KR950005329A - 서방성 비경구 투여제제 및 그 제조방법 - Google Patents
서방성 비경구 투여제제 및 그 제조방법 Download PDFInfo
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- KR950005329A KR950005329A KR1019940020306A KR19940020306A KR950005329A KR 950005329 A KR950005329 A KR 950005329A KR 1019940020306 A KR1019940020306 A KR 1019940020306A KR 19940020306 A KR19940020306 A KR 19940020306A KR 950005329 A KR950005329 A KR 950005329A
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- Prior art keywords
- sustained
- release parenteral
- preparation according
- parenteral preparation
- protein
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- 238000013268 sustained release Methods 0.000 title claims 20
- 239000012730 sustained-release form Substances 0.000 title claims 20
- 238000002360 preparation method Methods 0.000 title claims 17
- 108090000765 processed proteins & peptides Proteins 0.000 claims abstract 13
- 102000004169 proteins and genes Human genes 0.000 claims abstract 13
- 108090000623 proteins and genes Proteins 0.000 claims abstract 13
- 230000000975 bioactive effect Effects 0.000 claims abstract 12
- 150000004671 saturated fatty acids Chemical class 0.000 claims abstract 10
- 239000011159 matrix material Substances 0.000 claims abstract 9
- 150000005690 diesters Chemical class 0.000 claims abstract 8
- IPCSVZSSVZVIGE-UHFFFAOYSA-N hexadecanoic acid Chemical compound CCCCCCCCCCCCCCCC(O)=O IPCSVZSSVZVIGE-UHFFFAOYSA-N 0.000 claims abstract 6
- 229920000223 polyglycerol Polymers 0.000 claims abstract 6
- 125000004432 carbon atom Chemical group C* 0.000 claims abstract 5
- 239000006201 parenteral dosage form Substances 0.000 claims abstract 5
- 239000007787 solid Substances 0.000 claims abstract 4
- 235000021314 Palmitic acid Nutrition 0.000 claims abstract 3
- 235000021355 Stearic acid Nutrition 0.000 claims abstract 3
- WQEPLUUGTLDZJY-UHFFFAOYSA-N n-Pentadecanoic acid Natural products CCCCCCCCCCCCCCC(O)=O WQEPLUUGTLDZJY-UHFFFAOYSA-N 0.000 claims abstract 3
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 claims abstract 3
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 claims abstract 3
- 235000003441 saturated fatty acids Nutrition 0.000 claims abstract 3
- 239000008117 stearic acid Substances 0.000 claims abstract 3
- 238000002347 injection Methods 0.000 claims abstract 2
- 239000007924 injection Substances 0.000 claims abstract 2
- 239000000203 mixture Substances 0.000 claims 4
- 238000004519 manufacturing process Methods 0.000 claims 3
- 238000006116 polymerization reaction Methods 0.000 claims 3
- 102000014150 Interferons Human genes 0.000 claims 2
- 108010050904 Interferons Proteins 0.000 claims 2
- UKMSUNONTOPOIO-UHFFFAOYSA-N docosanoic acid Chemical compound CCCCCCCCCCCCCCCCCCCCCC(O)=O UKMSUNONTOPOIO-UHFFFAOYSA-N 0.000 claims 2
- 238000009472 formulation Methods 0.000 claims 2
