Granted Patent B2

US 12,186,431 · App. 16/920,341 · Granted Jan 7, 2025

Inventors: Malte Bogdahn (Greifswald, DE); Kirsten Kirsch (Greifswald, DE); Michael Grimm (Greifswald, DE); Mirko Koziolek (Greifswald, DE); Werner Weitschies (Greifswald, DE)

Assignee: EsoCap AG

A61K9/4808A61J7/0092A61K9/0031A61K9/0034A61K9/006A61K9/7007A61K9/7069A61K9/7084A61K31/196A61K31/56A61K31/58A61K45/06A61M31/00A61M31/002A61K9/0036A61K9/703A61K47/32

Abstract

Claims (28)

1. A pharmaceutical dosage form ( 1 ) for the application to a gastrointestinal mucous membrane, comprising at least

a film shaped, foil shaped or wafer shaped, preparation ( 3 ) comprising the active pharmaceutical ingredient,

a release mechanism ( 4 ) and

a trigger mechanism ( 5 ), wherein

the trigger mechanism ( 5 ) is adapted to trigger, at a predetermined site of action of the gastrointestinal tract, the release of the film shaped, foil shaped or wafer shaped preparation ( 3 ) by the release mechanism ( 4 );

further comprising a shell ( 2 ), wherein the shell ( 2 ) contains the film shaped, foil shaped or wafer shaped preparation ( 3 ) comprising the active pharmaceutical ingredient, and wherein the shell ( 2 ) comprises at least one aperture ( 6 ), wherein the trigger mechanism is a holding device which is exposed to the outside of the shell, wherein the holding device is a broadened part of the preparation ( 3 ) or is attached to the preparation, and wherein the release mechanism comprises a string member, wherein the preparation ( 3 ) is mucoadhesive and is adapted to at least partially form the string member, and wherein the string member is mucoadhesive.

2. The pharmaceutical dosage form ( 1 ) of claim 1 , wherein

the trigger mechanism ( 5 ) is adapted to trigger the release of the film shaped, foil shaped or wafer shaped preparation ( 3 ) by the release mechanism ( 4 ) after a contact of the pharmaceutical dosage form ( 1 ), or

the trigger mechanism ( 5 ) is adapted to trigger the release of the film shaped, foil shaped or wafer shaped preparation ( 3 ) by the release mechanism ( 4 ) in a time controlled manner or immediately or

the release mechanism ( 4 ) is adapted to release the film shaped, foil shaped or wafer shaped preparation ( 3 ) in a time controlled manner or immediately after triggering of the trigger mechanism ( 5 ).

3. The pharmaceutical dosage form ( 1 ) of claim 2 , wherein the dosage form ( 1 ) contains the film shaped, foil shaped or wafer shaped preparation ( 3 ) in a folded form.

4. The pharmaceutical dosage form ( 1 ) of claim 1 , wherein the film shaped, foil shaped or wafer shaped preparation ( 3 ) comprises a swelling agent ( 11 ).

5. The pharmaceutical dosage form ( 1 ) of claim 4 , wherein the swelling agent ( 11 ) is selected from the group consisting of a sponge and fibers.

6. The pharmaceutical dosage form ( 1 ) of claim 1 , wherein: the film shaped, foil shaped or wafer shaped preparation ( 3 ) provides, after its release by the release mechanism ( 4 ), a larger surface area; or

the release mechanism ( 4 ) is adapted to release, at least partially, the film shaped, foil shaped or wafer shaped preparation ( 3 ) while moving along the mucous membrane.

7. The pharmaceutical dosage form ( 1 ) of claim 6 , wherein the film shaped, foil shaped or wafer shaped preparation ( 3 ), after its release by the release mechanism ( 4 ), comes into contact with a larger surface area in comparison to the volume of the film shaped, foil shaped or wafer shaped preparation ( 3 ).

8. The pharmaceutical dosage form ( 1 ) of claim 1 , wherein:

the string member ( 3 ) is expandable from a compact form to an expanded form.

9. The pharmaceutical dosage form ( 1 ) of claim 8 , wherein the string member ( 3 ) is expandable from a folded, collapsed, rolled or coiled up form to an expanded form upon activation of the release mechanism ( 4 ), and the string member comprises, at least in the compact form, the film shaped, foil shaped or wafer shaped preparation ( 3 ).

10. The pharmaceutical dosage form ( 1 ) of claim 9 , wherein the expanded form is an unfolded, spread out, opened up, elongated, stretched, unrolled or oblong form.

11. The pharmaceutical dosage form ( 1 ) of claim 1 , wherein the trigger mechanism ( 5 ) is adapted to be fixed in an oral cavity, or held in a hand during administration of the pharmaceutical dosage form ( 1 ).

12. The pharmaceutical dosage form ( 1 ) of claim 11 , wherein the dosage form is for oral administration.

13. The pharmaceutical dosage form ( 1 ) of claim 11 , wherein the trigger mechanism ( 5 ) is adapted to be fixed to a tooth, to a tongue, to a lip or to an oral mucous membrane.

14. The pharmaceutical dosage form ( 1 ) of claim 11 , wherein administration is by swallowing of the pharmaceutical dosage form ( 1 ).

15. The pharmaceutical dosage form ( 1 ) of claim 14 , wherein the swallowable part of the dosage form ( 1 ) is the shell ( 2 ).

16. The pharmaceutical dosage form ( 1 ) of claim 11 , wherein, at least during the release of the film shaped, foil shaped or wafer shaped preparation ( 3 ), the released portion of the film shaped, foil shaped or wafer shaped preparation ( 3 ) and the dosage form ( 1 ) move relatively to each other thereby defining a movement path (PM) of the dosage form ( 1 ), and the enveloping cross-sectional area (AD) of the dosage form ( 1 ) viewed in the direction of the movement path is larger than the enveloping cross-sectional area (AP) of the released part of the film shaped, foil shaped or wafer shaped preparation ( 3 ).

17. The pharmaceutical dosage form ( 1 ) of claim 16 , wherein cross-sectional area (AD) of a swallowable part of the dosage form ( 1 ), viewed in the direction of the movement path is larger than the enveloping cross-sectional area (AP) of the released part of the film shaped, foil shaped or wafer shaped preparation ( 3 ).

18. The pharmaceutical dosage form ( 1 ) of claim 1 , wherein the holding device ( 5 ) comprises a mucoadhesive surface.

Assignments (1)

Priority Claims (1)

Continuity (2)

References Cited (45)