KR920002164A - 연속 방출성 약학 조성물 - Google Patents
연속 방출성 약학 조성물 Download PDFInfo
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- A61K47/642—Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent the peptide or protein in the drug conjugate being a cytokine, e.g. IL2, chemokine, growth factors or interferons being the inactive part of the conjugate
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Abstract
내용 없음
Description
본 내용은 요부공개 건이므로 전문내용을 수록하지 않았음
제1도는 참고에 5에 언급된 167bp 단편의 튜클레오티드 서열.
제2도는 인체(hu)G-CSF의 천연의 아미노산 서열과 대응 뉴클레오 티드 서열 및 제한부위를 나타내며.
제3도는 (Ser 17, 27)hu G-CSF의 아미노산 서열과 대응 뉴클레오 리드 서열 및 제한부위를 나타낸다.
Claims (20)
- 조성물 성분중 산에 안정한 생리적 활성 물질을 생리적 수성환경내로 연속방출하기 위한 약학 조성물에 있어서, 상기 활성물질은 수용성 중합체에 공유결합된 폴리펩티드로서, 소정의 사용기간동안 조성물이 처한 조건하에서 거의 가수분해되지 않으며, 상기 조성물은, i)생리적 수성 환경에 놓였을때, 상기 플리 펩티드를 상기 생리적 수성 환경에 연속방출함으로써, 적어도 일주일 동안 거의 단일상의 방출양상을 제공하거나, ii)상기 폴리펩티드를 두 가지 연속상으로 방출하는데, 즉 그 첫번째 상은 표며으로부터 확산방출하는 것이고, 두번째 상은 조성물성분의 분해시 방출하는 것으로서, 상기 확산상과 분해 유도상은 시간상 겹치며, 적어도 일주일의 기간동안 폴리펩티드를 방출하는 것을 특징으로 하며, 또는 iii)조성물 성분이 분해되어, 거의 모든 폴리펩티드가 생리적 수성환경내로 방출될 때까지, 적어도 일주일 동안 연속적으로 물을 흡수하여 거의 단일상의 물 흡수 양상을 제공하는 것을 특징으로 하는, 조성물 성분으로 부터 산안정성의 생리적 활성물질이 생리적 수성환경으로 연속 방출되는 약학 조성물.
- 제1항에 있어서, 생리적 활성물질 1분자가 폴리펩티드 3000 내지 8000Da 분자량당 수숑성 중합체 1분자 이상을 포함하는 것을 특징으로 하는 약학 조성물.
- 제1항 또는 제2항에 있어서, 상기 폴리펩티드가 천연발생의 G-CSF의 생물학적 특징을 적어도 하나 갖는 것을 특징으로 하는 약학 조성물.
- 제3항에 있어서, 상기 폴리펩티드가 천연 발생의 G-CSF의 생물학적 특징을 적어도 하나 지니며 5mg/㎖에 적어도 35%에 용액 안정성을 지니는 천연성 발생 G-CSF의 유도체이며, 상기 유도체는 천연 서열의 적어도 Cys17이 Ser17잔기로 대체되었으며 Asp27잔기로 대체된 것을 특징으로 하는 약학 조성물.
- 제4항에 있어서, 상기 폴리펩티드가 a)천연서열의 Glu11이 Arg11잔기로 대체된 변형체, b)천연서열의 Leu15가 Glu15잔기로 대체된 변형체, c)천연서열의 Lys23이 Arg23잔기로 대체된 변형체, d)천연서열의 Gly26이 Ala26잔기로 대체된 변형체, e)천연서열의 Gly28이 Ala28잔기로 데체된 변형체, f)천연서열의 Ala30이 Lys30또는 Arg30잔기로 대체된 변형체, g)천열서열의 Lgs34가 Arg34잔기로 데체된 변형체, h)천연서열의 Lys49가 Lys49잔기로 데체된 변형체, i)천연서열의 Pro44가 Ala44잔기로 대체된 변형체, j)천연서열이 Leu49가 Lys49잔기에 의해 대체된 변형체, k)천연서열의 Gly51가 Ala51잔기에 의해 대체된 변형체 l)천연서열의 Pro55이 Ser55잔기에 의해 대체된 변형체 m)천연서열의 Trp58이 Lys58잔기에 의해 대체된 변형체, n)천연서열의 Pro60이 Ser60잔기에 의해 대체된 변형체, o)천연서열의 Pro65가 Ser65잔기에 의해 대체된 변형체, q)천연서열이 Thr115가 Ser115잔기에 의해 대체된 변형체, r)천연서열의 Thr116이 Ser116잔기에 의해 대체된 변형체, s)천연서열의 Tyr165가 Arg165잔기에 의해 대체된 변형체, 중에서 선택된 변형체를 적어도 하나 더 포함하는 것을 특징으로 하는 약학 조성물.
