JP6157611B2 - 医薬製剤 - Google Patents
医薬製剤 Download PDFInfo
- Publication number
- JP6157611B2 JP6157611B2 JP2015517767A JP2015517767A JP6157611B2 JP 6157611 B2 JP6157611 B2 JP 6157611B2 JP 2015517767 A JP2015517767 A JP 2015517767A JP 2015517767 A JP2015517767 A JP 2015517767A JP 6157611 B2 JP6157611 B2 JP 6157611B2
- Authority
- JP
- Japan
- Prior art keywords
- antibody
- pharmaceutical formulation
- antibodies
- liquid
- concentration
- 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.)
- Expired - Fee Related
Links
Classifications
-
- 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
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
- A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
-
- 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
- A61K47/02—Inorganic compounds
-
- 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
-
- 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
- A61K47/26—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
- A61K9/08—Solutions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
- A61P35/02—Antineoplastic agents specific for leukemia
-
- 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
-
- 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
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2803—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
Description
300mg/mlの濃度のエピラツズマブの異なる医薬製剤を調製した。酢酸ナトリウム(NaOAc)及び塩化ナトリウム(NaCl)の濃度を変えて、製剤の粘度に対するこれらの塩の効果を調査した。
さらなる実験を行って高濃度抗体製剤の粘度に対するNaOAcの効果を調査した。
Claims (6)
- 270〜310mg/mlの濃度の有効成分としてのエピラツズマブ、40〜90mMの濃度のアセタート、220〜420mMの濃度のグリシン、0.01%のポリソルベート80を含む、pHが5.0である、液体医薬製剤。
- 粘度が110mPa s以下である、請求項1に記載の液体医薬製剤。
- 0〜100mMの濃度のNaClを含む、請求項1又は2に記載の液体医薬製剤。
- MgCl2又はCaCl2を含まないことを特徴とする、請求項1から3までのいずれか一項に記載の液体医薬製剤。
- 請求項1から4までのいずれか一項に記載の液体医薬製剤を含む容器。
- 請求項5に記載の容器及び使用説明書を含むキット。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201261662621P | 2012-06-21 | 2012-06-21 | |
US61/662,621 | 2012-06-21 | ||
PCT/EP2013/062898 WO2013190047A1 (en) | 2012-06-21 | 2013-06-20 | Pharmaceutical formulation |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2015520206A JP2015520206A (ja) | 2015-07-16 |
JP6157611B2 true JP6157611B2 (ja) | 2017-07-05 |
Family
ID=48745904
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2015517767A Expired - Fee Related JP6157611B2 (ja) | 2012-06-21 | 2013-06-20 | 医薬製剤 |
Country Status (25)
Country | Link |
---|---|
US (1) | US20150150979A1 (ja) |
EP (1) | EP2864356A1 (ja) |
JP (1) | JP6157611B2 (ja) |
KR (1) | KR20150032941A (ja) |
CN (1) | CN104520326A (ja) |
AR (1) | AR091530A1 (ja) |
AU (1) | AU2013279347A1 (ja) |
BR (1) | BR112014031841A2 (ja) |
CA (1) | CA2876012A1 (ja) |
CL (1) | CL2014003283A1 (ja) |
CO (1) | CO7170174A2 (ja) |
EA (1) | EA201590061A1 (ja) |
EC (1) | ECSP15002095A (ja) |
HK (1) | HK1205146A1 (ja) |
IL (1) | IL235921A0 (ja) |
MA (1) | MA37777B1 (ja) |
MX (1) | MX2014014717A (ja) |
NZ (1) | NZ702342A (ja) |
PE (1) | PE20150190A1 (ja) |
PH (1) | PH12014502596A1 (ja) |
SG (1) | SG11201407779YA (ja) |
TN (1) | TN2014000498A1 (ja) |
TW (1) | TW201406398A (ja) |
WO (1) | WO2013190047A1 (ja) |
ZA (1) | ZA201409020B (ja) |
Families Citing this family (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
MX2016003182A (es) | 2013-09-11 | 2017-03-31 | Arsia Therapeutics Inc | Formulaciones de proteínas líquidas que contienen líquidos iónicos. |
MX2017004306A (es) | 2014-10-01 | 2017-12-20 | Eagle Biologics Inc | Formulaciones de polisacáridos y ácido nucleico que contienen agentes de reducción de viscosidad. |
CA3026426C (en) * | 2016-05-28 | 2021-04-13 | Rajiv Gandhi Centre For Biotechnology, An Autonomous Institute Under The Department Of Bio-Technology, Government Of India | Uttroside b and derivatives thereof as therapeutics for hepatocellular carcinoma |
