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: from 5.0 micrograms to 100 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, wherein the administration of the dosage form to the subject provides a Tmax with a coefficient of variation less than 40%.
2. 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.
3. The dosage form of 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 dosage form of 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 dosage form of 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 dosage form of claim 1 , wherein after administration of the dosage form to the subject, the dosage form provides a T max of from about 19.8 minutes to about 60 minutes.
7. The dosage form of 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.
8. The dosage form of claim 1 , wherein after administration of the dosage form to the subject, the dosage form provides a T max of from about 19.8 minutes to about 60 minutes and a dose-normalized C max of about 2.72+/−0.84 pg/mL per mcg dosed.
9. The dosage form of claim 8 , wherein the transmucosal administration is to the sublingual membrane.
10. The dosage form of claim 8 , wherein the administration is to the buccal membrane.
11. 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%.
12. 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 75%.
13. 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 80%.
14. The dosage form of claim 1 , wherein sufentanil is sufentanil citrate.
15. A drug delivery device comprising the dosage form of claim 1 .
16. 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 5.0 micrograms to 100 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.
17. The method of claim 16 , wherein the dosage form has a volume of less than 10 microliters or a mass of less than 10 mg.
18. The method of claim 16 , wherein the administration of the dosage form to the subject provides a T max with a coefficient of variation less than 40%.
19. The method of claim 16 , wherein after administration of the dosage form to the subject, the dosage form provides a T max of from about 19.8 minutes to about 60 minutes.
20. The method of claim 16 , 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.
21. The method of claim 16 , 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.
22. The method of claim 16 , 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.