AU2013265255B2 - Aqueous pharmaceutical composition containing a biologic therapeutic agent and guanidine or a guanidine derivative and an injection including the composition - Google Patents
Aqueous pharmaceutical composition containing a biologic therapeutic agent and guanidine or a guanidine derivative and an injection including the composition Download PDFInfo
- Publication number
- AU2013265255B2 AU2013265255B2 AU2013265255A AU2013265255A AU2013265255B2 AU 2013265255 B2 AU2013265255 B2 AU 2013265255B2 AU 2013265255 A AU2013265255 A AU 2013265255A AU 2013265255 A AU2013265255 A AU 2013265255A AU 2013265255 B2 AU2013265255 B2 AU 2013265255B2
- Authority
- AU
- Australia
- Prior art keywords
- composition
- therapeutic agent
- viscosity
- biologic
- arginine
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Links
- 239000000203 mixture Substances 0.000 title claims abstract description 171
- 238000002347 injection Methods 0.000 title claims abstract description 49
- 239000007924 injection Substances 0.000 title claims abstract description 49
- 239000003814 drug Substances 0.000 title claims abstract description 32
- 229940124597 therapeutic agent Drugs 0.000 title claims abstract description 32
- 239000008194 pharmaceutical composition Substances 0.000 title claims abstract description 7
- ZRALSGWEFCBTJO-UHFFFAOYSA-N Guanidine Chemical compound NC(N)=N ZRALSGWEFCBTJO-UHFFFAOYSA-N 0.000 title abstract description 82
- CHJJGSNFBQVOTG-UHFFFAOYSA-N N-methyl-guanidine Natural products CNC(N)=N CHJJGSNFBQVOTG-UHFFFAOYSA-N 0.000 title abstract description 39
- SWSQBOPZIKWTGO-UHFFFAOYSA-N dimethylaminoamidine Natural products CN(C)C(N)=N SWSQBOPZIKWTGO-UHFFFAOYSA-N 0.000 title abstract description 39
- 150000002357 guanidines Chemical class 0.000 title abstract description 38
- 235000018102 proteins Nutrition 0.000 claims abstract description 23
- 102000004169 proteins and genes Human genes 0.000 claims abstract description 23
- 108090000623 proteins and genes Proteins 0.000 claims abstract description 23
- 229930064664 L-arginine Natural products 0.000 claims abstract description 17
- 235000014852 L-arginine Nutrition 0.000 claims abstract description 17
- 239000004475 Arginine Substances 0.000 claims description 40
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 claims description 40
- 235000009697 arginine Nutrition 0.000 claims description 40
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 13
- 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 description 12
- 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 description 12
- 239000003381 stabilizer Substances 0.000 claims description 10
- 239000004094 surface-active agent Substances 0.000 claims description 9
- 238000000034 method Methods 0.000 claims description 6
- 239000000243 solution Substances 0.000 claims description 6
- 238000004891 communication Methods 0.000 claims description 3
- 210000000795 conjunctiva Anatomy 0.000 claims description 3
- 210000004087 cornea Anatomy 0.000 claims description 3
- 239000012530 fluid Substances 0.000 claims description 3
- 210000003786 sclera Anatomy 0.000 claims description 3
- 125000002059 L-arginyl group Chemical group O=C([*])[C@](N([H])[H])([H])C([H])([H])C([H])([H])C([H])([H])N([H])C(=N[H])N([H])[H] 0.000 claims 2
- 125000000647 trehalose group Chemical group 0.000 claims 1
- ODKSFYDXXFIFQN-BYPYZUCNSA-N L-arginine Chemical compound OC(=O)[C@@H](N)CCCN=C(N)N ODKSFYDXXFIFQN-BYPYZUCNSA-N 0.000 abstract description 15
- ODKSFYDXXFIFQN-BYPYZUCNSA-P L-argininium(2+) Chemical compound NC(=[NH2+])NCCC[C@H]([NH3+])C(O)=O ODKSFYDXXFIFQN-BYPYZUCNSA-P 0.000 description 29
- -1 L-arginine Chemical compound 0.000 description 18
- 238000009472 formulation Methods 0.000 description 13
