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HK-40104479-B - PHARMACEUTICAL DOSAGE FORM COMPRISING CAPSULE DEVICE WITH AN APERTURE FORMED BY A WALL PART OF ONE OF TWO HALF‑CAPSULE SHELLS

HK40104479BHK 40104479 BHK40104479 BHK 40104479BHK-40104479-B

Inventors

  • ROSENBAUM, Christoph
  • GAMBONI, Viviane
  • Moser, Silvio
  • FRECH, PETER
  • KAISER, ANDREAS
  • STANGIER, PETER

Assignees

  • ESOCAP AG

Dates

Publication Date
20251010
Application Date
20240424
Priority Date
20210521

Claims (15)

  1. A pharmaceutical dosage form for the application to a mucous membrane, in particular to a buccal or gastro-intestinal, in particular an esophageal, mucous membrane, comprising a pharmaceutical preparation (2) having an elongated shape and comprising an active pharmaceutical ingredient, and capable of being arranged in a compact condition and in an expanded condition, a capsule device (13) configured to accommodate the pharmaceutical preparation (2), the capsule device (13) comprising a hollow space (14) for accommodating the preparation (2) in the compact condition, the capsule device (13) having an aperture (15), configured to allow a first end (2a) of the preparation in the compact condition to extend through the aperture (15) such that the preparation can be transferred from its compact condition in the hollow space (14) to its expanded condition in the surrounding area of the capsule device (13), the capsule device (13) comprising a first halve-capsule shell (11; 11') and a second halve-capsule shell (12), which are joined by overlapping the first halve-capsule shell (11; 11') and the second halve-capsule shell (12) in a joined position, characterized in that the capsule device (13) further comprises a hollow-cylindrical wall part (17; 17'), and in that the first halve-capsule shell (11; 11') has a hollow-cylindrical wall (11c; 11c') including an opening (16; 16'), and said hollow-cylindrical wall part (17; 17') overlaps a cross section of the opening (16;16') thereby forming the aperture (15) of the capsule device (13) in the joined position.
  2. The pharmaceutical dosage form according to claim 1, wherein the hollow-cylindrical wall (11c) of the first halve-capsule shell (11) is closed at a first end (11a) and open at a second end (11b), and wherein the opening (16) is fully surrounded by the material of the hollow-cylindrical wall (11c).
  3. The pharmaceutical dosage form according to claim 1, wherein the hollow-cylindrical wall (11c') of the first halve-capsule shell (11) is closed at a first end (11a) and open at a second end (11b), and wherein the opening (16') is formed as a recess starting at the second end (11b) and extending towards the first end (11a).
  4. The pharmaceutical dosage form according to any of the previous claims, wherein the cross-section of the opening (16; 16') is dimensioned to receive the preparation (2) in its compact condition before joining the first halve-capsule shell (11; 11') and the second halve-capsule shell (12; 12'), wherein preferably, in the joined position, the aperture (15) defined by the opening (16) and the hollow cylindrical wall part (17;17') has a cross-section dimensioned to prevent the preparation (2) in its compact condition from passing through the aperture (15).
  5. The pharmaceutical dosage form according to any of the previous claims, wherein the size A_o of the cross-section of the aperture (15) is a fraction f of the size A_a of the cross-section of the opening (16; 16'), wherein A_o = f * A_a, and wherein preferably 0.0010 < f < 0.7500.
  6. The pharmaceutical dosage form according to any of the previous claims, wherein, in the joined position, the first halve-capsule shell (11; 11') is inserted into the second halve-capsule shell (12; 12').
  7. The pharmaceutical dosage form according to any of the previous claims, wherein the aperture (15) is a slit-like opening, configured for allowing the preparation (2) to pass through the aperture (15), the cross-section (CS) of the aperture (15) being larger than the cross section of the strip-like preparation (2), when the latter is extending through the aperture (15).
  8. The pharmaceutical dosage form according to any of the previous claims, wherein the capsule device (13) is configured to be suitable to be swallowed by a patient.
  9. The pharmaceutical dosage form according to one of the previous claims, which comprises a sinker device (60), which occupies a part of the hollow space and which provides an additional weight to the capsule device.
  10. Method of producing a pharmaceutical dosage form according to any one of claims 1 to 9, comprising the following steps: a) Providing the preparation having an elongated shape and comprising an active pharmaceutical ingredient; b) Providing the first halve-capsule shell having a hollow-cylindrical wall including an opening (16;16') and the second halve-capsule shell; c) Accommodating the preparation, preferably in a compact condition, through the opening (16; 16') into the first halve-capsule shell, such that a part or an end of the preparation extends through the opening (16;16'); d) Sliding the second halve-capsule shell (12; 12') and the first halve-capsule shell (11; 11') to the joined position and providing the hollow-cylindrical wall part (17; 17') overlapping a cross section of the opening (16; 16') thereby forming the aperture (15) of the capsule device (13) in the joined position.
  11. The method of claim 10, wherein step b) comprises the further steps: a) Providing a material for forming the capsule device (13), in particular the first and second halve-capsule shell; b) Generating an opening (16; 16'), in particular a rectangular opening (16; 16'), in the material of the first and/or the second halve-capsule shell.
  12. The method of claim 11, wherein the opening (16; 16') is generated in the formed hollow-cylindrical wall material of the first and/or second halve-capsule shell.
  13. The method of any one of claims 10 to 12, comprising the following step: ∘ after step a) or b) providing a rotation axle (X), and, preferably, positioning the same in front of the opening (16; 16') or within the cross-section of the opening (16; 16'), and winding the preparation in its elongated condition by rotating therotation axle, thereby preferably using the opening (16; 16') for guiding and/or aligning the preparation, until the preparation has reached a compact condition.
  14. The method of any of claims 10 to 13, comprising the following step: ∘ after step b) or c) positioning a sinker device within at least a part of the hollow space of the first and/or the second halve-capsule shell.
  15. Kit comprising a pharmaceutical dosage form according to any one of claims 1 to 9, a drinking cup, and an applicator for administering the pharmaceutical dosage form to a patient, wherein the applicator is in fluid connection with the drinking cup and comprises the pharmaceutical dosage form and wherein the preparation of the pharmaceutical dosage form is connected to the applicator by a retainer for withdrawing the preparation from the capsule device after administration to the patient.

