KR101152470B1 - 치료제용 마이크로-입자 지방산 염 고형 투약 제형 - Google Patents
치료제용 마이크로-입자 지방산 염 고형 투약 제형 Download PDFInfo
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- KR101152470B1 KR101152470B1 KR1020067002974A KR20067002974A KR101152470B1 KR 101152470 B1 KR101152470 B1 KR 101152470B1 KR 1020067002974 A KR1020067002974 A KR 1020067002974A KR 20067002974 A KR20067002974 A KR 20067002974A KR 101152470 B1 KR101152470 B1 KR 101152470B1
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
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- 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
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- 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
- A61K38/23—Calcitonins
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- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
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- 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
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- 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
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- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
- A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P29/02—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID] without antiinflammatory effect
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
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- Proteomics, Peptides & Aminoacids (AREA)
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- Rheumatology (AREA)
- Physical Education & Sports Medicine (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Obesity (AREA)
- Hematology (AREA)
- Emergency Medicine (AREA)
- Pain & Pain Management (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
Description
부형제 | % w/w |
데칸산나트륨 | 53.4% |
라우르산나트륨 | 46.6% |
부형제 | % w/w | mg /정제 |
CT-025 (도 2 참조) | .036 | .43 |
데칸산나트륨/라우르산나트륨 프리믹스 | 50 | 450 |
만니톨 | 34.5 | 310.5 |
소르비톨 | 10 | 90 |
크로스카멜로스 나트륨 | 5 | 45 |
스테아릴푸마르산나트륨, NF | .5 | 4.5 |
총계 | 100 | 900.43 |
부형제 | % w/w | mg /정제 |
CT-025 (도 2 참조) | .048 | .430 |
데칸산나트륨/라우르산나트륨 프리믹스 | 32.94 | 221.17 |
만니톨 | 46.27 | 310.67 |
소르비톨 | 13.41 | 90.04 |
크로스카멜로스 나트륨 | 6.71 | 45.05 |
스테아릴푸마르산나트륨, NF | .67 | 4.5 |
총계 | 100 | 671.86 |
부형제 | % w/w | mg /정제 |
CT-025 (도 2 참조) | .036 | .43 |
데칸산나트륨/라우르산나트륨 프리믹스 | 49.55 | 442.0 |
만니톨 | 34.81 | 310.5 |
소르비톨 | 10.09 | 90.0 |
크로스카멜로스 나트륨 | 5.04 | 45.0 |
스테아릴푸마르산나트륨, NF | .5 | 4.5 |
총계 | 100 | 892.43 |
부형제 | % w/w | mg /정제 |
연어 칼시토닌 | .036 | 0.37 |
데칸산나트륨/라우르산나트륨 프리믹스 | 49.55 | 442.0 |
만니톨 | 34.81 | 310.5 |
소르비톨 | 10.09 | 90.0 |
크로스카멜로스 나트륨 | 5.04 | 45.0 |
스테아릴푸마르산나트륨, NF | .50 | 4.5 |
총계 | 100 | 892.37 |
부형제 | % w/w | mg /정제 |
CT-025 (도 2 참조) | 0 | 0 |
데칸산나트륨 | 23.1 | 155.07 |
라우르산나트륨 | 26.5 | 3.95 |
만니톨 | 34.8 | 5.18 |
소르비톨 | 10.1 | 1.50 |
크로스카멜로스 나트륨 | 5.0 | 0.74 |
스테아릴푸마르산나트륨, NF | 0.5 | 0.07 |
총계 | 100 | 671.3 |
부형제 | % w/w | mg /정제 |
CT-025 (도 2 참조) | 0 | 0 |
데칸산나트륨 | 23.1 | 155.07 |
라우르산나트륨 프리믹스 | 26.5 | 3.95 |
만니톨 | 34.8 | 5.18 |
소르비톨 | 10.1 | 1.50 |
크로스카멜로스나트륨 | 5.0 | 0.74 |
스테아릴푸마르산나트륨, NF | 0.5 | 0.07 |
총계 | 100 | 671.3 |
Claims (78)
- 직경이 50 내지 100 마이크론인 크기 분포를 가진 지방산 염 입자를 포함하는 약학 조성물로서, 상기 지방산 염은 낙산, 카프로산, 카프릴산, 카프르산, 라우르산, 미리스트산, 팔미트산, 팔미톨레산 및 스테아르산으로 구성된 군으로부터 선택되는 1종 이상의 지방산 성분을 포함하고, 상기 약학 조성물은 칼시토닌, 인슐린 또는 이의 동족체를 포함하는 페길레이티드(pegylated) 폴리펩티드 약물을 더 포함하며, 고형 경구 투여 형태이거나 과립화된 것인 약학 조성물.
