PHARMACEUTICAL COMPOSITIONS FOR DETERRING MISUSE, ABUSE, AND DIVERSION

• US 20120009129A1
• Filed: 12/23/2010
• Published: 01/12/2012
• Est. Priority Date: 12/24/2009
• Status: Abandoned Application

• Current Assignee: Acura Pharmaceuticals Incorporated (Abuse Deterrent Pharma LLC)
• Original Assignee: Acura Pharmaceuticals Incorporated (Abuse Deterrent Pharma LLC)
• Inventors: BRZECZKO, Albert Walter
• Application Number:
  US12/977,321
• Publication Number:
  US 20120009129A1
• Time in Patent Office: Days
• US Class Current: 424/43
• CPC Class Codes: A61K 31/44 Non condensed pyridines; Hydrogenated derivatives thereof
• CPC Class Codes: A61K 9/0007 Effervescent A61K9/0065 takes precedence
• CPC Class Codes: A61K 9/2013 Organic compounds, e.g. phospholipids, fats
• CPC Class Codes: A61K 9/2018 Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
• CPC Class Codes: A61P 25/30 for treating abuse or dependence

Abstract

Pharmaceutical compositions to deter misuse, abuse and diversion of pharmaceutical dosage units containing drugs susceptible to abuse with generation of high volume foam upon contact with a suitable media.

Claims

1. A pharmaceutical composition comprising:

a. a drug susceptible to abuse; and

b. foam forming agents comprising

i. an effervescent mixture;

ii. a surfactant; and

iii. a combination of at least one high viscosity polymer and at least one low viscosity polymer.

2. The pharmaceutical composition of claim 1, wherein the effervescent mixture liberates gas in the presence of a media.

3. The pharmaceutical composition of claim 1, wherein the effervescent mixture comprises an organic acid and a salt.

4. The pharmaceutical composition of claim 3, wherein the organic acid comprises citric acid.

5. The pharmaceutical composition of claim 3, wherein the salt comprises alkaline bicarbonate.

6. The pharmaceutical composition of claim 3, wherein the stoichiometric ratio of organic acid to salt is 1:

1.

7. The pharmaceutical composition of claim 1, wherein the effervescent mixture is present in an amount of about 10 wt % to about 50 wt %.

8. The pharmaceutical composition of claim 1, wherein the surfactant has a high hydrophilic/lipophilic balance.

9. The pharmaceutical composition of claim 1, wherein the surfactant comprises sodium lauryl sulfate.

10. The pharmaceutical composition of claim 1, wherein the surfactant is present in an amount of about 1 wt % to about 10 wt %.

11. The pharmaceutical composition of claim 1, wherein the ratio of a high viscosity polymer to a low viscosity polymer is about 5:

1 to about 1;

3.

12. The pharmaceutical composition of claim 1, wherein the ratio of a high viscosity polymer to a low viscosity polymer is about 3:

1 to about 1;

1.

13. The pharmaceutical composition of claim 1, wherein the combination of polymers is present in an amount of about 25 wt % to about 200 wt % relative to the effervescent mixture.

14. The pharmaceutical composition of claim 1, wherein the combination of polymers is present in an amount of about 50 wt % to about 150 wt % relative to the effervescent mixture.

15. The pharmaceutical composition of claim 1, the foam forming agents further comprising a foam stabilizing agent.

16. The pharmaceutical composition of claim 15, wherein the foam stabilizing agent is present in an amount of about 0.5 wt % to about 20 wt % relative to the effervescent mixture.

17. The pharmaceutical composition of claim 15, wherein the foam stabilizing agent is present in an amount of about 1 wt % to about 15 wt % relative to the effervescent mixture.

18. The pharmaceutical composition of claim 1, wherein the composition is in unit dose form.