Novel drug delivery system for expectorants

Claim 1

A dry particulate drug delivery system designed to be chewed or swallowed whole comprising: (A) an expectorant 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; (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 expectorant and hydrophobic matrix form an agglomerate, and (C) a coating for the expectorant/hydrophobic matrix agglomerate effective to delay hydration until ingested comprising about 200% to about 400% by weight of the agglomerate 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; wherein the coating forms a protective barrier effective to prevent unpleasant taste perception for the expectorant/hydrophobic matrix agglomerate.

Claim 17

A method of preparing a dry particulate drug delivery system comprising: (A) forming an agglomerate of an expectorant and a hydrophobic matrix wherein the hydrophobic matrix comprises about 0.5% to about 20% by weight of an emulsifier, 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 fatty acids having an iodine value of about 1 to about 10, natural waxes, synthetic waxes and mixtures thereof, and at least one glyceride, comprising the steps of melting the hydrophobic matrix and dispersing the expectorant 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 expectorant/hydrophobic matrix agglomerate by conducting the agglomerate through a stream of air passing through a zone of atomized droplets of a protective barrier matrix wherein the protective barrier matrix comprises an edible material having a melting point in the range of about 25° C. to about 100° C. selected from the group consisting of fatty acids having an iodine value of about 1 to about 10, natural waxes, synthetic waxes and mixtures thereof.

Claim 18

A method of preparing a dry particulate drug delivery system comprising: (A) forming an agglomerate of an expectorant and a hydrophobic matrix wherein the hydrophobic matrix comprises about 0.5% to about 20% by weight of an emulsifier, 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 fatty acids having an iodine value of about 1 to about 10, natural waxes, synthetic waxes and mixtures thereof, and at least one glyceride, comprising the steps of melting the hydrophobic matrix and dispersing the expectorant 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 expectorant/hydrophobic matrix agglomerate by conducting the agglomerate through a stream of air passing through a zone of atomized droplets of a protective barrier matrix wherein the protective barrier matrix comprises an edible material having a melting point in the range of about 25° C. to about 100° C. selected from the group consisting of fatty acids having an iodine value of about 1 to about 10, natural waxes, synthetic waxes and mixtures thereof.