- HNDVDQJCIGZPNO-YFKPBYRVSA-N L-histidine Chemical compound OC(=O)[C@@H](N)CC1=CN=CN1 HNDVDQJCIGZPNO-YFKPBYRVSA-N 0.000 description 12
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 description 12
- 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 description 11
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 9
- 125000000217 alkyl group Chemical group 0.000 description 9
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 description 9
- 239000000427 antigen Substances 0.000 description 8
- 102000036639 antigens Human genes 0.000 description 8
- 108091007433 antigens Proteins 0.000 description 8
- 239000012634 fragment Substances 0.000 description 8
- 239000004615 ingredient Substances 0.000 description 7
- 239000000546 pharmaceutical excipient Substances 0.000 description 7
- 125000003277 amino group Chemical group 0.000 description 6
- 210000004027 cell Anatomy 0.000 description 6
- 231100000419 toxicity Toxicity 0.000 description 6
- 230000001988 toxicity Effects 0.000 description 6
- 102100038968 WAP four-disulfide core domain protein 1 Human genes 0.000 description 5
- 206010064930 age-related macular degeneration Diseases 0.000 description 5
- 230000002776 aggregation Effects 0.000 description 5
- 238000004220 aggregation Methods 0.000 description 5
- 239000000872 buffer Substances 0.000 description 5
- 239000006172 buffering agent Substances 0.000 description 5
- 208000002780 macular degeneration Diseases 0.000 description 5
- 229920000136 polysorbate Polymers 0.000 description 5
- RTZKZFJDLAIYFH-UHFFFAOYSA-N Diethyl ether Chemical compound CCOCC RTZKZFJDLAIYFH-UHFFFAOYSA-N 0.000 description 4
- 229920001213 Polysorbate 20 Polymers 0.000 description 4
- XSQUKJJJFZCRTK-UHFFFAOYSA-N Urea Chemical compound NC(N)=O XSQUKJJJFZCRTK-UHFFFAOYSA-N 0.000 description 4
- 150000001875 compounds Chemical class 0.000 description 4
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 description 4
- 229940068977 polysorbate 20 Drugs 0.000 description 4
- 210000001525 retina Anatomy 0.000 description 4
- 108020004511 Recombinant DNA Proteins 0.000 description 3
- 230000006378 damage Effects 0.000 description 3
- 238000005259 measurement Methods 0.000 description 3
- 229950008882 polysorbate Drugs 0.000 description 3
- RSDQBPGKMDFRHH-MJVIGCOGSA-N (3s,3as,5ar,9bs)-3,5a,9-trimethyl-3a,4,5,7,8,9b-hexahydro-3h-benzo[g][1]benzofuran-2,6-dione Chemical compound O=C([C@]1(C)CC2)CCC(C)=C1[C@@H]1[C@@H]2[C@H](C)C(=O)O1 RSDQBPGKMDFRHH-MJVIGCOGSA-N 0.000 description 2
- 206010003694 Atrophy Diseases 0.000 description 2
- 108020004414 DNA Proteins 0.000 description 2
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 description 2
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 2
- 241000282567 Macaca fascicularis Species 0.000 description 2
- 241000283973 Oryctolagus cuniculus Species 0.000 description 2
- 229920003171 Poly (ethylene oxide) Polymers 0.000 description 2
- 208000017442 Retinal disease Diseases 0.000 description 2
- 229910006069 SO3H Inorganic materials 0.000 description 2
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 2
- RSDQBPGKMDFRHH-UHFFFAOYSA-N Taurin Natural products C1CC2(C)C(=O)CCC(C)=C2C2C1C(C)C(=O)O2 RSDQBPGKMDFRHH-UHFFFAOYSA-N 0.000 description 2
- 125000003545 alkoxy group Chemical group 0.000 description 2
- 125000003368 amide group Chemical group 0.000 description 2
- 235000001014 amino acid Nutrition 0.000 description 2
- 150000001413 amino acids Chemical class 0.000 description 2
- 230000037444 atrophy Effects 0.000 description 2
- 230000008901 benefit Effects 0.000 description 2
- 239000004202 carbamide Substances 0.000 description 2
- 150000001732 carboxylic acid derivatives Chemical class 0.000 description 2
- 125000002843 carboxylic acid group Chemical group 0.000 description 2
- 125000003636 chemical group Chemical group 0.000 description 2
