EP-4740978-A1 - A PHARMACEUTICAL KIT COMPRISING AN ENCLOSURE WITH SEPARATING MEANS

EP4740978A1EP 4740978 A1EP4740978 A1EP 4740978A1EP-4740978-A1

Abstract

A pharmaceutical kit, wherein the pharmaceutical kit comprises - a container comprising a pharmaceutical compound, - a medical device suitable for receiving the pharmaceutical compound from the container, - an enclosure enclosing the container and the medical device, wherein the enclosure comprises at least one wall enclosing a main cavity, wherein the main cavity is a closed cavity, wherein the cavity comprises the container and the medical device, wherein the cavity comprises a separating means separating the main cavity into a container cavity comprising the container and a device cavity comprising the medical device, wherein the container cavity and the device cavity each are closed cavities, and wherein the enclosure comprises an opening means.

Inventors

MEDICO, LEONARD
FRAUCHIGER, DANIEL
Vallotton, Raphael

Assignees

B. Braun Melsungen AG

Dates

Publication Date: 20260513
Application Date: 20241112

Claims (15)

A pharmaceutical kit, wherein the pharmaceutical kit comprises - a container comprising a pharmaceutical compound, - a medical device suitable for receiving the pharmaceutical compound from the container, - an enclosure enclosing the container and the medical device, wherein the enclosure comprises at least one wall enclosing a main cavity, wherein the main cavity is a closed cavity, wherein the cavity comprises the container and the medical device, wherein the cavity comprises a separating means separating the main cavity into a container cavity comprising the container and a device cavity comprising the medical device, wherein the container cavity and the device cavity each are closed cavities, and wherein the enclosure comprises an opening means.
The pharmaceutical kit according to claim 1, wherein the wall comprises, preferably consists of, at least one polymer film, preferably a flexible, thermoformable, and/or thermoformed polymer film.
The pharmaceutical kit according to any of the preceding claims 1 to 2, wherein the separating means comprises, preferably consists of, the polymer film.
The pharmaceutical kit according to claim 3, wherein the separating means comprises, preferably consists of, a peelable connection of the at least one polymer film.
The pharmaceutical kit according to any of the preceding claims 1 to 4, wherein the opening means comprises, preferably consists of, a peelable connection of the at least one polymer film.
The pharmaceutical kit according to any of the preceding claims 2 to 5, wherein the at least one polymer film is a weldable polymer film.
The pharmaceutical kit according to any of the preceding claim 2 to 6, wherein the polymer film is a multilayer polymer film.
The pharmaceutical kit according to claim 7, wherein the multilayer polymer film comprises a support layer and/or a barrier layer.
The pharmaceutical kit according to claim 8, wherein the barrier layer comprises, preferably consists of, a material selected from ethylene vinyl alcohol (EVOH) or a metal oxide, preferably aluminum oxide or silicon oxide.
The pharmaceutical kit according to any of the preceding claims 1 to 9, wherein the pharmaceutical compound is present in liquid form, preferably in solution, more preferably in aqueous solution.
The pharmaceutical kit according to any of the preceding claims 1 to 10, wherein the medical device is selected from the list consisting of syringes, preferably pre-filled syringes, conventional syringes, or auto-injectors; pumps; topical applicators, preferably transdermal patches, gel applicators, wipes, and ointment/cream dispensers; oral delivery devices, preferably oral dispensers, and capsule/tablet dispensers; injection pens, preferably insulin pens, and multi-dose pens; catheters; needle-free injectors; micro-needles; and infusion sets; infusion transfer devices; adaptors; connectors.
Use of a pharmaceutical kit according to any of the preceding claims 1 to 11 for sterile storing the pharmaceutical compound.
Use of a pharmaceutical kit according to any of the preceding claims 1 to 11 for filling the pharmaceutical compound into the medical device.
Process of filling the medical device of the pharmaceutical kit according to any of the preceding claims 1 to 11, comprising the steps of: - opening the enclosure; - opening the container; - transferring the pharmaceutical compound to the medical device.
Process according to claim 14, wherein the step of opening the enclosure comprises peeling the polymer film from the sealed seam of the opening means,.