- 제4항 또는 제5항에 있어서, 상기 폴리펩티드가 i)[Agr11, Ser17,27,60,65]인체 G-CSF, ii)[GlU15, Ser17,27,Ala26,28,Lys30]인체 G-CSF, iii)[Agr11, Glu15, Ser17,8,27,60,65,Ala26,28,Lys30]인체 G-CSF, iv)[Art11,40,Ser17,27,60,65]인체 G-CSF, v)[Arg11,23, Ser17,27,60,65]인체 G-CSF, vi)[Arg11,165, Glu15,Ser17,27,60,65, Ala26,28, Lys30,58]인체 G-CSF, vii)[Arg11, Glu15,111, Ser17,27,65,115,116, Ala26,28, Lys30]인체 G-CSF, viii)[Glu15, Ser17,27, Ala26,28, Lys30인체 G-CSF, and ix)[Arg1, Thr3, Tyr4, Arg5,11, Ser17,27,60,65]인체 -G-CSF, x)[Ser17,27,60,65]인체 G-CSF, 및 xi)[Arg11, Ser17,27,65]인체 G-CSF, xii)[Ser17,27,65]인체 G-CSF 중에서 선택되는 것을 특징으로 하는 약학 조성물.
- 제1항 또는 제2항에 있어서, 상기 폴리펩티드가 G-CSF 인체 칼시토닌, 인터루킨-2, 인터페론 및 인체성장 호르몬중에서 선택되는 것을 특징으로 하는 약학조성물.
- 제1항 내지 제7항중 어느 한 항에서, 수용성 중합체가 폴리에틸렌 글리콜 또는 폴리프로필렌 글리콜 단일 중합체, 폴리옥시에틸화 폴리올 또는 폴리비닐 알코올 중에서 선택되며, 이중 상기 단일 중합체가 알킬기로 한 말단이 치환되거나 비치환된 것을 특징으로 하는 약학 조성물.
- 제8항에 있어서, 상기 수용성 중합체가 비치환된 폴리에틸렌글리콜, 모노메틸 폴리에틸렌글리콜 및 폴리옥시 에틸화 글리세롤 중에서 선택되는 것을 특징으로 하는 약학 조성물.
- 제8항 또는 제9항에 있어서, 상기 수용성 중합체가 분자량이 1,000 내지 15,000인 것을 특징으로 하는 약학 조성물.
- 제1항 내지 제6항과 제8항 내지 제10항 중 어느 한항에 잇어서, 생리학적 활성물질이 예비서열 메티오닌이 존재하거나 도는 부재하는, 모노메틸 폴리에틸렌글리콜에 결합된 [Arg11, Ser17,27,60,65]인체 G-CSF이며, 상기 모노메틸 폴리에틸렌글리콜의 분자량이 2000 내지 5000인 것을 특징으로 하는 약학 조성물.
- 유기용매중에 조성물의 성분과 생리학적 활성물질을 용해시키거나 유기성 또는 수성 매체중에서 상기 조성물의 성분과 생리학적 활성물질을 균일하게 분산시킨후, 건조시키고 동물체내에 이식 또는 삽입하기에 적당한 조성물로 제형화하는 것을 포함하는 제1항 내지 제11항중 어느 한 항의 약학조성물의 제조방법.
- 조성물 성분이 폴리락티드를 포함하며, 생리학적 활성 물질을 25% 몰 이상의 젖산 유닛과 75% 몰 이하의 글리콜산 유닛으로 구성되는 상기 폴리락티드를 포함하는 매트릭스에 함입시키는 단계와 상기 조성물성분과 활성물질의 고형 혼합물을 완전히 용융시킴으로써 조성물성분과 생리학적 활성 물질을 균일하게 혼합하는 단계을 더 포함하는 것을 특징으로 하는, 제1항 내지 제11항중 어느 한항의 약학조성물의 제조방법.
- 제1항 내지 제11항중 어느 한항의 약학 조성물의 제조시 수용성 중합체에 공유결합된 폴리펩티드를 포함하는 것을 특징으로 하는 생리학적 활성물질의 사용방법.
