BR112021025458A2 - Formulação farmacêutica, método de preparação e uso da mesma - Google Patents

Formulação farmacêutica, método de preparação e uso da mesma

Info

Publication number
BR112021025458A2
BR112021025458A2 BR112021025458A BR112021025458A BR112021025458A2 BR 112021025458 A2 BR112021025458 A2 BR 112021025458A2 BR 112021025458 A BR112021025458 A BR 112021025458A BR 112021025458 A BR112021025458 A BR 112021025458A BR 112021025458 A2 BR112021025458 A2 BR 112021025458A2
Authority
BR
Brazil
Prior art keywords
pharmaceutical formulation
preparation
reducing
improving
taci
Prior art date
Application number
BR112021025458A
Other languages
English (en)
Inventor
Jianmin Fang
Qiaoyu Xu
Xuejing Yao
Zhuanglin Li
Original Assignee
Remegen Co Ltd
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Remegen Co Ltd filed Critical Remegen Co Ltd
Publication of BR112021025458A2 publication Critical patent/BR112021025458A2/pt

Links

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
    • A61K9/08—Solutions
    • 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
    • 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
    • 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
    • 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K9/14—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
    • 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
    • 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
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/46—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates
    • C07K14/47—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from mammals
    • C07K14/4701—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from mammals not used
    • C07K14/4702—Regulators; Modulating activity
    • C07K14/4705—Regulators; Modulating activity stimulating, promoting or activating activity
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/705—Receptors; Cell surface antigens; Cell surface determinants
    • C07K14/70578—NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K19/00—Hybrid peptides, i.e. peptides covalently bound to nucleic acids, or non-covalently bound protein-protein complexes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/30—Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Toxicology (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Cell Biology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)

Abstract

formulação farmacêutica, método de preparação e uso da mesma. trata-se de uma formulação farmacêutica que contém uma mistura de um açúcar não redutor, uma proteína de fusão de taci-fc e pelo menos um aminoácido. a formulação farmacêutica tem as características de redução de matéria particulada, redução de formação de agregado, aprimoramento da estabilidade, aprimoramento da aparência de um pó seco a frio, etc.
BR112021025458A 2019-12-10 2020-12-09 Formulação farmacêutica, método de preparação e uso da mesma BR112021025458A2 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201911261372 2019-12-10
PCT/CN2020/134872 WO2021115321A1 (zh) 2019-12-10 2020-12-09 TACI-Fc融合蛋白药物制剂

Publications (1)

Publication Number Publication Date
BR112021025458A2 true BR112021025458A2 (pt) 2022-06-21

Family

ID=76329589

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112021025458A BR112021025458A2 (pt) 2019-12-10 2020-12-09 Formulação farmacêutica, método de preparação e uso da mesma

Country Status (9)

Country Link
US (1) US20220133633A1 (pt)
EP (1) EP4074337A4 (pt)
JP (1) JP7326500B2 (pt)
KR (1) KR20220054324A (pt)
CN (1) CN113613675B (pt)
AU (1) AU2020401160A1 (pt)
BR (1) BR112021025458A2 (pt)
CA (1) CA3128113A1 (pt)
WO (1) WO2021115321A1 (pt)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3868403A4 (en) * 2019-12-24 2022-04-06 RemeGen Co., Ltd. TACI-FC FUSION PROTEIN AND USE THEREOF
TW202208414A (zh) 2020-05-08 2022-03-01 美商艾爾潘免疫科學有限公司 April及baff抑制性免疫調節蛋白及其使用方法
AU2023387777A1 (en) * 2022-12-07 2024-08-29 Remegen Co., Ltd. Taci-fc fusion protein liquid pharmaceutical preparation
WO2024180511A1 (en) * 2023-03-02 2024-09-06 Novetide Ltd. Process for preparation of glp-1 peptides having controlled particle size

