# US 8,769,841 B2 · Lyophilisation targeting defined residual moisture by limited desorption energy levels

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- Number: US 8,769,841 B2
- Document ID: US8769841B2
- Status: Granted
- Kind: B2
- Application number: 13/625,482
- Filed: 2012-09-24
- Published: 2013-05-16
- Granted: 2014-07-08
- Earliest claimed: 2006-06-20
- Assignees: Octapharma AG
- Applicants: Octapharma AG
- Inventors: Gerhard Gruber; Anton Reschny
- Web page: https://patentgrep.com/patent/US8769841B2

## CPC

- F26B 5/06: the process involving freezing
- A61K 9/19: lyophilised {, i.e. freeze-dried, solutions or dispersions (lyophilised products with subsequent particle size reduction A61K9/14; granules or pellets made by lyphilisation A61K9/1682; solid oral dosage forms made by lyophilisation A61K9/2095; lyophilisation additives A61K47/00)}
- F26B: DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM (drying devices for combines A01D41/133; racks for drying fruit or vegetables A01F25/12; drying foodstuffs A23; drying hair A45D20/00; body-drying implements A47K10/00; drying household articles A47L; drying gases or vapours B01D; chemical or physical processes for dewatering or like separating liquids from solids B01D43/00; centrifugal apparatus B04; drying ceramics C04B33/30; drying yarns or fabrics in association with some other form of treatment D06C; drying frames for laundry without heating or positive air circulation, domestic laundry-or spin-driers, wringing or hot pressing laundry D06F; furnaces, kilns, ovens F27)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)

## Abstract

A process of freeze drying of an essentially aqueous solution comprising at least one first step having a first temperature and pressure level (i.e. primary drying phase) and at least one second step having a second temperature and pressure level (i.e. secondary drying phase) following the first step, wherein in the secondary drying phase limited desorption energy input is applied.

## Claims

### Claim 1

A process of freeze drying an essentially aqueous solution comprising the sequential steps of
a) subjecting the solution to a primary drying phase at a first temperature and pressure level to obtain a product; and
b) subjecting the product to a secondary drying phase at 0.01 mbar and a temperature range from −5° C. to +3° C. for at least 3 hours; wherein a limited desorption energy input is applied in the secondary drying phase;
to obtain a lyophilized product having a predefined target rest moisture in steady-state conditions of 0.79-1.14%.

### Claim 2 (depends on 1)

The process of claim 1 wherein the limited desorption energy input applied results in a desorption rate at the target rest moisture of the product approaching zero.

### Claim 3 (depends on 1)

The process of claim 1 having a first shelf temperature level and a first chamber pressure level (primary or sublimation drying phase) and at least one second step having a second shelf temperature level and a second chamber pressure level (secondary or desorption drying phase) following the first step, characterized in that in the secondary desorption drying phase at which the desorption rate at the target at rest moisture of the product approaches zero.

### Claim 4 (depends on 1)

The process of claim 1, wherein the aqueous solution contains biopolymers such as proteins, polysaccharides, nucleic acids.

### Claim 5 (depends on 1)

The process of claim 1, wherein the biopolymers are pharmaceutically active substances.

### Claim 6 (depends on 1)

The process of claim 1, wherein the aqueous solution contains proteins selected from the group consisting of plasma proteins such as blood plasma, coagulation factors, proteases or cofactors, protease inhibitors, immunoglobulins, albumin and mixtures thereof.

### Claim 7 (depends on 1)

The process of claim 1, wherein the aqueous solution contains proteins selected from the group consisting of one or more growth factors, hormones, cytokines and mixtures thereof.

### Claim 8 (depends on 1)

The process of claim 1, wherein the aqueous solution contains recombinantly or transgenically produced proteins.

### Claim 9 (depends on 1)

The process of claim 1, wherein the aqueous solution contains prior to drying additionally buffer substances.