- 제1항 내지 제11항중 어느 한항의 약학 조성물을 포유류에 투여함으로써, 수용성중합체에 공유결합된 폴리펩티드의 유효량을 전달시키며, 상기 폴리펩티드는 천연발생의 G-CSF의 생물학적 특징중 적어도 하나늘 갖는 것을 특징으로 하는 포유류의 조혈증(haematopoietic)을 치료하는 방법.
- 제1항 내지 제11항중 어느 한항의 약학조성물을 포유류에 투여함으로써 수용성 중합체에 공유결합된 폴리펩티드의 유효량을 전달시키며, 상기 폴리펩티드는 천연 발생의 G-CSF의 생물학적 특징중 적어도 하나를 갖는 것을 특징으로 하는 포유류의 백혈구 세포의 증식을 억제하는 방법.
- 제1항 내지 제11항중 어느 한항의 약학 조성물을 인체에 투여함으로써 수용성 중합체에 결합된 인체 칼시토닌의 유효량을 전달하는 것을 포함하는 다공증 또는 파겟츠(Paget's) 질환의 환자를 치료하는 방법.
- 제1항 내지 제11항중 어느 한항의 약학조성물을 포유류에 투여함으로써 수용성 중합체에 결합된 인터루킨-2의 유효량을 전달하는 것을 포함하는 포유류의 신생종양 또는 면역결핍증을 치효하는 방법.
- 제1항 내지 제11항중 어느 한항의 약학조성물을 포유류에 투여함으로써 수용성 중합체에 결합된 인터페론의 유효량을 전달하는 것을 포함하는 포유류의 신생종양이나 바이러스 질환을 치료하는 방법.
- 제1항 내지 제11항중 어느 한항의 약학조성물을 인체에 투여함으로써 수용성 중합체에 결하된 인체 증식호르몬의 유효량을 전달하는 것을 포함하는 인체의 성장을 촉진하는방법.※ 참고사항 : 최초출원 내용에 의하여 공개하는 것임.
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GB9016138.1 | 1990-07-23 | ||
GB909016138A GB9016138D0 (en) | 1990-07-23 | 1990-07-23 | Continuous release pharmaceutical compositions |
GB909018414A GB9018414D0 (en) | 1990-08-23 | 1990-08-23 | Continuous release pharmaceutical compositions |
GB909018415A GB9018415D0 (en) | 1990-08-23 | 1990-08-23 | Continuous release pharmaceutical compositions |
GB9018417.7 | 1990-08-23 | ||
GB909018417A GB9018417D0 (en) | 1990-08-23 | 1990-08-23 | Continuous release pharmaceutical compositions |
GB9018418.5 | 1990-08-23 | ||
GB9018416.9 | 1990-08-23 | ||
GB9018414.4 | 1990-08-23 | ||
GB909018416A GB9018416D0 (en) | 1990-08-23 | 1990-08-23 | Continuous release pharmaceutical compositions |
GB9018415.1 | 1990-08-23 | ||
GB909018418A GB9018418D0 (en) | 1990-08-23 | 1990-08-23 | Continuous release pharmaceutical compositions |
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KR1019910012589A KR920002164A (ko) | 1990-07-23 | 1991-07-22 | 연속 방출성 약학 조성물 |
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US (2) | US5320840A (ko) |
EP (1) | EP0473268B1 (ko) |
JP (1) | JP3188292B2 (ko) |
KR (1) | KR920002164A (ko) |
AT (1) | ATE251641T1 (ko) |
AU (1) | AU655187B2 (ko) |
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CA (1) | CA2047540A1 (ko) |
CS (1) | CS228591A3 (ko) |
DE (1) | DE69133324T2 (ko) |
FI (1) | FI913410A (ko) |
GB (1) | GB2246295B (ko) |
HU (1) | HUT60632A (ko) |
IE (1) | IE912365A1 (ko) |
IL (1) | IL98831A0 (ko) |
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US4818769A (en) * | 1985-09-20 | 1989-04-04 | Cetus Corporation | Method of controlling stress-related disease in livestock by administration of human IL-2 |
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US4894226A (en) * | 1986-11-14 | 1990-01-16 | Cetus Corporation | Solubilization of proteins for pharmaceutical compositions using polyproline conjugation |
GB2209937B (en) * | 1987-09-21 | 1991-07-03 | Depiopharm S A | Water insoluble polypeptides |
US4904584A (en) * | 1987-12-23 | 1990-02-27 | Genetics Institute, Inc. | Site-specific homogeneous modification of polypeptides |
US4847325A (en) * | 1988-01-20 | 1989-07-11 | Cetus Corporation | Conjugation of polymer to colony stimulating factor-1 |
