Immediate release abuse deterrent liquid fill dosage form

• US 9,707,184 B2
• Filed: 07/07/2015
• Issued: 07/18/2017
• Est. Priority Date: 07/17/2014
• Status: Active Grant

• Current Assignee: Pharmaceutical Manufacturing Research Services, Inc.
• Original Assignee: Pharmaceutical Manufacturing Research Services, Inc.
• Inventors: Hart, Matthew N., Thompson, Edwin R., Thompson, Eric R., Myslinski, Nicholas R., Kemeny, Steven F.
• Primary Examiner(s): Milligan, Adam C
• Assistant Examiner(s): Alawadi, Sarah
• Application Number:
  US14/792,699
• Publication Number:
  US 20160015650A1
• Time in Patent Office: 742 Days
• CPC Class Codes: A61K 31/485 Morphinan derivatives, e.g. morphine, codeine
• CPC Class Codes: A61K 9/4833 Encapsulating processes; Filling of capsules mechanical aspects A61J3/07
• CPC Class Codes: A61K 9/4858 Organic compounds
• CPC Class Codes: A61K 9/4866 Organic macromolecular compounds
• CPC Class Codes: A61P 25/04 Centrally acting analgesics, e.g. opioids

Abstract

The present disclosure relates to an oral, immediate release, abuse deterrent liquid filled capsule containing polyethylene glycol and at least one active pharmaceutical ingredient susceptible to abuse. The dosage form is abuse deterrent to parenteral administration. The present disclosure also relates to processes of preparing the dosage form.

Claims

1. An immediate release, abuse deterrent capsule comprising:

(a) an active substance susceptible to abuse;

(b) a first polyethylene glycol (PEG) having an average molecular weight of 35,000 Daltons; and

(c) a second PEG having an average molecular weight between about 3350 Daltons, wherein the ratio of the first PEG to the second PEG is less than about 1;

4 w/w.

2. The capsule of claim 1, wherein the first PEG and the second PEG together are at least about 60 wt % of the dosage form.

3. The capsule of claim 1, wherein at least 80% of the contents are soluble both water and alcohol.

4. The capsule of claim 1, wherein the active substance is hydrocodone bitartrate.

5. The capsule of claim 1, wherein the active substance is oxycodone HCl.

6. The capsule of claim 1, further comprising a grey dye comprising FD&

C Blue #1, FD&

C Yellow #6, and FD&

C Red #40.

7. The capsule of claim 6, wherein the dye provides a visual deterrent to abuse.

8. The capsule of claim 1, wherein the ratio of the first PEG to the second PEG is between about 1:

7 w/w and about 1;

11 w/w.

9. The capsule of claim 1, wherein the capsule comprises at least about 2.5 wt % of the active substance.

10. The capsule of claim 1, wherein the capsule is prepared by filling a capsule body with a heated homogenized suspension comprising the active substance, the first PEG and the second PEG.

16. A method of treating pain comprising administering to a subject in need thereof a therapeutically effective amount of the capsule of claim 1.

11. A process for the production of an immediate release, abuse deterrent capsule comprising at least one active substance susceptible to abuse comprising:

(a) preparing a homogenized suspension of;

(i) the at least one active substance susceptible to abuse;

(ii) a first PEG having an average molecular weight of 35,000 Daltons; and

(iii) a second PEG having an average molecular weight of 3350 Daltons; and

(b) filling the homogenized suspension into a capsule body to produce the capsule, wherein the ratio of the first PEG to the second PEG is less than about 1;

4 w/w.

12. The process of claim 11, wherein the first PEG and the second PEG together are at least about 60 wt % of the capsule.

13. The process of claim 11, wherein the active substance is hydrocodone bitartrate.

14. The process of claim 11, wherein the active substance is oxycodone HCl.

15. The process of claim 11, wherein the capsule is formed by joining a capsule body with a capsule cap.