Description

Technical Field of the Invention The present invention is related to packaging pharmaceutical products, in particular packaging pharmaceutical kits. The present invention is further related to the use of such pharmaceutical kits. Background of the Invention In the technical field of packaging, in particular in the technical field of pharmaceutical product, several products are often packaged together in one container. Such packages are usually described as kits. Well-known kits in the field of pharmaceutical products are combination drug kits, diagnostic kits, injectable kits, surgical and wound care kits, antidote and emergency kits, and respiratory treatment kits. Usually, packaging of such pharmaceutical kits requires sterile packaging. To reduce complexity during handling, these pharmaceutical kits are often already positioned in the container before sterilization. Hence, they are sterilized within the container after packaging. Usually, sterilization of such pharmaceutical kits is carried out using UV radiation sterilization or ethylene oxide sterilization. Reason is that the lack of humidity present in the packaging container prevents sterilization by heat to be achieved into device cavities, as usually water molecules in the surrounding atmosphere transport the heat. However, the packaging usually contains measures to reduce the water content in the packaging. Thus, in summary, typical pharmaceutical kits require complex sterilization methods. Additionally, usually, in pharmaceutical kits known from the prior art the products group therein and packaged thereby are put all together in one chamber. For example, patent application EP 0 240 144 A1 discloses a syringe being provided together with a pharmaceutical container in a packaging container within one chamber. Moreover, patent application EP 2 903 660 A1 discloses a prefilled syringe being stored with its plunger and an oxygen absorber in one chamber in a packaging container. Summary of the Invention The solutions provided by the prior art have the disadvantage that the one chamber forms a large headspace. Pharmaceutical containers containing, e.g., an oxygen-sensitive solution, are generally provided in an oxygen-permeable primary container, which is wrapped in a secondary packing with barrier functions. For the sterilization and for the storage of such solutions it is, however, advisable to have a reduced headspace between the primary and the secondary packaging. Moreover, the solutions known from the prior art have the further disadvantage of potential migration of extractables and leachables from one product to another within the one chamber of the packaging. Generally, it is important to protect pharmaceutical solutions from migrating chemical ingredients, such as volatile, semi-volatile, as well as non-volatile compounds of various nature during the sterilization step, wherein they are exposed to elevated temperature such as in an autoclave, or during shelf-life. Such migrating chemical ingredients which could affect the stability and the quality of the packaged pharmaceutical solution. However, these chemical ingredients may origin from the label, the ink, the stopper of a syringe, etc. Hence, it is an object of the present invention to provide a pharmaceutical packaging, which enables packaging more than one pharmaceutical product and reducing the secondary headspace of the packaging at the same time. It is another object of the present invention to provide a pharmaceutical packaging, which enables packaging more than one pharmaceutical product and reducing migration of chemical compounds between the pharmaceutical products at the same time. It has now surprisingly found out that above-mentioned objects can be achieved by a pharmaceutical kit, wherein the pharmaceutical kit comprises a container comprising a pharmaceutical compound,a medical device suitable for receiving the pharmaceutical compound from the container,an enclosure enclosing the container and the medical device, wherein the enclosure comprises at least one wall enclosing a main cavity,wherein the main cavity is a closed cavity,wherein the cavity comprises the container and the medical device,wherein the cavity comprises a separating means separating the main cavity into a container cavity comprising the container and a device cavity comprising the medical device,wherein the container cavity and the device cavity each are closed cavities, andwherein the enclosure comprises an opening means. It has been further surprisingly found that above-mentioned object can be achieved by the use of a pharmaceutical kit according to the present invention for sterile storing the pharmaceutical compound. Moreover, it has been surprisingly found that above-mentioned object can be achieved by the use of a pharmaceutical kit according to the present invention for transferring the pharmaceutical compound to the medical device. Finally, it has been surprisingly found out that above-mentioned objec