US4778676A — Confectionery delivery system for actives

Claim 1

Independent Claim 119 words

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° 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 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.

Claim 2

Dependent Claim 119 words

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° 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 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.

Claim 3

Dependent Claim 33 words

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.

Claim 4

Dependent Claim 22 words

The delivery system of claim 1 wherein the ratio of coating to achive is about 1:3 to about 1:8 parts by weight.

Claim 5

Dependent Claim 32 words

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.

Claim 6

Dependent Claim 22 words

The delivery system of claim 1 wherein the polyalkyleneglycol is selected from the group consisting of polyethyleneglycol, polypropyleneglycol, polybutyleneglycol and mixtures thereof.

Claim 7

Dependent Claim 27 words

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.

Claim 8

Dependent Claim 22 words

The delivery system of claim 6 wherein the humectant is selected from the group consisting of glycerine, triacetin, tributyrin and mixtures thereof.

Claim 9

Dependent Claim 15 words

The delivery system of claim 1 wherein there is additionally incorporated a nonionic hydrocolloid gum.

Claim 10

Dependent Claim 24 words

The delivery system of claim 8 wherein the gum is selected from the group consisting of guar gum, locust bean gum, and mixtures thereof.

Claim 11

Dependent Claim 30 words

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.

Claim 12

Dependent Claim 21 words

A method of treating hypercholesterolemia and related disorders comprising administering a therapeutically effective amount of the delivery system of claim 1.

Claim 13

Independent Claim 142 words

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° 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 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.

Claim 14

Independent Claim 142 words

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° 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 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.

Claim 15

Dependent Claim 17 words

The delivery system of claim 1 wherein the pre-coated cholestyramine is present in a pharmaceutically effective amount.

Claim 16

Dependent Claim 20 words

The delivery system of claim 1 wherein the pre-coated cholestyramine comprises about 15 to about 30% of the final product.

Claim 17

Independent Claim 101 words

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 2-7 ) ester derivatives; a sweetener; and about 1% to about 30% by weight water.

Claim 18

Independent Claim 101 words

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 2-7 ) ester derivatives; a sweetener; and about 1% to about 30% by weight water.

Claim 19

Dependent Claim 27 words

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.

Annuity Stage	Window Opens	Payment Deadline	Surcharge Period Until	Estimated Fee	Status
3.5 Years (Year 4)	1991-10-18	1992-04-18	1992-10-18	$2000.00	Window Closed / Lapsed
7.5 Years (Year 8)	1995-10-18	1996-04-18	1996-10-18	$3760.00	Window Closed / Lapsed
11.5 Years (Year 12)	1999-10-18	2000-04-18	2000-10-18	$7700.00	Window Closed / Lapsed

Confectionery delivery system for actives

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