Method and Composition for Making an Orally Disintegrating Dosage Form
The present invention relates to a process for making orally disintegrating dosage forms and means for packaging such dosage forms.
1 - 14 . (canceled)
15 . A process for making a dosage form comprising:
a) introducing a flowable powder mixture into a recess, said mixture comprising (i) a pharmaceutical and (ii) a binder having a melting point of about 20-160° C.;
b) heating said mixture to melt said binder to form an agglomerate, wherein said heating is applied via radiofrequency or microwave heating; and
c) cooling the agglomerate such that the melted binder solidifies into said dosage form.
16 . The process of claim 15 , wherein said binder is selected from the group consisting of fats, waxes, water soluble polymers, long chain alcohols and mixtures thereof.
17 . The process of claim 15 , wherein said binder is polyethylene glycol.
18 . The process of claim 15 , wherein at least 95% by weight of the binder has a particle size of less than 100 microns.
19 . The process of claim 15 , wherein at least 50% by weight of the binder has a particle size of from 100 to 400 microns.
20 . The process of claim 15 , wherein dosage form comprises less than 40% of said binder.
21 . The process of claim 15 , wherein said mixture further comprises at least one carbohydrate or a carbohydrate alcohol.
22 . The process of claim 21 , wherein said dosage form comprises from 20 to about 90 percent of said at least one carbohydrate or a carbohydrate alcohol.
23 . The process of claim 15 , wherein said mixture is tamped in said recess prior to heating.
24 . The process of claim 23 , wherein said tamping step is conducted using a force less than 0.3 kiloNewtons.
25 . The process of claim 15 , 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.
26 . The process of claim 15 , wherein said dosage form meets the criteria for Orally Disintegrating tablets as defined by the draft Food & Drug Administration guidance, as published April, 2007.
27 . The process of claim 15 , wherein said dosage form has a hardness of less than 1000 grams as measure using Texture Analyser TA-XT2i that is fitted with a 7 millimeter diameter flat faced probe.
28 . The process of claim 15 , wherein said dosage form has a hardness of from 700 to 6000 grams as measure using Texture Analyser TA-XT2i that is fitted with a 7 millimeter diameter flat faced probe.
29 . The process of claim 15 , wherein said dosage form has a density less than 0.9 g/cc.
30 . The process of claim 15 , wherein said dosage form has a density less than 0.7 g/cc.
31 . The process of claim 15 , wherein the recess is a blister-type package.
32 . The process of claim 15 , wherein the heating is applied via radio frequency.
33 . The process of claim 15 , wherein said cooling takes place at room temperature.
34 . The process of claim 15 , wherein said heating step melts the binder partially throughout the agglomerate.
35 . A dosage form made by the process of claim 15 .
36 . A process for making a dosage form comprising an edible outer portion and an inner orally disintegrating portion comprising:
a) preparing an edible outer form having a recess in a desired shape and volume suitable for containing the orally disintegrating portion of said dosage form;
b) introducing a flowable powder mixture into a recess to form an agglomerate, said mixture comprising (i) a pharmaceutical and (ii) a binder having a melting point of about 20-160° C.;
c) heating said mixture to melt said binder to form an agglomerate, wherein said heating is applied via radiofrequency or microwave heating; and
d) cooling the agglomerate such that the melted binder solidified into said orally disintegrating portion.