- NOESYZHRGYRDHS-UHFFFAOYSA-N insulin Chemical compound N1C(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(NC(=O)CN)C(C)CC)CSSCC(C(NC(CO)C(=O)NC(CC(C)C)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CCC(N)=O)C(=O)NC(CC(C)C)C(=O)NC(CCC(O)=O)C(=O)NC(CC(N)=O)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CSSCC(NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2C=CC(O)=CC=2)NC(=O)C(CC(C)C)NC(=O)C(C)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2NC=NC=2)NC(=O)C(CO)NC(=O)CNC2=O)C(=O)NCC(=O)NC(CCC(O)=O)C(=O)NC(CCCNC(N)=N)C(=O)NCC(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC(O)=CC=3)C(=O)NC(C(C)O)C(=O)N3C(CCC3)C(=O)NC(CCCCN)C(=O)NC(C)C(O)=O)C(=O)NC(CC(N)=O)C(O)=O)=O)NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C1CSSCC2NC(=O)C(CC(C)C)NC(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)CC=1C=CC=CC=1)C(C)C)CC1=CN=CN1 NOESYZHRGYRDHS-UHFFFAOYSA-N 0.000 claims 2
- 229940079322 interferon Drugs 0.000 claims 2
- 235000021357 Behenic acid Nutrition 0.000 claims 1
- 102000004877 Insulin Human genes 0.000 claims 1
- 108090001061 Insulin Proteins 0.000 claims 1
- 102000015696 Interleukins Human genes 0.000 claims 1
- 108010063738 Interleukins Proteins 0.000 claims 1
- 229940116226 behenic acid Drugs 0.000 claims 1
- 238000002513 implantation Methods 0.000 claims 1
- 229940125396 insulin Drugs 0.000 claims 1
- 238000002844 melting Methods 0.000 claims 1
- 230000008018 melting Effects 0.000 claims 1
- 238000000465 moulding Methods 0.000 claims 1
- 210000000056 organ Anatomy 0.000 claims 1
- 235000014113 dietary fatty acids Nutrition 0.000 abstract 1
- 229930195729 fatty acid Natural products 0.000 abstract 1
- 239000000194 fatty acid Substances 0.000 abstract 1
- 150000004665 fatty acids Chemical class 0.000 abstract 1
- 239000008188 pellet Substances 0.000 abstract 1
- 102000004196 processed proteins & peptides Human genes 0.000 abstract 1
- 238000007920 subcutaneous administration Methods 0.000 abstract 1
- 239000000829 suppository Substances 0.000 abstract 1
- 238000002054 transplantation Methods 0.000 abstract 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/19—Cytokines; Lymphokines; Interferons
- A61K38/20—Interleukins [IL]
- A61K38/2013—IL-2
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/19—Cytokines; Lymphokines; Interferons
- A61K38/21—Interferons [IFN]
- A61K38/212—IFN-alpha
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/22—Hormones
- A61K38/28—Insulins
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
- A61K9/0024—Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Gastroenterology & Hepatology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Immunology (AREA)
- Zoology (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Diabetes (AREA)
- Endocrinology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Agricultural Chemicals And Associated Chemicals (AREA)
Abstract
비경구 투여제제는 생리활성의 펩티드 또는 단백질과 포화 지방산의 폴리글리세롤 디에스테르를 함유하는 매트릭스로 구성되어 있고, 이 매트릭스는 실론에서 고체이다. 생리활성의 팹티드 또는 단백질의 분자량은 2,000달톤 이상이다. 포화 지방산은 팔미트산, 스테아르산 등과 같이 16∼30개 정도의 탄소원자를 가지는 지방산을 포함한다. 매트릭스는 주상 또는 입상일 수 있다. 비경구 투여제제는 피하 또는 정맥내 투여된 고형주사제(예:이식용 펠렛 또는 정제), 좌약 등으로서 사용될 수 있으며 1주간 이상의 장기간 동안 생리활성 펩티드 또는 단백질을 지속적으로 방출할 수 있다.
Description
본 내용은 요부공개 건이므로 전문내용을 수록하지 않았음
Claims (19)
- 생리활성 펩티드 또는 단백질 및 포화 지방산의 폴리글리세롤 디에스테르를 함유하는 매트릭스로 구성된 서방성 비경구 투여제제.
- 제1항에 있어서, 폴리글리세롤의 평균 중합도가 4인 서방성 비경구 투여제제.
- 제1항에 있어서, 포화 지방산이 16∼30개의 탄소원자를 가지는 서방성 비경구 투여제제.
- 제1항에 있어서, 폴리글리세롤의 평균 중합도가 4이고, 포화 지방산의 탄소원자수가 16∼30개인 서방성 비경구 투여제제.
- 제1항에 있어서, 생리활성 펩티드 또는 단백질이 상기 디에스테르 중에 분산된 서방성 비경구 투여제제.
