RU2016150640A - Жидкая фармацевтическая композиция - Google Patents
Жидкая фармацевтическая композиция Download PDFInfo
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- RU2016150640A RU2016150640A RU2016150640A RU2016150640A RU2016150640A RU 2016150640 A RU2016150640 A RU 2016150640A RU 2016150640 A RU2016150640 A RU 2016150640A RU 2016150640 A RU2016150640 A RU 2016150640A RU 2016150640 A RU2016150640 A RU 2016150640A
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- liquid pharmaceutical
- pharmaceutical composition
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- 239000007788 liquid Substances 0.000 title claims 19
- 239000008194 pharmaceutical composition Substances 0.000 title claims 19
- 239000000203 mixture Substances 0.000 claims 13
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 6
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims 6
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims 6
- 229920000053 polysorbate 80 Polymers 0.000 claims 6
- 229940068968 polysorbate 80 Drugs 0.000 claims 6
- HDTRYLNUVZCQOY-UHFFFAOYSA-N α-D-glucopyranosyl-α-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OC1C(O)C(O)C(O)C(CO)O1 HDTRYLNUVZCQOY-UHFFFAOYSA-N 0.000 claims 5
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Natural products CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 claims 5
- HDTRYLNUVZCQOY-WSWWMNSNSA-N Trehalose Natural products O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-WSWWMNSNSA-N 0.000 claims 5
- 229960002964 adalimumab Drugs 0.000 claims 5
- 150000001413 amino acids Chemical class 0.000 claims 5
- 239000004475 Arginine Substances 0.000 claims 4
- HDTRYLNUVZCQOY-LIZSDCNHSA-N alpha,alpha-trehalose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-LIZSDCNHSA-N 0.000 claims 4
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 claims 4
- 239000006172 buffering agent Substances 0.000 claims 4
- 239000008363 phosphate buffer Substances 0.000 claims 4
- 239000004094 surface-active agent Substances 0.000 claims 4
- QTBSBXVTEAMEQO-UHFFFAOYSA-M Acetate Chemical compound CC([O-])=O QTBSBXVTEAMEQO-UHFFFAOYSA-M 0.000 claims 3
- 239000002253 acid Substances 0.000 claims 3
- 239000011780 sodium chloride Substances 0.000 claims 3
- TWRXJAOTZQYOKJ-UHFFFAOYSA-L Magnesium chloride Chemical compound [Mg+2].[Cl-].[Cl-] TWRXJAOTZQYOKJ-UHFFFAOYSA-L 0.000 claims 2
- WCUXLLCKKVVCTQ-UHFFFAOYSA-M Potassium chloride Chemical compound [Cl-].[K+] WCUXLLCKKVVCTQ-UHFFFAOYSA-M 0.000 claims 2
- VMHLLURERBWHNL-UHFFFAOYSA-M Sodium acetate Chemical group [Na+].CC([O-])=O VMHLLURERBWHNL-UHFFFAOYSA-M 0.000 claims 2
- 239000008351 acetate buffer Substances 0.000 claims 2
- 230000001186 cumulative effect Effects 0.000 claims 2
- BNIILDVGGAEEIG-UHFFFAOYSA-L disodium hydrogen phosphate Chemical compound [Na+].[Na+].OP([O-])([O-])=O BNIILDVGGAEEIG-UHFFFAOYSA-L 0.000 claims 2
- 229910000397 disodium phosphate Inorganic materials 0.000 claims 2
- 235000019800 disodium phosphate Nutrition 0.000 claims 2
- HEBKCHPVOIAQTA-UHFFFAOYSA-N meso ribitol Natural products OCC(O)C(O)C(O)CO HEBKCHPVOIAQTA-UHFFFAOYSA-N 0.000 claims 2
- 239000002245 particle Substances 0.000 claims 2
- 239000001632 sodium acetate Substances 0.000 claims 2
- 235000017281 sodium acetate Nutrition 0.000 claims 2
- 230000000087 stabilizing effect Effects 0.000 claims 2
- OWEGMIWEEQEYGQ-UHFFFAOYSA-N 100676-05-9 Natural products OC1C(O)C(O)C(CO)OC1OCC1C(O)C(O)C(O)C(OC2C(OC(O)C(O)C2O)CO)O1 OWEGMIWEEQEYGQ-UHFFFAOYSA-N 0.000 claims 1
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 claims 1
- 206010002556 Ankylosing Spondylitis Diseases 0.000 claims 1
- UXVMQQNJUSDDNG-UHFFFAOYSA-L Calcium chloride Chemical compound [Cl-].[Cl-].[Ca+2] UXVMQQNJUSDDNG-UHFFFAOYSA-L 0.000 claims 1
- 206010009900 Colitis ulcerative Diseases 0.000 claims 1
