Metered mixing technology for improved taste masking
The present invention relates to metered mixing technology for producing a film type product having improved taste-masking properties of a drug substance. In one aspect, a film-based product and a process for making the product are provided wherein a drug substance coated with a taste-masking substance and a film-forming solution are suitably combined and mixed yet the contact time between the components is controlled such that a bitter taste quality is not sensed by a person ingesting the product.
1 . A method for making a consumable film, comprising:
adding a film-forming solution to an extrusion device;
adding a drug substance to the extrusion device, said drug substance including a taste-masking substance;
mixing the film-forming solution and the taste-masked drug substance to form a mixture in the extrusion device;
extruding the mixture; and
drying the mixture to provide the consumable film.
2 . The method of claim 1 , wherein the drug substance is coated with the taste-masking substance.
3 . The method of claim 1 , wherein the amount of contact time between the film-forming solution and the taste-masked drug substance is less than about thirty minutes.
4 . The method of claim 1 , wherein the amount of contact time between the film-forming solution and the taste-masked drug substance is less than about five minutes.
5 . A single-layer film produced according to claim 1 .
6 . A multiple-layer film produced by the method comprising coextruding two films produced by the method according to claim 1 .
7 . A consumable film produced according to claim 1 that adheres to and dissolves in a mouth of a consumer, wherein the amount of contact time between the film-forming solution and the taste-masked drug substance is controlled during processing such that a bitter aftertaste is eliminated when the film is ingested.
8 . A method for making a consumable film, comprising:
adding a film-forming solution to a mixing device;
adding a taste-masked drug substance;
mixing the film-forming solution and the taste-masked drug substance to form a mixture for a mixing time;
casting the mixture on a substrate; and
drying the mixture to provide the consumable film;
wherein the mixing time of the film-forming solution and the taste-masked drug substance is less than about thirty minutes.
9 . The method of claim 8 , wherein the drug substance is coated with the taste-masking substance.
10 . The method of claim 8 , wherein the mixing time is less than about ten minutes.
11 . A single-layer film produced according to claim 8 .
12 . A multiple-layer film produced by the method according to claim 8 further comprising extruding a second mixture onto a previously dried film.
13 . A consumable film produced according to claim 8 that adheres to and dissolves in a mouth of a consumer, wherein the mixing time between the film-forming solution and the taste-masked drug substance is minimized during processing such that a bitter aftertaste is eliminated when the film is ingested.
14 . A method for making a consumable film, comprising:
adding a film-forming solution to a mixing device;
adding a drug substance to the mixing device, said drug substance including a taste-masking substance;
mixing the film-forming solution and the taste-masked drug substance to form a mixture for an amount of contact time;
controlling the amount of contact time between the film-forming solution and the taste-masked drug substance;
casting the mixture on a substrate; and
drying the mixture to provide the consumable film;
wherein the amount of contact time is such that the consumable film does not have a bitter taste.
15 . The method of claim 14 , wherein the drug substance is coated with the taste-masking substance.
16 . The method of claim 14 , wherein the amount of contact time is less than about thirty minutes.
17 . The method of claim 14 , wherein the amount of contact time is less than about five minutes.
18 . A single-layer film produced according to claim 14 .
19 . A multiple-layer film produced by the method comprising adhering two films produced by the method of claim 14 together with an adhesive.
20 . A consumable film produced according to claim 14 that adheres to and dissolves in a mouth of a consumer, wherein the contact time between the film-forming solution and the taste-masked drug substance is controlled during processing such that a bitter aftertaste is eliminated when the film is ingested.