- 230000000052 comparative effect Effects 0.000 description 2
- 201000010099 disease Diseases 0.000 description 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 2
- 150000002148 esters Chemical class 0.000 description 2
- 229940083094 guanine derivative acting on arteriolar smooth muscle Drugs 0.000 description 2
- 125000000956 methoxy group Chemical group [H]C([H])([H])O* 0.000 description 2
- 230000037361 pathway Effects 0.000 description 2
- 210000000608 photoreceptor cell Anatomy 0.000 description 2
- 231100000331 toxic Toxicity 0.000 description 2
- 230000002588 toxic effect Effects 0.000 description 2
- IQXJCCZJOIKIAD-UHFFFAOYSA-N 1-(2-methoxyethoxy)hexadecane Chemical compound CCCCCCCCCCCCCCCCOCCOC IQXJCCZJOIKIAD-UHFFFAOYSA-N 0.000 description 1
- KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 description 1
- 229920000858 Cyclodextrin Polymers 0.000 description 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 description 1
- 239000004471 Glycine Substances 0.000 description 1
- 102000001706 Immunoglobulin Fab Fragments Human genes 0.000 description 1
- 108010054477 Immunoglobulin Fab Fragments Proteins 0.000 description 1
- 241000124008 Mammalia Species 0.000 description 1
- 229930195725 Mannitol Natural products 0.000 description 1
- 241001465754 Metazoa Species 0.000 description 1
- 206010061137 Ocular toxicity Diseases 0.000 description 1
- 229920001214 Polysorbate 60 Polymers 0.000 description 1
- 206010048955 Retinal toxicity Diseases 0.000 description 1
- 206010044245 Toxic optic neuropathy Diseases 0.000 description 1
- 239000012190 activator Substances 0.000 description 1
- 239000008186 active pharmaceutical agent Substances 0.000 description 1
- 239000000654 additive Substances 0.000 description 1
- 150000005215 alkyl ethers Chemical class 0.000 description 1
- 239000002280 amphoteric surfactant Substances 0.000 description 1
- 125000000129 anionic group Chemical group 0.000 description 1
- 125000000637 arginyl group Chemical group N[C@@H](CCCNC(N)=N)C(=O)* 0.000 description 1
- 238000003556 assay Methods 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 239000004359 castor oil Substances 0.000 description 1
- 235000019438 castor oil Nutrition 0.000 description 1
- 125000002091 cationic group Chemical group 0.000 description 1
- 229950009789 cetomacrogol 1000 Drugs 0.000 description 1
- 150000005829 chemical entities Chemical class 0.000 description 1
- 230000000295 complement effect Effects 0.000 description 1
- 229940097362 cyclodextrins Drugs 0.000 description 1
- 230000007850 degeneration Effects 0.000 description 1
- 235000014113 dietary fatty acids Nutrition 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 239000000839 emulsion Substances 0.000 description 1
- 150000002170 ethers Chemical class 0.000 description 1
- 239000000194 fatty acid Substances 0.000 description 1
- 229930195729 fatty acid Natural products 0.000 description 1
- 150000002191 fatty alcohols Chemical class 0.000 description 1
- 239000012537 formulation buffer Substances 0.000 description 1
- 210000004602 germ cell Anatomy 0.000 description 1
- ZEMPKEQAKRGZGQ-XOQCFJPHSA-N glycerol triricinoleate Natural products CCCCCC[C@@H](O)CC=CCCCCCCCC(=O)OC[C@@H](COC(=O)CCCCCCCC=CC[C@@H](O)CCCCCC)OC(=O)CCCCCCCC=CC[C@H](O)CCCCCC ZEMPKEQAKRGZGQ-XOQCFJPHSA-N 0.000 description 1
- ZRALSGWEFCBTJO-UHFFFAOYSA-O guanidinium Chemical group NC(N)=[NH2+] ZRALSGWEFCBTJO-UHFFFAOYSA-O 0.000 description 1
- 230000002949 hemolytic effect Effects 0.000 description 1
- 238000000338 in vitro Methods 0.000 description 1
- 239000007927 intramuscular injection Substances 0.000 description 1
- 238000010255 intramuscular injection Methods 0.000 description 1
- 150000002605 large molecules Chemical class 0.000 description 1
- 229960003511 macrogol Drugs 0.000 description 1
