Method and system for forming a pharmaceutical product directly onto a packaging surface
View Patent ↗The present invention relates to a method for forming a pharmaceutical product, such as a dissolvable film dosage form, onto a surface. Particularly, the present invention relates to a method of forming a pharmaceutical product directly onto the surface of a substrate.
1. A method of forming an individual film dosage, comprising the steps of:
a. Preparing a film forming matrix;
b. Providing a substantially flat packaging material substrate having a top surface;
c. Depositing a pre-determined amount of said matrix onto said top surface of said packaging material substrate to form a wet film forming product;
d. Drying said wet film forming product to form a dried film product removably adhered to said packaging material substrate; and
e. Placing a sealing layer on said top surface of said packaging material substrate, wherein said sealing layer effectively seals the dried film product between the sealing layer and the substrate to form a package.
2. The method of claim 1 , wherein said pre-determined amount of said matrix comprises a sufficient level of active material to provide one dosage of said active material.
3. The method of claim 1 , wherein said packaging material substrate and said sealing material each individually comprise a material selected from the group consisting of foil, plastic, mylar, and combinations thereof.
4. The method of claim 1 , wherein said step of depositing is achieved via off-set printing, via direct printing, or via start-and-stop slot die coating.
5. The method of claim 1 , wherein said wet film forming product is substantially square shaped or substantially rectangular shaped.
6. The method of claim 1 , wherein said wet film forming product is deposited onto the top surface of said packaging material substrate such that at least a portion of said top surface is exposed around the periphery of the deposited wet film forming product.
7. The method of claim 6 , wherein the sealing layer is adhered to the top surface of packaging material substrate at said periphery.
8. The method of claim 7 , wherein said sealing layer is adhered to the top surface of the packaging material substrate via a method selected from the group consisting of heat laminating, chemical laminating, radiation, ultrasonic welding, compression, adhesive bonding, and combinations thereof.
9. The method of claim 1 , wherein a plurality of individual wet film forming products are deposited onto said top surface of said packaging material substrate.
10. The method of claim 9 , wherein each wet film forming product is deposited on said top surface of said packaging material substrate with a gap between adjacent wet film forming products.
11. The method of claim 1 , further comprising the step (f) of cutting said packaging material substrate and sealing layer to provide an individual sealed product.
12. The method of claim 1 , wherein said individual dosage form comprises at least one active.
13. The method of claim 12 , wherein said film forming matrix comprises said at least one active.
14. The method of claim 12 , further comprising the step of adding said at least one active to said wet film forming product prior to drying.
15. The method of claim 14 , wherein said adding of said at least one active comprises controllably metering and disposing said at least one active on a surface of said wet film forming product.
16. The method of claim 14 , wherein said adding of said at least one active comprises:
a. use of a doctor blade to add said at least one active on a surface of said wet film forming product;
b. use of a roller to add said at least one active on a surface of said wet film forming product;
c. spraying said at least one active on a surface of said wet film forming product;
d. depositing said at least one active on a surface of said wet film forming product;
e. use of simple or dual slot die extrusion to add said at least one active on a surface of said wet film forming product; or
f. a combination thereof.
17. The method of claim 14 , wherein said adding of said at least one active is in the form of active-containing particles and said active containing particles are securably disposed onto said wet film forming product.
18. The method of claim 17 , wherein said active containing particles are partially embedded in or partially encased by said wet film forming product.
19. The method of claim 12 , further comprising the step of adding said at least one active to said dried film product.
20. The method of claim 19 , wherein said adding of said at least one active comprises controllably metering and disposing said at least one active on a surface of said dried film product.
21. The method of claim 19 , wherein said adding of said at least one active comprises:
a. use of a doctor blade to add said at least one active on a surface of said dried film product;
b. use of a roller to add said at least one active on a surface of said dried film product;
c. spraying said at least one active on a surface of said dried film product;
d. depositing said at least one active on a surface of said dried film product;
e. use of simple or dual slot die extrusion to add said at least one active on a surface of said dried film product; or
f. a combination thereof.
22. The method of claim 19 , wherein said adding of said at least one active is in the form of active-containing particles and said active-containing particles are securably disposed onto a surface of said dried film product.
23. The method of claim 22 , wherein said active containing particles are partially embedded in or partially encased by said dried film product.
