Orally disintegrative dosage form

Abstract

The present invention features an orally disintegrating dosage form including from about 5% to about 40%, by weight, of at least one hydrated salt and a pharmaceutically active agent, wherein the at least hydrated salt has a dehydration temperature of from about 20 to about 120° C.

1 . An orally disintegrating dosage form comprising from about 5% to about 40%, by weight, of at least one hydrated salt and a pharmaceutically active agent, wherein said at least hydrated salt has a dehydration temperature of from about 20 to about 120° C. 
   
   
       2 . The orally disintegrating dosage form of  claim 1 , wherein said orally disintegrating dosage form has a in-vitro disintegration time of less than thirty seconds. 
   
   
       3 . The orally disintegrating dosage form of  claim 1 , wherein said orally disintegrating dosage form further comprises at least 40%, by weight, of at least one carbohydrate. 
   
   
       4 . The orally disintegrating dosage form of  claim 3 , wherein said at least one carbohydrate is selected from the group consisting of dextrose, dextrose monohydrate, lactose, glucose, fructose, isomalt, sucrose, mannose, maltose, maltodextrin, corn syrup solids, hydrogenated starch hydrolysates, lactitol, xylitol, mannitol, erythritol, and sorbitol, and mixtures thereof. 
   
   
       5 . The orally disintegrating dosage form of  claim 3 , wherein the weight ratio of said at least one hydrated salt to said at least one carbohydrate is from about 1:4 to about 1:30. 
   
   
       6 . The orally disintegrating dosage form of  claim 1 , wherein said at least one hydrated salt is selected from the group consisting of sodium sulfate hydrate, sodium carbonate hydrate, calcium chloride hydrate, sodium hydrogen phosphate hydrate, and mixtures thereof. 
   
   
       7 . An orally disintegrating dosage form of  claim 1 , wherein said orally disintegrating dosage form has a hardness of less than 5 kp/cm 3 . 
   
   
       8 . An orally disintegrating dosage form of  claim 1 , wherein said pharmaceutically active agent is selected from the group consisting of acetaminophen, ibuprofen, ketoprofen, loperamide, famotidine, cetirizine, phenylephrine, dextromethorphan, calcium carbonate, ascorbic acid, and diphenyhydramine. 
   
   
       9 . An orally disintegrating dosage form of  claim 1  comprising gel-coated liquid filled beads. 
   
   
       10 . A process for making an orally disintegrating dosage form, said method comprising the steps of:
 a) providing a unit product sheet having a recess in a desired shape and volume suitable for containing said orally disintegrating dosage form;   b) introducing into the recess a predetermined amount of a flowable material comprising at least about 5%, by weight, of at least one hydrated salt and a pharmaceutically active agent, wherein said at least one hydrated salt has a dehydration temperature of from about 20 to about 120° C.;   c) heating the material in the recess to a temperature above said dehydration temperature for said at least one hydrated salt and for a sufficient period of time to cause the material to fuse into an aggregate, and   d) cooling the aggregate in the recess so that the aggregate solidifies into the orally dissolving dosage form suitable for consumption.   
   
   
       11 . The process of  claim 10 , wherein the unit product sheet is a blister-type package. 
   
   
       12 . The process of  claim 10 , wherein the heat is applied via convection, conduction, sonic heating, radiofrequency, laser, infrared, or microwave. 
   
   
       13 . The process of  claim 10 , wherein the recess has positive imprinted portions on its interior surface and which produce corresponding patterns in the final dosage form. 
   
   
       14 . The process of  claim 10 , wherein said process further comprises the step of sealing the flowable material within the recess prior to said heating step (c). 
   
   
       15 . A dosage form comprising an edible outer portion and an orally disintegrating portion, said edible outer portion containing the orally disintegrating portion of said dosage form and said orally disintegrating portion comprising at least about 5%, by weight, of at least one hydrated salt and a pharmaceutically active agent, wherein said at least one hydrated salt has a dehydration temperature of from about 20 to about 120° C. 
   
   
       16 . A dosage form of  claim 15 , wherein said edible outer portion comprises a pharmaceutically active agent 
   
   
       17 . A dosage form of  claim 15 , wherein said edible outer portion is a hard candy 
   
   
       18 . A process for making a dosage form comprising an edible outer portion and an orally disintegrating portion, said method comprising the steps of:
 a) preparing an edible outer portion having a recess in a desired shape and volume suitable for containing the orally disintegrating portion of said dosage form;   b) introducing into the recess a predetermined amount of a flowable material comprising at least about 5%, by weight, of at least one hydrated salt and a pharmaceutically active agent, wherein said at least one hydrated salt has a dehydration temperature of from about 20 to about 120° C.;   c) heating the material in the recess to a temperature above said dehydration temperature for said at least one hydrated salt and for a sufficient period of time to cause the material to fuse into an aggregate, and   d) cooling the aggregate in the recess so that the aggregate solidifies into the orally dissolving dosage form suitable for consumption.   
   
   
       19 . The process of  claim 18  wherein the edible outer portion is prepared via compression. 
   
   
       20 . The process of  claim 18  wherein the edible outer portion is a outer hard candy form prepared by a method selected from the group consisting of uniplast rolling, roping and subsequent cutting and stamping, or mold depositing.