Edible unit dosage form consisting of outer mannitol shell and inner liquid or gel center and method for manufacturing the same

Claim 2

An edible unit dosage form capable of delivering a liquid or soft gel product comprising: (a) an outer relatingly hard edible shell made of meltable material which is moldable by slush molding techniques and removable from the mold without residual tack, comprising from about 80% to about 100% by weight based on the total weight of the shell material of mannitol; and (b) a liquid or gel center contained within said shell said liquid or gel center comprising an oil base or water-in-oil emulsion base containing a pharmaceutically effective amount of medicament, said shell being sealed to the atmosphere with sealing material to contain said liquid or gel center within said shell.

Claim 3

A process for preparing an edible unit dosage form comprising an outer edible shell and a liquid or soft gel center which comprises: (a) forming a melt containing at least 50% by weight of mannitol; (b) pouring said melt into a mold cavity to substantially fill the same with said melt; (c) permitting said melt to cool sufficiently to form a shell having an opening therein; (d) removing the excess molten material; (e) introducing into said formed shell a liquid or gel product to a level adjacent the upper margin of said shell; (f) forming a melt of sealing material; (g) introducing said sealing material into said liquid or gel product; (h) allowing said sealing material to solidify whereby a sealing means is formed which seals off the liquid or gel contents of the shell from the outer atmosphere.

Claim 4

A process for preparing an edible unit dosage form comprising an outer edible shell and a liquid or soft gel center which comprises: (a) forming a melt containing at least 50% by weight of mannitol; (b) pouring said melt into a mold cavity to substantially fill the same with said melt; (c) permitting said melt to cool sufficiently to form a shell having an opening therein; (d) removing the excess molten material; (e) introducing into said formed shell a liquid or gel product to a level adjacent the upper margin of said shell; (f) forming a melt of sealing material; (g) introducing said sealing material into said liquid or gel product; (h) allowing said sealing material to solidify whereby a sealing means is formed which seals off the liquid or gel contents of the shell from the outer atmosphere.

Claim 5

A unit dosage form according to claim 1 in which said shell material also includes a material selected from the group consisting of sorbitol, glycerin, propylene glycol, sugar and mixtures thereof.

Claim 6

A unit dosage form according to claim 1 in which said sealing material comprises a material which in molten condition is floatable on said liquid or gel center.

Claim 7

A unit dosage from according to claim 4 in which said sealing material is selected from the group consisting of mannitol, sorbitol, polyethylene glycol of formula H(OCH 2 CH 2 ) n OH where n has an average value of 75, polyethylene glycol of formula H(OCH 2 CH 2 ) n' OH where n' has an average value of 150 and mixtures thereof.

Claim 8

A unit dosage form according to claim 5 in which said sealing material also includes a material selected from the group consisting of glycerin, propylene glycol, butylene glycol, sugar, medicaments, flavors, colorants and mixtures thereof.

Claim 9

A unit dosage form according to claim 1 wherein the pharmaceutically effective amount of medicament contained in said liquid or gel center is selected from the group consisting of antiseptics, topical anesthetics, pulmonary decongestants, cough suppressants, analgesics, anti-pyretics, antihistamines, antacids and mixtures thereof.

Claim 10

An edible sore throat remedy in unit dosage form comprising: (a) an outer relatively hard edible shell made of meltable material which is moldable by slush molding techniques and removable from the mold without residual tack, comprising from about 80% to about 100% by weight of mannitol; and (b) an anhydrous liquid center containing a therapeutically effective amount of a material selected from the group consisting of benzocaine, hexylresorcinol and mixtures thereof; (c) said shell being sealed from the atmosphere with a sealing material selected from the group consisting of polyethylene glycol of formula H(OCH 2 CH 2 ) n OH where n has an average value of 75, polyethylene glycol of formula H(OCH 2 CH 2 ) n' OH where n' has an average value of 150, mannitol, sorbitol and mixtures thereof.

Claim 11

An edible sore throat remedy in unit dosage form comprising: (a) an outer relatively hard edible shell made of meltable material which is moldable by slush molding techniques and removable from the mold without residual tack, comprising from about 80% to about 100% by weight of mannitol; and (b) an anhydrous liquid center containing a therapeutically effective amount of a material selected from the group consisting of benzocaine, hexylresorcinol and mixtures thereof; (c) said shell being sealed from the atmosphere with a sealing material selected from the group consisting of polyethylene glycol of formula H(OCH 2 CH 2 ) n OH where n has an average value of 75, polyethylene glycol of formula H(OCH 2 CH 2 ) n' OH where n' has an average value of 150, mannitol, sorbitol and mixtures thereof.