- 제1항에 있어서, 생리활성 펩티드 또는 단백질의 평균 분자량이 2,000달톤 이상인 서방성 비경구 투여제제.
- 제1항에 있어서, 생리활성 펩티드 또는 단백질이 인터페론, 인터류킨 또는 인슐린인 서방성 비경구 투여제제.
- 제1항에 있어서, 상기 포화 지방산의 탄소원자수가 16∼22개인 서방성 비경구 투여제제.
- 제1항에 있어서, 상기 포화 지방산이 팔미트산 또는 스테아르산인 서방성 비경구 투여제제.
- 제1항에 있어서, 생리활성 펩티드 또는 단백질의 비율이 매트릭스를 기준으로 0.0001∼50중량%인 서방성 비경구 투여제제.
- 제1항에 있어서, 상기 매트릭스가 주상(pillar) 또는 입상(granular)인 서방성 비경구 투여제제.
- 제1항에 있어서, 장기 매트릭스가 이식용의 고형주사제인 서방성 비경구 투여제제.
- 평균 분자량이 5,000∼1,000,000달톤인 생리활성 펩티드 또는 단백질과, 평균 중합도가 4인 폴리글리세롤과 16∼22개인 탄소원자를 가지는 포화 지방산의 디에스테르를 함유하는 매트릭스로 구성된 제제로서, 매트릭스를 기준으로 하여 0,001∼20중량%의 생리활성 펩티드 또는 단백질이 디에스테르 중에 분산되며, 피하 또는 근육내에 투여할 수 있는 매트릭스로 구성된 서방성 비경구 투여제제.
- 제13항에 있어서, 상기 포화 지방산이 팔미트산, 스테아르산 또는 베헨산인 서방성 비경구 투여제제.
- 제13항에 있어서, 상기 디에스테르의 융점이 40∼60℃이고, 상기 매트릭스가 실온에서 고체인 서방성 비경구 투여제제.
- 제13항에 있어서, 생리활성 펩티드 또는 단백질이 인터페론인 서방성 비경구 투여제제.
- 생리활성 펩티드 또는 단백질과 포화 지방산의 용융 또는 연화된 폴리글리세롤 디에스테르를 혼합하고, 용융 혼합물을 성형시킨 서방성 비경구 투여제제의 제조방법.
- 제17항에 있어서, 용융 혼합물을 주상 또는 입상으로 성형하는 서방성 비경구 투여제제의 제조방법.
- 제17항에 있어서, 건조시킨 분말상의 생리활성 펩티드 또는 단백질을 용융 또는 연화된 디에스테르와 혼합시킨 서방성 비경구 투여제제의 제조방법.※참고사항:최초출원 내용에 의하여 공개하는 것임.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP93-235823 | 1993-08-26 | ||
JP23582393 | 1993-08-26 |
Publications (2)
Publication Number | Publication Date |
---|---|
KR950005329A true KR950005329A (ko) | 1995-03-20 |
KR100338400B1 KR100338400B1 (ko) | 2002-11-22 |
Family
ID=16991792
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
KR1019940020306A KR100338400B1 (ko) | 1993-08-26 | 1994-08-17 | 서방성비경구투여제제및그제조방법 |
Country Status (10)
Country | Link |
---|---|
US (2) | US5628993A (ko) |
EP (1) | EP0640336B1 (ko) |
JP (1) | JPH07112940A (ko) |
KR (1) | KR100338400B1 (ko) |
CN (1) | CN1105557C (ko) |
AT (1) | ATE148625T1 (ko) |
CA (1) | CA2130868A1 (ko) |
DE (1) | DE69401691T2 (ko) |
DK (1) | DK0640336T3 (ko) |
TW (1) | TW282403B (ko) |
Families Citing this family (43)
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US6051558A (en) * | 1997-05-28 | 2000-04-18 | Southern Biosystems, Inc. | Compositions suitable for controlled release of the hormone GnRH and its analogs |
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JP2001058955A (ja) * | 1999-06-17 | 2001-03-06 | Inst Of Physical & Chemical Res | 生理活性ペプチド徐放性製剤 |
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US7005136B2 (en) * | 2002-03-29 | 2006-02-28 | Ethicon, Inc. | Bone replacement materials utilizing bioabsorbable liquid polymers |
US7326426B2 (en) | 2002-03-29 | 2008-02-05 | Ethicon, Inc. | Compositions and medical devices utilizing bioabsorbable liquid polymers |
