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Claims for Patent: 6,740,341

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Claims for Patent: 6,740,341

Title: Taste masking rapid release coating system
Abstract:The present invention relates to a core containing a drug encased in a spacing layer and a taste masking layer which provides effective taste masking for in-mouth disintegrable dosage forms containing highly objectionable tasting drugs, as well as dosage forms containing these cores.
Inventor(s): Holt; Kris E. (Maple Grove, MN), Khankari; Rajendra K. (Maple Grove, MN), Hontz; John (Plymouth, MN)
Assignee: Cima Labs Inc. (Eden Prairie, MN)
Application Number:09/449,851
Patent Claims: 1. A taste masked formulation which rapidly releases a drug in the stomach of a patient comprising: a drug-containing core; a taste masking layer having a thickness of between about 5 and about 75 microns composed of a material which is generally insoluble in saliva at a neutral to basic pH and completely soluble in saliva at a pH of less than about 6.5; and a spacing layer having a thickness of between about 5 and about 75 microns surrounding said core and substantially completely sequestering said core from said taste masking layer and being capable of rapidly exposing said core when exposed in the stomach of a patient; said taste masking layer preventing exposure of said spacing layer in the mouth of a patient for a period of at least about 20 seconds after being placed into the mouth and being capable of rapidly exposing said spacing layer when in the stomach of a patient; wherein the taste-masked formulation disintegrates in the mouth of a patient in less than 90 seconds to form a suspension of particles; wherein the coated drug-containing core generally has a diameter of no larger than 1,500 microns.

2. The formulation of claim 1 wherein said drug is a pharmaceutically active material, a vitamin, a mineral, a nutritional supplement and mixtures thereof.

3. The formulation of claim 1 wherein said spacing layer increases the weight of the core by between about 5 and about 100 percent by weight.

4. The formulation of claim 3 wherein said spacing layer increases the weight of the core by between about 20 and about 50 percent by weight.

5. The formulation of claim 1 wherein said spacing layer has a thickness of between about 5 and about 30 microns.

6. The formulation of claim 1 wherein said taste masking layer increases the weight of the core by between about 5 and about 100 percent by weight.

7. The formulation of claim 6 wherein said taste masking layer increases the weight of the core by between about 20 and about 70 percent by weight.

8. The formulation of claim 1 wherein said taste masking layer has a thickness of between about 5 and about 30 microns.

9. A dosage form intended for direct oral administration, comprising: an effective amount of at least one drug, said drug present in the cores of coated particles, said particles including a taste masking layer having a thickness of between about 5 and about 75 microns composed of a material which is generally insoluble in saliva at a neutral to basic pH and completely soluble in saliva at a pH of less than about 6.5; and a spacing layer having a thickness of between about 5 and about 75 microns surrounding said core and substantially completely sequestering said core from said taste masking layer and being capable of rapidly exposing said core when exposed in the stomach of a patient; said taste masking layer preventing exposure of said spacing layer in the mouth of a patient for a period of at least about 20 seconds after being placed into the mouth and being capable of rapidly exposing said spacing layer when in the stomach of a patient; and at least one pharmaceutically acceptable excipient provided in an amount of between greater than zero and less than 100%, based on the weight of the finished dosage form; wherein the taste-masked formulation disintegrates in the mouth of a patient in less than 90 seconds to form a suspension of particles; wherein the coated drug-containing core generally has a diameter of no larger than 1,500 micron.

10. The dosage form of claim 9 wherein said coated particles are present in an amount of between greater than zero and about 95% by weight based on the weight of the fished dosage forms.

11. The dosage form of claim 10 wherein said coated particles are present in an amount of between greater than zero and about 75% by weight based on the weight of the finished dosage forms.

12. The dosage form of claim 9 further comprising a disintegrant wherein the amount of said disintegrant and said excipient are between greater than zero and about 95% by weight based on the weight of the finished dosage forms.

13. The dosage form of claim 12 wherein said disintegrant and said excipient are present in an amount of between greater than zero and about 75% by weight based on the weight of the finished dosage forms.

14. The taste masked formulation of claim 1, wherein the coated drug-containing core has a diameter of no larger than 1200 microns.

15. The taste masked formulation of claim 14, wherein the coated drug-containing core has a diameter of no larger than 850 microns.

16. The dosage form of claim 9, wherein the coated drug-containing core has a diameter of no larger than 1200 microns.

17. The dosage form of claim 16, wherein the coated drug-containing core has a diameter of no larger than 850 microns.
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