Method for providing in a primary packaging container a dried solid product containing an active pharmaceutical ingredient

Patent metadata

Field	Value
Publication number	US-10696431-B2
Application number	US-201515518396-A
Country	US
Kind code	B2
Filing date	Oct 14, 2015
Priority date	Oct 15, 2014
Publication date	Jun 30, 2020
Grant date	Jun 30, 2020

Abstract

A method for providing a dried solid product containing an active pharmaceutical ingredient is disclosed and includes providing a primary packaging container, providing a drying cartridge different from the primary packaging container, the drying cartridge made of a material adapted to hold a liquid product to be dried, wherein the liquid product contains an active pharmaceutical ingredient and the drying cartridge is made of a material having a thermal conductivity higher than the thermal conductivity of glass. The method also includes filling the liquid product into the drying cartridge, drying the liquid product in the drying cartridge to form a dried solid product containing the active pharmaceutical ingredient, transferring the dried solid product into the primary packaging container.

First claim

The invention claimed is:

1. A method for providing in a primary packaging container a dried solid product containing an active pharmaceutical ingredient, the method comprising the following steps:
providing a primary packaging container;
providing a drying cartridge different from the primary packaging container, the drying cartridge being made of a material adapted to hold a liquid product to be dried, wherein the liquid product to be dried contains an active pharmaceutical ingredient, and wherein the drying cartridge is made of a material having a thermal conductivity which is higher than the thermal conductivity of glass;
filling the liquid product to be dried into the drying cartridge;
drying the liquid product in the drying cartridge to form a dried solid product containing the active pharmaceutical ingredient;
transferring the dried solid product from the drying cartridge into the primary packaging container;
providing an adapter tube having an outer diameter (D 6 ) smaller than the inner diameter (D 4 ) of the primary packaging container, the adapter tube having an inner diameter (D 5 ) equal to or larger than the inner diameter (D 1 ) of the drying cartridge;
positioning the adapter tube between the drying cartridge and the primary packaging container;
partly inserting the adapter tube into the primary packaging container; and
thereafter transferring the dried solid product only or the dried solid product together with a plunger from the drying cartridge through the adapter tube into the primary packaging container.

2. The method of claim 1 , wherein the step of drying the liquid product to be dried is performed through lyophilizing the liquid product to be dried, and wherein the dried solid product is a lyophilisate.

3. The method of claim 1 , wherein the drying cartridge is made of metal or a material other than metal which is compatible with the liquid product to be dried and the dried solid product.

4. The method of claim 1 , wherein the drying cartridge is used only once for the drying of a said liquid product and is not reused.

5. The method of claim 1 , wherein the drying cartridge has a length (L 1 ) which is at least 20% shorter than a length of the primary packaging container and has an inner diameter (D 1 ) which is smaller than an inner diameter (D 4 ) of the primary packaging container.

6. The method of claim 1 , wherein the drying cartridge is a tube having two ends, one end of the two ends being sealed by a plunger and the other end of the two ends being open, and wherein the step of transferring the dried solid product from the drying cartridge into the primary packaging container comprises transferring the dried solid product only or the dried solid product together with the plunger through the open end of the tube into the primary packaging container.

7. The method of claim 1 , wherein the step of providing a drying cartridge different from the primary packaging container comprises simultaneously providing a plurality of drying cartridges, the plurality of drying cartridges being embodied as a stripe or a plate containing a plurality of cylindrical holes.

8. The method of claim 1 , further comprising the steps of:
providing at least one additional drying cartridge containing an additional dried solid product and
transferring the additional dried solid product from the at least one additional drying cartridge into the primary packaging container.

9. The method of claim 1 , further comprising the steps of:
providing a primary packaging tray carrying a plurality of the said primary packaging containers arranged along a plurality of parallel straight lines, each line of the plurality of parallel straight lines having the same number of primary packaging containers arranged thereon in a predetermined pattern;
providing a drying tray carrying a plurality of the said drying cartridges arranged along a further plurality of parallel straight lines corresponding to the plurality of parallel straight lines of the primary packaging tray, each of the drying cartridges-containing a said dried solid product;
aligning the drying cartridges arranged along a said line of the drying tray with the primary packaging containers arranged along a said corresponding line of the primary packaging tray;
simultaneously transferring the dried solid products from the drying cartridges of the said line of the drying tray into the aligned primary packaging containers of the said corresponding line of the primary packaging tray;
moving the drying tray and the primary packaging tray relative to each other such that the drying cartridges of another line of the drying tray and containing dried solid products are aligned with the primary packaging containers of a said line of the primary packaging tray already containing transferred dried solid products, or with the primary packaging containers of another line of the primary packaging tray not containing dried solid products;
simultaneously transferring the dried solid products from the drying cartridges of the said another line of the drying tray into the said aligned primary packaging containers of the primary packaging tray already containing transferred dried solid products, or into the said aligned primary packaging containers not containing dried solid products; and
repeating the step of moving the drying tray and the primary packaging tray relative to each other and the step of simultaneously transferring the dried solid products from the drying cartridges of the drying tray into the aligned primary packaging containers of the primary packaging tray until the dried solid products of all drying cartridges of the drying tray are transferred into the primary packaging containers of the primary packaging tray.

10. The method of claim 1 , wherein an inner wall of the drying cartridge is coated with a coating material adapted for the processing of the liquid product containing the active pharmaceutical ingredient as well as for the processing of the dried solid product containing the active pharmaceutical ingredient, the inner wall coated with the coating material exhibiting less friction than the uncoated inner wall of the drying cartridge when moving a plunger along the coated inner wall of the drying cartridge and/or preventing the liquid product and the dried solid product from reacting with a material the uncoated drying cartridge is made of.

Assignees

• Hoffmann La Roche

Inventors

• Lümkemann Jörg
• Mahler Hanns-Christian
• Schneider Sebastian
• Völkle Jörg
• Werk Tobias

Classifications

• A61J1/062 Primary

  Carpules · CPC title

• B65B3/003

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

• B65B7/2821

  applying plugs or threadless stoppers (for bottles or jars B67B1/04) · CPC title

• B65B1/04 Primary

  Methods of, or means for, filling the material into the containers or receptacles · CPC title

• A61J1/1412

  Containers with closing means, e.g. caps · CPC title