- 208000011231 Crohn disease Diseases 0.000 claims 1
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims 1
- HEBKCHPVOIAQTA-QWWZWVQMSA-N D-arabinitol Chemical compound OC[C@@H](O)C(O)[C@H](O)CO HEBKCHPVOIAQTA-QWWZWVQMSA-N 0.000 claims 1
- 239000004386 Erythritol Substances 0.000 claims 1
- UNXHWFMMPAWVPI-UHFFFAOYSA-N Erythritol Natural products OCC(O)C(O)CO UNXHWFMMPAWVPI-UHFFFAOYSA-N 0.000 claims 1
- SQUHHTBVTRBESD-UHFFFAOYSA-N Hexa-Ac-myo-Inositol Natural products CC(=O)OC1C(OC(C)=O)C(OC(C)=O)C(OC(C)=O)C(OC(C)=O)C1OC(C)=O SQUHHTBVTRBESD-UHFFFAOYSA-N 0.000 claims 1
- 208000003456 Juvenile Arthritis Diseases 0.000 claims 1
- 206010059176 Juvenile idiopathic arthritis Diseases 0.000 claims 1
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims 1
- GUBGYTABKSRVRQ-PICCSMPSSA-N Maltose Natural products O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@@H](CO)OC(O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-PICCSMPSSA-N 0.000 claims 1
- 229930195725 Mannitol Natural products 0.000 claims 1
- 229920001213 Polysorbate 20 Polymers 0.000 claims 1
- 201000004681 Psoriasis Diseases 0.000 claims 1
- 201000001263 Psoriatic Arthritis Diseases 0.000 claims 1
- 208000036824 Psoriatic arthropathy Diseases 0.000 claims 1
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims 1
- 229930006000 Sucrose Natural products 0.000 claims 1
- 201000006704 Ulcerative Colitis Diseases 0.000 claims 1
- TVXBFESIOXBWNM-UHFFFAOYSA-N Xylitol Natural products OCCC(O)C(O)C(O)CCO TVXBFESIOXBWNM-UHFFFAOYSA-N 0.000 claims 1
- 125000000218 acetic acid group Chemical group C(C)(=O)* 0.000 claims 1
- GUBGYTABKSRVRQ-QUYVBRFLSA-N beta-maltose Chemical compound OC[C@H]1O[C@H](O[C@H]2[C@H](O)[C@@H](O)[C@H](O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@@H]1O GUBGYTABKSRVRQ-QUYVBRFLSA-N 0.000 claims 1
- 239000007853 buffer solution Substances 0.000 claims 1
- 230000003139 buffering effect Effects 0.000 claims 1
- 239000001110 calcium chloride Substances 0.000 claims 1
- 229910001628 calcium chloride Inorganic materials 0.000 claims 1
- 230000001684 chronic effect Effects 0.000 claims 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 1
- 208000035475 disorder Diseases 0.000 claims 1
- 238000012377 drug delivery Methods 0.000 claims 1
- 235000019414 erythritol Nutrition 0.000 claims 1
- UNXHWFMMPAWVPI-ZXZARUISSA-N erythritol Chemical compound OC[C@H](O)[C@H](O)CO UNXHWFMMPAWVPI-ZXZARUISSA-N 0.000 claims 1
- 229940009714 erythritol Drugs 0.000 claims 1
- 238000002347 injection Methods 0.000 claims 1
- 239000007924 injection Substances 0.000 claims 1
- CDAISMWEOUEBRE-GPIVLXJGSA-N inositol Chemical compound O[C@H]1[C@H](O)[C@@H](O)[C@H](O)[C@H](O)[C@@H]1O CDAISMWEOUEBRE-GPIVLXJGSA-N 0.000 claims 1
- 229960000367 inositol Drugs 0.000 claims 1
- 201000002215 juvenile rheumatoid arthritis Diseases 0.000 claims 1
- 239000000832 lactitol Substances 0.000 claims 1
- 235000010448 lactitol Nutrition 0.000 claims 1
- VQHSOMBJVWLPSR-JVCRWLNRSA-N lactitol Chemical compound OC[C@H](O)[C@@H](O)[C@@H]([C@H](O)CO)O[C@@H]1O[C@H](CO)[C@H](O)[C@H](O)[C@H]1O VQHSOMBJVWLPSR-JVCRWLNRSA-N 0.000 claims 1
- 229960003451 lactitol Drugs 0.000 claims 1
- 239000008101 lactose Substances 0.000 claims 1
- 229910001629 magnesium chloride Inorganic materials 0.000 claims 1
- 239000000845 maltitol Substances 0.000 claims 1
- VQHSOMBJVWLPSR-WUJBLJFYSA-N maltitol Chemical compound OC[C@H](O)[C@@H](O)[C@@H]([C@H](O)CO)O[C@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O VQHSOMBJVWLPSR-WUJBLJFYSA-N 0.000 claims 1
- 235000010449 maltitol Nutrition 0.000 claims 1
- 229940035436 maltitol Drugs 0.000 claims 1
- 239000000594 mannitol Substances 0.000 claims 1
- 235000010355 mannitol Nutrition 0.000 claims 1
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 claims 1
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 claims 1