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- 제1항에 있어서, 완충제를 추가로 포함하는 약학 조성물.
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- 제1항에 있어서, pH가 7.6 내지 8.0인 완충제를 추가로 포함하는 약학 조성물.
- 제1항에 있어서, 지방산 염이 pH 7.4 완충액에서 10분 이내에 50%를 초과하는 용해율을 나타내는 것인 약학 조성물.
- 제1항에 있어서, 지방산 염이 pH 7.4 완충액에서 10분 이내에 75%를 초과하는 용해율을 나타내는 것인 약학 조성물.
- 제1항에 있어서, 지방산 염이 pH 7.4 완충액에서 10분 이내에 100%의 용해율을 나타내는 것인 약학 조성물.
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- 제1항에 있어서, 페길레이티드 폴리펩티드 약물이 올리고머에 접합되는 것인 약학 조성물.
- 제1항에 있어서, 페길레이티드 폴리펩티드 약물이 전구약물을 포함하는 것인 약학 조성물.
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- 제1항에 있어서, 페길레이티드 폴리펩티드 약물이 하기의 서열(서열번호 1)을 포함하는 것인 약학 조성물:Cys Ser Asn Leu Ser Thr Cys Val Leu Gly Lys (NH-CO(CH2)7(OCH2CH2)7OCH3) Leu Ser Gln Glu Leu His Lys (NH-CO(CH2)7(OCH2CH2)7OCH3) Leu Gln Thr Tyr Pro Arg Thr Asn Thr Gly Ser Gly Thr Pro.
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- 제1항에 있어서, 페길레이티드 폴리펩티드 약물이 인슐린 B29 Lys-(NH-CO(CH2)5(OCH2CH2)70CH3)을 포함하는 것인 약학 조성물.
- 제1항에 있어서, 페길레이티드 폴리펩티드 약물의 분자량 범위가 300 내지 10,000,000 달톤인 약학 조성물.
- 제1항에 있어서, 페길레이티드 폴리펩티드 약물의 분자량 범위가 1,000 내지 50,000 달톤인 약학 조성물.
- 제1항에 있어서, 페길레이티드 폴리펩티드 약물의 분자량 범위가 1,000 내지 10,000 달톤인 약학 조성물.
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- 제1항에 있어서, 10분 이내에 용액 내로 30%의 지방산의 용해율을 나타내는 정제 형태의 약학 조성물.
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- 제1항에 있어서, 10분 이내에 용액 내로 95%의 지방산의 용해율을 나타내는 정제 형태의 약학 조성물.
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Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US49482103P | 2003-08-13 | 2003-08-13 | |
US60/494,821 | 2003-08-13 |
Publications (2)
Publication Number | Publication Date |
---|---|
KR20060082851A KR20060082851A (ko) | 2006-07-19 |
KR101152470B1 true KR101152470B1 (ko) | 2012-06-01 |
Family
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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KR1020067002974A Expired - Fee Related KR101152470B1 (ko) | 2003-08-13 | 2004-08-13 | 치료제용 마이크로-입자 지방산 염 고형 투약 제형 |
Country Status (12)
Country | Link |
---|---|
US (1) | US7635675B2 (ko) |
EP (1) | EP1660047B1 (ko) |
JP (1) | JP4880461B2 (ko) |
KR (1) | KR101152470B1 (ko) |
CN (2) | CN102552917A (ko) |
AU (1) | AU2004264958B2 (ko) |
CA (1) | CA2535013C (ko) |
DK (1) | DK1660047T3 (ko) |
ES (1) | ES2445947T3 (ko) |
PL (1) | PL1660047T3 (ko) |
PT (1) | PT1660047E (ko) |
WO (1) | WO2005016312A1 (ko) |
Families Citing this family (20)
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US20090281023A9 (en) * | 2001-06-04 | 2009-11-12 | Nobex Corporation | Mixtures Of Calcitonin Drug-Oligomer Conjugates And Methods Of Use In Pain Treatment |
CN103223160B (zh) * | 2004-07-19 | 2015-02-18 | 比奥孔有限公司 | 胰岛素-低聚物共轭物,制剂及其用途 |
WO2007006320A1 (en) * | 2005-07-12 | 2007-01-18 | Sherine Hassan Abbas Helmy | Drinkable oral insulin liquid and capsules |
DK1934252T3 (en) * | 2005-10-13 | 2015-08-31 | Biocon Ltd | METHOD FOR PRODUCING insulin conjugates |
KR101729986B1 (ko) | 2006-09-22 | 2017-04-25 | 노보 노르디스크 에이/에스 | 프로테아제 내성 인슐린 유사체 |
US9387176B2 (en) | 2007-04-30 | 2016-07-12 | Novo Nordisk A/S | Method for drying a protein composition, a dried protein composition and a pharmaceutical composition comprising the dried protein |
