IP Library Granted Patent US 10,004,699
Granted Patent B2
US 10,004,699 · App. 14/734,364 · Granted Jun 26, 2018

Methods and compositions for interfering with extraction or conversion of a drug susceptible to abuse

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Quick Facts
Patent No.
US 10,004,699
App. No.
14/734,364
Granted
Jun 26, 2018
Kind
B2
Abstract

Effective methods and compositions to deter abuse of pharmaceutical products (e.g., orally administered pharmaceutical products) including but not limited to immediate release, sustained or extended release and delayed release formulations for drugs subject to abuse.

Claims (31)

1. An immediate release therapeutic composition comprising:

a pharmaceutically effective amount of pseudoephedrine or a salt thereof;

a triglyceride in an amount of about 1 wt % to about 50 wt % of the therapeutic composition;

hydroxypropylcellulose;

polyethylene oxide; and

a disintegrant selected from the group consisting of crospovidone, sodium starch glycolate and croscarmellose sodium.

2. The therapeutic composition of claim 1 , wherein the hydroxypropylcellulose has a viscosity of about 1,500 mPa to about 3,000 mPa at a concentration of 1% in water.

3. The therapeutic composition of claim 1 , wherein the hydroxypropylcellulose has a molecular weight of about 1,150,000.

4. The therapeutic composition of claim 1 , wherein the polyethylene oxide is present in an amount of about 3 wt % to about 7 wt %.

5. The therapeutic composition of claim 1 , wherein the polyethylene oxide is present in an amount of about 5 wt % to about 10 wt %.

6. The therapeutic composition of claim 1 , wherein the triglyceride has a melting point of about 50° C. to about 80° C.

7. The therapeutic composition of claim 1 , wherein the triglyceride is tristearin.

8. The therapeutic composition of claim 1 , wherein the disintegrant is crospovidone and is present in an amount of about 15 wt % to about 25 wt %.

9. The therapeutic composition of claim 1 , wherein the disintegrant is crospovidone and is present in an amount of about 18 wt % to about 22 wt %.

10. The therapeutic composition of claim 1 , further comprising a glidant.

11. The therapeutic composition of claim 10 , wherein the glidant comprises colloidal silicon dioxide.

12. The therapeutic composition of claim 1 , further comprising a lubricant.

13. The therapeutic composition of claim 12 , wherein the lubricant comprises magnesium stearate.

14. The therapeutic composition of claim 1 , wherein the composition is a suppository, capsule, caplet, pill, gel, soft gelatin capsule, or compressed tablet form.

15. The therapeutic composition of claim 1 , wherein the composition is in unit dose form.

16. An immediate release composition suitable for reducing the chemical conversion of a precursor compound included in the composition to a drug susceptible to abuse comprising:

a precursor compound that can be used in a chemical synthesis of a drug that is susceptible to abuse;

a triglyceride in an amount of about 1 wt % to about 50 wt % of composition;

hydroxypropylcellulose;

polyethylene oxide; and

a disintegrant selected from the group consisting of crospovidone, sodium starch glycolate and croscarmellose sodium.

17. The composition of claim 16 , wherein the precursor compound comprises pseudoephedrine.

18. The therapeutic composition of composition of claim 15 , wherein the unit dose form is a direct compressed unit dose form.

19. A method of making an immediate release composition suitable for reducing the chemical conversion of precursor compound included in the composition to a drug susceptible to abuse comprising:

providing ingredients comprising: a precursor compound that can be used in a chemical synthesis of a drug that is susceptible to abuse; a triglyceride in an amount of about 1 wt % to about 50 wt % of composition, hydroxypropylcellulose; polyethylene oxide, and a disintegrant selected from the group consisting of crospovidone, sodium starch glycolate, and croscarmellose sodium; and

directly compressing the ingredients into a unit dose form.

Assignments (5)
SECURITY INTEREST Recorded Jul 2, 2019
From: ACURA PHARMACEUTICALS, INC.
To: SCHUTTE, JOHN
Reel/Frame 049649/0950 →
SECURITY INTEREST Recorded Jul 2, 2019
From: SCHUTTE, JOHN
To: ABUSE DETERRENT PHARMACEUTICALS, LLC
Reel/Frame 049650/0104 →
RELEASE OF SECURITY INTEREST Recorded Oct 11, 2018
From: OXFORD FINANCE LLC
To: ACURA PHARMACEUTICALS, INC.; ACURA PHARMACEUTICALS TECHNOLOGIES, INC.
Reel/Frame 047140/0800 →
SECURITY INTEREST Recorded Mar 17, 2017
From: ACURA PHARMACEUTICALS, INC.; ACURA PHARMACEUTICAL TECHNOLOGIES, INC.
To: OXFORD FINANCE LLC, AS COLLATERAL AGENT
Reel/Frame 041623/0740 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 8, 2015
From: LEECH, RONALD L., JR.
To: ACURA PHARMACEUTICALS, INC.
Reel/Frame 036022/0758 →