IP Library › Granted Patent US 8,183,290
Granted Patent B2
US 8,183,290 · App. 12/839,550 · Granted May 22, 2012

Pharmaceutically acceptable propylene glycol solvate of naproxen

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Quick Facts
Patent No.
US 8,183,290
App. No.
12/839,550
Granted
May 22, 2012
Kind
B2
Abstract

The invention relates to pharmaceutical compositions comprising propylene glycol solvates of APIs. In particular a 2:1 complex of naproxen sodium to propylene glycol is disclosed which is a crystalline solid. The complex is prepared by crystallization of a mixture of naproxen sodium and propylene glycol from diethyl ether. It is identifiable by its X-ray powder diffraction pattern described herein.

Claims (18)

1. A pharmaceutical composition comprising a crystallized form of a solvate of 2:1 naproxen sodium: propylene glycol.

2. The composition according to claim 1 , wherein the composition is characterized by a PXRD pattern comprising peaks expressed in terms of 2-theta angles, wherein said PXRD pattern comprises peaks selected from the group consisting of:

a) a PXRD pattern comprising peaks at 6.67, 18.55, and 22.79 degrees;

b) a PXRD pattern comprising peaks at 9.65, 15.77, and 20.83 degrees;

c) a PXRD pattern comprising peaks at 6.67 and 18.55 degrees;

d) a PXRD pattern comprising a peak at 9.65 degrees;

f) a PXRD pattern comprising a peak at 6.67 degrees;

g) a PXRD pattern comprising peaks at 15.77, 18.55, and 27.17 degrees; and

h) a PXRD pattern comprising peaks at 9.65 and 22.79 degrees.

3. The composition according to claim 2 , wherein said PXRD pattern comprises a peak at 9.65 degrees.

4. The composition according to claim 2 , wherein said PXRD pattern comprises a peak at 6.67 degrees.

5. The composition according to claim 2 , wherein said PXRD pattern comprises peaks selected from the group consisting of:

a) a PXRD pattern comprising peaks at 6.67, 18.55, and 22.79 degrees; and

b) a PXRD pattern comprising peaks at 6.67 and 18.55 degrees.

6. The composition according to claim 2 , wherein said PXRD pattern comprises peaks at 15.77, 18.55, and 27.17 degrees.

7. The composition according to claim 2 , wherein said PXRD pattern comprises peaks selected from the group consisting of:

a) a PXRD pattern comprising peaks at 9.65 and 22.79 degrees; and

b) a PXRD pattern comprising peaks at 9.65, 15.77, and 20.83 degrees.

Assignments (1)
MERGER AND CHANGE OF NAME Recorded Jul 2, 2015
From: MCNEIL-PPC, INC.; JOHNSON & JOHNSON CONSUMER INC.
To: JOHNSON & JOHNSON CONSUMER INC.
Reel/Frame 036049/0254 →