Manufacturing a flexible container

Patent metadata

Field	Value
Publication number	US-11952155-B2
Application number	US-201917296770-A
Country	US
Kind code	B2
Filing date	Nov 25, 2019
Priority date	Nov 26, 2018
Publication date	Apr 9, 2024
Grant date	Apr 9, 2024

Abstract

A method of manufacturing a flexible container housing a drug substance is disclosed that includes forming a first compartment from a flexible sheet-like material, filling a liquid into the first compartment, sealing the first compartment, forming a second compartment from the flexible sheet-like material, filling a dry drug formulation into the second compartment, and sealing the second compartment. The method further involves lyophilizing the drug formulation inside a tubular cartridge, filling the second compartment by introducing the tubular cartridge through an opening of the second compartment such that an open end of the tubular cartridge is positioned distant from the opening of the second compartment, providing the drug formulation from the open end of the tubular cartridge into the second compartment, and withdrawing the tubular cartridge from the second compartment. The first and second compartments are separated by a frangible seal which opens when the first compartment is compressed.

First claim

The invention claimed is:

1. A method of manufacturing a flexible container housing a drug substance, the method comprising:
forming a first compartment of a container out of a flexible sheet-like material;
filling a liquid into the first compartment of the container;
sealing the first compartment;
forming a second compartment of the container out of the flexible sheet-like material;
filling a dry drug formulation into the second compartment;
sealing the second compartment; and
lyophilizing the dry drug formulation inside a tubular cartridge such that the dry drug formulation is generated and held in the tubular cartridge,
wherein filling the dry drug formulation into the second compartment comprises:
introducing the tubular cartridge holding the dry drug formulation through an opening of the second compartment of the container such that an open end of the tubular cartridge is positioned distant from the opening of the second compartment,
providing the dry drug formulation out of the open end of the tubular cartridge into the second compartment, and
withdrawing the tubular cartridge out of the opening of the second compartment of the container,

wherein the first compartment is separated from the second compartment by a frangible seal which opens when the first compartment is compressed; and
wherein the second compartment has an opposite end at a maximum distance to the opening of the second compartment, and the dry drug formulation is provided out of the open end of the tubular cartridge into the second compartment near the opposite end of the second compartment.

2. The method of claim 1 , wherein the dry drug formulation is a high potency drug formulation.

3. The method of claim 2 , wherein the high potency drug formulation comprises a biological component.

4. The method of claim 1 , wherein the liquid comprises a solvent for dissolving the dry drug formulation.

5. The method of claim 1 , wherein the tubular cartridge has a conical shape widening towards the open end of the tubular cartridge.

6. The method of claim 1 , wherein the tubular cartridge is essentially cylindrical.

7. The method of claim 1 , wherein an inner wall of the tubular cartridge is coated with a friction reducing material.

8. The method of claim 1 , wherein providing the dry drug formulation out of the open end of the tubular cartridge into the second compartment comprises forwarding a plunger through the tubular cartridge towards the open end such that the dry drug formulation is pushed out of the open end of the tubular cartridge.

9. The method of claim 1 , wherein forming the first compartment of the container comprises sealing the flexible sheet-like material such that a firm seal is generated which does not open when the first compartment is compressed.

10. The method of claim 9 , wherein the firm seal is generated by sealing the flexible sheet-like material at first conditions and the frangible seal is generated by sealing the flexible sheet-like material at second conditions different from the first conditions.

11. The method of claim 1 , wherein forming the second compartment of the container comprises sealing a port to the flexible sheet-like material such that a content of the second compartment can be expelled through the port.

12. The method of claim 1 , further comprising:
forming a third compartment of the container out of the flexible sheet-like material,
lyophilizing a dry further drug formulation inside a further tubular cartridge such that the dry further drug formulation is generated and held in the further tubular cartridge,
filling the dry further drug formulation into the third compartment by
introducing the further tubular cartridge holding the dry further drug formulation through an opening of the third compartment of the container such that an open end of the further tubular cartridge is positioned distant from the opening of the third compartment,
providing the dry further drug formulation out of the open end of the further tubular cartridge into the third compartment, and
withdrawing the further tubular cartridge out of the opening of the third compartment of the container, and
sealing the third compartment.

13. The method of claim 1 , wherein the container is an infusion bag.

14. The method of claim 1 , comprising visually inspecting the first compartment and the second compartment for particulate matter, after sealing the first compartment and the second compartment.

15. The method of claim 14 , wherein the first compartment and the second compartment are at least partially transparent.

16. The method of claim 1 , implemented in a blow fill and seal process.

Assignees

• Hoffmann La Roche

Inventors

• Lema Martinez Carmen
• Luemkemann Joerg
• Werk Tobias
• Zumstein Thomas
• Kullmann Daniel

Classifications

• B65B3/003 Primary

  Filling medical containers such as ampoules, vials, syringes or the like · CPC title

• A61J1/10

  Bag-type containers · CPC title

• A61J1/1475

  Inlet or outlet ports · CPC title

• A61J1/2024 Primary

  having peelable seals · CPC title

• A61J1/2093

  Containers having several compartments for products to be mixed · CPC title