Freeze drying of nested vials
AssigneeProject Pharmaceutics GmbH
InventorsAndreas SCHUETZ, Klaus HELLERBRAND
Life of this patent
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Abstract
The present invention is directed to an improved lyophilization process wherein a plurality of vials is not in contact with the shelf of the lyophilization device. The present invention is further directed to lyophilization cake and intermediate cake obtainable according to the process of the invention.
Claims20
A method for lyophilizing a composition comprising lyophilizing a composition comprised in a vial, said vial being comprised in a plurality of vials housed by a device, said plurality of vials is preferably positioned adjacent to each other, preferably in a predetermined distance, wherein said vial comprising said composition to be lyophilized is not in direct contact with the shelf of a lyophilization device.
A device formed to house a plurality of vials, preferably positioned adjacent to each other, preferably in a predetermined distance, wherein at least one vial of said plurality of vials is suitable to comprise a composition to be lyophilized, and
- (i) wherein said device is separated from the shelf of a lyophilization device by a spacer;
- or
- (ii) wherein vials adjacent to said vial suitable to comprise a composition to be lyophilized are separated from the shelf of a lyophilization device by a spacer, or
- (iii) wherein vials are separated from the shelf in that they are positioned or suspended in a device, e.g., by holders or racks such that their bottom is not in direct contact with the bottom of the device;
- or
- (iv) wherein vials are separated from the shelf in that they are positioned in a device such that their bottom is not in direct contact with the shelf, if the device in which the vials are positioned may not have a bottom;
- or
- (v) wherein vials adjacent to said vial suitable to comprise a composition to be lyophilized protrude beyond said vial suitable to comprise said composition.
Use of a spacer in aiding in the preparation of an essentially defect-free lyophilized composition, wherein
- (i) said spacer is positioned between a device formed to accommodate a plurality of vials positioned adjacent to each other in a predetermined distance, wherein at least one vial of said plurality of vials is suitable to comprise a composition to be lyophilized, and a shelf of a lyophilization device, or
- (ii) wherein said spacer is positioned between at least two vials adjacent to a vial suitable to comprise a composition to be lyophilized, and a shelf of a lyophilization device.
Dependencies are inferred from the claim text.