Dispenser with reservoir containing a drug of abuse

• US 20060157491A1
• Filed: 07/06/2004
• Published: 07/20/2006
• Est. Priority Date: 07/07/2003
• Status: Abandoned Application

• Current Assignee: GW Pharmaceuticals Limited (Jazz Pharmaceuticals Plc)
• Original Assignee: GW Pharmaceuticals Limited (Jazz Pharmaceuticals Plc)
• Inventors: Whittle, Brian A., Dave, Rajiv B
• Application Number:
  US10/563,566
• Publication Number:
  US 20060157491A1
• Time in Patent Office: Days
• US Class Current: 221/9
• CPC Class Codes: A61J 2205/70 Audible labels, e.g. for pre-recorded info or messages
• CPC Class Codes: A61J 7/0418 with electronic history memory
• CPC Class Codes: A61J 7/0445 for preventing drug dispensing during a predetermined time period
• CPC Class Codes: A61J 7/0481 working on a schedule basis
• CPC Class Codes: A61M 15/00 Inhalators drug delivery in endotracheal tubes A61M16/04
• CPC Class Codes: A61M 15/0066 with means for varying the dose size
• CPC Class Codes: A61M 15/008 Electronic counters
• CPC Class Codes: A61M 15/009 using medicine packages with incorporated spraying means, e.g. aerosol cans pocket atomiser of the injector type A61M11/08
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3553 remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3584 using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/6072 Bar codes
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 2205/8237 Charging means
• CPC Class Codes: A61M 2209/086 Docking stations
• CPC Class Codes: A61P 25/36 : Opioid-abuse
• CPC Class Codes: G07F 17/0092 : for assembling and dispensing of pharmaceutical articles medical dispensers for private use, A61J7/00

Abstract

The present invention relates to novel formulations, dosage forms and modes of delivery for treating patients addicted to a group of drugs which can result in dependence and misuse. The most serious drugs of addiction are cocaine, diamorphine (heroin), morphine and the synthetic opioids.

Claims

1. A dispenser comprising a reservoir containing a plurality of dosage units each of which comprise a formulation of a controlled drug or drug of abuse, said dosage units being contained in a tamper-evident manner such that access to the dosage units in use is controlled either by the dispenser or remotely and/or is monitored either by the dispenser or remotely.

2. The dispenser as claimed in claim 1, wherein the controlled drug or drug of abuse is a class A drug in a non-intravenous formulation, as defined by The Misuse of Drugs Act 1971.

3. The dispenser as claimed in claim 1, wherein the controlled drug or drug of abuse is an opioid.

4. The dispenser as claimed in claim 1, wherein the opioid is methadone or a pharmaceutically acceptable salt or derivative thereof.

5. The dispenser as claimed in claim 4, wherein the opioid is methadone hydrochloride.

6. The dispenser as claimed in claim 4, wherein the formulation is for oral delivery.

7. The dispenser as claimed in claim 1, wherein the opioid is diamorphine or a pharmaceutically acceptable salt or derivative thereof.

8. The dispenser as claimed in claim 7, wherein the opioid is diamorphine hydrochloride.

9. The dispenser as claimed in claim 7, wherein the formulation is dry and suitable for nasal delivery upon mixing with an aqueous solution.

10. The dispenser as claimed in claim 9, wherein the formulation further comprises a solubility enhancer.

11. The dispenser as claimed in claim 10, wherein the solubility enhancer is one or more of caffeine, sodium benzoate and sodium salicylate.

12. The dispenser as claimed in claim 10, wherein the solubility enhancer comprises caffeine and sodium benzoate and/or sodium salicylate.

13. The dispenser as claimed in claim 9, wherein said formulation is a freeze-dried formulation.

14. The dispenser as claimed in claim 1, wherein more than 1 day'"'"'s supply of dosage units are contained in the dispenser.

15. A reservoir as claimed in claim 1, for use in the dispenser of claim 1.

16. A method of making a dispenser as defined in claim 1, comprising introducing the plurality of dosage units into the reservoir and then sealing the reservoir in the dispenser so as to render the dispenser tamper-evident.

17. A formulation as defined in claim 9.

18. A controlled method of taking a drug of abuse or a controlled drug comprising administering said drug of abuse or controlled drug from a dispenser as defined in claim 1.

19. A method as claimed in claim 18, wherein said drug of abuse or controlled drug is present in a formulation as defined in claim 9.

20. Use of a drug of abuse or a controlled drug in the manufacture of a medicament for use in a controlled method of taking a drug of abuse or controlled drug comprising administering said drug of abuse or controlled drug from a dispenser as defined in claim 1.

21. Use as claimed in claim 20, wherein said drug of abuse or controlled drug is present in a formulation as defined in claim 9.

22. A kit of parts comprising a dispenser as claimed in claim 9, and aqueous liquid for introduction into the dispenser for rendering the formulation suitable for nasal administration.