Description

The present invention relates to a capsule device and a pharmaceutical dosage form for the application to a mucous membrane, in particular to a buccal, or gastro-intestinal mucous membrane. The invention also relates to a method of producing the capsule device and the pharmaceutical dosage form comprising the capsule device. Such capsule devices are known from WO 2020/183005 or WO 2016/102067 A1. The capsule device form of WO 2016/102067 A1 is designed such that it comprises at least one sheet like, in particular film shaped, foil shaped or wafer shaped preparation comprising the active pharmaceutical ingredient, a release mechanism, and a trigger mechanism, wherein the trigger mechanism is adapted to trigger, at a predetermined site of action, in particular of the gastrointestinal tract, of the rectum or of the vagina, the release of the sheet like preparation by the release mechanism. From the embodiment according to Figs. 8a, 8b, 8c of WO 2016/102067 A1, a dosage form is known having an elongated, strip-shaped preparation, which comprises the active pharmaceutical ingredient, the preparation being capable to be arranged in a compact condition and in an expanded condition, the dosage form having a capsule comprising a hollow space for accommodating the compacted preparation, the capsule device having an aperture and a first end of the preparation extending, in the compact condition, through the aperture for allowing pulling out the preparation from the hollow space into the surrounding area of the capsule thereby transferring the preparation from the compact condition to the expanded condition. It is furthermore known in the art, in particular in relation to the treatment of gastrointestinal and in particular esophageal membranes, to use catheter or stent-like devices for the topical application of active ingredient. Another approach lies in the use of liquid or gel-like media with comparably high viscosity. The object underlying the present invention is to provide a capsule device, which can be produced efficiently, and to provide a method for efficiently producing the capsule device and a pharmaceutical dosage form, and a method for producing the pharmaceutical dosage form comprising the method of producing the capsule device. The problem is solved by the pharmaceutical dosage form of claim 1 and the method of producing a pharmaceutical dosage form according to claim 10. Preferred embodiments of the invention are subject matter of the dependent claims. According to the invention, the capsule device, comprises a first halve-capsule shell and a second halve-capsule shell, which are joined by overlapping of the first halve-capsule shell and the second halve-capsule shell in a joined position, wherein the first halve-capsule shell has a hollow-cylindrical wall including an opening, and a further provided hollow-cylindrical wall part overlaps a cross section of the opening thereby forming the aperture of the capsule device in the joined position. The joined position thus relates to the position in which the first and the second halve-capsule shell are telescoped, or slid into each other, thereby forming the capsule device. By pushing them partially into each other, the two halves are mechanically connected and efficiently stabilized. The two halves are pushed into each other to such an extent that the preparation in its compact, i.e., coiled form, can be inserted effortlessly into the opening of the first halve-capsule shell, which then defines the joined position. If necessary, the joined position can also be defined by the two halves being pushed together a little further after the preparation has been inserted in its compact form, so that the preparation in its compact form can no longer fall out of the opening. If necessary, the joined position can also be defined by the two halves being pushed together, so that winding of the preparation in the cavity of the capsule device is facilitated. The joined position can also be understood as the blunt abutment of the first and second capsule halves. In this case, the two capsule halves are held together by a connecting mechanism. This can be implemented in the form of a band, e.g. a adhesive tape, a mechanical clamping by means of grooves in both capsule halves or at least partially by the hollow cylindrical wall part. The hollow cylindrical wall part can be provided in the form of a film or a sheet, which can be made of the same material as one of the halve-capsule shells. For example, the hollow cylindrical wall partn may be stamped out of the outer surface of a cylinder, whereas the curvature of the hollow cylindrical wall part may be matched to the curvature of the capsule device in the region of the opening and thus is configured to partially cover the opening like a patch. Alternatively, e.g., a tape may be used as the hollow cylindrical wall part suitable for the use in a pharmaceutical dosage form, e.g., the tape is degraded in the patient's body. T