Claim 12

A unit dosage form according to claim 8 in which said sealing material is a mixture of mannitol and sorbitol.

Claim 13

An edible sore throat remedy in unit dosage form comprising: (a) an outer relatively hard edible shell made of meltable material which is moldable by slush molding techniques and removable from the mold without residual tack, comprising from about 80% to about 100% by weight of mannitol; and (b) a water-in-oil emulsion liquid center containing a therapeutically effective amount of benzocaine, hexylresorcinol and mixtures thereof; (c) said shell being sealed from the atmosphere with a sealing material selected from the group consisting of polyethylene glycol of formula H(OCH 2 CH 2 ) n OH where n has an average value of 75, polyethylene glycol of formula H(OCH 2 CH 2 ) n' OH where n' has an average value of 150, mannitol, sorbitol and mixtures thereof.

Claim 14

An edible sore throat remedy in unit dosage form comprising: (a) an outer relatively hard edible shell made of meltable material which is moldable by slush molding techniques and removable from the mold without residual tack, comprising from about 80% to about 100% by weight of mannitol; and (b) a water-in-oil emulsion liquid center containing a therapeutically effective amount of benzocaine, hexylresorcinol and mixtures thereof; (c) said shell being sealed from the atmosphere with a sealing material selected from the group consisting of polyethylene glycol of formula H(OCH 2 CH 2 ) n OH where n has an average value of 75, polyethylene glycol of formula H(OCH 2 CH 2 ) n' OH where n' has an average value of 150, mannitol, sorbitol and mixtures thereof.

Claim 15

A unit dosage form according to claim 10 wherein said sealing material is polyethylene glycol of formula H(OCH 2 CH 2 ) n' OH where n' has an average value of 150.

Claim 16

An edible cough and cold product in unit dosage form comprising: (a) an outer relatively hard edible shell made of meltable material which is moldable by slush molding techniques and removable from the mold without residual tack, comprising from about 80% to about 100% by weight of mannitol; and (b) a liquid center gel containing a therapeutically effective amount of a material selected from the group consisting of dextromethorphan and its salts, d-pseudoephedrine and its salts, and mixtures thereof; (c) said shell being sealed from the atmosphere with a sealing material selected from the group consisting of polyethylene glycol of formula H(OCH 2 CH 2 ) n OH where n has an average value of 75, polyethylene glycol of formula H(OCH 2 CH 2 ) n' OH where n' has an average value of 150, mannitol, sorbitol and mixtures thereof.

Claim 17

An edible cough and cold product in unit dosage form comprising: (a) an outer relatively hard edible shell made of meltable material which is moldable by slush molding techniques and removable from the mold without residual tack, comprising from about 80% to about 100% by weight of mannitol; and (b) a liquid center gel containing a therapeutically effective amount of a material selected from the group consisting of dextromethorphan and its salts, d-pseudoephedrine and its salts, and mixtures thereof; (c) said shell being sealed from the atmosphere with a sealing material selected from the group consisting of polyethylene glycol of formula H(OCH 2 CH 2 ) n OH where n has an average value of 75, polyethylene glycol of formula H(OCH 2 CH 2 ) n' OH where n' has an average value of 150, mannitol, sorbitol and mixtures thereof.

Claim 18

A unit dosage form according to claim 12 in which the therapeutically active material contained in said liquid center gel contains a mixture of dextromethophan HBr and d-pseudoephedrine HCl.

Claim 19

An edible antacid product in unit dosage form comprising: (a) an outer relatively hard edible shell made of meltable material which is moldable by slush molding techniques and removable from the mold without residual tack, comprising from about 80% to about 100% by weight of mannitol; and (b) a water-in-oil antacid emulsion liquid center containing a therapeutically effective amount of an antacid selected from the group consisting of calcium carbonate, magnesium hydroxide, aluminum hydroxide and mixtures thereof; (c) said shell being sealed from the atmosphere with a sealing material selected from the group consisting of polyethylene glycol of formula H(OCH 2 CH 2 ) n OH where n has an average value of 75, polyethylene glycol of formula H(OCH 2 CH 2 ) n' where n' has an average value of 150, mannitol, sorbitol and mixtures thereof.

