Laser Marked Dosage Forms

1 . A dosage form comprising:

a) a core having an exterior surface;

b) a first coating over at least part of the exterior surface of the core; and

c) a second coating over at least part of the first coating;

wherein each of the first and second coatings contain at least one colorant and the colorant in the first and second coatings are different from one another; and

wherein at least one opening is provided through the first coating and the second coating to expose a portion of the exterior surface of the core.

2 . A dosage form according to claim 1 further comprising at least one opening through the second coating and through the first coating to expose a portion of the exterior surface of the core.

3 . A dosage form according to claim 1 further comprising a transparent third coating that is provided over at least a portion of the second coating.

4 . A dosage form according to claim 1 , wherein the core is a compressed tablet.

5 . A dosage form according to claim 1 , wherein the compressed tablet has an elongated shape.

6 . A dosage form according to claim 1 , wherein printed matter is provided on the exterior surface of at least one of the first and second coatings.

7 . The dosage form of claim 1 , wherein the core comprises acetaminophen and from which at least about 90% of the acetaminophen is released after 6 minutes in USP pH 5.8 phosphate buffer in USP Apparatus II (paddle method) at 50 rpm.

8 . A dosage form comprising:

a) a colored core having an exterior surface;

b) a first coating over at least part of the exterior surface of the core; and

c) a second coating over at least part of the first coating;

wherein the second coating contains at least one colorant and the colorant in the first coating is different from the color of the core; and

wherein at least one opening is provided through the second coating to expose a portion of the exterior surface of the colored core.

9 . A dosage form according to claim 8 , wherein at least one opening passes through the second coating to expose at least a portion underlying first coating.

10 . A dosage form according to claim 8 , wherein printed matter is provided on the exterior surface of at least one of the first and second coatings.

11 . A dosage form according to claim 8 further comprising a transparent third coating that is provided over at least a portion of the second coating.

12 . The dosage form of claim 8 , wherein the core comprises acetaminophen and from which at least about 90% of the acetaminophen is released after 6 minutes in USP pH 5.8 phosphate buffer in USP Apparatus II (paddle method) at 50 rpm.

13 . A dosage form comprising:

a) a core having an exterior surface;

b) a first coating over at least part of the exterior surface of the core; and

c) a second coating over at least part of the first coating;

wherein each of the first and second coatings contain at least one colorant and the colorant in the first and second coatings are different from one another; and

wherein at least one opening is provided through the second coating to expose at least a portion of the first coating.

14 . The dosage form of claim 13 , wherein the core comprises acetaminophen and from which at least about 90% of the acetaminophen is released after 6 minutes in USP pH 5.8 phosphate buffer in USP Apparatus II (paddle method) at 50 rpm.

15 . A dosage form comprising:

a) a core having an exterior surface;

b) a first coating over at least part of the exterior surface of the core; and

c) a second coating over at least part of the first coating;

wherein each of the first and second coatings contain at least one colorant and the colorant in the first and second coatings are different from one another; and

wherein at least one opening is provided through the second coating to expose at least a portion of the first coating and at least one opening is provided through the second coating to expose a portion of the exterior surface of the core; and wherein the one or more openings through at least the second coating exposes less than 15% of the surface area of first coating and the core.

16 . A dosage form according to claim 15 further comprising a transparent third coating that is provided over at least a portion of the second coating.

17 . A dosage form according to claim 15 , wherein printed matter is provided on the exterior surface of at least one of the first and second coatings.

18 . A dosage form according to claim 15 , wherein the first or second coating is non-gelatinous.

19 . The dosage form of claim 15 , wherein the core comprises acetaminophen and from which at least about 90% of the acetaminophen is released after 6 minutes in USP pH 5.8 phosphate buffer in USP Apparatus II (paddle method) at 50 rpm.

20 . A dosage form according to claim 15 further comprising at least one opening through the second coating and the first coating to expose a portion of the exterior surface of the core.