- 229940068977 polysorbate 20 Drugs 0.000 claims 1
- 239000001103 potassium chloride Substances 0.000 claims 1
- 235000011164 potassium chloride Nutrition 0.000 claims 1
- 102000004169 proteins and genes Human genes 0.000 claims 1
- 108090000623 proteins and genes Proteins 0.000 claims 1
- 206010039073 rheumatoid arthritis Diseases 0.000 claims 1
- CDAISMWEOUEBRE-UHFFFAOYSA-N scyllo-inosotol Natural products OC1C(O)C(O)C(O)C(O)C1O CDAISMWEOUEBRE-UHFFFAOYSA-N 0.000 claims 1
- 239000005720 sucrose Substances 0.000 claims 1
- 125000000647 trehalose group Chemical group 0.000 claims 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 1
- 239000000811 xylitol Substances 0.000 claims 1
- 235000010447 xylitol Nutrition 0.000 claims 1
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 claims 1
- 229960002675 xylitol Drugs 0.000 claims 1
Classifications
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- A61K39/39591—Stabilisation, fragmentation
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- 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
- A61K47/02—Inorganic compounds
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- A—HUMAN NECESSITIES
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- 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
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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- 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
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- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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- 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
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- A—HUMAN NECESSITIES
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
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- A—HUMAN NECESSITIES
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- A61P37/02—Immunomodulators
- A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
- C07K16/241—Tumor Necrosis Factors
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- A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
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- C—CHEMISTRY; METALLURGY
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- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
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- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
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- Rheumatology (AREA)
- Physical Education & Sports Medicine (AREA)
- Biophysics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
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- Orthopedic Medicine & Surgery (AREA)
- Inorganic Chemistry (AREA)
- Transplantation (AREA)
- Pain & Pain Management (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Endocrinology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Claims (33)
1. Жидкая фармацевтическая композиция, которая содержит:
(a) адалимумаб;
(b) ацетатное буферное средство (или ацетатную буферную систему); и
(c) сахар-стабилизатор, выбранный из группы, включающей трегалозу, маннит, сахарозу, мальтозу, лактозу, ксилит, арабит, эритрит, лактит, мальтит и инозитол;
где композиция или (по существу или полностью) не содержит аргинин или содержит аргинин в концентрации по большей мере 0,1 мМ.
2. Жидкая фармацевтическая композиция по п. 1, где композиция дополнительно содержит сопряженную кислоту/основание буферного средства так, что вместе буферное средство и его сопряженная кислота/основание присутствуют на уровне и в относительном количестве, достаточном для того, чтобы композиция имела pH между pH 5,0 и 5,5, где ацетатное буферное средство представляет собой ацетат натрия и сопряженная кислота/основание представляет собой уксусную кислоту.
