Arzneimittel und Vorrichtungssystem für Druckbeaufschlagte Aerosoltherapien in einem Säugetierhohlraum

Details

Veröffentlichungs-Nr.

EP3427781

Aktenzeichen

EP18181042

Anmeldetag

30. Juni 2018

Veröffentlichung

25. September 2024

Erteilung

25. September 2024

Rechtsraum

EP

IPC

A61M11/00A61J1/10A61J1/14A61J1/20B65D81/32A61M13/00

Abstract

The invention relates to a drug and device system for the directed application of a substance into a hollow space, such as a hollow organ, or into a body cavity of a patient, i.e. a mammalian patient, in particular for use in the course of a therapeutic pneumoperitoneum. In particular, herein the present invention is for use in cancer/tumor treatment, including metastatic forms thereof, and is also directed to a kit and its use in a method of treatment, comprising the said drug and device system for the said directed application. Especially, the invention pertains to a sterile and closed prefilled drug containing (medical) device system for administering at least one pharmaceutically active substance (drug) by pressurized aerosol therapy (PAT) in a hollow organ, or preferably in a body cavity, of a patient, in particular a therapeutic pneumoperitoneum, comprising a flexible package, comprising at least one container comprising at least one pharmaceutically active substance in powder, lyophilisate, solution, liquid, gel or other form (suspension, emulsion), and being provided with breakable, an openable, or perforable cap; and a bag of liquid diluent), wherein the bag is optionally equipped with at least one drain tube provided with a closing device; and wherein the bag is equipped with a mixing tube, optionally equipped with an openable closure, and which optionally ends with a perforation device, which container is preferably a vial, syringe, single-use syringe, ampoule, phial, or bottle, comprising the said pharmaceutically active substance, and which container is provided with breakable, an openable, or perforable cap; and wherein said package is comprising at least one flexible airtight sterile casing, containing said container, preferably a vial, syringe, single-use syringe, ampoule, phial, or bottle, of the said pharmaceutically active substance, and said perforation device, said container being housed in the casing; and wherein the said container is manually maneuverable from the outside of the casing in order to be opened inside the closed casing, optionally is manually maneuverable from the outside of the casing up to a perforating position of said cap through the same perforation device; and whereupon after opening of the said container and of the said closure, and selectively mixing (i.e. dissolving, reconstituting) the at least one pharmaceutically active substance (drug) with the liquid diluent through the mixing tube, a solution of the at least one pharmaceutically active substance (drug) in the liquid diluent is provided for administering by pressurized aerosol therapy (PAT) in a hollow organ, or preferably in a body cavity of a patient.

Anmelder

Firma

Pharma Resources GmbH

Land

🇩🇪 Deutschland

Fachgebiete