RU96102017A - STABILIZED PHARMACEUTICAL PEPTIDE COMPOSITIONS - Google Patents

STABILIZED PHARMACEUTICAL PEPTIDE COMPOSITIONS

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Publication number
RU96102017A
RU96102017A RU96102017/14A RU96102017A RU96102017A RU 96102017 A RU96102017 A RU 96102017A RU 96102017/14 A RU96102017/14 A RU 96102017/14A RU 96102017 A RU96102017 A RU 96102017A RU 96102017 A RU96102017 A RU 96102017A
Authority
RU
Russia
Prior art keywords
composition
composition according
specified
citrate
phosphate
Prior art date
Application number
RU96102017/14A
Other languages
Russian (ru)
Other versions
RU2140281C1 (en
Inventor
Алан Харрис
Биргитта Теннхаммар-Экман
Original Assignee
Ферринг Б.В.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US08/084,563 external-priority patent/US5482931A/en
Application filed by Ферринг Б.В. filed Critical Ферринг Б.В.
Publication of RU96102017A publication Critical patent/RU96102017A/en
Application granted granted Critical
Publication of RU2140281C1 publication Critical patent/RU2140281C1/en

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Claims (17)

1. Стабильный водный состав для введения пациенту по меньшей мере одного биологически активного пептида, выбранного из группы, содержащей окситоцин, вазопрессин, атосибан, карбетоцин и трипторелин и их аналоги и производные, включающий указанный биологически активный пептид, буфер, выбранный из группы, состоящей из цитрата, фосфата и смеси цитрата и фосфата, поддерживающий рН указанного состава между 4,0 и 6,0, бензалкониум хлорид, контролирующий осмотическое давление агент.1. A stable aqueous composition for administering to the patient at least one biologically active peptide selected from the group consisting of oxytocin, vasopressin, atosiban, carbetocin and triptorelin and their analogues and derivatives, including the specified biologically active peptide, a buffer selected from the group consisting of citrate, phosphate and a mixture of citrate and phosphate, maintaining the pH of the specified composition between 4.0 and 6.0, benzalkonium chloride, an osmotic pressure controlling agent. 2. Состав по п. 1, отличающийся тем, что указанный буфер поддерживает упомянутое значение рН около 5,0. 2. The composition according to p. 1, characterized in that the buffer supports the aforementioned pH value of about 5.0. 3. Состав по п.1 или 2, отличающийся тем, что указанная буферная смесь цитрата и фосфата содержит ионы натрия, так что молярное отношение ионов цитрата, фосфата и натрия составляет от приблизительно 1 : 3 : 3 до приблизительно 1 : 1 : 2. 3. The composition according to claim 1 or 2, characterized in that the specified buffer mixture of citrate and phosphate contains sodium ions, so that the molar ratio of citrate, phosphate and sodium ions is from about 1: 3: 3 to about 1: 1: 2. 4. Состав по пп.1 - 3, отличающийся тем, что указанный контролирующий осмотическое давление агент является хлоридом натрия. 4. The composition according to claims 1 to 3, characterized in that said osmotic pressure controlling agent is sodium chloride. 5. Состав по п. 1, отличающийся тем, что указанное введение является оральным. 5. The composition according to p. 1, characterized in that the introduction is oral. 6. Состав по п. 1, отличающийся тем, что указанное введение является парэнтеральным. 6. The composition according to p. 1, characterized in that the introduction is parenteral. 7. Состав по пп.1 - 6, отличающийся тем, что указанный пептид является десмопрессином. 7. The composition according to claims 1 to 6, characterized in that said peptide is desmopressin. 8. Водный состав для назального введения по меньшей мере одного биологически активного пептида, выбранного из группы, содержащей окситоцин, вазопрессин, терлипрессин, атосибан, карбетоцин и трипторелин, и их аналоги и производные, включающий указанный биологически активный пептид, буфер, выбранный из группы, состоящей из цитрата, фосфата и смеси цитрата и фосфата, поддерживающий рН указанного состава между 4,0 и 6,0, бензалкониум хлорид и контролирующий осмотическое давление агент такой, что указанный состав способен сохранять упомянутый биологически активный пептид в функционально стабильном состоянии в течение длительных периодов и при комнатной температуре. 8. An aqueous composition for nasal administration of at least one biologically active peptide selected from the group consisting of oxytocin, vasopressin, terlipressin, atosiban, carbetocin and triptorelin, and their analogues and derivatives, including the specified biologically active peptide, a buffer selected from the group consisting of citrate, phosphate and a mixture of citrate and phosphate, maintaining a pH of the specified composition between 4.0 and 6.0, benzalkonium chloride and an osmotic pressure controlling agent such that the composition is able to maintain the aforementioned bi An active peptide in a functionally stable state for long periods and at room temperature. 