ASYMMETRIC MEMBRANES FOR DRUG DELIVERY DEVICES

• US 20070248671A1
• Filed: 04/24/2007
• Published: 10/25/2007
• Est. Priority Date: 04/24/2006
• Status: Abandoned Application

• Current Assignee: Pfizer Inc.
• Original Assignee: Pfizer Inc.
• Inventors: Johnson, Barbara Alice, Waterman, Kenneth C.
• Application Number:
  US11/739,117
• Publication Number:
  US 20070248671A1
• Time in Patent Office: Days
• US Class Current: 424/472
• CPC Class Codes: A61K 31/495 having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazinesA61K31/48 takes precedence ; with three nitrogen atoms A61K31/53
• CPC Class Codes: A61K 31/519 ortho- or peri-condensed with heterocyclic rings
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
• CPC Class Codes: A61K 9/2866 Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
• CPC Class Codes: A61P 25/34 Tobacco-abuse

Abstract

The present invention provides an osmotic dosage form comprising a core containing at least one pharmaceutically active ingredient and which also comprises at least one asymmetric membrane coating wherein said coating comprises one or more substantially water-insoluble polymers, and, one or more solid, water-soluble polymeric materials that do not generate significant amounts of hydrogen peroxide or formaldehyde in long term storage.

Claims

1. A dosage form comprising a core containing at least one pharmaceutically active ingredient and which comprises at least one asymmetric membrane technology coating wherein said coating comprises:

one or more substantially water-insoluble polymers, and

one or more solid, water-soluble polymeric materials that do not contain amounts of hydrogen peroxide or formaldehyde greater than about 0.01% w;

w after storage at 40°

C./75% RH for 12 weeks.

2. The dosage form of claim 1 wherein said dosage form delivers drug primarily by osmotic pressure.

3. The dosage form of claim 1 wherein said pharmaceutically active ingredient is varenicline or a pharmaceutically acceptable salt thereof.

4. The dosage form of claim 1 wherein said water-insoluble polymer comprises a cellulose derivative.

5. The dosage form of claim 4 wherein said cellulose derivative is cellulose acetate.

6. The dosage form of claim 1 wherein said solid, water-soluble polymeric material comprises a polymer having a weight average molecular weight between 2000 and 50,000 daltons.

7. The dosage form of claim 1 wherein said solid, water-soluble polymeric material is selected from the group consisting of water-soluble cellulose derivatives, acacia, dextrin, guar gum, maltodextrin, sodium alginate, starch, polyacrylates, polyvinyl alcohols and zein.

8. The dosage form of claim 7 wherein said water-soluble cellulose derivatives comprise hydroxypropylcellulose, hydroxypropylmethylcellulose and hydroxyethylcellulose.

9. The dosage form of claim 1 wherein said solid, water-soluble, polymeric material has a viscosity for a 5% w:

w aqueous solution of less than 400 mPa s.

10. The dosage form of claim 1 wherein said solid, water-soluble, polymeric material has a viscosity for a 5% w:

w aqueous solution of less than 300 mPa s.

11. The dosage form of claim 1 wherein said solid, water-soluble, polymeric material has a softening temperature greater than 55°

C.

12. The dosage form of claim 1 wherein said core contains a sugar.

13. The dosage form of claim 12 wherein said sugar is mannitol.

14. A method of treatment for nicotine dependency, addiction and withdrawal, in particular for use in smoking cessation therapy, comprising the administration of one tablet daily of a dosage form comprising a core containing varenicline, or a pharmaceutically acceptable salt thereof, and an asymmetric membrane technology coating containing cellulose acetate and hydroxypropylcellulose.