DUAL PORTION DOSAGE LOZENGE FORM

• US 20090004248A1
• Filed: 06/23/2008
• Published: 01/01/2009
• Est. Priority Date: 06/29/2007
• Status: Abandoned Application

• Current Assignee: McNeil-PPC Incorporated (Johnson & Johnson)
• Original Assignee: McNeil-PPC Incorporated (Johnson & Johnson)
• Inventors: Wynn, David, Luber, Joseph, Bunick, Frank, McNally, Gerard P., Wiet, Stephan G.
• Application Number:
  US12/143,916
• Publication Number:
  US 20090004248A1
• Time in Patent Office: Days
• US Class Current: 424/440
• CPC Class Codes: A61K 31/485 Morphinan derivatives, e.g. morphine, codeine
• 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 9/209 containing drug in at least two layers or in the core and in at least one outer layer

Abstract

The present invention relates to a dosage form including both a disintegrative tablet portion and a hard candy portion, wherein: (i) the disintegrative tablet portion comprises at least one pharmaceutically active agent, and (ii) the hard candy portion covers at least 20% of the surface of the disintegrative tablet portion, and wherein the disintegration time of the hard candy portion is at least ten times longer than the disintegration time of the disintegrative tablet portion.

Claims

1. A dosage form comprised of both a disintegrative tablet portion and a hard candy portion, wherein:

(i) the disintegrative tablet portion comprises at least one pharmaceutically active agent, and

(ii) the hard candy portion covers at least 20% of the surface of the disintegrative tablet portion, and

wherein the disintegration time of the hard candy portion is at least ten times longer than the disintegration time of the disintegrative tablet portion.

2. The dosage form of claim 1 wherein the disintegrative tablet portion has a hardness of less than about 15 kp/cm², and the hard candy portion has hardness of greater than about 15 kp/cm².

3. The dosage form of claim 1, wherein the pharmaceutically active agent comprised within the disintegrative tablet portion is selected from the group consisting of phenylephrine, dextromethorphan, pseudoephedrine , acetaminophen, ibuprofen, ketoprofen, loperamide, famotidine, calcium carbonate, simethicone, and menthol, and pharmaceutically acceptable salts thereof.

4. The dosage form of claim 1 wherein the pharmaceutically active agent is in the form of particles that are further coated with a taste-masking polymer and wherein the average particle diameter of the particles is from about 50 microns to about 1000 microns.

5. The dosage form of claim 1, wherein the hard candy portion comprises a pharmaceutically active agent different from the pharmaceutically active agent comprised within the disintegrative tablet portion.

6. The dosage form of claim 5, wherein the pharmaceutically active agent comprised within the hard candy portion is selected from the group consisting of phenylephrine, dextromethorphan, pseudoephedrine, chlorpheniramine, methocarbomal, chlophedianol, ascorbic acid, menthol, pectin, dyclonine, and benzocaine, and pharmaceutically acceptable salts thereof.

7. A dosage form of claim 1 wherein the hard candy portion comprises at least 50%, by weight, of a sugar selected from the group consisting of isomalt, sucrose, dextrose, corn syrup, lactitol, and lycasin, and mixtures thereof.

8. The dosage form of claim 1, wherein the disintegrative tablet portion comprises at least 40 percent by weight of a compressible excipient selected from the group consisting of isomalt, dextrose monohydrate, maltodextrin, lactose monohydrate, dextrin, mannitol, lactitol, sorbitol, xylitol, erythritol, sucrose, and lactose, and mixtures thereof.

9. The dosage form of claim 8 wherein the compressible excipient is in the form of particles with an average particle diameter of about 75 to about 400 microns.

10. A dosage form of claim 9, wherein the disintegrative tablet portion further comprises a water-swellable excipient selected from the group consisting of sodium starch glycolate, crospovidone, croscarmellose, microcrystalline cellulose, starches, hydroxypropyl cellulose, and alginic acid.

11. The dosage form of claim 9, wherein the weight ratio of the compressible excipient to the water-swellable excipient is from about 10:

1 to about 100;

1.

12. A dosage form of claim 7, wherein the disintegrative tablet portion further comprises a effervescent couple comprising one member selected from the group consisting of sodium bicarbonate, potassium bicarbonate, calcium carbonate, magnesium carbonate, and sodium carbonate and one member selected from the group consisting of citric acid, malic acid, fumaric acid, tartaric acid, and alginic acid.

13. The dosage form of claim 1, wherein the weight ratio between the disintegrative tablet portion and a hard candy portion is from about 10:

90 to about 60;

40.

14. A dosage form of claim 1, wherein the hard candy portion covers at least 50 percent of the surface area of the disintegrative tablet portion.

15. A dosage portion of claim 14, wherein the hard candy portion comprises a plurality of openings exposing the surface area of the disintegrative tablet portion.

16. The dosage form of claim 14, wherein the hard candy portion substantially covers all of the surface area of the disintegrative tablet portion and wherein the hard candy portion further comprises a plurality of indentations that, upon contact with the fluids in the oral cavity, are adapted to dissolve and expose the surface area of the disintegrative tablet portion.

17. The dosage form of claim 1, wherein the disintegrative tablet portion has multiple layers comprising at least one different ingredient.

18. The dosage form of claim 17, wherein said disintegrative tablet portion comprises two layers, wherein the first layer comprises the pharmaceutically active agent and a second layer comprises a second pharmaceutically active agent that may be different from the pharmaceutically active agent comprised within the first layer.

19. The dosage form of claim 17, wherein said disintegrative tablet portion comprises two layers, wherein both the first layer and the second comprises the pharmaceutically active agent and further wherein pharmaceutically active agent within the second layer is coated with a sustained release coating.

20. The dosage form of claim 17, wherein both the first layer of the second layer of the are exposed on the surface of the dosage form.

21. The dosage form of claim 1, wherein the dosage form has a multiple layer structure, wherein the disintegrative tablet portion is a first layer and the hard candy portion is a second layer.

22. The dosage form of claim 21, wherein the face of one layer has a convex shape and the face of the other layer has a concave shape.

23. The dosage form of claim 21, further comprising a third layer positioned between a face of the first layer and a face of the second layer, wherein the third layer comprises an edible adhesive-like material.

24. The dosage form of claim 23, wherein the edible adhesive-liker material comprises an ingredient selected from the group consisting of polyethylene glycol, polyethylene oxide, polycaprolactone, carnuba wax, microcrystalline wax, oppanol, shellac wax and beeswax.

25. A method of treating a ailment, the method comprising orally administering the dosage form of claim 1 wherein the dosage form comprises an amount of the pharmaceutically active agent effective to treat the ailment.

26. The method of claim 25, wherein the disintegrative tablet portion comprises at least one pharmaceutically active agent selected from the group of phenylephrine, dextromethorphan, chlorpheniramine, chlophedianol, and pseudoephedrine and the hard candy portion comprises at least one pharmaceutically active agent selected from the group of menthol, nicotine, dyclonine, pectin, and benzocaine.