RU95118293A - METHOD FOR STABILIZING A POLYPEPTIDE, METHODS FOR PRODUCING POLYPEPTIDE COMPOSITIONS AND COMPOSITIONS - Google Patents

METHOD FOR STABILIZING A POLYPEPTIDE, METHODS FOR PRODUCING POLYPEPTIDE COMPOSITIONS AND COMPOSITIONS

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Publication number
RU95118293A
RU95118293A RU95118293/14A RU95118293A RU95118293A RU 95118293 A RU95118293 A RU 95118293A RU 95118293/14 A RU95118293/14 A RU 95118293/14A RU 95118293 A RU95118293 A RU 95118293A RU 95118293 A RU95118293 A RU 95118293A
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RU
Russia
Prior art keywords
polypeptide
composition
polyol
organic solvent
excipient
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Application number
RU95118293/14A
Other languages
Russian (ru)
Other versions
RU2143889C1 (en
Inventor
Л.Клилэнд Джеффри
Дж.С.Джоунс Эндрю
Original Assignee
Генентек, Инк.
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Filing date
Publication date
Application filed by Генентек, Инк. filed Critical Генентек, Инк.
Priority claimed from PCT/US1994/001666 external-priority patent/WO1994019020A1/en
Publication of RU95118293A publication Critical patent/RU95118293A/en
Application granted granted Critical
Publication of RU2143889C1 publication Critical patent/RU2143889C1/en

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Claims (32)