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CA1257199A (en) * | 1986-05-20 | 1989-07-11 | Paul Y. Wang | Preparation containing bioactive macromolecular substance for multi-months release in vivo |
NZ231281A (en) * | 1988-11-08 | 1991-01-29 | Takeda Chemical Industries Ltd | Sustained release pharmaceutical preparations comprising the active agent dispersed in a solid matrix of a fatty acid ester of a polyglycerol |
CA2020654A1 (en) * | 1989-07-07 | 1991-01-08 | Yohko Akiyama | Stabilized fgf composition and production thereof |
JP3078859B2 (ja) * | 1990-02-23 | 2000-08-21 | 武田薬品工業株式会社 | 安定な放出制御性製剤用コーティング剤 |
IE65045B1 (en) * | 1990-04-28 | 1995-10-04 | Takeda Chemical Industries Ltd | Granulated preparations and method of producing the same |
TW209174B (ko) * | 1991-04-19 | 1993-07-11 | Takeda Pharm Industry Co Ltd | |
IL103275A0 (en) * | 1991-10-01 | 1993-02-21 | Lilly Co Eli | Injectable extended release formulations and methods |
YU87892A (sh) * | 1991-10-01 | 1995-12-04 | Eli Lilly And Company Lilly Corporate Center | Injektibilne formulacije produženog otpuštanja i postupci za njihovo dobijanje i primenu |
JPH06219960A (ja) * | 1993-01-25 | 1994-08-09 | Takeda Chem Ind Ltd | 生理活性ポリペプチド含有組成物の製造法 |
TW282403B (ko) * | 1993-08-26 | 1996-08-01 | Takeda Pharm Industry Co Ltd |
-
1994
- 1994-07-12 TW TW083106287A patent/TW282403B/zh active
- 1994-07-12 JP JP6184078A patent/JPH07112940A/ja not_active Withdrawn
- 1994-08-17 KR KR1019940020306A patent/KR100338400B1/ko not_active IP Right Cessation
- 1994-08-19 DE DE69401691T patent/DE69401691T2/de not_active Expired - Fee Related
- 1994-08-19 EP EP94306145A patent/EP0640336B1/en not_active Expired - Lifetime
- 1994-08-19 DK DK94306145.7T patent/DK0640336T3/da active
- 1994-08-19 AT AT94306145T patent/ATE148625T1/de not_active IP Right Cessation
- 1994-08-24 US US08/294,972 patent/US5628993A/en not_active Expired - Fee Related
- 1994-08-24 CN CN94115750A patent/CN1105557C/zh not_active Expired - Fee Related
- 1994-08-25 CA CA002130868A patent/CA2130868A1/en not_active Abandoned
-
1996
- 1996-10-21 US US08/734,636 patent/US5750100A/en not_active Expired - Fee Related
Also Published As
Publication number | Publication date |
---|---|
DE69401691D1 (de) | 1997-03-20 |
EP0640336A1 (en) | 1995-03-01 |
ATE148625T1 (de) | 1997-02-15 |
CA2130868A1 (en) | 1995-02-27 |
CN1104488A (zh) | 1995-07-05 |
DE69401691T2 (de) | 1997-07-17 |
DK0640336T3 (da) | 1997-04-01 |
KR100338400B1 (ko) | 2002-11-22 |
US5628993A (en) | 1997-05-13 |
CN1105557C (zh) | 2003-04-16 |
EP0640336B1 (en) | 1997-02-05 |
JPH07112940A (ja) | 1995-05-02 |
US5750100A (en) | 1998-05-12 |
TW282403B (ko) | 1996-08-01 |
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