IP Library › Granted Patent US 8,940,790
Granted Patent B2
US 8,940,790 · App. 13/505,877 · Granted Jan 27, 2015

Stable pharmaceutical formulations comprising lubiprostone

Inventor: Bernard Charles Sherman (Toronto, CA)
A61K31/558A61K47/34
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Quick Facts
Patent No.
US 8,940,790
App. No.
13/505,877
Granted
Jan 27, 2015
Kind
B2
Abstract

Provided is a pharmaceutical formulation comprising lubiprostone and at least one propylene glycol ester. The propylene glycol ester is typically selected from the group consisting of: propylene glycol mono-ester of lauric acid, propylene glycol mono-ester of caprylic acid, propylene glycol mono-ester of capric acid, propylene glycol di-ester of lauric acid, propylene glycol di-ester of caprylic acid and propylene glycol di-ester of capric acid.

Claims (7)

1. A pharmaceutical formulation comprising lubiprostone and a propylene glycol ester, wherein the propylene glycol ester is a mixture of propylene glycol di-ester of caprylic acid and propylene glycol di-ester of capric acid, and the mixture has a di-ester content greater than its mono-ester content.

2. The pharmaceutical formulation of claim 1 wherein a by weight ratio of lubiprostone to propylene glycol ester is between from about 1:250,000 to about 1:1,000.

3. The pharmaceutical formulation of claim 1 wherein a by weight ratio of lubiprostone to propylene glycol ester is about 3:12,500.

4. The pharmaceutical formulation of claim 1 wherein lubiprostone is dissolved in the propylene glycol ester at a concentration of about 25 μg to about 1,000 μg per gram.

5. The pharmaceutical formulation of claim 1 , wherein a by weight ratio of lubiprostone to propylene glycol ester is about 1:4,000.

6. The pharmaceutical formulation of claim 1 , wherein the mixture of propylene glycol di-ester of caprylic acid and propylene glycol di-ester of capric acid comprises Propylene Glycol Dicaprylate/Dicaprate NF27.

7. The pharmaceutical formulation of claim 6 , wherein a by weight ratio of lubiprostone to propylene glycol ester is about 1:4,000.

Assignments (2)
SECURITY INTEREST Recorded Apr 15, 2023
From: APOTEX INC.
To: THE BANK OF NOVA SCOTIA
Reel/Frame 063364/0710 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 12, 2022
From: SHERMAN, BERNARD CHARLES
To: APOTEX INC.
Reel/Frame 060487/0558 →
Continuity (2)
Provisional Application 61257500 · Nov 3, 2009
Related Publication 20120270931A1 · Oct 25, 2012