CA1338839C (en) * | 1988-01-29 | 1997-01-14 | Yoshio Sasaki | Controlled release formulation |
CA1340810C (en) * | 1988-03-31 | 1999-11-02 | Motoo Yamasaki | Polypeptide derivatives of human granulocyte colony stimulating factor |
FR2630329B1 (fr) * | 1988-04-20 | 1991-07-05 | Merieux Inst | Conjugues macromoleculaires d'hemoglobine, leur procede de preparation et leurs applications |
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IE912365A1 (en) * | 1990-07-23 | 1992-01-29 | Zeneca Ltd | Continuous release pharmaceutical compositions |
-
1991
- 1991-07-05 IE IE236591A patent/IE912365A1/en unknown
- 1991-07-09 NZ NZ238889A patent/NZ238889A/en unknown
- 1991-07-15 GB GB9115207A patent/GB2246295B/en not_active Expired - Lifetime
- 1991-07-15 ZW ZW93/91A patent/ZW9391A1/xx unknown
- 1991-07-15 IL IL98831A patent/IL98831A0/xx unknown
- 1991-07-15 FI FI913410A patent/FI913410A/fi unknown
- 1991-07-16 DE DE69133324T patent/DE69133324T2/de not_active Expired - Lifetime
- 1991-07-16 EP EP91306452A patent/EP0473268B1/en not_active Expired - Lifetime
- 1991-07-16 AT AT91306452T patent/ATE251641T1/de not_active IP Right Cessation
- 1991-07-19 BG BG94861A patent/BG94861A/xx unknown
- 1991-07-22 AU AU81238/91A patent/AU655187B2/en not_active Ceased
- 1991-07-22 PT PT98410A patent/PT98410A/pt not_active Application Discontinuation
- 1991-07-22 CS CS912285A patent/CS228591A3/cs unknown
- 1991-07-22 US US07/734,225 patent/US5320840A/en not_active Expired - Lifetime
- 1991-07-22 HU HU912442A patent/HUT60632A/hu unknown
- 1991-07-22 JP JP27174391A patent/JP3188292B2/ja not_active Expired - Lifetime
- 1991-07-22 CA CA002047540A patent/CA2047540A1/en not_active Abandoned
- 1991-07-22 KR KR1019910012589A patent/KR920002164A/ko not_active Application Discontinuation
-
1995
- 1995-06-07 US US08/488,457 patent/US5773581A/en not_active Expired - Lifetime
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
KR100815114B1 (ko) * | 2005-02-21 | 2008-03-20 | 주식회사 엘지생명과학 | 단백질 약물의 지속 방출 조성물 |
Also Published As
Publication number | Publication date |
---|---|
ZW9391A1 (en) | 1992-03-25 |
PT98410A (pt) | 1992-06-30 |
HU912442D0 (en) | 1991-12-30 |
FI913410A0 (fi) | 1991-07-15 |
US5773581A (en) | 1998-06-30 |
IE912365A1 (en) | 1992-01-29 |
IL98831A0 (en) | 1992-07-15 |
EP0473268A3 (en) | 1992-09-16 |
CA2047540A1 (en) | 1992-01-24 |
FI913410A (fi) | 1992-01-24 |
EP0473268B1 (en) | 2003-10-08 |
NZ238889A (en) | 1993-08-26 |
AU8123891A (en) | 1992-01-30 |
JP3188292B2 (ja) | 2001-07-16 |
EP0473268A2 (en) | 1992-03-04 |
ATE251641T1 (de) | 2003-10-15 |
GB9115207D0 (en) | 1991-08-28 |
BG94861A (en) | 1994-03-24 |
GB2246295A (en) | 1992-01-29 |
US5320840A (en) | 1994-06-14 |
HUT60632A (en) | 1992-10-28 |
CS228591A3 (en) | 1992-03-18 |
GB2246295B (en) | 1994-05-11 |
AU655187B2 (en) | 1994-12-08 |
JPH0532559A (ja) | 1993-02-09 |
DE69133324T2 (de) | 2004-07-29 |
DE69133324D1 (de) | 2003-11-13 |
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