- 229920002521 macromolecule Polymers 0.000 description 1
- 210000004962 mammalian cell Anatomy 0.000 description 1
- 239000000594 mannitol Substances 0.000 description 1
- 235000010355 mannitol Nutrition 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 230000007246 mechanism Effects 0.000 description 1
- 238000011587 new zealand white rabbit Methods 0.000 description 1
- 231100000956 nontoxicity Toxicity 0.000 description 1
- 108020004707 nucleic acids Proteins 0.000 description 1
- 150000007523 nucleic acids Chemical class 0.000 description 1
- 102000039446 nucleic acids Human genes 0.000 description 1
- 231100000327 ocular toxicity Toxicity 0.000 description 1
- 108091008695 photoreceptors Proteins 0.000 description 1
- 229940068965 polysorbates Drugs 0.000 description 1
- 239000008213 purified water Substances 0.000 description 1
- 230000009467 reduction Effects 0.000 description 1
- 230000002207 retinal effect Effects 0.000 description 1
- 231100000385 retinal toxicity Toxicity 0.000 description 1
- 239000011780 sodium chloride Substances 0.000 description 1
- 239000001509 sodium citrate Substances 0.000 description 1
- 239000001488 sodium phosphate Substances 0.000 description 1
- 229910000162 sodium phosphate Inorganic materials 0.000 description 1
- 231100000048 toxicity data Toxicity 0.000 description 1
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 description 1
- 239000013598 vector Substances 0.000 description 1
- 230000003442 weekly effect Effects 0.000 description 1
- 239000002888 zwitterionic surfactant Substances 0.000 description 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F9/00—Methods or devices for treatment of the eyes; Devices for putting in contact-lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
- A61F9/0008—Introducing ophthalmic products into the ocular cavity or retaining products therein
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/155—Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
- A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39591—Stabilisation, fragmentation
-
- 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
- A61K47/16—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
-
- 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
- A61K47/16—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
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
-
- 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
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
-
- 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
- A61K47/26—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
-
- 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
-
- 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
- A61K9/0048—Eye, e.g. artificial tears
-
- 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
- A61K9/0048—Eye, e.g. artificial tears
- A61K9/0051—Ocular inserts, ocular implants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Mycology (AREA)
- Immunology (AREA)
- Microbiology (AREA)
- Ophthalmology & Optometry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Vascular Medicine (AREA)
- Heart & Thoracic Surgery (AREA)
- Biomedical Technology (AREA)
- Dermatology (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| AU2018203929A AU2018203929A1 (en) | 2012-05-25 | 2018-06-04 | Aqueous pharmaceutical composition containing a biologic therapeutic agent and guanidine or a guanidine derivative and an injection including the composition |
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201261651588P | 2012-05-25 | 2012-05-25 | |
| US61/651,588 | 2012-05-25 | ||
