Small volume oral transmucosal dosage forms containing sufentanil for treatment of pain
Compositions, systems and methods for administration of small volume sufentanil drug dosage forms to the sublingual mucosa of a subject for treatment of pain using a device are disclosed.
1. A dosage form for oral transmucosal administration to a subject, comprising: an analgesic drug, wherein said dosage form is bioadhesive and has a volume of less than 30 microliters or a mass of less than 30 mg.
2. The dosage form of claim 1 , wherein the drug is sufentanil or a congener of sufentanil.
3. The dosage form of claim 2 , wherein the congener of sufentanil is alfentanil, lofentanil, carfentanil, remifentanil, trefentanil or mirfentanil.
4. The dosage form of claim 1 , wherein the dosage form has a volume of less than 10 microliters or a mass of less than 10 mg.
5. The dosage form of claim 1 , wherein after administration of the dosage form to the subject, at least 50% of the drug delivery of the active drug occurs via the oral transmucosal route.
6. The dosage form of claim 5 , wherein after administration of the dosage form to the subject, at least 55% of the drug delivery of the active drug occurs via the oral transmucosal route.
7. The dosage form of claim 5 , wherein after administration of the dosage form to the subject, at least 60% of the drug delivery of the active drug occurs via the oral transmucosal route.
8. The dosage form of claim 1 , wherein the transmucosal administration is to the sublingual membrane.
9. The dosage form of claim 8 , wherein the administration is to the buccal membrane.
10. The dosage form of claim 1 , wherein a single oral transmucosal administration of the dosage form to the subject results in a bioavailability of greater than 65%.
11. The dosage form of claim 10 , wherein a single oral transmucosal administration of the dosage form to the subject results in a bioavailability of greater than 75%.
12. The dosage form of claim 11 , wherein a single oral transmucosal administration of the dosage form to the subject results in a bioavailability of greater than 80%.
13. A drug delivery device comprising the dosage form of claim 1 .
14. 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 active drug, wherein said dosage form is bioadhesive and has a volume of less than 30 microliters or a mass of less than 30 mg.
15. The method of claim 14 , wherein the drug is an analgesic drug.
16. The dosage form of claim 14 , wherein the drug is sufentanil or a congener of sufentanil.
17. The dosage form of claim 16 , wherein the congener of sufentanil is alfentanil, lofentanil, carfentanil, remifentanil, trefentanil or mirfentanil.
18. The method of claim 14 , wherein the dosage form has a volume of less than 10 microliters or a mass of less than 10 mg.
19. The method of claim 14 , wherein after administration of the dosage form to the subject, at least 50% of the drug delivery of the active drug occurs via the oral transmucosal route.
20. The method of claim 14 , wherein after administration of the dosage form to the subject, at least 55% of the drug delivery of the active drug occurs via the oral transmucosal route.
21. The method of claim 20 , wherein after administration of the dosage form to the subject, at least 60% of the drug delivery of the active drug occurs via the oral transmucosal route.
22. The method of claim 14 , wherein the transmucosal administration is to the sublingual membrane.
23. The method of claim 22 , wherein the administration is to the buccal membrane.
24. The method of claim 14 , wherein a single oral transmucosal administration of the dosage form to the subject results in a bioavailability of greater than 65%.