US4894233A — Novel drug delivery system for decongestants

Claim 1

Independent Claim 200 words

A dry particulate drug delivery system designed to be chewed or swallowed whole comprising: (A) a decongestant in an amount of about 1%, to about 75%; and (B) a hydrophobic matrix comprising (i) about 0.5% to about 20% by weight of an emulsifier; and (ii) about 61% to about 95% by weight of an edible material having a melting point in the range of about 25° C. to about 100° C. selected from the group consisting of (a) fatty acids having an iodine value of about 1 to about 10, (b) natural waxes, (c) synthetic waxes and (d) mixtures thereof; and (iii) at least one glyceride, wherein the decongestant and hydrophobic matrix form an agglomerate, and (C) a coat effective to delay hydration until ingested comprising about 200% to about 400% by weight of the agglomerate an edible material having a melting point in the range of about 25° C. to about 100° C. selected from the group consisting of (a) fatty acids having an iodine value of about 1 to about 10, (b) natural waxes, (c) synthetic waxes and (d) mixtures thereof; wherein the coat forms a protective barrier effective to prevent unpleasant taste perception for the decongestant agglomerate.

Claim 2

Dependent Claim 200 words

A dry particulate drug delivery system designed to be chewed or swallowed whole comprising: (A) a decongestant in an amount of about 1%, to about 75%; and (B) a hydrophobic matrix comprising (i) about 0.5% to about 20% by weight of an emulsifier; and (ii) about 61% to about 95% by weight of an edible material having a melting point in the range of about 25° C. to about 100° C. selected from the group consisting of (a) fatty acids having an iodine value of about 1 to about 10, (b) natural waxes, (c) synthetic waxes and (d) mixtures thereof; and (iii) at least one glyceride, wherein the decongestant and hydrophobic matrix form an agglomerate, and (C) a coat effective to delay hydration until ingested comprising about 200% to about 400% by weight of the agglomerate an edible material having a melting point in the range of about 25° C. to about 100° C. selected from the group consisting of (a) fatty acids having an iodine value of about 1 to about 10, (b) natural waxes, (c) synthetic waxes and (d) mixtures thereof; wherein the coat forms a protective barrier effective to prevent unpleasant taste perception for the decongestant agglomerate.

Claim 3

Dependent Claim 11 words

The delivery system of claim 1 wherein the emulsifier is lecithin.

Claim 4

Dependent Claim 46 words

The delivery system of claim 1 wherein the fatty acid is selected from the group consisting of hydrogenated palm oil, hydrogenated palm kernel oil, hydrogenated peanut oil, hydrogenated rapeseed oil, hydrogenated rice bran oil, hydrogenated soybean oil, hydrogenated cottonseed oil, hydrogenated sunflower oil and mixtures thereof.

Claim 5

Dependent Claim 26 words

The delivery system of claim 3 wherein the fatty acid is present in amounts of about 61% to about 95% by weight of the delivery system.

Claim 6

Dependent Claim 30 words

The delivery system of claim 3 wherein the fatty acid is refined hydrogenated palm oil present in amounts of about 63% to about 90% by weight of the delivery system.

Claim 7

Dependent Claim 25 words

The delivery system of claim 1 wherein the glyceride is present in amounts of about 0.5% to about 20% by weight of the delivery system.

Claim 8

Dependent Claim 28 words

The delivery system of claim 6 wherein the glyceride is a distilled monoglyceride present in amounts of about 1% to about 3% by weight of the delivery system.

Claim 9

Dependent Claim 20 words

The delivery system of claim 6 wherein the emulsifier is lecithin, present in amounts of about 0.5% to about 9%.

Claim 10

Dependent Claim 21 words

The delivery system of claim 3 having a melting point in the range of about 25° C. to about 90° C.

Claim 11

Dependent Claim 20 words

The delivery system of claim 1 having a particle size of about 200 to about 30 U.S. Standard mesh size.

