Membrane-based two component therapeutic gas release system for oral administration

Patent metadata

Field	Value
Publication number	US-12569448-B2
Application number	US-202017766722-A
Country	US
Kind code	B2
Filing date	Oct 13, 2020
Priority date	Oct 14, 2019
Publication date	Mar 10, 2026
Grant date	Mar 10, 2026

Abstract

The present invention discloses a therapeutic gas release system for oral administration comprising a therapeutic gas releasing compound A, and a therapeutic gas release triggering compound B, wherein compound A and B are separated from each other by an inner septum during storage of the system, wherein compound A and B are surrounded by an outer membrane, which is a gas-permeable and water- and solid-impermeable membrane, preferably a silicone membrane, and wherein therapeutic gas release from the system is activated before oral administration by breaking the inner septum. The therapeutic gas released from the system of the present invention is suitable for the treatment of (inflammatory) diseases of the gastrointestinal tract.

First claim

The invention claimed is:

1 . A therapeutic gas release system for oral administration comprising:
a therapeutic gas releasing compound A, and a therapeutic gas release triggering compound B, wherein compound A and compound B are separated from each other during storage of the system by an inner septum, wherein compound A is in a first unit and compound B is in a second unit, whereby the first and second units are surrounded by an outer membrane that is a gas-permeable and water- and solid-impermeable membrane, further wherein the inner septum forms part of the second unit and the first unit has an obliquely tapered, hollow tipped open end that pints towards the inner septum, further wherein therapeutic gas release from the system can be activated before oral administration by squeezing the system along a longitudinal axis, which in turn pushes the obliquely tapered, hollow tipped open end of first unit towards the inner septum, thereby causing the inner septum to break.

2 . The therapeutic gas release system according to claim 1 , wherein the inner septum breaks upon squeezing the system manually or in a partly automated process using an external activator device.

3 . The therapeutic gas release system according to claim 1 , wherein the second unit comprises a top that closes an open end of the second unit, further wherein the top is optionally glued to the second unit using an adhesive.

4 . The therapeutic gas release system according to claim 1 , wherein the first unit, the second unit and the top of the second unit are made of a biocompatible material.

5 . The therapeutic gas release system according to claim 1 , wherein the first unit is made of a thermoplastic material, and/or the second unit and/or the top of the second unit is/are made of a thermoset material.

6 . The therapeutic gas release system according to claim 1 , wherein the outer membrane is tubular, and wherein the open ends of the tubular outer membrane are closed with an adhesive.

7 . The therapeutic gas release system according to claim 1 , wherein the obliquely tapered, hollow tipped open end of the first unit includes one or more elevations that point towards the inner septum and facilitate its breakage.

8 . The therapeutic gas release system according to claim 1 , wherein the therapeutic gas is selected from the group consisting of carbon monoxide (CO), hydrogen sulfide (H 2 S) and nitric oxide (NO).

9 . The therapeutic gas release system according to claim 1 , wherein compound A is selected from the group consisting of a carbon monoxide releasing molecule (CORM), a hydrogen sulfide (H 2 S) releasing molecule and a nitric oxide (NO) releasing molecule.

10 . The therapeutic gas release system according to claim 1 , wherein compound B is selected from the group consisting of a sulfur containing compound, a nitrogen containing compound, an oxidizing compound and water.

11 . The therapeutic gas release system according to claim 1 , wherein the therapeutic gas is carbon monoxide (CO), the therapeutic gas releasing compound A is a molybdenum carbonyl compound, and the therapeutic gas release triggering compound B is selected from the group consisting of FeCl 3 , Ce(SO 4 ) 2 and H 2 O 2 .

12 . The therapeutic gas release system according to claim 1 , wherein the system is surrounded by a protective shell.

13 . The therapeutic gas release system according to claim 1 , wherein the gas-permeable and water- and solid-impermeable outer membrane is a silicone membrane.

14 . The therapeutic gas release system according to claim 5 , wherein the thermoplastic material is a polyamide and the thermoset material is an acrylic resin or an epoxy resin.

15 . The therapeutic gas release system according to claim 8 , wherein the therapeutic gas is carbon monoxide (CO).

16 . The therapeutic gas release system according to claim 8 , wherein the therapeutic gas releasing compound A is a carbon monoxide releasing molecule.

17 . The therapeutic gas release system according to claim 16 , wherein the carbon monoxide releasing molecule is a metal carbonyl compound.

18 . The therapeutic gas release system according to claim 11 , wherein the molybdenum carbonyl compound is Mo(CO) 3 (CNCH 2 CO 2 H) 3 , and the therapeutic gas release triggering compound B is FeCl 3 .

Assignees

• Univ Wuerzburg J Maximilians

Inventors

• Hermann Cornelius
• Meinel Lorenz
• Schmehl Wolfgang
• Popp Kevin
• Reilaender Simon

Classifications

• A61K33/04

  Sulfur, selenium or tellurium; Compounds thereof · CPC title

• A61K9/4816

  Wall or shell material · CPC title

• A61K9/4808

  characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release (capsules filled with granules or microparticles A61K9/16; filled with microcapsules or coated microparticles A61K9/50; with mixture of different granules, microcapsules, (coated) microparticles A61K9/5084) · CPC title

• A61P29/02

  without antiinflammatory effect · CPC title

• A61P1/04

  for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants · CPC title