3. Жидкая фармацевтическая композиция как заявлено в любом предшествующем пункте, в которой сахар-стабилизатор представляет собой трегалозу.
4. Жидкая фармацевтическая композиция как заявлено в любом предшествующем пункте, где композиция или (по существу или полностью) не содержит аминокислоты или содержит одну или несколько аминокислот в (совокупной) концентрации по большей мере 0,1 мМ.
5. Жидкая фармацевтическая композиция по п. 4, где композиция не содержит аминокислоты.
6. Жидкая фармацевтическая композиция как заявлено в любом предшествующем пункте, где композиция или (по существу или полностью) не содержит поверхностно-активные вещества, необязательно за исключением полисорбата 80, или содержит одно или несколько из поверхностно-активных веществ (необязательно за исключением полисорбата 80) в (совокупной) концентрации по большей мере 0,001 мМ.
7. Жидкая фармацевтическая композиция как заявлено в любом предшествующем пункте, где композиция (по существу или полностью) не содержит полисорбат 20.
8. Жидкая фармацевтическая композиция как заявлено в любом предшествующем пункте, где композиция или (по существу или полностью) не содержит фосфатные буферные средства или содержит фосфатную буферную систему в концентрации по большей мере 0,1 мМ.
9. Жидкая фармацевтическая композиция как заявлено в любом предшествующем пункте, которая дополнительно содержит регулятор тоничности, выбранный из хлорида натрия, хлорида калия, хлорида магния или хлорида кальция.
10. Жидкая фармацевтическая композиция как заявлено в любом предшествующем пункте, которая дополнительно содержит полисорбат 80.
11. Жидкая фармацевтическая композиция как заявлено в любом предшествующем пункте, где осмоляльность композиции составляет между 220 и 400 мОсм/кг.
12. Жидкая фармацевтическая композиция как заявлено в любом предшествующем пункте, в которой температура нарушения укладки белка адалимумаба в жидкой фармацевтической композиции составляет больше чем или равна 70°C.
13. Жидкая фармацевтическая композиция как заявлено в любом предшествующем пункте, где композиция содержит адалимумаб, ацетатные буферные частицы и трегалозу при массовом соотношении 25-75:0,12-3,0:15-140, соответственно.
14. Жидкая фармацевтическая композиция как заявлено в любом предшествующем пункте, где композиция содержит адалимумаб, ацетатные буферные частицы, трегалозу и хлорид натрия при массовом соотношении 45-55:0,30-0,84:65-72:2,7-3,1, соответственно.
15. Жидкая фармацевтическая композиция как заявлено в любом предшествующем пункте, где композиция содержит:
- от 45 приблизительно до 55 мг/мл адалимумаба;
- от 5 до 14 мМ буферной системы из ацетата натрия/уксусной кислоты;
- от 190 до 210 мМ трегалозы;
- от 40 до 60 мМ хлорида натрия;
- от 0,9 мг/мл и 1,1 мг/мл полисорбата 80; и
- воду (для инъекций);
- где композиция:
имеет pH между 5,1 и 5,3;
не содержит аргинин или содержит аргинин в концентрации по большей мере 0,001 мМ;
не содержит аминокислоты или содержит одну или несколько аминокислот в (совокупной) концентрации по большей мере 0,001 мМ.
не содержит поверхностно-активные вещества, за исключением полисорбата 80, или содержит одно или несколько из указанных поверхностно-активных веществ (за исключением полисорбата 80) в (совокупной) концентрации по большей мере 0,0001 мМ; и/или
не содержит фосфатные буферные средства (например, первичный кислый фосфат натрия, вторичный кислый фосфат натрия) или содержит фосфатную буферную систему в концентрации по большей мере 0,001 мМ.
16. Устройство доставки лекарственного средства, которое содержит жидкую фармацевтическую композицию как заявлено в любом предшествующем пункте
17. Жидкая фармацевтическая композиция как заявлено в любом из пп. 1-15 для применения в лечении ревматоидного артрита, псориатического артрита, анкилозирующего спондилита, болезни Крона, язвенного колита, хронического псориаза от умеренного до тяжелого и/или ювенильного идиопатического артрита.
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