Primary packaging and method for the manufacture of a primary packaging

Inventors

Kühnle, Sarah • Böttger, Frank • Nelles, Paul

Assignees

Vetter Pharma Fertigung GmbH and Co KG

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Publication Number

US-10940037-B2

Patent

Publication Date

2021-03-09

Expiration Date


Abstract

A primary packaging for medical preparations includes a base body having a plastic material. The base body has at least one wall including an outer surface and at least one inner surface. The outer surface of the primary packaging is provided with a gas tight coating.

Core Innovation

The invention relates to a primary packaging for medical preparation that includes a plastic base body having at least one wall with an outer surface and at least one inner surface. The outer surface is provided with a gas tight coating, and the inner surface is provided with a gas tight inner coating.

An inner functional layer is situated at least in sections on the gas tight inner coating, while the inner functional layer is omitted in at least one free region of the inner surface. The free region is located in a region configured to receive a freeze drying product solution, a freeze drying material, a lyophilisate, or a combination thereof, and is located within a first distal chamber of a dual chamber system.

The primary packaging is configured as a dual chamber system with a first distal chamber and a second proximal chamber separated by a center plug or by an elastomeric plug. In the elastomeric plug configuration, the inner functional layer is configured to reduce a sticking friction on the elastomeric plug.

Claims Coverage

The partial content provides two independent claims. Each independent claim centers on a primary packaging with a plastic base body plus gas tight outer and inner coatings, and each includes an omitted inner functional layer in a free region related to freeze-drying, with dual-chamber separation by a center plug or an elastomeric plug.

Dual-chamber plastic primary packaging with gas-tight outer and inner coatings and omitted inner functional layer in a freeze-drying region

A primary packaging for medical preparation with a plastic base body having outer and inner surfaces, the outer surface provided with a gas tight coating and the inner surface provided with a gas tight inner coating; an inner functional layer situated at least in sections on the gas tight inner coating and omitted in at least one free region; the free region configured to receive a freeze drying product solution, a freeze drying material, a lyophilisate, or a combination; and a dual chamber system with a first distal chamber and a second proximal chamber separated by a center plug, where the free region is located within the first distal chamber.

Dual-chamber plastic primary packaging with gas-tight coatings and an elastomeric plug with friction-reducing omitted inner functional layer

A primary packaging for medical preparation with a plastic base body having an outer surface with a gas tight coating and an inner surface with a gas tight inner coating; an elastomeric plug defining a distal chamber and a proximal chamber separated by the elastomeric plug; an inner functional layer situated at least in sections on the gas tight inner coating and omitted in at least one free region of the inner surface in the distal chamber; wherein the inner functional layer is configured to reduce a sticking friction on the elastomeric plug.

Across both independent claims, the core inventive coverage is a dual-chamber plastic primary packaging that uses gas tight outer and inner coatings, with an inner functional layer omitted in at least one free region for freeze-drying or lyophilisate reception, and dual-chamber separation achieved via a center plug or an elastomeric plug, with the elastomeric-plug form expressly requiring reduced sticking friction via the inner functional layer.

Stated Advantages

Reduces sticking friction on the elastomeric plug.

Documented Applications

Ophthalmic application using an ophthalmic dual-chamber configuration with distal lyophilized solids and proximal solvent separated by elastomer plugs and including a bypass.

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