CN110062620B (zh) * | 2016-10-31 | 2023-12-05 | 德国费森尤斯卡比有限公司 | 液体药物组合物 |
KR102513828B1 (ko) | 2017-01-11 | 2023-03-24 | (주)셀트리온 | 안정한 액체 제제 |
US10646569B2 (en) | 2017-05-16 | 2020-05-12 | Bhami's Research Laboratory, Pvt. Ltd. | High concentration protein formulations with reduced viscosity |
GB201719447D0 (en) * | 2017-11-23 | 2018-01-10 | Ucb Biopharma Sprl | Pharmaceutical composition |
US20230405018A1 (en) * | 2020-11-18 | 2023-12-21 | Bexson Biomedical, Inc. | Flumazenil formulations for subcutaneous injection and methods of treatment using gaba receptor modulators |
Family Cites Families (11)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
AU1344102A (en) * | 2000-10-12 | 2002-04-22 | Genentech Inc | Reduced-viscosity concentrated protein formulations |
GB0113179D0 (en) * | 2001-05-31 | 2001-07-25 | Novartis Ag | Organic compounds |
JP4869064B2 (ja) * | 2003-04-04 | 2012-02-01 | ジェネンテック, インコーポレイテッド | 高濃度抗体及びタンパク質製剤 |
WO2006096488A2 (en) * | 2005-03-08 | 2006-09-14 | Pharmacia & Upjohn Company Llc | Composition comprising human igg2 antibody and chelating agent |
CL2008000058A1 (es) * | 2007-01-09 | 2008-05-23 | Wyeth Corp | Formulacion que comprende un anticuerpo anti-il13, un criprotector, y una solucion amortiguadora; composicion farmaceutica que la comprende; metodo para tratar un trastorno relacionado con il13; y formas farmaceuticas que la comprenden. |
DK2170390T3 (en) * | 2007-06-14 | 2019-01-21 | Biogen Ma Inc | NATALIZUMABANTISTIC FORMULATIONS |
WO2011139718A1 (en) * | 2010-05-03 | 2011-11-10 | Genentech, Inc. | Compositions and methods useful for reducing the viscosity of protein-containing formulations |
DK3195880T3 (da) * | 2010-05-14 | 2020-03-02 | Amgen Inc | Højkoncentrerede anti-sclerostin-antistofformuleringer |
JP2013531679A (ja) * | 2010-07-02 | 2013-08-08 | メディミューン,エルエルシー | 抗体製剤 |
JP2014510152A (ja) * | 2011-04-07 | 2014-04-24 | グラクソスミスクライン・リミテッド・ライアビリティ・カンパニー | 粘度が低減された処方物 |
EP2704751B1 (en) * | 2011-05-02 | 2019-04-17 | Immunomedics, Inc. | Ultrafiltration concentration of allotype selected antibodies for small-volume administration |
-
2013
- 2013-06-20 PE PE2014002385A patent/PE20150190A1/es not_active Application Discontinuation
- 2013-06-20 EP EP13733246.6A patent/EP2864356A1/en not_active Withdrawn
- 2013-06-20 CA CA2876012A patent/CA2876012A1/en not_active Abandoned
- 2013-06-20 MA MA37777A patent/MA37777B1/fr unknown
- 2013-06-20 EA EA201590061A patent/EA201590061A1/ru unknown
- 2013-06-20 WO PCT/EP2013/062898 patent/WO2013190047A1/en active Application Filing
- 2013-06-20 JP JP2015517767A patent/JP6157611B2/ja not_active Expired - Fee Related
- 2013-06-20 CN CN201380032420.1A patent/CN104520326A/zh active Pending
- 2013-06-20 NZ NZ702342A patent/NZ702342A/en not_active IP Right Cessation
- 2013-06-20 KR KR20147034759A patent/KR20150032941A/ko not_active Application Discontinuation
- 2013-06-20 US US14/406,758 patent/US20150150979A1/en not_active Abandoned
- 2013-06-20 MX MX2014014717A patent/MX2014014717A/es unknown
- 2013-06-20 BR BR112014031841A patent/BR112014031841A2/pt not_active IP Right Cessation
- 2013-06-20 AU AU2013279347A patent/AU2013279347A1/en not_active Abandoned
- 2013-06-20 SG SG11201407779YA patent/SG11201407779YA/en unknown
- 2013-06-21 TW TW102122152A patent/TW201406398A/zh unknown
- 2013-06-24 AR ARP130102208 patent/AR091530A1/es unknown
-
2014
- 2014-11-21 PH PH12014502596A patent/PH12014502596A1/en unknown
- 2014-11-26 IL IL235921A patent/IL235921A0/en unknown
- 2014-11-28 CL CL2014003283A patent/CL2014003283A1/es unknown
- 2014-11-28 TN TN2014000498A patent/TN2014000498A1/fr unknown
- 2014-12-09 ZA ZA2014/09020A patent/ZA201409020B/en unknown
-
2015
- 2015-01-09 CO CO15004860A patent/CO7170174A2/es unknown
