DRY GRANULATED PHARMACEUTICAL COMPOSITIONS AND METHODS FOR PRODUCING SAME

• US 20080102130A1
• Filed: 10/26/2007
• Published: 05/01/2008
• Est. Priority Date: 10/27/2006
• Status: Abandoned Application

• Current Assignee: Janssen Pharmaceutica NV (Johnson & Johnson)
• Original Assignee: Janssen Pharmaceutica NV (Johnson & Johnson)
• Inventors: Cunningham, John, Woldu, Abraham
• Application Number:
  US11/925,614
• Publication Number:
  US 20080102130A1
• Time in Patent Office: Days
• US Class Current: 424/489
• CPC Class Codes: A61K 9/1694 resulting in granules or microspheres of the matrix type containing more than 5% of excipient
• CPC Class Codes: A61P 25/04 Centrally acting analgesics, e.g. opioids

Abstract

Method are provided for dry granulation processing of a pharmaceutical composition to provide granulated pharmaceutical compositions with improved flow characteristics and reduced amounts of fine particles.

Claims

1. A method for producing a dry granule composition comprising

compressing a pharmaceutical composition to 800 to 900 kPa hardness to produce one or more slugs, and

milling the one or more slugs with an oscillating granulator to form granules.

2. The method of claim 1 further comprising sizing the granules.

3. The method of claim 2 wherein said sizing is performed with the oscillating granulator.

4. The method of claim 1 wherein the oscillating granulator has a 0.25 inch screen for milling the slugs.

5. The method of claim 3 wherein the oscillating granulator has a 16 mesh screen for sizing the granules.

6. The method of claim 2 wherein the sized granules have an average diameter from about 100 microns to about 200 microns.

7. The method of claim 6 wherein the sized granules have an average diameter of about 150 microns.

8. The method of claim 2 wherein no more than 35% of the sized granules have a diameter that is about 75 microns or less.