Controlling water release from a dimensionally stable aqueous composition

Patent metadata

Field	Value
Publication number	US-12433851-B2
Application number	US-202318446645-A
Country	US
Kind code	B2
Filing date	Aug 9, 2023
Priority date	Jan 20, 2016
Publication date	Oct 7, 2025
Grant date	Oct 7, 2025

Abstract

The invention relates to systems formed from closed liquid-tight packaging and a preferably dimensionally stable aqueous composition which is sealed therein and which, upon activation, releases a liquid phase essentially composed of water in a time-delayed manner. The invention further relates to methods for manufacturing such systems and the use thereof during the production of self-decomposing transdermal therapeutic systems (TTS).

First claim

That which is claimed:

1. A self-destructing transdermal therapeutic system (TTS) comprising
(i) at least one active ingredient,
(ii) at least one water-soluble agent that renders the active ingredient unusable,
(iii) a separation between the active ingredient and the at least one water-soluble agent that renders the active ingredient unusable, and
(iv) a liquid-tight packaging comprising
(a) a hydrous composition comprising a gel whose liquid phase consists substantially of water; and
(b) a sufficient amount of an activating agent to release the liquid phase from said gel after a temporal delay; and

(v) an at least one mechanical means for opening, perforating or destroying said liquid-tight packaging disposed either within the liquid-tight packaging or affixed to the outside of the liquid-tight packaging,
wherein when the TTS is removed after use the at least one mechanical means opens, perforates or destroys the liquid tight packaging, resulting in an ingress of the liquid phase to the at least one water-soluble agent that undoes the separation between the active ingredient and the at least one water-soluble agent so that the active ingredient and the at least one water-soluble agent come into contact with one another and this contact destroys the active ingredient.

2. The self-destructing transdermal therapeutic system as claimed in claim 1 , wherein the gel comprises a low-ester pectin, a low-ester amidated pectin, a depolymerized guar gum or a polyacrylate.

3. The self-destructing transdermal therapeutic system as claimed in claim 1 , wherein the activating agent is an alkaline earth or earth metal salt, organic acid or a salt hydrate having a melting temperature below 37° C.

4. The self-destructing transdermal therapeutic system as claimed in claim 3 , wherein the alkaline earth or earth metal salt is calcium chloride.

5. The self-destructing transdermal therapeutic system as claimed in claim 3 , wherein the organic acid is citric acid or oleic acid.

6. The self-destructing therapeutic system as claimed in claim 3 , wherein the salt hydrate having a melting temperature below 37° C. is selected from the group consisting of calcium chloride hexahydrate, manganese sulfate tetrahydrate, sodium hydrogenphosphate dodecahydrate and lithium nitrate trihydrate.

7. The self-destructing transdermal therapeutic system as claimed in claim 1 , wherein the agent that renders the active ingredient unusable is a solid or in pasty form.

8. The self-destructing transdermal therapeutic system as claimed in claim 1 , wherein the active ingredient is an analgesic or narcotic.

9. The self-destructing transdermal therapeutic system as claimed in claim 8 , wherein the active ingredient is a morphine derivative, heroin, buprenorphine, fentanyl, remifentanil, sufentanil or alfentanyl.

10. The self-destructing transdermal therapeutic system as claimed in claim 1 , wherein the agent that renders the active ingredient unusable is a water-soluble oxidizing agent.

11. The self-destructing transdermal therapeutic system as claimed claim 10 , wherein the water-soluble oxidizing agent is potassium permanganate.

12. The self-destructing transdermal therapeutic system as claimed in claim 1 , wherein the separation is a layer which is permeable to liquids but impermeable to solids.

13. The self-destructing transdermal therapeutic system as claimed in claim 12 , wherein the separation is a paper, a membrane or a nonwoven web.

14. The self-destructing transdermal therapeutic system as claimed in claim 1 , wherein the mechanical means for opening, perforating or destroying the packaging possesses a multiplicity of sharp or pointed regions.

15. The self-destructing transdermal therapeutic system as claimed in claim 14 , wherein the mechanical means for opening, perforating or destroying the packaging possesses a stellate shape.

16. The self-destructing transdermal therapeutic system as claimed in claim 14 , wherein the mechanical means for opening, perforating or destroying the packaging possesses a blunt outer contour and a sharp or pointed inlying region.

17. The self-destructing transdermal therapeutic system as claimed in claim 16 , wherein, the mechanical means for opening, perforating or destroying the packaging, is bent during removal of the TTS from the skin such that at least one correspondingly arranged sharp or pointed inlying region is rotated, around pivot points dictated by its geometry, by an angle of up to a maximum of 90° out of the plane in the direction of the adjacent layer, and in this way brings about perforation of at least one adjacent layer.

18. The self-destructing transdermal therapeutic system as claimed in claim 1 , wherein said gel is in wafer form.

19. The self-destructing transdermal therapeutic system as claimed in claim 1 , wherein sufficient activating agent has been added to the system to render the gel into a brittle gel.

Assignees

• Lts Lohmann Therapie Systeme Ag

Inventors

• Hammes Florian
• EIFLER René

Classifications

• A61K31/485

  Morphinan derivatives, e.g. morphine, codeine · CPC title

• A61K9/0014

  Skin, i.e. galenical aspects of topical compositions (non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00) · CPC title

• A61P25/04

  Centrally acting analgesics, e.g. opioids · CPC title

• A61K9/7061 Primary

  Polyacrylates · CPC title

• A61K9/703 Primary

  characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches · CPC title