TWI455731B - 醫藥應用的乾燥重建之囊胞結構 - Google Patents
醫藥應用的乾燥重建之囊胞結構 Download PDFInfo
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- TWI455731B TWI455731B TW096137658A TW96137658A TWI455731B TW I455731 B TWI455731 B TW I455731B TW 096137658 A TW096137658 A TW 096137658A TW 96137658 A TW96137658 A TW 96137658A TW I455731 B TWI455731 B TW I455731B
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- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/18—Growth factors; Growth regulators
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- 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
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
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- 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
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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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0085—Brain, e.g. brain implants; Spinal cord
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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
- A61K9/10—Dispersions; Emulsions
- A61K9/127—Liposomes
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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
- A61K9/10—Dispersions; Emulsions
- A61K9/127—Liposomes
- A61K9/1271—Non-conventional liposomes, e.g. PEGylated liposomes, liposomes coated with polymers
- A61K9/1272—Non-conventional liposomes, e.g. PEGylated liposomes, liposomes coated with polymers with substantial amounts of non-phosphatidyl, i.e. non-acylglycerophosphate, surfactants as bilayer-forming substances, e.g. cationic lipids
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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
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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
- A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
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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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/02—Drugs for disorders of the nervous system for peripheral neuropathies
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
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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]
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
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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
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
Claims (17)
- 一種乾燥醫藥組成物,其包括含囊胞之冷凍乾燥活性劑,該囊胞a)包含至少一種脂質,b)包含至少一種活性劑,c)包含促融劑,該促融劑係選自精胺酸、組胺酸、或離胺酸中之鹼性胺基酸,及d)不包含膜穩定劑,該膜穩定劑係選自保護性糖、糖醇或配糖體,其中此乾燥醫藥組成物以含水溶液再水化導致具有平均脂質體直徑為1微米以上之多層脂質體形成,該脂質體包封該活性劑。
- 如申請專利範圍第1項之乾燥醫藥組成物,其中該至少一種活性劑係蛋白質,特別是親水性蛋白質或其活性片段。
- 如申請專利範圍第2項之乾燥醫藥組成物,其中該親水性蛋白質係骨及/或軟骨再生劑。
- 如申請專利範圍第3項之乾燥醫藥組成物,其中該骨及/或軟骨再生劑為CD-RAP或其活性片段。
- 如申請專利範圍第1至4項中任一項之乾燥醫藥組成物,其進一步包含無機或有機陰離子,特別是選自琥珀酸根、延胡索酸根、檸檬酸根、蘋果酸根、磷酸根、乙酸根及氯離子。
- 一種用於製備乾燥脂質體組成物之方法,該組成 物經含水溶液再水化後形成平均脂質體直徑為1微米以上且包封活性劑之多層脂質體,該方法包含下列步驟a)在有機溶劑不存在時,水化脂質、脂質混合物或脂質膜,b)形成小型單層囊胞,其平均直徑以介於50至200奈米較佳,c)添加活性劑之含水溶液,d)在步驟c)之後、之前或同時,添加促融劑及選擇性的無機或有機陰離子,其中該促融劑係選自精胺酸、組胺酸、或離胺酸中之鹼性胺基酸,及e)在不添加膜穩定劑時,冷凍乾燥該脂質分散液,其中,該膜穩定劑係選自保護性糖、糖醇或配糖體。
- 如申請專利範圍第6項之方法,其中於步驟b)及/或步驟c)之後進行滅菌過濾步驟。
- 一種用於製備可投服之脂質體組成物之方法,該組成物包含平均脂質體直徑為1微米以上且包封活性劑之多層脂質體,該方法包含下列步驟a)在有機溶劑不存在時,水化脂質、脂質混合物或脂質膜,b)形成小型單層囊胞,其平均直徑以介於50至200奈米較佳,c)添加活性劑之含水溶液,d)在步驟c)之後、之前或同時,添加促融劑及選擇性的無機或有機陰離子,其中該促融劑係選自精胺酸、組 胺酸、或離胺酸中之鹼性胺基酸,e)在不添加膜穩定劑時,冷凍乾燥該脂質分散液,其中,該膜穩定劑係選自保護性糖、糖醇或配糖體,f)以含水溶液再水化及形成包封活性劑且平均脂質體直徑1微米以上之多層囊胞,其中於步驟b)及/或c)之後進行滅菌過濾步驟。
- 如申請專利範圍第6至8項中任一項之方法,其中該活性劑係蛋白質,較佳是親水性蛋白質。
- 如申請專利範圍第9項之方法,其中該活性劑係骨及/或軟骨再生劑,較佳為CD-RAP或其活性片段。
- 如申請專利範圍第6至8項中任一項之方法,其中該脂質包含至少一種中性脂肪,較佳為至少二種中性脂肪,更佳為磷脂膽鹼(PC)及膽固醇(Chol)。
- 如申請專利範圍第6至8項中任一項之方法,其中該無機或有機陰離子係選自琥珀酸根、延胡索酸根、檸檬酸根、蘋果酸根、磷酸根、乙酸根及氯離子。
- 如申請專利範圍第6至8項中任一項之方法,其中該形成之多層脂質體係於再水化該冷凍乾燥脂質體組成物之期間形成。
- 如申請專利範圍第6至8項中任一項之方法,其中該活性劑之包封效率係高於40%。
- 一種如申請專利範圍第1至5項中任一項之冷凍乾燥醫藥組成物之用途,係用於製造藉由注射經含水溶液再水化之該冷凍乾燥醫藥組成物治療個體之骨及/或軟骨 缺損、較佳為骨關節炎、類風濕性關節炎之免疫疾病及脊椎疾病上之醫藥組成物。
- 如申請專利範圍第15項之用途,其中該注射係局部或非全身性注射,較佳為注射至滑液、滑液腔、髓核、髓核腔、椎間盤內或經椎間盤注射。
- 如申請專利範圍第15或16項之用途,其中該注射係至少每週一次。
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TW200829283A TW200829283A (en) | 2008-07-16 |
TWI455731B true TWI455731B (zh) | 2014-10-11 |
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US (3) | US20090297580A1 (zh) |
EP (2) | EP2081551B1 (zh) |
JP (2) | JP5404402B2 (zh) |
KR (1) | KR101333279B1 (zh) |
CN (3) | CN101605534A (zh) |
CA (1) | CA2664637C (zh) |
CY (1) | CY1113934T1 (zh) |
DK (1) | DK2081551T3 (zh) |
ES (2) | ES2400162T3 (zh) |
HR (1) | HRP20130328T1 (zh) |
PL (1) | PL2081551T3 (zh) |
PT (1) | PT2081551E (zh) |
RS (1) | RS52706B (zh) |
RU (1) | RU2443412C2 (zh) |
SI (1) | SI2081551T1 (zh) |
TW (1) | TWI455731B (zh) |
WO (2) | WO2008040556A1 (zh) |
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