24. The method of claim 12 , wherein said film forming matrix comprises said at least one first active and the method further comprises the step of adding said at least one second active to said wet film forming product prior to drying.
25. The method of claim 24 , wherein said adding of said at least one second active comprises controllably metering and disposing said at least one second active on a surface of said wet film forming product.
26. The method of claim 24 , wherein said adding of said at least one second active comprises:
a. use of a doctor blade to add said at least one second active on a surface of said wet film forming product;
b. use of a roller to add said at least one second active on a surface of said wet film forming product;
c. spraying said at least one second active on a surface of said wet film forming product;
d. depositing said at least one second active on a surface of said wet film forming product;
e. use of simple or dual slot die extrusion to add said at least one second active on a surface of said wet film forming product; or
f. a combination thereof.
27. The method of claim 24 , wherein said adding of said at least one second active is in the form of active-containing particles and said active containing particles are securably disposed onto said wet film forming product.
28. The method of claim 27 , wherein said active containing particles are partially embedded in or partially encased by said wet film forming product.
29. The method of claim 12 , wherein said film forming matrix comprises said at least one first active and the method further comprises the step of adding said at least one second active to said dried film product.
30. The method of claim 29 , wherein said adding of said at least one second active comprises controllably metering and disposing said at least one second active on a surface of said dried film product.
31. The method of claim 29 , wherein said adding of said at least one second active comprises:
a. use of a doctor blade to add said at least one second active on a surface of said dried film product;
b. use of a roller to add said at least one second active on a surface of said dried film product;
c. spraying said at least one second active on a surface of said dried film product;
d. depositing said at least one second active on a surface of said dried film product;
e. use of simple or dual slot die second extrusion to add said at least one active on a surface of said dried film product; or
f. a combination thereof.
32. The method of claim 29 , wherein said adding of said at least one second active is in the form of active-containing particles and said active-containing particles are securably disposed onto a surface of said dried film product.
33. The method of claim 32 , wherein said active containing particles are partially embedded in or partially encased by said dried film product.
34. The method of claim 1 , wherein each individual film dosage comprises a target weight of an active, and wherein the amount of said active in each individual film dosage does not vary more than 10% from said target weight of said active.
35. A method of forming an individual film dosage, comprising the steps of:
a. Preparing a film forming matrix comprising at least one water soluble polymer;
b. Providing a substantially flat packaging material substrate having at least one top surface;
c. Depositing a pre-determined amount of said film forming matrix onto said top surface of said packaging material substrate to form a wet film forming product;
d. Drying said wet film forming product to form a dried film product removably adhered to said packaging material substrate;
e. Storing said dried film product for a pre-determined length of time; and
f. Placing a sealing layer on said top surface of said packaging material substrate, wherein said sealing layer effectively seals the dried film product between the sealing layer and the substrate to form a package.
36. The method of claim 35 , wherein said pre-determined amount of said matrix comprises a sufficient level of active material to provide one dosage of said active material.
37. The method of claim 35 , wherein said packaging material substrate and said sealing material each individually comprise a material selected from the group consisting of foil, plastic, mylar, and combinations thereof.
38. The method of claim 35 , wherein said step of depositing is achieved via off-set printing, via direct printing, or via start-and-stop slot die coating.
39. The method of claim 35 , wherein said wet film forming product is substantially square shaped or substantially rectangular shaped.
40. The method of claim 35 , wherein said wet film forming product is deposited onto the top surface of said packaging material substrate such that at least a portion of said top surface of said packaging material substrate is exposed around the periphery of the deposited wet film forming product.
41. The method of claim 40 , wherein the sealing layer is adhered to the top surface of said packaging material substrate at said periphery.
42. The method of claim 41 , wherein said sealing layer is adhered to the top surface of the packaging material substrate via a method selected from the group consisting of heat laminating, chemical laminating, radiation, ultrasonic welding, compression, adhesive bonding, and combinations thereof.
43. The method of claim 35 , wherein a plurality of individual wet film forming products are deposited onto said top surface of said packaging material substrate.
44. The method of claim 43 , wherein each wet film forming product is deposited on said top surface of said packaging material substrate with a gap between adjacent wet film forming products.