| PCT/EP2013/060649 WO2013174936A1 (en) | 2012-05-25 | 2013-05-23 | Aqueous pharmaceutical composition containing a biologic therapeutic agent and guanidine or a guanidine derivative and an injection including the composition |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| AU2018203929A Division AU2018203929A1 (en) | 2012-05-25 | 2018-06-04 | Aqueous pharmaceutical composition containing a biologic therapeutic agent and guanidine or a guanidine derivative and an injection including the composition |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| AU2013265255A1 AU2013265255A1 (en) | 2014-09-25 |
| AU2013265255B2 true AU2013265255B2 (en) | 2018-03-29 |
Family
ID=48534372
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| AU2013265255A Active AU2013265255B2 (en) | 2012-05-25 | 2013-05-23 | Aqueous pharmaceutical composition containing a biologic therapeutic agent and guanidine or a guanidine derivative and an injection including the composition |
| AU2018203929A Abandoned AU2018203929A1 (en) | 2012-05-25 | 2018-06-04 | Aqueous pharmaceutical composition containing a biologic therapeutic agent and guanidine or a guanidine derivative and an injection including the composition |
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| AU2018203929A Abandoned AU2018203929A1 (en) | 2012-05-25 | 2018-06-04 | Aqueous pharmaceutical composition containing a biologic therapeutic agent and guanidine or a guanidine derivative and an injection including the composition |
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| EP (1) | EP2854760B1 (enExample) |
| JP (3) | JP6250646B2 (enExample) |
| KR (1) | KR20150024301A (enExample) |
| CN (1) | CN104220047B (enExample) |
| AR (1) | AR091155A1 (enExample) |
| AU (2) | AU2013265255B2 (enExample) |
| CA (1) | CA2866232A1 (enExample) |
| CL (1) | CL2014003148A1 (enExample) |
| CO (1) | CO7270463A2 (enExample) |
| ES (1) | ES2706059T3 (enExample) |
| MX (1) | MX2014014318A (enExample) |
| PH (1) | PH12014502352A1 (enExample) |
| RU (1) | RU2014152803A (enExample) |
| WO (1) | WO2013174936A1 (enExample) |
| ZA (1) | ZA201406403B (enExample) |
Families Citing this family (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105164204A (zh) | 2012-11-21 | 2015-12-16 | 路易斯维尔大学研究基金会 | 用于降低氧化损伤的组合物和方法 |
| IL312865B2 (en) | 2013-09-11 | 2025-06-01 | Eagle Biologics Inc | Liquid protein formulations containing viscosity-lowering agents |
| ES2769783T3 (es) * | 2014-03-11 | 2020-06-29 | Green Cross Holdings Corp | Procedimiento de purificación de inmunoglobulina |
| AU2015325055B2 (en) * | 2014-10-01 | 2021-02-25 | Eagle Biologics, Inc. | Polysaccharide and nucleic acid formulations containing viscosity-lowering agents |
| EP3256136A4 (en) | 2015-02-09 | 2018-11-21 | University Of Louisville Research Foundation, Inc. | Ophthalmic compositions and methods for reducing oxidative damage to an eye lens |
| TW201722437A (zh) * | 2015-11-30 | 2017-07-01 | Rohto Pharma | 眼科組成物 |
| MY191668A (en) | 2016-06-14 | 2022-07-06 | Regeneron Pharma | Anti-c5 antibodies and uses thereof |
| ES2968923T3 (es) | 2016-08-10 | 2024-05-14 | Celltrion Inc | Preparación farmacéutica líquida estable de anticuerpo contra el virus de la gripe |
| KR102262743B1 (ko) | 2017-07-07 | 2021-06-09 | 에이치케이이노엔 주식회사 | 주사용 조성물 |
| GB201713660D0 (en) * | 2017-08-25 | 2017-10-11 | Kalvista Pharmaceuticals Ltd | Pharmaceutical compositions |
| JP2021506241A (ja) | 2017-12-13 | 2021-02-22 | リジェネロン・ファーマシューティカルズ・インコーポレイテッドＲｅｇｅｎｅｒｏｎ Ｐｈａｒｍａｃｅｕｔｉｃａｌｓ， Ｉｎｃ． | 抗ｃ５抗体組み合わせ物およびその使用 |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2004055164A2 (en) * | 2002-12-13 | 2004-07-01 | Abgenix, Inc. | System and method for stabilizing antibodies with histidine |
| WO2008113834A2 (en) * | 2007-03-22 | 2008-09-25 | Novartis Ag | C5 antigens and uses thereof |
| WO2011084750A1 (en) * | 2009-12-21 | 2011-07-14 | Genentech, Inc. | Antibody formulation |
