Orally disintegrative dosage form
View Patent ↗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 one hydrated salt has a dehydration temperature of from about 20 to about 120 ° C.
1. A process for making a dosage form comprising:
a) introducing a flowable powder material into a recess, said flowable material comprising (i) at least about 5% by weight, of at least one hydrated salt and (ii) a pharmaceutically active agent, wherein said at least one hydrated salt has a dehydration temperature of from about 20 to about 120° C.;
b) heating the flowable powder 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 flowable powder material to fuse into an aggregate, wherein said heating is applied via radiofrequency heating; and
c) cooling the aggregate in the recess so that the aggregate solidifies into said dosage form; wherein said dosage form disintegrates in the mouth when placed on the tongue in less than about 60 seconds.
2. A process 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.
3. The process of claim 1 , wherein the dosage form comprises from about 5% to about 40%, by weight, of at least one hydrated salt.
4. The process of claim 1 , wherein said flowable material further comprises at least one carbohydrate.
5. The process of claim 4 , wherein at least one of 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.
6. The process of claim 4 , wherein at least one of said at least carbohydrate is dextrose monohydrate.
7. The process of claim 4 , wherein said dosage form comprises at least 40% of said at least one carbohydrate.
8. The process of claim 4 , 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.
9. The process of claim 1 , wherein said flowable material is tamped in said recess prior to heating.
10. The process of claim 1 , wherein said dosage form has an in vitro disintegration time of approximately 30 seconds or less based on the United States Pharmacopeia (USP) disintegration test method for the specific medicinal substance or substances.
11. The process of claim 1 , wherein said dosage form meets the criteria for Orally Disintegrating tablets as defined by the draft Food & Drug Administration guidance, as published April, 2007.
12. The process of claim 1 , wherein said dosage form has a hardness of from about 700 to about 6000 grams as measured using Texture Analyzer TA-XT2i that is fitted with a 7 millimeter diameter flat faced probe.
13. The process of claim 1 , wherein said dosage form has a hardness of less than 5 kp/cm 3 .
14. The process of claim 1 , wherein the recess is a blister-type package.
15. The process of claim 1 , wherein said cooling takes place at room temperature.
16. A dosage form made by the process of claim 1 .
17. The dosage form of claim 16 , wherein said flowable material further comprises at least one carbohydrate.