Methods for administering small volume oral transmucosal dosage forms using a dispensing device

• US 20080147044A1
• Filed: 10/30/2007
• Published: 06/19/2008
• Est. Priority Date: 01/06/2006
• Status: Active Grant

• Current Assignee: AcelRx Pharmaceuticals Incorporated
• Original Assignee: AcelRx Pharmaceuticals Incorporated
• Inventors: Edwards, Bruce, Tzannis, Stelios, Schreck, Thomas, Hamel, Larry, Palmer, Pamela, Rampersaud, Charles, Chiu, Edmond, Poutiatine, Andrew I.
• Granted Patent: US 9,289,583 B2
• Time in Patent Office: Days
• US Class Current: 604/514
• CPC Class Codes: A61M 31/00 Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008

Abstract

Systems and methods for administration of small volume sufentanil drug dosage forms to the sublingual mucosa of a subject using a device are disclosed. The dispensing device includes a lock-out feature and a means to retard or prevent saliva and/or moisture ingress such that the drug dosage forms in the device remain dry prior to administration.

Claims

1. A method for sublingual administration of a bioadhesive small volume sufentanil-containing drug dosage form to a subject using a device, comprising:

a. obtaining a hand-held device comprising one or more drug dosage forms, each of said dosage forms comprising a dose of sufentanil selected from the group consisting of 5 mcg, 10 mcg, 15 mcg, 20 mcg, 30 mcg, 40 mcg, 50 mcg, 60 mcg, 70 mcg, 80 mcg and 100 mcg and having a volume of less than 100 microliters or a mass of less than 100 mg;

b. inserting the dispensing end of said device into the mouth of said subject; and

c. dispensing a dosage form through the dispensing end of the device, wherein said dosage form is placed on a sublingual membrane of said subject.

2. The method of claim 1, wherein the dispensing end of said device has a proboscis comprising a shroud for placing said dosage form and said shroud includes a means to prevent or retard saliva and other moisture ingress into said device, wherein said dosage forms remain dry prior to placement on said sublingual membrane.

3. The method of claim 2, wherein said device further comprises a lock-out feature for setting a lock-out time and wherein a dosage form cannot be dispensed from said device during said lock-out time.

4. The method of claim 3, wherein said lock-out time is a fixed time lock-out interval, a predetermined lock-out interval, a predetermined variable lock-out interval, a lock-out interval determined by an algorithm or a variable lock-out interval communicated to the device from a remote computer, docking station or other device.

5. The method of claim 3, wherein said dispensing device comprises a disposable cartridge configured to hold one or more drug dosage forms.

6. The method of claim 5, wherein said cartridge comprises one or more shipping tablets and at least one shipping tablet is dispensed prior to dispensing of a dosage form.

7. The method of claim 5, wherein said cartridge includes a smart cartridge recognition system comprising a physical keyed feature on the cartridge, an optically detected feature or pattern, a bar code on the cartridge, a magnetic tag on the cartridge, an RFID tag on the cartridge, an electronic microchip on the cartridge, or a combination thereof.

8. The method of claim 5, wherein said dispensing device further comprises a patient identification means wherein said patient identification means is a radio frequency identification (RFID) reader configured to couple with a matching RFID tag on a patient to be identified and said dispensing device is unlocked when the RFID reader on the dispensing device detects a matching RFID tag on a patient.

9. The method of claim 4, wherein said dispensing device comprises a disposable cartridge configured to hold one up to 200 drug dosage forms.

10. The method of claim 1, wherein said dispensing device further comprises one or more of a means for:

(i) recording dosing or use history, (ii) recording dosing and use history, (iii) a means to view or download dosing or use history, or (iv) a means to view or download dosing and use history.

11. The method of claim 1, wherein erosion of said dosage form is complete in from about 30 seconds to about 30 minutes following the dispensing of said dosage form on the sublingual membrane.

12. The method of claim 1, wherein a single sublingual administration of said dosage form to a subject results in a bioavailability of at least 50%.

13. The method of claim 1, wherein repeated sublingual administration of said dosage form to a subject, results in a bioavailability that is greater than the bioavailability following a single sublingual administration to said subject.

14. The method of claim 1, wherein a single sublingual administration of said dosage form to a subject results in an AUC with a coefficient of variation of less than 40%.

15. The method of claim 1, wherein a single sublingual administration of said dosage form to a subject results in a T_max with a coefficient of variation of less than 40%

16. The method of claim 1, wherein the difference between the T_max following repeated sublingual administration and the time of the previous sublingual administration is shorter than the T_max following a single sublingual administration to said subject.

17. The method of claim 1, wherein an amount of drug selected from the group consisting of at least 55%, at least 60%, at least 65%, at least 70%, at least 75%, at least 80%, at least 85%, at least 90%, at least 95%, at least 98% and at least 99% of the total amount of drug in said dosage form is absorbed via the sublingual route.

18. The method of claim 1, wherein said dosage form administration is patient controlled.

19. The method according to claim 1, for treating pain in a subject, wherein following administration of said dosage form, pain relief is evident in said subject.

20. The method according to claim 5, wherein repeated sublingual administration of said dosage form to a subject, results in a bioavailability that is greater than the bioavailability following a single sublingual administration to said subject.

21. The method according to claim 5, wherein the difference between the T_max following repeated sublingual administration and the time of the previous sublingual administration is shorter than the T_max following a single sublingual administration to said subject.

22. The method of claim 5, wherein a single sublingual administration of said dosage form to a subject results in a bioavailability of at least 50%

23. The method according to claim 5, wherein an amount of drug selected from the group consisting of at least 55%, at least 60%, at least 65%, at least 70%, at least 75%, at least 80%, at least 85%, at least 90%, at least 95%, at least 98% and at least 99% of the total amount of drug in said dosage form is absorbed via the sublingual route.

24. The method of claim 5, wherein said dosage form administration is patient controlled.

25. The method according to claim 5, for treating pain in a subject, wherein following administration of said dosage form, pain relief is evident in said subject.