. 
     
     
         28 . The transoral dosage form of  claim 16 , wherein the acidifying material is present in an amount sufficient to provide a mean pH ranging from about 4.5 to about 5.5 during a dosing period, as determined using an in vitro donor media test. 
     
     
         29 . The transoral dosage form of  claim 16 , further comprising a pharmaceutical carrier. 
     
     
         30 . The transoral dosage form of  claim 29 , wherein the pharmaceutical carrier comprises one or more permeation enhancers. 
     
     
         31 .- 68 . (canceled)