초록 ▼

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 am

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.

대표청구항 ▼

1. 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, nucl

1. 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, andd. determining the Tg of said glassy powder, wherein said glassy powder has a Tg above about 30°C. 2. The method of claim 1, wherein said aqueous mixture is a solution. 3. The method of claim 1, wherein said aqueous mixture is a suspension. 4. The method of claim 1, wherein said inlet temperature ranges from 100° C. to 300° C. 5. The method of claim 1, wherein said inlet temperatures ranges from 100° C. to 250° C. 6. The method of claim 1, comprising further drying the powder from step c. to obtain a glassy powder having a moisture content from about 3% to about 9% by weight. 7. The method of claim 6, wherein said further drying is conducted at sub-atmospheric pressure. 8. The method of claim 1, wherein the glassy powder from step d, has a Tg above 50° C. 9. The method of claim 1, wherein the carrier, when anhydrous, possesses a Tg of at least about 40° C. 10. The method of claim 1, wherein the carrier, when anhydrous, possesses a Tg of at least about 50° C. 11. The method of claim 1, wherein the carrier, when anhydrous, possesses a Tg from about 50° C. to 200° C. 12. The method of claim 1, wherein said gas stream comprises air. 13. The method of claim 1, wherein said gas stream comprises nitrogen. 14. The method of claim 1, wherein said carrier comprises at least 20% by weight of the glassy powder. 15. The method of claim 1, wherein said carrier comprises at least 30% by weight of the glassy powder. 16. The method of claim 1, wherein said carrier comprises at least 50% by weight of the glassy powder. 17. The method of claim 1, wherein the carrier is a polyhydroxy compound. 18. The method of claim 1, wherein the carrier is selected from the group consisting of carbohydrates sugars, proteins, and protein hydrolysates. 19. The method of claim 1, wherein the carrier is selected from the group consisting of carbohydrate derivatives, chemically modified carbohydrates, synthetic polymers, and sugar copolymers. 20. The method of claim 1, wherein said carrier comprises a mixture of carriers, wherein each carrier is water-soluble or water-swellable, and, when anhydrous, can exist as a glass with a glass transition temperature (Tg) above about 20° C. 21. The method of claim 20, wherein said carriers are miscible as a solid solution. 22. The method of claim 1, wherein said aqueous mixture contains from about 10 to 250 grams per litre of the carrier. 23. The method of claim 1, further comprising the step of storing the glassy powder at ambient temperature for a period of at least 30 days.