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US 8,769,841 B2Granted
Lyophilisation targeting defined residual moisture by limited desorption energy levels
AssigneeOctapharma AG
InventorsGerhard Gruber, Anton Reschny
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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.
Claims9
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%.
2 more elements
Dependencies are inferred from the claim text.