# US 2019/0167664 A1 · Polymorphic Forms of Naltrexone

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- Number: US 2019/0167664 A1
- Document ID: US20190167664A1
- Status: Published application
- Kind: A1
- Application number: 16/201,067
- Filed: 2018-11-27
- Published: 2019-06-06
- Earliest claimed: 2003-06-04
- Assignees: Alkermes Pharma Ireland Limited
- Applicants: Alkermes Pharma Ireland Limited
- Inventors: Harry G. Brittain; David A. Dickason; Joyce M. Hotz; Shawn L. Lyons; J. Michael Ramstack; Steven G. Wright
- Web page: https://patentgrep.com/patent/US20190167664A1

## CPC

- A61K 31/485: Morphinan derivatives, e.g. morphine, codeine
- A61P 25/32: Alcohol-abuse
- C07C 19/03: Chloromethanes
- C07D 489/06: with a hetero atom directly attached in position 14
- C07D 489/08: Oxygen atom
- C07B 2200/13: Crystalline forms, e.g. polymorphs
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C07C: ACYCLIC OR CARBOCYCLIC COMPOUNDS
- C07D: HETEROCYCLIC COMPOUNDS (macromolecular compounds C08)
- C07B: GENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR (preparation of carboxylic acid esters by telomerisation C07C67/47; telomerisation C08F)

## Abstract

This invention relates to the discovery of novel polymorphic forms of naltrexone, including solvates, hydrates, anhydrous and other crystalline forms and combinations thereof. These novel forms of naltrexone impart advantages in pharmaceutical formulations incorporating them, including sustained release, or long acting, formulations.

## Claims

### Claim 1

(canceled)

### Claim 2

A polymorphic form of naltrexone dimethylformamide solvate which is characterized by at least one of:
(a) the X-ray powder diffraction pattern of FIG. 2A;
(b) the differential scanning calorimetry thermogram of FIG. 14A; and
(c) the IR-ATR spectrum of FIG. 26A.

### Claim 3 (depends on 2)

A pharmaceutical composition comprising the polymorphic form according to claim 2 and a pharmaceutically acceptable carrier.

### Claim 4

A polymorphic form of naltrexone dimethylformamide solvate which is characterized by at least one of:
(a) the X-ray powder diffraction pattern of FIG. 2B;
(b) the differential scanning calorimetry thermogram of FIG. 14B; and
(c) the IR-ATR spectrum of FIG. 26B.

### Claim 5 (depends on 4)

A pharmaceutical composition comprising the polymorphic form according to claim 4 and a pharmaceutically acceptable carrier.