45. The method of claim 35 , further comprising the step (g) of cutting said packaging material substrate and sealing layer to provide an individual sealed product.
46. The method of claim 35 , wherein said individual dosage form comprises at least one active.
47. The method of claim 46 , wherein said film forming matrix comprises said at least one active.
48. The method of claim 46 , further comprising the step of adding said at least one active to said wet film forming product prior to drying.
49. The method of claim 48 , wherein said adding of said at least one active comprises controllably metering and disposing said at least one active on a surface of said wet film forming product.
50. The method of claim 48 , wherein said adding of said at least one active comprises:
a. use of a doctor blade to add said at least one active on a surface of said wet film forming product;
b. use of a roller to add said at least one active on a surface of said wet film forming product;
c. spraying said at least one active on a surface of said wet film forming product;
d. depositing said at least one active on a surface of said wet film forming product;
e. use of simple or dual slot die extrusion to add said at least one active on a surface of said wet film forming product; or
f. a combination thereof.
51. The method of claim 48 , wherein said adding of said at least one active is in the form of active-containing particles and said active containing particles are securably disposed onto said wet film forming product.
52. The method of claim 51 , wherein said active containing particles are partially embedded in or partially encased by said wet film forming product.
53. The method of claim 46 , further comprising the step of adding said at least one active to said dried film product.
54. The method of claim 53 , wherein said adding of said at least one active comprises controllably metering and disposing said at least one active on a surface of said dried film product.
55. The method of claim 53 , wherein said adding of said at least one active comprises:
a. use of a doctor blade to add said at least one active on a surface of said dried film product;
b. use of a roller to add said at least one active on a surface of said dried film product;
c. spraying said at least one active on a surface of said dried film product;
d. depositing said at least one active on a surface of said dried film product;
e. use of simple or dual slot die extrusion to add said at least one active on a surface of said dried film product; or
f. a combination thereof.
56. The method of claim 53 , wherein said adding of said at least one active is in the form of active-containing particles and said active-containing particles are securably disposed onto a surface of said dried film product.
57. The method of claim 56 , wherein said active containing particles are partially embedded in or partially encased by said dried film product.
58. The method of claim 46 , wherein said film forming matrix comprises said at least one first active and the method further comprises the step of adding said at least one second active to said wet film forming product prior to drying.
59. The method of claim 58 , wherein said adding of said at least one second active comprises controllably metering and disposing said at least one second active on a surface of said wet film forming product.
60. The method of claim 58 , wherein said adding of said at least one second active comprises:
a. use of a doctor blade to add said at least one second active on a surface of said wet film forming product;
b. use of a roller to add said at least one second active on a surface of said wet film forming product;
c. spraying said at least one second active on a surface of said wet film forming product;
d. depositing said at least one second active on a surface of said wet film forming product;
e. use of simple or dual slot die extrusion to add said at least one second active on a surface of said wet film forming product; or
f. a combination thereof.
61. The method of claim 58 , wherein said adding of said at least one second active is in the form of active-containing particles and said active containing particles are securably disposed onto said wet film forming product.
62. The method of claim 61 , wherein said active containing particles are partially embedded in or partially encased by said wet film forming product.
63. The method of claim 46 , wherein said film forming matrix comprises said at least one first active and the method further comprises the step of adding said at least one second active to said dried film product.
64. The method of claim 63 , wherein said adding of said at least one second active comprises controllably metering and disposing said at least one second active on a surface of said dried film product.
65. The method of claim 63 , wherein said adding of said at least one second active comprises:
a. use of a doctor blade to add said at least one second active on a surface of said dried film product;
b. use of a roller to add said at least one second active on a surface of said dried film product;
c. spraying said at least one second active on a surface of said dried film product;
d. depositing said at least one second active on a surface of said dried film product;
e. use of simple or dual slot die second extrusion to add said at least one active on a surface of said dried film product; or
f. a combination thereof.
66. The method of claim 63 , wherein said adding of said at least one second active is in the form of active-containing particles and said active-containing particles are securably disposed onto a surface of said dried film product.
67. The method of claim 66 , wherein said active containing particles are partially embedded in or partially encased by said dried film product.
68. The method of claim 35 , wherein each individual film dosage comprises a target weight of an active, and wherein the amount of said active in each individual film dosage does not vary more than 10% from said target weight of said active.