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101323643B (zh) * 2007-06-15 2010-12-01 烟台荣昌生物工程有限公司 优化的TACI-Fc融合蛋白
JP5469077B2 (ja) * 2007-11-12 2014-04-09 アレス トレーディング ソシエテ アノニム Ｔａｃｉ−免疫グロブリン融合タンパク質のための調製物
WO2011017070A1 (en) * 2009-07-28 2011-02-10 Merck Sharp & Dohme Corp. Methods for producing high concentration lyophilized pharmaceutical formulations
CN102085367B (zh) * 2011-01-19 2012-08-22 烟台荣昌生物工程有限公司 优化的TACI-Fc融合蛋白用于制备治疗类风湿性关节炎药物的应用
CN102085368B (zh) 2011-01-19 2013-06-12 烟台荣昌生物工程有限公司 优化的TACI-Fc融合蛋白用于制备治疗系统性红斑狼疮药物的应用
CN104740609A (zh) * 2013-12-31 2015-07-01 上海中信国健药业股份有限公司 一种受体抗体融合蛋白的药物组合物
KR102386735B1 (ko) * 2015-11-06 2022-04-14 주식회사 제넥신 변형된 인터루킨-7 융합 단백질의 제형
CN108671229B (zh) * 2018-05-08 2022-03-25 华博生物医药技术（上海）有限公司 一种重组人血管内皮生长因子受体-抗体融合蛋白的药物组合制剂
CN110522908A (zh) * 2018-05-25 2019-12-03 荣昌生物制药（烟台）有限公司 TACI-Fc融合蛋白用于制备治疗视神经脊髓炎谱系疾病和多发性硬化之药物中的应用

Also Published As

Publication number Publication date
CA3128113A1 (en) 2021-06-17
US20220133633A1 (en) 2022-05-05
JP2022546899A (ja) 2022-11-10
CN113613675A (zh) 2021-11-05
EP4074337A4 (en) 2023-12-13
KR20220054324A (ko) 2022-05-02
AU2020401160A1 (en) 2021-08-19
WO2021115321A1 (zh) 2021-06-17
JP7326500B2 (ja) 2023-08-15
CN113613675B (zh) 2023-11-07
EP4074337A1 (en) 2022-10-19

Similar Documents

Publication Publication Date Title
BR112021025458A2 (pt) Formulação farmacêutica, método de preparação e uso da mesma
CL2019002511A1 (es) Composición farmacéutica que comprende selexipag.
PH12017500844A1 (en) Stable protein solution formulation containing high concentration of an anti-vegf antibody
DK1478394T3 (da) Stabiliseret TNFR-Fc formulation med arginin
BR112016004073A8 (pt) Anticorpos criados por engenharia, conjugados de anticorpo fármaco, seu método de preparação e seu uso, composição farmacêutica e seu uso, kits, e métodos para administrar uma pirrolobenzodiazepina (pbd) a uma célula de câncer que expressa dll3 e para determinar a citotoxicidade de um conjugado de anticorpo fármaco anti-dll3
BRPI0509894A (pt) composições farmacêuticas compreendendo um amido anfifìlico
BR122012030846B8 (pt) composição farmacêutica não aquosa para uso dermatológico compreendendo calcipotriol e pelo menos um corticoesteróide, e, uso da mesma
WO2015120231A3 (en) Stable peptide formulations and methods for preparation
WO2019171253A8 (en) Anti-pd-1 antibody compositions
MX2019003800A (es) Proteina liofilizada estable a temperatura ambiente.
EP4327880A3 (en) Solid state form of ribociclib succinate
BR112016020181A8 (pt) composições de ácido lipoico éster colina e métodos de uso.
BR112017019920A2 (pt) preparação sólida farmacêutica, e, método para estabilização de uma preparação sólida farmacêutica
BR112021019612A2 (pt) Formulações, recipiente, artigo de fabricação, método para produzir a formulação e método para inibir a agregação de uma proteína presente em uma solução aquosa
MX2023003230A (es) Procesos e intermediario para la preparacion a gran escala de hemisuccinato de 2,4,6-trifluoro-n-[6-(1-metil-piperidina-4-carbon il)-piridin-2-il]-benzamida y preparacion de acetato de 2,4,6-trifluoro-n-[6-(1-metil-piperidina-4-carbonil)-piridin-2-il ]-benzamida.
ECSP21060917A (es) Formulación de anticuerpos terapéuticos
BR112019025591A2 (pt) Composição farmacêutica compreendendo conjugado de fármaco-anticorpo c-met e uso do mesmo
BR112022008172A2 (pt) Composição aquosa estável, método para obter uma composição e forma de dosagem farmacêutica
MX2021005015A (es) Formulaciones farmaceuticas acuosas.
BR112022010976A2 (pt) Produtos oral com liberação controlada
SG11201808119UA (en) Pharmaceutical composition comprising pegylated fab' fragment of anti-human ngf antibody
BR112018008769A2 (pt) formulações farmacêuticas, formulações líquidas aquosa reconstituída e liofilizada, seringa, método de fabricação de uma formulação farmacêutica, método para tratamento de uma doença e uso de uma formulação reconstruída
BR112016018279A2 (pt) Bastão cosmético de cor sem suporte
WO2020003139A3 (en) Stable lyophilized dosage form of protein
CL2019000099A1 (es) Factor vii de coagulación de larga duración y métodos para producir el mismo.