9. Состав по п.8, отличающийся тем, что указанный пептид является десмопрессином. 9. The composition of claim 8, characterized in that the peptide is desmopressin. 10. Состав по п.8 или 9, отличающийся тем, что указанный буфер сохраняет упомянутое рН при значении около 5,0. 10. The composition according to claim 8 or 9, characterized in that said buffer retains the said pH at a value of about 5.0. 11. Состав по пп.8 - 10, отличающийся тем, что указанный буфер включает смесь цитрата и динатрийгидрофосфата так, что молярное отношение ионов цитрата, фосфата и натрия составляет от приблизительно 1 : 3 : 3 до приблизительно 1 : 1 : 2. 11. The composition according to claims 8 to 10, characterized in that said buffer comprises a mixture of citrate and disodium hydrogen phosphate such that the molar ratio of citrate, phosphate and sodium ions is from about 1: 3: 3 to about 1: 1: 2. 12. Состав по пп.8 - 11, отличающийся тем, что указанный контролирующий осмотическое давление агент является хлоридом натрия, причем этот хлорид натрия добавлен к указанному составу в количестве, достаточном для превращения указанного состава в совместимый с осмотическим давлением человеческой плазмы. 12. The composition according to PP.8 to 11, characterized in that the specified osmotic pressure controlling agent is sodium chloride, and this sodium chloride is added to the specified composition in an amount sufficient to turn the specified composition compatible with the osmotic pressure of human plasma. 13. Стабильный водный состав для назального применения, включающий от 0,025 до 1,5 мг ацетата десмопрессина, от 1,35 до 1,75 мг лимонной кислоты, от 2,25 до 2,65 мг динатрийгидрофосфата, от 0,05 до 0,20 мг бензалкониум хлорида, хлорид натрия в количестве, достаточном для создания в указанном составе осмотического давления, сравнимого с таковым для человеческой плазмы. 13. A stable aqueous composition for nasal use, comprising from 0.025 to 1.5 mg of desmopressin acetate, from 1.35 to 1.75 mg of citric acid, from 2.25 to 2.65 mg of disodium hydrogen phosphate, from 0.05 to 0, 20 mg of benzalkonium chloride, sodium chloride in an amount sufficient to create osmotic pressure in the specified composition, comparable to that for human plasma. 14. Герметичный контейнер, наполненный стабилизированным водным аэрозольным составом в соответствии с п.13 для назального введения указанного десмопрессина. 14. A sealed container filled with a stabilized aqueous aerosol composition in accordance with paragraph 13 for nasal administration of the indicated desmopressin. 15. Способ лечения болезней и патологических состояний организме, на которые можно воздействовать введением коротких или среднего размера пептидов, при котором используют состав по п.1. 15. A method of treating diseases and pathological conditions of the body, which can be affected by the introduction of short or medium size peptides, which use the composition according to claim 1. 16. Способ лечения болезней и патологических состояний организма, на которые можно воздействовать введением коротких или среднего размера пептидов, при котором используют состав по п.9. 16. A method for the treatment of diseases and pathological conditions of the body, which can be affected by the introduction of short or medium size peptides, which use the composition according to claim 9. 17. Способ лечения болезней и патологических состояний организма, на которые можно воздействовать введением коротких и среднего размера пептидов, при котором используют состав по п.13. 17. A method for the treatment of diseases and pathological conditions of the body, which can be affected by the introduction of short and medium size peptides, which use the composition according to item 13.
RU96102017A 1993-06-29 1994-06-22 Aqueous solution for nasal injection of biologically-active peptide, and sealed container RU2140281C1 (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US084,563 1993-06-29
US08/084,563 US5482931A (en) 1993-06-29 1993-06-29 Stabilized pharmaceutical peptide compositions
US084.563 1993-06-29
PCT/SE1994/000622 WO1995001185A1 (en) 1993-06-29 1994-06-22 Stabilized pharmaceutical peptide compositions

Publications (2)

Publication Number Publication Date
RU96102017A true RU96102017A (en) 1998-03-27
RU2140281C1 RU2140281C1 (en) 1999-10-27

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Country Status (20)

Country Link
US (1) US5482931A (en)
EP (1) EP0710122B1 (en)
JP (1) JP3795520B2 (en)
KR (1) KR100195323B1 (en)
CN (1) CN1109558C (en)
AT (1) ATE210462T1 (en)
CA (1) CA2166296C (en)
CZ (1) CZ283186B6 (en)
DE (1) DE69429431T2 (en)
DK (1) DK0710122T3 (en)
ES (1) ES2168301T3 (en)
FI (1) FI117544B (en)
HK (1) HK1000903A1 (en)
HU (1) HU220044B (en)
NZ (1) NZ268441A (en)
PL (1) PL184437B1 (en)
PT (1) PT710122E (en)
RU (1) RU2140281C1 (en)
SK (1) SK281470B6 (en)
WO (1) WO1995001185A1 (en)

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