Claims
- 1. A granule consisting of:
(a) crystals of potassium chloride; and (b) a thermoplastic cellulose ether.
- 2. The granule of claim 1, wherein the potassium chloride crystals are between about 20 to about 60 mesh.
- 3. The granule of claim 1, wherein the thermoplastic cellulose ether is ethylcellulose.
- 4. The granule of claim 3, wherein the ethylcellulose has a viscosity between approximately 10-30 cP.
- 5. An extended release tablet comprising a plurality of granules consisting of potassium chloride crystals and a thermoplastic cellulose ether.
- 6. The tablet of claim 5, wherein the granules are essentially free of surfactants or processing aids and agents.
- 7. The tablet of claim 5, wherein the potassium chloride crystals comprise approximately 75.3% by weight based on the total weight of the tablet.
- 8. The tablet of claim 5, wherein the thermoplastic cellulose ether is ethylcellulose.
- 9. The tablet of claim 8, wherein ethylcellulose comprises approximately 15.5% by weight based on the total weight of the tablet.
- 10. The tablet of claim 5, wherein the tablet contains about 10 mEq to about 20 mEq potassium provided by the potassium chloride crystals.
- 11. The tablet of claim 5, wherein the tablet contains 10 mEq potassium, 15 mEq potassium, or 20 mEq potassium provided by the potassium chloride crystals.
- 12. A pharmaceutical dosage unit in tablet form comprising a plurality of granules having an internal core of potassium chloride and an external coating of ethylcellulose, wherein the granules are essentially free of surfactants or processing aids and agents.
- 13. The tablet of claim 12, wherein the core of potassium chloride comprises approximately 75.3% by weight based on the total weight of said tablet.
- 14. The tablet of claim 12, wherein the ethylcellulose comprises approximately 15.5% by weight based on the total weight of said tablet.
- 15. The tablet of claim 12, wherein the tablet contains about 10 mEq to about 20 mEq potassium provided by the potassium chloride.
- 16. The tablet of claim 12, wherein the tablet contains 10 mEq potassium, 15 mEq potassium, or 20 mEq potassium provided by the potassium chloride.
- 17. A process to produce ethylcellulose-coated potassium chloride granules comprising the steps of:
i) forming a fluidized bed of potassium chloride crystals at a dew point of about 10-20° C., ii) spraying the fluidized crystals with a mixture consisting of ethylcellulose, alcohol and water sufficient to coat the crystals, and iii) drying the coated crystals to remove the water and alcohol to provide coated potassium chloride granules.
- 18. The process according to claim 17 wherein the dew point in step i) is 15° C.
- 19. The process according to claim 17 wherein the coated potassium chloride granules of step iii) are essentially free of surfactants or processing aids and agents.
- 20. The process according to claim 17 wherein the alcohol is methyl alcohol.
- 21. The process according to claim 20 wherein the mixture of step ii) is about 10.3% ethylcellulose, 2.1% water and 87.6% methyl alcohol, by weight.
- 22. A method of manufacturing ethylcellulose-coated potassium chloride granules comprising the steps of:
i) forming a fluidized bed of potassium chloride crystals, ii) spraying the fluidized crystals with a mixture consisting of ethylcellulose, alcohol, and sufficient water to control the buildup of static charge so as to enable substantially complete coating of the crystals, and iii) drying the coated crystals to remove the water and alcohol to provide coated potassium chloride granules.
- 23. The method of claim 22 wherein the coated potassium chloride granules of step iii) are essentially free of surfactants or processing aids and agents.
- 24. The method of claim 22 wherein the mixture of step ii) comprises 0.5-2% water, by weight.
- 25. The method of claim 22 wherein the alcohol is methyl alcohol.
- 26. The method of claim 25 wherein the mixture of step ii) is about 10.3% ethylcellulose, 2.1% water and 87.6% methyl alcohol, by weight.
- 27. A method for customizing a patient's supplemental potassium dosage regimen, the method comprising:
i) providing pharmaceutical dosage units containing about 10 mEq potassium, 15 mEq potassium, and 20 mEq potassium; and ii) administering the 10 mEq, 15 mEq, and 20 mEq dosage units in suitable combination to meet a patient's supplemental potassium requirements.
RELATED APPLICATION
[0001] This application is a continuation-in-part of U.S. patent application Ser. No. 10/040,070, filed on Oct. 23, 2001, entitled “Coated Potassium Chloride Granules and Tablets.”
Continuation in Parts (1)
|
Number |
Date |
Country |
Parent |
10040070 |
Oct 2001 |
US |
Child |
10076892 |
Feb 2002 |
US |