- 2015-01-21 EC ECIEPI20152095A patent/ECSP15002095A/es unknown
- 2015-06-16 HK HK15105706.7A patent/HK1205146A1/xx unknown
Also Published As
Publication number | Publication date |
---|---|
SG11201407779YA (en) | 2015-02-27 |
CN104520326A (zh) | 2015-04-15 |
ECSP15002095A (es) | 2015-11-30 |
CA2876012A1 (en) | 2013-12-27 |
MX2014014717A (es) | 2015-03-06 |
EP2864356A1 (en) | 2015-04-29 |
AR091530A1 (es) | 2015-02-11 |
HK1205146A1 (en) | 2015-12-11 |
AU2013279347A1 (en) | 2014-12-18 |
CO7170174A2 (es) | 2015-01-28 |
EA201590061A1 (ru) | 2015-05-29 |
MA37777B1 (fr) | 2017-07-31 |
NZ702342A (en) | 2016-07-29 |
PH12014502596A1 (en) | 2015-01-12 |
IL235921A0 (en) | 2015-01-29 |
JP2015520206A (ja) | 2015-07-16 |
PE20150190A1 (es) | 2015-02-13 |
TN2014000498A1 (en) | 2016-03-30 |
ZA201409020B (en) | 2016-09-28 |
CL2014003283A1 (es) | 2016-04-01 |
US20150150979A1 (en) | 2015-06-04 |
BR112014031841A2 (pt) | 2017-06-27 |
TW201406398A (zh) | 2014-02-16 |
MA20150436A1 (fr) | 2015-11-30 |
WO2013190047A1 (en) | 2013-12-27 |
KR20150032941A (ko) | 2015-03-31 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
JP6157611B2 (ja) | 医薬製剤 | |
JP6923602B2 (ja) | 抗アクチビンa抗体及びその使用 | |
US10111958B2 (en) | Anti-CD40 antibody formulation | |
RU2707745C2 (ru) | Способы лечения или профилактики мигренозной головной боли | |
DK2831113T3 (en) | ANTIBODIES AGAINST BRADYKININ-B1 RECEPTOR LIGANDS | |
HRP20220637T1 (hr) | Protutijela anti-komplementa c1s i njihova upotreba | |
CN109963577B (zh) | 用于通过施用il-4r抑制剂治疗严重特应性皮炎的方法 | |
CN112153982A (zh) | 用于通过施用il-4r抑制剂治疗特应性皮炎的方法 | |
WO2018223923A1 (zh) | Pd-1抗体与vegf配体或vegf受体抑制剂联合在制备治疗肿瘤的药物中的用途 | |
JP2020515577A (ja) | 免疫原性の低下のための方法及び組成物 | |
CN114286828A (zh) | 针对靶向b细胞成熟抗原的多特异性抗体的给药方案和组合疗法 | |
US20200369760A1 (en) | Stabilized formulations containing anti-angptl3 antibodies | |
EP3256154B1 (en) | Pharmaceutical formulation comprising antibody | |
JP2020516651A (ja) | 安定的抗osmr抗体製剤 | |
JP2021515003A (ja) | 体組成を変更するための方法 | |
TW202114734A (zh) | Il-17拮抗劑治療自身免疫疾病的方法 | |
TW202110892A (zh) | 治療具有類風濕性關節炎的個體中疼痛之組成物及方法 | |
US20230242626A1 (en) | Composition for treatment and prevention of covid-19 | |
WO2023025303A1 (zh) | 抗cldn-18.2抗体药物偶联物及其用途 | |
WO2023250507A1 (en) | Methods for treating complement-mediated diseases | |
CA3215919A1 (en) | Treatment for systemic lupus erythematosus using anti-baffr antibodies | |
KR20230130561A (ko) | Fviii 모방 이중특이적 항체를 2주마다 1회 투여하는 방법 | |
KR20230130560A (ko) | Fviii 모방 이중특이적 항체의 주 1회 투여 방법 | |
KR20230167968A (ko) | 점도 감소 부형제 조성물 및 이를 포함하는 저점도 고농축 단백질 제형 | |
KR20220100634A (ko) | 안정한 수성 항-tfpi 항체 제제 |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
A621 | Written request for application examination |
Free format text: JAPANESE INTERMEDIATE CODE: A621 Effective date: 20160309 |
|
A131 | Notification of reasons for refusal |
Free format text: JAPANESE INTERMEDIATE CODE: A131 Effective date: 20161202 |
|
A521 | Request for written amendment filed |
Free format text: JAPANESE INTERMEDIATE CODE: A523 Effective date: 20170301 |
|
TRDD | Decision of grant or rejection written | ||
A01 | Written decision to grant a patent or to grant a registration (utility model) |
Free format text: JAPANESE INTERMEDIATE CODE: A01 Effective date: 20170413 |
|
A601 | Written request for extension of time |
Free format text: JAPANESE INTERMEDIATE CODE: A601 Effective date: 20170428 |
|
A61 | First payment of annual fees (during grant procedure) |
Free format text: JAPANESE INTERMEDIATE CODE: A61 Effective date: 20170606 |
|
R150 | Certificate of patent or registration of utility model |
Ref document number: 6157611 Country of ref document: JP Free format text: JAPANESE INTERMEDIATE CODE: R150 |
|
LAPS | Cancellation because of no payment of annual fees |