Soft tablet containing high molecular weight polyethylene oxide

• US 6,753,009 B2
• Filed: 03/13/2002
• Issued: 06/22/2004
• Est. Priority Date: 03/13/2002
• Status: Expired due to Fees

• Current Assignee: McNeil-PPC Incorporated (Johnson & Johnson)
• Original Assignee: McNeil-PPC Incorporated (Johnson & Johnson)
• Inventors: Bunick, Frank J., Luber, Joseph
• Primary Examiner(s): Spear, James M.
• Application Number:
  US10/097,000
• Publication Number:
  US 20030175336A1
• Time in Patent Office: 832 Days
• Field of Search: 424/435, 424/441, 424/465
• US Class Current: 424/441
• CPC Class Codes: A61K 31/137 Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
• CPC Class Codes: A61K 31/473 ortho- or peri-condensed with carbocyclic ring systems, e.g. acridines, phenanthridines
• 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 31/665 having oxygen as a ring hetero atom, e.g. fosfomycin
• CPC Class Codes: A61K 9/0056 Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
• CPC Class Codes: A61K 9/2081 with microcapsules or coated microparticles according to A61K9/50

Abstract

The invention relates to an immediate release tablet capable of being chewed or disintegrated in the oral cavity, which comprises a pharmaceutically active ingredient, and a matrix comprising polyethylene oxide having a weight average molecular weight of from about 500,000 to about 10,000,000. The tablet possesses exceptionally good mouthfeel and stability.

Claims

1. An immediate release dosage form capable of being chewed or disintegrated in the oral cavity prior to swallowing, comprising:

a. a pharmaceutically active ingredient; and

b. a matrix comprising, based upon the total weight of the dosage form, from about 0.25 percent to about 5 percent of polyethylene oxide having a weight average molecular weight of from about 500,000 to about 10,000,000,

wherein the active ingredient is selected from the group consisting of bisacodyl, famotadine, ranitidine, cimetidine, prucalopride, diphenoxylate, loperamide, lactase, mesalamine, bismuth, antacids, and pharmaceutically acceptable salts, esters, isomers, and mixtures therof.

2. An immediate release dosage form capable of being chewed or disintegrated in the oral cavity prior to swallowing, comprising:

a. a pharmaceutically active ingredient; and

b. a matrix comprising, based upon the total weight of the dosage form, from about 0.25 percent to about 5 percent of polyethylene oxide having a weight average molecular weight of from about 500,000 to about 10,000,000,

wherein the active ingredient is selected from the group consisting of acetaminophen, acetyl salicylic acid, ibuprofen, naproxen, ketoprofen, flurbiprofen, diclofenac, cyclobenzaprine, meloxicam, rofecoxib, celecoxib, and pharmaceutically acceptable salts, esters, isomers, and mixtures thereof.

3. An immediate release dosage form capable of being chewed or disintegrated in the oral cavity prior to swallowing, comprising:

a. a pharmaceutically active ingredient; and

b. a matrix comprising, based upon the total weight of the dosage form, from about 0.25 percent to about 5 percent of polyethylene oxide having a weight average molecular weight of from about 500,000 to about 10,000,000,

wherein the active ingredient is selected from the group consisting of pseudoephedrine, phenylpropanolamine, chlorpheniramine, dextromethorphan, diphenhydramine, astemizole, terfenadine, fexofenadine, loratadine, cetirizine, mixtures thereof and pharmaceutically acceptable salts, esters, isomers, and mixtures thereof.

4. An immediate release dosage form capable of being chewed or disintegrated in the oral cavity prior to swallowing, comprising:

a. a pharmaceutically active ingredient; and

b. a matrix comprising polyethylene oxide having a weight average molecular weight of from about 500,000 to about 10,000,000, wherein the dosage form contains, based upon the total weight of the dosage form, from about 0.25 percent to about 2.0 percent of polyethylene oxide.

5. An immediate release dosage form capable of being chewed or disintegrated in the oral cavity prior to swallowing, comprising:

a. a pharmaceutically active ingredient;

b. a matrix comprising, based upon the total weight of the dosage form, from about 0.25 percent to about 5.0 percent of polyethylene oxide having a weight average molecular weight of from about 500,000 to about 10,000,000; and

c. an antioxidant.

6. The dosage form of claim 5 wherein the antioxidant is selected from the group consisting of alpha-tocopherol and derivatives thereof;

butyl hydroxytoluene;

butyl hydroxyacetate;

tetrabutylhydroxyquinone;

propyl gallate; and

mixtures thereof.

7. The dosage form of claim 5, wherein the active ingredient is selected from the group consisting of bisacodyl, famotadine, ranitidine, cimetidine, prucalopride, diphenoxylate, loperamide, lactase, mesalamine, bismuth, antacids, and pharmaceutically acceptable salts, esters, isomers, and mixtures thereof.

8. The dosage form of claim 5, wherein the active ingredient is selected from the group consisting of acetaminophen, acetyl salicylic acid, ibuprofen, naproxen, ketoprofen, flurbiprofen, diclofenac, cyclobenzaprine, meloxicam, rofecoxib, celecoxib, and pharmaceutically acceptable salts, esters, isomers, and mixtures thereof.

9. The dosage form of claim 5, wherein the active ingredient is selected from the group consisting of pseudoephedrine, phenylpropanolamine, chlorpheniramine, dextromethorphan, diphenhydramine, astemizole, terfenadine, fexofenadine, loratadine, cetirizine, mixtures thereof and pharmaceutically acceptable salts, esters, isomers, and mixtures thereof.

10. The dosage form of claim 5, wherein the dosage form is a tablet.

11. The dosage form of claim 5, wherein the polyethylene oxide has a weight average molecular weight of from about 2,000,000 to about 5,000,000.

12. The dosage form of claim 5 containing, based upon the weight of the polyethylene oxide, from about 10 percent to about 1000 percent of the antioxidant.

13. The dosage form of claim 5, wherein the pharmaceutically active ingredient is coated with a taste masking coating, wherein said taste masking coating is substantially free of polyethylene oxide.