Claim 20

An edible antacid product in unit dosage form comprising: (a) an outer relatively hard edible shell made of meltable material which is moldable by slush molding techniques and removable from the mold without residual tack, comprising from about 80% to about 100% by weight of mannitol; and (b) a water-in-oil antacid emulsion liquid center containing a therapeutically effective amount of an antacid selected from the group consisting of calcium carbonate, magnesium hydroxide, aluminum hydroxide and mixtures thereof; (c) said shell being sealed from the atmosphere with a sealing material selected from the group consisting of polyethylene glycol of formula H(OCH 2 CH 2 ) n OH where n has an average value of 75, polyethylene glycol of formula H(OCH 2 CH 2 ) n' where n' has an average value of 150, mannitol, sorbitol and mixtures thereof.

Claim 21

A unit dosage form according to claim 14 in which the antacid is a mixture of calcium carbonate and magnesium hydroxide.

Claim 22

An edible analgesic product in unit dosage form comprising: (a) an outer relatively hard edible shell made of meltable material which is moldable by slush molding techniques and removable from the mold without residual tack, comprising from about 80% to about 100% by weight of mannitol; and (b) a liquid or gel center comprising an oil base or a water-in-oil emulsion base containing a therapeutically effective amount of an analgesic selected from the group consisting of aspirin, acetaminophen and mixtures thereof; (c) said shell being sealed from the atmosphere with a sealing material selected from the group consisting of polyethylene glycol of formula H(OCH 2 CH 2 ) n OH where n has an average value of 75, polyethylene glycol of formula H(OCH 2 CH 2 ) n' OH where n' has an average value of 150, mannitol, sorbitol and mixtures thereof.

Claim 23

An edible analgesic product in unit dosage form comprising: (a) an outer relatively hard edible shell made of meltable material which is moldable by slush molding techniques and removable from the mold without residual tack, comprising from about 80% to about 100% by weight of mannitol; and (b) a liquid or gel center comprising an oil base or a water-in-oil emulsion base containing a therapeutically effective amount of an analgesic selected from the group consisting of aspirin, acetaminophen and mixtures thereof; (c) said shell being sealed from the atmosphere with a sealing material selected from the group consisting of polyethylene glycol of formula H(OCH 2 CH 2 ) n OH where n has an average value of 75, polyethylene glycol of formula H(OCH 2 CH 2 ) n' OH where n' has an average value of 150, mannitol, sorbitol and mixtures thereof.

Claim 24

An edible cold product in unit dosage form comprising: (a) an outer relatively hard edible shell made of meltable material which is moldable by slush molding techniques and removable from the mold without residual tack, comprising from about 80% to about 100% by weight of mannitol; and (b) a liquid or gel center comprising an oil base or a water-in-oil emulsion base containing a therapeutically effective amount of a mixture of acetaminophen and phenylpropanolamine hydrochloride; (c) said shell being sealed from the atmosphere with a sealing material selected from the group consisting of polyethylene glycol of formula H(OCH 2 CH 2 ) n OH where n has an average value of 75, polyethylene glycol of formula H(OCH 2 CH 2 ) n' OH where n' has an average value of 150, mannitol, sorbitol and mixtures thereof.

Claim 25

An edible cold product in unit dosage form comprising: (a) an outer relatively hard edible shell made of meltable material which is moldable by slush molding techniques and removable from the mold without residual tack, comprising from about 80% to about 100% by weight of mannitol; and (b) a liquid or gel center comprising an oil base or a water-in-oil emulsion base containing a therapeutically effective amount of a mixture of acetaminophen and phenylpropanolamine hydrochloride; (c) said shell being sealed from the atmosphere with a sealing material selected from the group consisting of polyethylene glycol of formula H(OCH 2 CH 2 ) n OH where n has an average value of 75, polyethylene glycol of formula H(OCH 2 CH 2 ) n' OH where n' has an average value of 150, mannitol, sorbitol and mixtures thereof.

Claim 26

A dosage form according to claims 1, 8, 10, 12, 14, 16 or 17 in which the edible shell contains 90% by weight of mannitol and 10% by weight of glycerin.