Film-coated solid dosage forms
An orally dissolvable film coating for solid dosage forms which contains pullulan, one or more sensory cue agents, and a plasticizer. The film coating disintegrates in the mouth releasing the sensory cue agent resulting in an immediately perceivable sensory cue. A method for coating a solid oral dosage form with the pullulan coating composition.
1 . A film-coated solid oral dosage form comprising
a) a solid core
b) an orally dissolvable film coating composition comprising:
i) pullulan;
ii) at least one sensory cue agent; and
iii) a plasticizer;
wherein said film coating is applied to said core.
2 . The orally dissolvable film coating composition of claim 1 where said pullulan comprises from about 0.1 to about 20 w/w % of the composition.
3 . The orally dissolvable film coating composition of claim 1 wherein said plasticizer is selected from the group consisting of polyhydric alcohols, esters of polyhydric alcohols and mixtures thereof.
4 . The orally dissolvable film coating composition of claim 1 wherein said plasticizer is an ester of a polyhydric alcohol.
5 . The orally dissolvable film coating composition of claim 1 wherein the plasticizer comprises from about 0.01 wt/wt % to about 10 wt/wt %.
6 . The orally dissolvable film coating according to claim 1 wherein at least one sensory cue agent is in amount from about 0.01 to about 25 wt/wt % of the film.
7 . The orally dissolvable film coating composition according to claim 1 wherein the sensory cue agent is a volatile sensory cue agent.
8 . The orally dissolvable film coating composition according to claim 1 wherein the sensory cue agent is selected from the group consisting of cooling agents, heat sensation agents, essential oils, flavoring agents, acidulants and mixtures thereof.
9 . The orally dissolvable film coating composition of claim 1 further comprising a surfactant.
10 . The composition according to claim 1 wherein the solid core is selected from the group consisting of tablet, caplet, wafer, granule, powder, and chewable tablet.
11 . The composition according to claim 1 where the orally dissolvable film coating comprises from about 1 to 15 w/w % of the total solid oral dosage form.
12 . A means for treating a patient comprising administering a pharmaceutical dosage form coated with an orally dissolvable film coating containing pullulan, a plasticizer, and at least one sensory cue agent, such that said sensory cue agent imparts an immediate perceivable sensory cue in the mouth or nasal passages.
13 . A method for preparing a film-coated solid oral dosage form comprising the steps of:
a) blending pullulan with a plasticizer for a time sufficient to form a homogeneous mixture;
b) adding volatile sensory cue agents to the homogeneous mixture in a); and
c) applying the mixture to a solid oral dosage form core.