1. Способ стабилизации полипептида от денатурации при обработке органическим растворителем, отличающийся тем, что включает смешивание полипептида с полиолом, причем молекулярная масса полиола меньше, чем примерно 70000 кD, для образования смеси и обработку смеси органическим растворителем.1. A method of stabilizing a polypeptide from denaturation by treatment with an organic solvent, characterized in that it comprises mixing the polypeptide with a polyol, the molecular weight of the polyol being less than about 70,000 kD, to form a mixture and treating the mixture with an organic solvent. 2. Способ по п. 1, отличающийся тем, что полипептид является гормоном роста. 2. The method according to p. 1, characterized in that the polypeptide is a growth hormone. 3. Способ по п. 2, отличающийся тем, что гормон роста является человеческим. 3. The method according to p. 2, characterized in that the growth hormone is human. 4. Способ по п. 1, отличающийся тем, что полипептид является гамма-интерфероном. 4. The method according to p. 1, characterized in that the polypeptide is a gamma interferon. 5. Способ по п. 1, отличающийся тем, что органический растворитель является метиленхлоридом. 5. The method according to p. 1, characterized in that the organic solvent is methylene chloride. 6. Способ по п. 1, отличающийся тем, что органический растворитель является этилацетатом. 6. The method according to p. 1, characterized in that the organic solvent is ethyl acetate. 7. Способ по п. 1, отличающийся тем, что полиол является трегалозой. 7. The method according to p. 1, characterized in that the polyol is trehalose. 8. Способ по п. 1, отличающийся тем, что полиол является маннитом. 8. The method according to p. 1, characterized in that the polyol is mannitol. 9. Способ по п. 1, отличающийся тем, что полиол является полиэтиленгликолем. 9. The method according to p. 1, characterized in that the polyol is polyethylene glycol. 10. Способ по п. 1, отличающийся тем, что полипептид является сухим веществом. 10. The method according to p. 1, characterized in that the polypeptide is a dry substance. 11. Способ по п.10, отличающийся тем, что полипептид является лиофилизированным. 11. The method according to claim 10, characterized in that the polypeptide is lyophilized. 12. Способ по п.7, отличающийся тем, что массовое соотношение трегалозы и полипептида составляет от 100 : 1 до 1 : 100. 12. The method according to claim 7, characterized in that the mass ratio of trehalose and polypeptide is from 100: 1 to 1: 100. 13. Способ по п.7, отличающийся тем, что массовое соотношение трегалозы и полипептида составляет от 1 : 1 до 1 : 10. 13. The method according to claim 7, characterized in that the mass ratio of trehalose and polypeptide is from 1: 1 to 1: 10. 14. Способ по п.7, отличающийся тем, что массовое соотношение трегалозы и полипептида составляет от 1 : 3 до 1: 4. 14. The method according to claim 7, characterized in that the mass ratio of trehalose and polypeptide is from 1: 3 to 1: 4. 15. Способ по п. 8, отличающийся тем, что массовое соотношение маннита и полипептида составляет от 100 : 1 до 1 : 100. 15. The method according to p. 8, characterized in that the mass ratio of mannitol and polypeptide is from 100: 1 to 1: 100. 16. Способ по п. 8, отличающийся тем, что массовое соотношение маннита и полипептида составляет от 1 : 1 до 1 : 10. 16. The method according to p. 8, characterized in that the mass ratio of mannitol and polypeptide is from 1: 1 to 1: 10. 17. Способ по п. 8, отличающийся тем, что массовое соотношение маннита и полипептида составляет от 1 : 1 до 1 : 2. 17. The method according to p. 8, characterized in that the mass ratio of mannitol and polypeptide is from 1: 1 to 1: 2. 18. Способ получения композиции полипептира, включающий смешивание полипептида в водном растворе с полиолом, имеющим молекулярную массу менее 70000 кD и обработку полипептида в водном растворе органическим растворителем. 18. A method of obtaining a polypeptide composition, comprising mixing the polypeptide in an aqueous solution with a polyol having a molecular weight of less than 70,000 kD and treating the polypeptide in an aqueous solution with an organic solvent. 19. Способ по п. 18, отличающийся тем, что продукт стадии а) высушивают и повторно переводят в водную форму препарата. 19. The method according to p. 18, characterized in that the product of stage a) is dried and re-transferred into the aqueous form of the drug. 20. Способ по п. 18, отличающийся тем, что дополнительно включает получение композиции полипептида с регулируемым выделением. 20. The method according to p. 18, characterized in that it further includes obtaining a composition of the polypeptide with controlled release. 21. Способ получения композиции сухого полипептипа с регулируемым выделением, включающий смешивание полипептида с наполнителем, причем указанный наполнитель является полиолом, имеющим молекулярную массу менее примерно 70000 кD и обработку продукта со стадии а) органическим растворителем. 21. A method of obtaining a dry polypeptide composition with controlled release, comprising mixing the polypeptide with a filler, said filler being a polyol having a molecular weight of less than about 70,000 kD and treating the product from step a) with an organic solvent. 22. Способ по п. 21, отличающийся тем, что дополнительно включает инкапсулирование полипептида в полимерную матрицу. 22. The method according to p. 21, characterized in that it further includes encapsulating the polypeptide in the polymer matrix. 23. Инкапсулированная композиция, подученная способом по п. 21. 23. The encapsulated composition obtained by the method according to p. 21. 24. Композиция с регулируемым выделением полипептида, содержащая полипептид, смешанный с наполнителем, причем наполнитель является полиолом, имеющим молекулярную массу менее примерно 70000 кD, отличающаяся тем, что полипептид, смешанный с наполнителем, обрабатывается органическим растворителем и инкапсулируется в полимерную матрицу. 24. A controlled release polypeptide composition comprising a polypeptide mixed with an excipient, wherein the excipient is a polyol having a molecular weight of less than about 70,000 KD, characterized in that the polypeptide mixed with an excipient is treated with an organic solvent and encapsulated in a polymer matrix. 25. Композиция по п. 24, отличающаяся тем, что полипептид, смешанный с наполнителем, представляет собой водный препарат. 25. The composition according to p. 24, characterized in that the polypeptide mixed with an excipient is an aqueous preparation. 26. Композиция по п. 24, отличающаяся тем, что полипептид, смешанный с наполнителем, является сухим веществом. 26. The composition according to p. 24, characterized in that the polypeptide mixed with an excipient is a dry substance. 27. Композиция по п. 24, отличающаяся тем, что полипептид, смешанный с наполнителем, лиофилизируется. 27. The composition according to p. 24, characterized in that the polypeptide mixed with an excipient is lyophilized. 28. Композиция по п. 24, отличающаяся тем, что полимер является полилактидом. 28. The composition according to p. 24, wherein the polymer is polylactide. 29. Композиция по п. 24, отличающаяся тем, что дополнительно включает буфер. 29. The composition according to p. 24, characterized in that it further comprises a buffer. 30. Композиция по п. 29, отличающаяся тем, что буфер является фосфатным буфером. 30. The composition according to p. 29, wherein the buffer is a phosphate buffer. 31. Композиция по п. 29, отличающаяся тем, что буфер является сукцинатным буфером. 31. The composition according to p. 29, wherein the buffer is a succinate buffer. 32. Композиция по п. 29, отличающаяся тем, что дополнительно включает консервант. 32. The composition according to p. 29, characterized in that it further includes a preservative.
RU95118293A 1993-02-23 1994-02-17 Method of stabilization of polypeptide, and methods of preparing polypeptide compositions RU2143889C1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US2142193A 1993-02-23 1993-02-23
US08/021,421 1993-02-23
PCT/US1994/001666 WO1994019020A1 (en) 1993-02-23 1994-02-17 Excipient stabilization of polypeptides treated with organic solvents

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RU95118293A true RU95118293A (en) 1998-01-10
RU2143889C1 RU2143889C1 (en) 2000-01-10

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JP (1) JP3698721B2 (en)
CN (1) CN1108823C (en)
AT (1) ATE197550T1 (en)
AU (1) AU685784B2 (en)
CZ (1) CZ296649B6 (en)
DE (1) DE69426292T2 (en)
DK (1) DK0686045T3 (en)
ES (1) ES2153418T3 (en)
GR (1) GR3035383T3 (en)
IL (1) IL108713A (en)
NZ (1) NZ262634A (en)
PT (1) PT686045E (en)
RU (1) RU2143889C1 (en)
WO (1) WO1994019020A1 (en)
ZA (1) ZA941239B (en)

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