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 method of treating pain in a subject, comprising administering a bioadhesive dosage form to the oral mucosa of a subject, wherein said bioadhesive dosage form comprises: from about 2 micrograms to about 200 micrograms sufentanil, 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 method according to claim 1 , wherein the dosage form has a volume of less than 10 microliters or a mass of less than 10 mg.
3. The method according to claim 1 , wherein after administration of the dosage form to the subject, at least 50% of the drug delivery of sufentanil occurs via the oral transmucosal route.
4. The method according to claim 3 , wherein after administration of the dosage form to the subject, at least 55% of the drug delivery of sufentanil occurs via the oral transmucosal route.
5. The method according to claim 3 , wherein after administration of the dosage form to the subject, at least 60% of the drug delivery of sufentanil occurs via the oral transmucosal route.
6. The method according to claim 1 , wherein after administration of the dosage form to the subject, the dosage form provides a Tmax of from about 19.8 minutes to about 60 minutes.
7. The method according to claim 1 , wherein after administration of the dosage form to the subject, the dosage form provides a mean Tmax of from 0.68 to 0.89 hours.
8. The method according to claim 1 , wherein after administration of the dosage form to the subject results in a dose-normalized C max of about 2.72+/−0.84 pg/mL per mcg dosed.
9. The method according to claim 1 , wherein the bioadhesive dosage form adheres to the oral mucosa of said subject during the period of drug delivery.
10. The method according to claim 9 , wherein the bioadhesive dosage form adheres to the sublingual membrane of said subject during the period of drug delivery.
11. The method according to claim 9 , wherein the bioadhesive dosage form adheres to the buccal membrane of said subject during the period of drug delivery.
12. The method according to claim 1 , wherein after administration of the dosage form to the subject, the dosage form provides a Tmax with a coefficient of variation less than 40%.
13. The method according to claim 1 , wherein a single oral transmucosal administration of the dosage form to the subject results in a bioavailability of greater than 65%.
14. The method according to claim 1 , wherein a single oral transmucosal administration of the dosage form to the subject results in a bioavailability of greater than 75%.
15. The method according to claim 1 , wherein a single oral transmucosal administration of the dosage form to the subject results in a bioavailability of greater than 80%.
16. The method according to claim 1 , wherein sufentanil is sufentanil citrate.
17. The method according to claim 1 , wherein said bioadhesive dosage form is administered using a drug delivery device.