Claims for Patent: 4,778,676

Summary for Patent: 4,778,676

Title:	Confectionery delivery system for actives
Abstract:	A chewable delivery system for actives comprising: (a) an active pre-coated with at least one material selected from the group consisting of lecithin, polyoxyalkylenes having chain lengths of about 4 carbons or less, glycerides having a melting point of 100.degree. C. or less, polyalkyleneglycols having a molecular weight of 3,700 or less, synthetic and natural waxes and mixtures thereof; and (b) a confectionery matrix comprising a binder system comprising gelatin and a humectant material selected from the group consisting of glycerin and its lower alkyl (C.sub.2-7) ester derivatives; a sweetener; and about 1% to about 30% by weight water.
Inventor(s):	Yang; Robert K. (Randolph, NJ), Sharma; Shri C. (Mendham, NJ), Sheu; Shan-Shan (Parsippany, NJ), Shaw; James J. (Morristown, NJ)
Assignee:	Warner-Lambert Company (Morris Plains, NJ)
Application Number:	06/811,601
Patent Claims:	1. A chewable confectionery delivery system for cholestyramine comprising: (a) cholestyramine pre-coated with at least one material selected from the group consisting of lecithin, polyoxyalkylenes having chain lengths of about 4 carbons or less, glycerides having a melting point of 100.degree. C. or less, polyalkyleneglycols having a molecular weight of 3,700 or less, synthetic and natural waxes and mixtures thereof; and (b) a confectionery matrix comprising a binder system comprising from about 0.1% to about 5% by weight gelatin and a humectant material selected from the group consisting of glycerin and its lower alkyl (C.sub.2-7) ester derivatives, a sweetener; and about 1% to about 30% by weight water, all weights are in percent of the final delivery system. 2. The delivery system of claim 1 wherein the material used for the pre-coating of the active is present in amounts of about 1 to about 10% by weight of the total delivery system. 3. The delivery system of claim 1 wherein the ratio of coating to achive is about 1:3 to about 1:8 parts by weight. 4. The delivery system of claim 1 wherein the material used for the pre-coating of the active is selected from the group consisting of polyoxyethylene, polyoxypropylene, polyoxybutylene, copolymers of these and mixtures thereof. 5. The delivery system of claim 1 wherein the polyalkyleneglycol is selected from the group consisting of polyethyleneglycol, polypropyleneglycol, polybutyleneglycol and mixtures thereof. 6. The delivery system of claim 1 wherein the binder system comprises about 0.1 to about 5.0% gelatin and about 0.1 to about 25% of the humectant material. 7. The delivery system of claim 6 wherein the humectant is selected from the group consisting of glycerine, triacetin, tributyrin and mixtures thereof. 8. The delivery system of claim 1 wherein there is additionally incorporated a nonionic hydrocolloid gum. 9. The delivery system of claim 8 wherein the gum is selected from the group consisting of guar gum, locust bean gum, and mixtures thereof. 10. The delivery system of claim 1 wherein there is additionally included a material selected from the group consisting of pectin, sweeteners, flavorings, colorings, humectants, fillers, emulsifiers thickeners, and mixtures thereof. 11. A method of treating hypercholesterolemia and related disorders comprising administering a therapeutically effective amount of the delivery system of claim 1. 12. A method of preparing a confectionery delivery system for cholestyramine comprising: (a) pre-coating the cholestyramine with at least one material selected from the group consisting of lecithin, polyoxyalkylenes having a chain length of about 4 carbons or less, glycerides having a melting point of 100.degree. C. or less, polyalkyleneglycols having a molecular weight of 3,700 or less, synthetic and natural waxes and mixtures thereof, wherein the coating does not interfere with the function or release of the active; and (b) preparing a confectionery matrix comprising the steps of (i) forming a solution of gelatin and a humectant selected from the group consisting of glycerin and its lower alkyl (C.sub.2-7) ester derivatives; a sweetener; and about 1% to about 30% by weight water; and (c) admixing mixtures from (a) and (b) together; and (d) forming the resultant delivery system into shapes. 13. The delivery system of claim 1 wherein the pre-coated cholestyramine is present in a pharmaceutically effective amount. 14. The delivery system of claim 1 wherein the pre-coated cholestyramine comprises about 15 to about 30% of the final product. 15. A method of treating hypercholesterolemia and related disorders comprising administering a therapeutically effect amount of a confectionery delivery system comprising: (a) cholestyramine resin wherein the cholestyramine resin is coated with at least one material selected from the group consisting of lecithin, polyoxyalkylenes having 4 carbons or less, polyalkyleneglycols having a molecular weight of 3,700 or less and mixtures thereof; and (b) a confectionery matrix comprising a binder system comprising gelatin and a humectant material selected from the group consisting of glycerin and its lower alkyl (C.sub.2-7) ester derivatives; a sweetener; and about 1% to about 30% by weight water. 16. The method of claim 15 wherein the pre-coating is conducted at room temperature and employs one of the following techniques: simple mixing, spray-coating; spray-congealing or fluidized-bed granulation.