Buccal dosage form

• US 5,135,752 A
• Filed: 10/14/1988
• Issued: 08/04/1992
• Est. Priority Date: 10/14/1988
• Status: Expired due to Term

• Current Assignee: Watson Laboratories, Inc. (Connecticut) (Abbvie Incorporated)
• Original Assignee: Zetachron Incorporated
• Inventors: Snipes, Wallace C.
• Primary Examiner(s): Page, Thurman K.
• Assistant Examiner(s): MCPHAIL, DONALD
• Application Number:
  US07/257,569
• Time in Patent Office: 1,390 Days
• Field of Search: 424/486, 424/435
• US Class Current: 424/435
• CPC Class Codes: A61K 9/006 Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
• CPC Class Codes: A61K 9/02 Suppositories; Bougies; Bases therefor; Ovulesapparatus for making A61J3/08; devices for introducing into the body A61M31/00
• CPC Class Codes: A61K 9/2009 Inorganic compounds
• CPC Class Codes: A61K 9/2013 Organic compounds, e.g. phospholipids, fats
• CPC Class Codes: A61K 9/2031 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers

Abstract

A matrix for a buccal dosage form which melts in the oral cavity at body temperature but will not spontaneously deform at higher temperatures encountered in shipment and storage comprises:

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Low MW Polyethylene glycol 75-90% (M.P. about 37° C.) Medium to high MW polyethylene glycol 0-4% Long chain saturated carboxylic acid 0-4% Polyethylene oxide 0.1-4% (MW 100,000-5,000,000) Colloidal silica 10-20%. ______________________________________

Claims

1. A matrix composition for a buccal dosage form comprising

View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17)

2. The composition of claim 1 wherein said low MW polyethylene glycol is PEG 1000.

3. The composition of claim 1 wherein said medium to high MW polyethylene glycol is PEG 8000.

4. The composition of claim 1 wherein said long chain saturated carboxylic acid has 12 to 18 carbon atoms in the chain.

5. The composition of claim 3 wherein said long chain carboxylic acid is myristic acid.

6. The composition of claim 1 wherein said polyethylene oxide has a MW of about 5,000,000.

7. The composition of claim 1 wherein said low molecular weight polyethylene glycol is present in a proportion of about 82.5% by weight.

8. The composition of claim 7 wherein said low molecular weight polyethylene glycol is PEG 1000.

9. The composition of claim 1 wherein said medium to high molecular weight PEG is present in a proportion of about 0.5% by weight.

10. The composition of claim 9 wherein said medium to high molecular weight PEG is PEG 8000.

11. The composition of claim 1 wherein said long chain saturated carboxylic acid is present in a proportion of about 0.5% by weight.

12. The composition of claim 11 wherein said long chain saturated carboxylic acid has 12 to 18 carbon atoms in the chain.

13. The composition of claim 12 wherein said long chain carboxylic acid is myristic acid.

14. The composition of claim 1 wherein said polyethylene oxide is present in a proportion of about 0.5% by weight.

15. The composition of claim 1 wherein said polyethylene oxide has a molecular weight of about 5,000,000.

16. The composition of claim 15 wherein said colloidal silica is present in a proportion of about 12% to about 18% by weight.

17. The composition of claim 16 wherein said colloidal silica is present in a proportion of about 16% by weight.

18. A matrix composition for a buccal dosage form comprising