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Claims for Patent: 5,607,697

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Claims for Patent: 5,607,697

Title: Taste masking microparticles for oral dosage forms
Abstract:The present invention relates to a solid dosage form including a new type of taste masking microparticle having an adsorbate of, for example, mannitol, in the core thereof.
Inventor(s): Alkire; Todd G. (Crystal, MN), Sanftleben; Ronald A. (Maple Grove, MN), Schuehle; Steven S. (Maple Grove, MN)
Assignee: Cima Labs, Incorporated (Eden Prairie, MN)
Application Number:08/478,419
Patent Claims: 1. A solid pharmaceutical dosage form adapted for direct oral administration, in solid form, to a mammal comprising:

a plurality of microparticles, each said microparticle having a core including at least one pharmaceutical ingredient and a compound which is sweet in taste and which has a negative heat of solution, said compound which is sweet in taste and which has a negative heat of solution being selected from the group consisting of mannitol, sorbitol, a mixture of an artificial sweetener and menthol, a mixture of a sugar and menthol, and methyl salicylate, said compound being present in said microparticles in an amount of between greater than 0 and about 80% by weight of the resulting microparticle, said core being coated with a coating material, which will retard dissolution of said pharmaceutical ingredient in the mouth, as well as the objectionable taste of said pharmaceutical ingredient, surrounding at least a portion of said core; said solid dosage form being sized and shaped and having a composition and hardness which are adapted for direct oral administration, said dosage form being disintegratable in the mouth so as to release said microparticles.

2. The dosage form of claim 1 further comprising at least one saliva activated effervescent agent in an amount which is effective to provide disintegration of said dosage form in the mouth of a patient, without chewing, to thereby release said microparticles.

3. The pharmaceutical dosage form of claim 1 wherein said microparticles are discrete particulate at least partially coated with said coating material.

4. The pharmaceutical dosage form of claim 3 wherein said microparticles are coated with said coating material.

5. The pharmaceutical dosage form of claim 1 wherein said pharmaceutical ingredient is adsorbed on said compound which is sweet in taste and which has a negative heat of solution.

6. The pharmaceutical dosage form of claim 1 wherein said pharmaceutical ingredient is intimately mixed with said compound which is sweet in taste and which has a negative heat of solution.

7. The pharmaceutical dosage form of claim 1 wherein said microparticles comprise between about 1 and 80% of the dosage form by weight.

8. The pharmaceutical dosage form of claim 7 wherein said compound which is sweet in taste and which has a negative heat of solution is selected from a group consisting of mannitol and sorbitol.

9. The pharmaceutical dosage form of claim 1 further comprising at least one binder disposed within said core.

10. The pharmaceutical dosage form of claim 1 wherein said coating material is ethylcellulose.

11. The pharmaceutical dosage form of claim 1 wherein the balance of the weight of the dosage form is composed of one or more compounds of the group consisting of lubricants, fillers, disintegrants, binding agents, disintegration agents, sweeteners, flavors, colorants.

12. The pharmaceutical dosage form of claim 1 wherein said coating material is provided in an amount of at least about 5% by weight, based on the weight of the particle.

13. The pharmaceutical dosage form of claim 12 wherein said coating material is provided in an amount of at least about 10% by weight, based on the weight of the particle.

14. The pharmaceutical dosage form of claim 12 wherein said coating material is provided in an amount at between about 5% and about 75% by weight of the microparticles.

15. The pharmaceutical dosage form of claim 1 wherein said dosage form is a tablet having a hardness ranging from between about 5 to about 250 newtons.

16. The tablet of claim 15 having a hardness of between about 10 and about 50 newtons.

17. The pharmaceutical dosage form of claim 7 wherein said microparticles comprise between about 5 and about 50% of the dosage form by weight.
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