21 . A dosage form comprising:

a) a colored liquid or semi-solid core having an exterior surface;

b) a first gelatinous coating over at least part of the exterior surface of the core; and

c) a second coating over at least part of the first coating;

wherein the second coating contains at least one colorant and the colorant in the second coating is different from the color of the first coated core; and

wherein at least one opening is provided through the second coating to expose a portion of the exterior surface of the coated colored liquid or semi-solid core.

22 . A method for producing a dosage form comprising:

a) providing a first coating having a first color over at least a part of an exterior surface of a solid core;

b) providing a second coating having a second color over at least a part of the first coating;

c) providing at least one opening through the second coating to expose a portion of the first coating.

23 . A method according to claim 22 , wherein the at least one opening through the second coating is provided by removing a portion of the second coating using a laser.

24 . A method for producing a dosage form comprising:

a) providing a first coating over at least a part of an exterior surface of a solid core having a first color;

b) providing a second coating having a second color over at least a part of the first coating;

c) providing at least one opening through the second coating to expose a portion of the solid core.

25 . A method according to claim 24 , wherein the at least one opening through the second coating is provided by removing a portion of the second coating using a laser.

26 . A method for producing a dosage form comprising:

a) providing a first coating having a first color over at least a part of an exterior surface of a core;

b) providing a second coating having a second color over at least a part of the first coating; and in no particular order,

c) providing at least one opening through the second coating to expose a portion of the first coating;

d) providing at least one opening through at least the second coating to expose a portion of the core.

27 . A method according to claim 26 , wherein the at least one opening through the second coating to expose a portion of the first coating is provided by removing a portion of the second coating using a laser that is operating at a first energy level and the at least one opening through at least the second coating to expose a portion of the core is provided by removing a portion of the second coating using a laser that is operating at a second energy level.

28 . A method according to claim 26 , wherein the at least one opening through the second coating to expose a portion of the first coating is provided by removing a portion of the second coating using a laser having a first filter that produces a beam having a first energy level and the at least one opening through at least the second coating to expose a portion of the core is provided by removing a portion of the second coating using a laser at an energy level different from the beam exiting from the first filter.

29 . A method of identifying dosage forms with unique characters and colors wherein the dosage form has a) a core having an exterior surface;

a) a first coating over at least part of the exterior surface of the core; and

b) a second coating over at least part of the first coating;

wherein each of the first and second coatings contain at least one colorant and the colorant in the first and second coatings are different from one another; and

wherein at least one opening is provided through the second coating to expose a portion of the exterior surface of the core.

30 . A dosage form comprising:

a) a core having an exterior surface;

b) a single film coating over at least 80% of the exterior surface of the core; and

c) an image formed by the absence of the film coated layer exposing the core which is composed of at least two or more characters as defined by a subset of ASCII characters with DEC code values of #49 to #57 (numbers); #65-78 and #80-90 (upper case letters); and #97-110 and #112 to #122 (lower case letters).

31 . A dosage form according to claim 30 , wherein the image is visually detected by detecting a difference in color.

32 . A dosage form according to claim 30 , wherein the core color is non-white.

33 . A dosage form according to claim 30 , wherein the active ingredient is immediate release.

34 . A method for making the dosage form according to claim 30 , wherein a laser is used to remove up to 20% of the exterior surface resulting in an image formed by absence of film coating.

35 . A method for making the dosage form according to claim 30 wherein a laser is used to remove up to 20% of the exterior surface resulting in an image formed by absence of film coating.

37 . A dosage form according to claim 30 , wherein the dosage form has an additional marking on the film coated portion comprised of ink.

38 . A dosage form according to claim 30 , wherein the core has a lightness value of 8.5 to 10 and the coating has a lightness value of zero to 2.5.

39 . A dosage form according to claim 34 , wherein the ink cannot be detected by the naked eye but is visible only under ultraviolet light.

40 . A dosage form according to claim 31 , wherein an additional marking on the film coated portion formed by a layer of ink can be detected by the human eye.