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Claims for Patent: 5,215,755

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Claims for Patent: 5,215,755

Title: Rotogranulations and taste masking coatings for preparation of chewable pharmaceutical tablets
Abstract:Chewable medicament tablets are made from coated rotogranules of a medicament wherein the rotogranules are formed from a granulation mixture of medicament, e.g. ibuprofen, polyvinylpyrrolidone, sodium starch glycolate and sodium lauryl sulfate and the rotogranules are coated with hydroxyethyl cellulose or a mixture of hydroxyethyl cellulose and hydroxypropyl methylcellulose and a process for making such tablets and a method of providing taste masking of medicaments utilizing such coated rotogranules in a tablet.
Inventor(s): Roche; Edward J. (Paoli, PA), Reo; Joseph P. (Harleysville, PA)
Assignee: McNeil-PPC, Inc. (Milltown, NJ)
Application Number:07/686,723
Patent Claims: 1. A chewable tablet of a medicament comprising compressed coated granules, said coated granules individually consisting essentially of a granule containing a medicament provided in the range of from about 84 to about 96.5 percent by weight which has been granulated with polyvinylpyrrolidone provided in the range of from about 2 to about 10 percent by weight, sodium starch glycolate provided in the range of from about 1.0 to about 4 percent by weight and sodium lauryl sulfate provided in the range of from about 0.5 to about 2.0 percent by weight, wherein the percents by weight are based on the total weight of the granule, and coated with a coating material selected from the group consisting of hydroxyethyl cellulose and a mixture of hydroxyethyl cellulose and hydroxypropyl methylcellulose wherein said coating is provided in an amount effective to remain effectively intact through normal chewing in the mouth.

2. The chewable tablet of claim 1 wherein the medicament is selected from the group consisting of ibuprofen, naproxen, pseudoephedrine hydrochloride, dextromethorphan, chlorpheniramine, loperamide, and combinations thereof.

3. The chewable tablet of claim 1 wherein the coating mixture has a weight ratio in the range of from 90:10 to 40:60 of hydroxyethyl cellulose to hydroxypropyl methylcellulose.

4. The chewable tablet of claim 1 wherein the hydroxyethylcellulose comprises from about 15 to 24% by weight of the total weight of the coated granules.

5. The chewable tablet of claim 1 wherein the coated granules are substantially spherical in shape.

6. The chewable tablet of claim 1 wherein the medicament comprises ibuprofen.

7. The chewable tablet of claim 1 wherein the medicament comprises loperamide.

8. The chewable tablet of claim 1 wherein the medicament comprises a combination of ibuprofen with a medicament selected from the group consisting of pseudoephedrine hydrochloride, dextromethorphan, chlorpheniramine and mixtures thereof.

9. The chewable tablet of claim 1 wherein in addition to the coated granules in said tablet there are one or more excipients selected from the group consisting of sweeteners, binders, artificial sweeteners, lubricants and acidifying agents, and optionally artificial and natural flavors.

10. The chewable tablet of claim 1 wherein the chewable tablet contains in addition to said coated granules one or more of the excipients selected from the group consisting of:

a. an effective amount of a sweetener selected from the group consisting of mannitol, dextrose, fructose, sorbitol, compressible sugar and lactose;

b. an effective amount of a binder selected from the group consisting of microcrystalline cellulose, alginic acid, carboxymethyl cellulose and hydroxypropyl cellulose;

c. an effective amount of an artificial sweetener selected from the group consisting of asparatame and saccharin;

d. an effective amount of a lubricant selected from the group consisting of magnesium stearate, talc, stearic acid, calcium stearate zinc stearate, leucine, glycerides and sodium stearyl fumarate; and

e. an effective amount of an acidifying agent selected from the group consisting of citric acid and malic acid;

and optionally an effective amount of flavoring agent selected from the group consisting of artificial and natural flavors.

11. The chewable tablet of claim 10 wherein;

a. the medicament is ibuprofen;

b. the polyvinylpyrrolidone is Povidone K 29-32;

c. the sweetener is mannitol;

d. the binder is microcrystalline cellulose;

e. the acidifying agent is citric acid in the form of an anhydrous powder;

f. the artificial sweetener is aspartame; and

g. the lubricant is magnesium stearate.

12. A process of preparing a chewable medicament tablet consisting essentially of:

rotogranulating a medicament provided in the range of from about 84 to about 96.5 percent by weight with polyvinylpyrrolidone provided in the range of from about 2 to about 10 percent by weight, sodium starch glycolate provided in the range of from about 1.0 to about 4 percent by weight and sodium lauryl sulfate provided in the range of from about 0.5 to about 2.0 percent by weight to form a medicament rotogranulation composition;

coating the medicament rotogranulation composition with a coating material selected from the group consisting of hydroxyethyl cellulose and a mixture of hydroxyethyl cellulose and hydroxypropyl methylcellulose wherein said coating is provided in an amount effective to remain effectively intact through normal chewing in the mouth thereby forming a coated medicament rotogranulation composition; and

forming a chewable tablet by compressing the coated medicament rotogranulation composition in the presence of pharmaceutically acceptable excipients.

13. The process of claim 12 wherein the coating mixture has a weight ratio in the range of 90:10 to 40:60 of hydroxyethyl cellulose to hydroxypropyl methylcellulose.

14. The process of claim 13 wherein the coating mixture weight ratio is 50:50.

15. A method of taste masking medicaments consisting essentially of rotogranulating a medicament provided in the range of from about 84 to about 96.5 percent by weight with polyvinylpyrrolidone provided in the range of from about 2 to about 10 percent by weight, sodium starch glycolate provided in the range of from about 2 to about 10 percent by weight and sodium lauryl sulfate provided in the range of from about 0.5 to about 2.0 percent by weight to form a rotogranulated medicament composition wherein the percent by weight is based on the total weight of the granule and coating the rotogranulated medicament composition with a taste masking effective amount of a coating material selected from the group consisting of hydroxyethyl cellulose and a mixture of hydroxyethyl cellulose and hydroxypropyl methycellulose.

16. The method of claim 15 wherein the medicament coated is selected from the group consisting of ibuprofen, naproxen, loperamide, pseudoephedrine hydrochloride, dextromethorphan, chlorpheniramine, and mixtures thereof.

17. The method of claim 15 wherein the medicament is ibuprofen.
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