JP5868594B2 (ja) | 2007-10-16 | 2016-02-24 | バイオコン・リミテッドBiocon Limited | 経口投与可能な固形医薬組成物及びそのプロセス |
ES2618073T3 (es) | 2008-03-14 | 2017-06-20 | Novo Nordisk A/S | Análogos de insulina estabilizados frente a proteasas |
EP2910569B1 (en) | 2008-03-18 | 2016-10-05 | Novo Nordisk A/S | Protease stabilized, acylated insulin analogues |
KR20110007614A (ko) * | 2008-05-07 | 2011-01-24 | 메리온 리서치 Ⅲ 리미티드 | GnRH 관련 화합물의 조성물 및 제조 방법 |
WO2010033217A1 (en) * | 2008-09-19 | 2010-03-25 | Nektar Therapeutics | Polymer conjugates of cd-np peptides |
US20110182985A1 (en) * | 2010-01-28 | 2011-07-28 | Coughlan David C | Solid Pharmaceutical Composition with Enhancers and Methods of Preparing thereof |
CN103596584B (zh) | 2011-06-15 | 2016-12-14 | 诺沃—诺迪斯克有限公司 | 多取代的胰岛素 |
AU2013247047A1 (en) | 2012-04-11 | 2014-10-23 | Novo Nordisk A/S | Insulin formulations |
PL3055325T3 (pl) | 2013-10-07 | 2018-06-29 | Novo Nordisk A/S | Nowa pochodna analogu insuliny |
AR099569A1 (es) | 2014-02-28 | 2016-08-03 | Novo Nordisk As | Derivados de insulina y los usos médicos de estos |
EP3250225A1 (en) * | 2015-01-29 | 2017-12-06 | Novo Nordisk A/S | Pharmaceutical composition for oral insulin administration comprising a tablet core and a polyvinyl alcohol coating |
ES2975708T3 (es) | 2015-01-29 | 2024-07-12 | Novo Nordisk As | Comprimidos que comprenden agonista del GLP-1 y recubrimiento entérico |
US9907323B2 (en) | 2015-09-25 | 2018-03-06 | Mead Johnson Nutrition Co. | Infant formula tablets |
HRP20221324T1 (hr) | 2016-12-16 | 2022-12-23 | Novo Nordisk A/S | Farmaceutski pripravci koji sadrže inzulin |
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US20020187536A1 (en) * | 1995-06-29 | 2002-12-12 | Kulkarni Sunanda R. | Stable lactase tablets and methods of production |
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JPS55153712A (en) | 1979-05-18 | 1980-11-29 | Kao Corp | Insulin pharmaceutical preparation and its production |
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JPS5764610A (en) | 1980-10-08 | 1982-04-19 | Fujisawa Pharmaceut Co Ltd | Pharmaceutical for rectal administration |
JPS5764609A (en) | 1980-10-09 | 1982-04-19 | Nissan Chem Ind Ltd | Cyclophosphamide composition for rectal administration |
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- 2004-08-13 AU AU2004264958A patent/AU2004264958B2/en not_active Ceased
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US7635675B2 (en) | 2009-12-22 |
CA2535013C (en) | 2013-02-12 |
CN1863510A (zh) | 2006-11-15 |
EP1660047A1 (en) | 2006-05-31 |
JP4880461B2 (ja) | 2012-02-22 |
CA2535013A1 (en) | 2005-02-24 |
WO2005016312A1 (en) | 2005-02-24 |
DK1660047T3 (en) | 2014-03-10 |
ES2445947T3 (es) | 2014-03-06 |
CN102552917A (zh) | 2012-07-11 |
AU2004264958B2 (en) | 2010-04-15 |
AU2004264958A1 (en) | 2005-02-24 |
EP1660047B1 (en) | 2013-11-27 |
US20050095216A1 (en) | 2005-05-05 |
JP2007502303A (ja) | 2007-02-08 |
PT1660047E (pt) | 2014-02-27 |
KR20060082851A (ko) | 2006-07-19 |
PL1660047T3 (pl) | 2014-05-30 |
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