IP Library Granted Patent US 12661314
Granted Patent B2
US 12661314 · App. 16/964,351 · Granted Jun 23, 2026

Multi-layer oral thin film

Inventors: Christoph Schmitz (Rheinbrohl, DE); Michael Linn (Waldbockelheim, DE)
Assignee: LTS LOHMANN THERAPIE-SYSTEME AG
A61K9/0056
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Quick Facts
Patent No.
US 12661314
App. No.
16/964,351
Granted
Jun 23, 2026
Kind
B2
Abstract

Described are: a multi-layer oral thin film, comprising at least two layers arranged one on top of the other, which each comprise at least one water-soluble polymer, these at least two layers being connected to one another by at least one sealing, characterised in that the at least one sealing is not provided over the entire surface; a method for producing same; and use thereof as a medicament.

Claims (18)

1 . A multi-layer oral thin film comprising at least two layers having the same size or area arranged one on top of the other, wherein each layer comprises at least one water-soluble polymer, the at least two layers being connected to one another by at least one sealing, wherein the at least one sealing is not provided over an entire surface, and wherein that the at least one sealing is applied in such a way that at least one overlapping edge of the at least two layers arranged one on top of the other is not closed by a sealing as to allow saliva to infiltrate between the individual layers, wherein at least one layer of the multi-layer oral thin film comprises at least one pharmaceutical active ingredient, wherein the at least one sealing comprises no more than approximately 66% of the total area of a surface of the multi-layer oral thin film, wherein at least one pharmaceutically active ingredient is contained within at least one layer of the multi-layer oral thin film.

2 . The multi-layer oral thin film according to claim 1 , wherein the at least one water-soluble polymer comprises a heat-sealable polymer.

3 . The multi-layer oral thin film according to claim 2 , wherein the at least one sealing not provided over the entire surface comprises a heat sealing not provided over the entire surface.

4 . The multi-layer oral thin film according to claim 1 , wherein the at least one water-soluble polymer comprises polyvinyl alcohol, pullulan, polyethylene oxide, polyethylene glycol and/or copolymers thereof.

5 . The multi-layer oral thin film according to claim 1 , wherein the at least two layers are connected to one another by precisely one sealing not provided over the entire surface.

6 . The multi-layer oral thin film according to claim 1 , wherein the at least two layers are connected to one another by two sealings not provided over the entire surface.

7 . A method for producing a multi-layer oral thin film comprising the steps of

a) providing a first layer comprising at least one water-soluble polymer;

b) providing a further layer comprising at least one water-soluble polymer and having the same size and area as the first layer; wherein at least one of the layers provided in step a) and/or step b) contains at least one pharmaceutical active ingredient;

c) arranging the first layer on the further layer; and

d) performing at least one sealing, which covers no more than 66% of a total surface of the multi-layer oral thin film, in order to connect the first layer and the further layer to one another, provided that the at least one sealing is applied in such a way that at least one overlapping edge of the at least two layers arranged one on top of the other is not closed by a sealing as to allow saliva to infiltrate between the individual layers.

8 . The method for producing a multi-layer oral thin film according to claim 7 , wherein the at least one sealing performed in step d), not provided over the entire surface, is a heat-sealing not provided over the entire surface.

9 . A multi-layer oral thin film obtained by the method of claim 7 .

10 . A method of administering a medicament comprised of the multi-layer oral thin film of claim 1 , the method comprising oral administration.

11 . The multi-layer oral thin film according to claim 1 , wherein the at least one sealing is not adhesive.

12 . The multi-layer oral thin film according to claim 1 , wherein each of the at least two layers of the multi-layer oral thin film include at least one pharmaceutical active ingredient.

13 . The multi-layer oral thin film according to claim 1 , wherein the at least two layers are arranged congruently one on top of the other.

14 . The method for producing a multi-layer oral thin film according to claim 8 , wherein the heat-sealing is performed between 50° C. and 200° C. for 5 seconds or less.