Storage of materials
AssigneeNektar Therapeutics
InventorsFelix Franks, Ross Henry Hatley, Sheila Frances Mathias
Life of this patent
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Abstract
Materials which are not themselves storage-stable at room temperature are made suitable for storage by mixing them with a carrier substance and spray drying the resulting mixture so as to form particles containing both the material and the carrier substance in which the carrier substance is in an amorphous, i.e. glassy or rubbery, state. Formation of such a composition greatly enhances stability. The material stored may be a biological material such as an enzyme, the components of a chemical reaction such as reagents for carrying out an assay, or even viable biological cells.
Claims23
A method for rendering suitable for storage a material that is not, on its own, stable upon storage at ambient temperature, said method comprising:
- a. providing an aqueous mixture of (i) a pharmacologically active, therapeutic material selected from the group consisting of proteins, peptides, nucleosides, nucleotides, dinucleotides, and oligonucleotides, and (ii) a carrier that is water-soluble or water-swellable, and, that when anhydrous, can exist as a glass with a glass transition temperature (Tg) above about 20° C.,
- b. spraying into a hot gas stream at an inlet temperature from 80° C. to 300° C. droplets of the aqueous mixture from (a),
- c. drying said droplets by passage through said gas stream to form a powder, and optionally further drying the powder, to obtain a glassy powder having a moisture content from about 3% to about 9% by weight, and
- d. determining the Tg of said glassy powder, wherein said glassy powder has a Tg above about 30°C.
Dependencies are inferred from the claim text.