Family Cites Families (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5364884A (en) * | 1993-01-21 | 1994-11-15 | Baylor College Of Medicine | Arginine compounds as ocular hypotensive agents |
| US5658948A (en) * | 1994-03-02 | 1997-08-19 | Allergan | Enhancement of benzalkonium chloride preservative activity in formulations containing an incompatible drug using amino acids having net positive charge |
| US6171586B1 (en) * | 1997-06-13 | 2001-01-09 | Genentech, Inc. | Antibody formulation |
| US6462071B1 (en) * | 2000-03-02 | 2002-10-08 | Vitreo-Retinal Technologies, Inc. | Agents for intravitreal administration to treat or prevent disorders of the eye |
| AU2001271417B2 (en) | 2000-08-30 | 2006-10-05 | Johns Hopkins University | Devices for intraocular drug delivery |
| US20060182783A1 (en) * | 2004-04-30 | 2006-08-17 | Allergan, Inc. | Sustained release intraocular drug delivery systems |
| WO2010015608A1 (en) | 2008-08-05 | 2010-02-11 | Novartis Ag | Compositions and methods for antibodies targeting complement protein c5 |
| WO2011104381A2 (en) * | 2010-02-26 | 2011-09-01 | Novo Nordisk A/S | Stable antibody containing compositions |
-
2013
- 2013-05-23 AU AU2013265255A patent/AU2013265255B2/en active Active
- 2013-05-23 EP EP13725348.0A patent/EP2854760B1/en active Active
- 2013-05-23 MX MX2014014318A patent/MX2014014318A/es unknown
- 2013-05-23 US US13/900,724 patent/US10010513B2/en active Active
- 2013-05-23 RU RU2014152803A patent/RU2014152803A/ru not_active Application Discontinuation
- 2013-05-23 CA CA2866232A patent/CA2866232A1/en not_active Abandoned
- 2013-05-23 JP JP2015513185A patent/JP6250646B2/ja active Active
- 2013-05-23 KR KR20147026263A patent/KR20150024301A/ko not_active Ceased
- 2013-05-23 WO PCT/EP2013/060649 patent/WO2013174936A1/en not_active Ceased
- 2013-05-23 CN CN201380020203.0A patent/CN104220047B/zh active Active
- 2013-05-23 ES ES13725348T patent/ES2706059T3/es active Active
- 2013-05-24 AR ARP130101819 patent/AR091155A1/es unknown
-
2014
- 2014-09-01 ZA ZA2014/06403A patent/ZA201406403B/en unknown
- 2014-10-21 PH PH12014502352A patent/PH12014502352A1/en unknown
- 2014-11-20 CL CL2014003148A patent/CL2014003148A1/es unknown
- 2014-11-27 CO CO14261585A patent/CO7270463A2/es unknown
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2017
- 2017-03-31 JP JP2017071601A patent/JP6405406B2/ja not_active Expired - Fee Related
-
2018
- 2018-06-04 AU AU2018203929A patent/AU2018203929A1/en not_active Abandoned
- 2018-09-14 JP JP2018172328A patent/JP2018193406A/ja active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2004055164A2 (en) * | 2002-12-13 | 2004-07-01 | Abgenix, Inc. | System and method for stabilizing antibodies with histidine |
| WO2008113834A2 (en) * | 2007-03-22 | 2008-09-25 | Novartis Ag | C5 antigens and uses thereof |
| WO2011084750A1 (en) * | 2009-12-21 | 2011-07-14 | Genentech, Inc. | Antibody formulation |
Also Published As
| Publication number | Publication date |
|---|---|
| US20130317457A1 (en) | 2013-11-28 |
| JP2018193406A (ja) | 2018-12-06 |
| PH12014502352A1 (en) | 2015-01-12 |
| CN104220047A (zh) | 2014-12-17 |
| CO7270463A2 (es) | 2015-05-19 |
| AU2013265255A1 (en) | 2014-09-25 |
| WO2013174936A1 (en) | 2013-11-28 |
| EP2854760A1 (en) | 2015-04-08 |
| ES2706059T3 (es) | 2019-03-27 |
| KR20150024301A (ko) | 2015-03-06 |
| ZA201406403B (en) | 2019-01-30 |
| JP6405406B2 (ja) | 2018-10-17 |
| EP2854760B1 (en) | 2018-10-17 |
| AU2018203929A1 (en) | 2018-06-21 |
| AR091155A1 (es) | 2015-01-14 |
| US10010513B2 (en) | 2018-07-03 |
| CL2014003148A1 (es) | 2015-02-27 |
| CA2866232A1 (en) | 2013-11-28 |
| RU2014152803A (ru) | 2016-07-20 |
| CN104220047B (zh) | 2019-11-15 |
| JP6250646B2 (ja) | 2017-12-20 |
| JP2017122123A (ja) | 2017-07-13 |
| JP2015517556A (ja) | 2015-06-22 |
| MX2014014318A (es) | 2015-02-12 |
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