Claim 12

Dependent Claim 127 words

A dry particulate composite having a substantially hydrophobic exterior designed to be chewed or swallowed whole comprising (A) an agglomerated mixture of about 1% to about 75% of a decongestant and a matrix wherein the matrix comprises: (i) about 0.5% to about 20% fat soluble lecithin; (ii) about 61% to about 90% of an edible material having a melting point in the range of about 25° C. to about 100° C. selected from the group consisting of (a) a fatty acid having an iodine value of about 1 to about 10; (b) natural waxes; (c) synthetic waxes; (d) and mixtures thereof; (iii) about 0.5% to about 30% of a glyceride; said composite having a melting point in the range of about 20° C. to about 90° C.

Claim 13

Dependent Claim 127 words

A dry particulate composite having a substantially hydrophobic exterior designed to be chewed or swallowed whole comprising (A) an agglomerated mixture of about 1% to about 75% of a decongestant and a matrix wherein the matrix comprises: (i) about 0.5% to about 20% fat soluble lecithin; (ii) about 61% to about 90% of an edible material having a melting point in the range of about 25° C. to about 100° C. selected from the group consisting of (a) a fatty acid having an iodine value of about 1 to about 10; (b) natural waxes; (c) synthetic waxes; (d) and mixtures thereof; (iii) about 0.5% to about 30% of a glyceride; said composite having a melting point in the range of about 20° C. to about 90° C.

Claim 14

Dependent Claim 10 words

The composite of claim 11 contained in a confectionery product.

Claim 15

Dependent Claim 11 words

The composite of claim 11 contained in a chewing gum product.

Claim 16

Dependent Claim 10 words

The composite of claim 11 contained in a pharmaceutical preparation.

Claim 17

Independent Claim 90 words

A method of preparing a drug delivery system comprising: (A) forming an agglomerate of the drug and a hydrophobic matrix coating comprising the steps of melting the hydrophobic matrix coating and dispersing the drug uniformly therein; feeding the dispersion into a spray nozzle; spraying the dispersion under controlled pressure to maintain the particle size between about 200 to about 30 mesh; collecting the agglomerate; and (B) coating the agglomerate by conducting the agglomerate through a stream of air passing through a zone of atomized droplets of a second hydrophobic material.

Claim 18

Independent Claim 90 words

A method of preparing a drug delivery system comprising: (A) forming an agglomerate of the drug and a hydrophobic matrix coating comprising the steps of melting the hydrophobic matrix coating and dispersing the drug uniformly therein; feeding the dispersion into a spray nozzle; spraying the dispersion under controlled pressure to maintain the particle size between about 200 to about 30 mesh; collecting the agglomerate; and (B) coating the agglomerate by conducting the agglomerate through a stream of air passing through a zone of atomized droplets of a second hydrophobic material.

Claim 19

Dependent Claim 23 words

The delivery system of claim 1 wherein the decongestant is selected from the group consisting of phenylephrine hydrochloride, phenylpropanolamine hydrochloride, pseudoephedrine, hydrochloride ephedrine.

Claim 20

Dependent Claim 11 words

The delivery system of claim 1 wherein the decongestant is pseudoephedrine.

Claim 21

Dependent Claim 22 words

The composite of claim 11 wherein the decongestant is selected from the group consisting of phenylephrine hydrochloride, phenylpropanolamine hydrochloride, pseudoephedrine, hydrochloride ephedrine.

Claim 22

Dependent Claim 10 words

The composite of claim 11 wherein the decongestant is pseudoephedrine.

Annuity Stage	Window Opens	Payment Deadline	Surcharge Period Until	Estimated Fee	Status
3.5 Years (Year 4)	1993-01-15	1993-07-17	1994-01-16	$2000.00	Window Closed / Lapsed
7.5 Years (Year 8)	1997-01-15	1997-07-17	1998-01-16	$3760.00	Window Closed / Lapsed
11.5 Years (Year 12)	2001-01-15	2001-07-17	2002-01-16	$7700.00	Window Closed / Lapsed

Novel drug delivery system for decongestants

Abstract

Inventors

Bibliographic Details

Claims Analysis

References Cited (Backward Citations)

USPTO Annuity & Maintenance Windows

Assigned Categories & Tags

Assign Category Tag