BR112018010743A2 - ?método para fabricação de um pó farmacêutico formulado, e, pó farmacêutico formulado? - Google Patents

?método para fabricação de um pó farmacêutico formulado, e, pó farmacêutico formulado?

Info

Publication number
BR112018010743A2
BR112018010743A2 BR112018010743A BR112018010743A BR112018010743A2 BR 112018010743 A2 BR112018010743 A2 BR 112018010743A2 BR 112018010743 A BR112018010743 A BR 112018010743A BR 112018010743 A BR112018010743 A BR 112018010743A BR 112018010743 A2 BR112018010743 A2 BR 112018010743A2
Authority
BR
Brazil
Prior art keywords
pharmaceutical powder
formulated pharmaceutical
making
therapeutic protein
formulated
Prior art date
Application number
BR112018010743A
Other languages
English (en)
Other versions
BR112018010743B1 (pt
BR112018010743A8 (pt
Inventor
Chen Hunter
BRUDNICKI Philip
Original Assignee
Regeneron Pharma
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=57708873&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=BR112018010743(A2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Regeneron Pharma filed Critical Regeneron Pharma
Publication of BR112018010743A2 publication Critical patent/BR112018010743A2/pt
Publication of BR112018010743A8 publication Critical patent/BR112018010743A8/pt
Publication of BR112018010743B1 publication Critical patent/BR112018010743B1/pt

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682Processes
    • A61K9/1694Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/177Receptors; Cell surface antigens; Cell surface determinants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/177Receptors; Cell surface antigens; Cell surface determinants
    • A61K38/179Receptors; Cell surface antigens; Cell surface determinants for growth factors; for growth regulators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/62Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being a protein, peptide or polyamino acid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1611Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • A61K9/1623Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1658Proteins, e.g. albumin, gelatin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5031Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poly(lactide-co-glycolide)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5089Processes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00Drugs for disorders of the senses
    • A61P27/02Ophthalmic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/10Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Immunology (AREA)
  • Cell Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Inorganic Chemistry (AREA)
  • Urology & Nephrology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Ophthalmology & Optometry (AREA)
  • Cardiology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)

Abstract

são fornecidas partículas micronizadas contendo uma proteína terapêutica e, opcionalmente, excipientes e um revestimento de polímero biocompatível ou biodegradável, e métodos de fabricar e usar essas micropartículas. a proteína terapêutica formulada como um pó farmacêutico de partículas de tamanho micrométrico permanece estável por longos períodos de tempo e é passível de revestimento de polímero para liberação prolongada e estabilidade sob condições fisiológicas.
BR112018010743-3A 2015-12-16 2016-12-16 Método para fabricação de um pó farmacêutico formulado, e, pó farmacêutico formulado BR112018010743B1 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201562268259P 2015-12-16 2015-12-16
US62/268,259 2015-12-16
PCT/US2016/067280 WO2017106716A1 (en) 2015-12-16 2016-12-16 Compositions and methods of manufacturing protein microparticles

Publications (3)

Publication Number Publication Date
BR112018010743A2 true BR112018010743A2 (pt) 2018-11-21
BR112018010743A8 BR112018010743A8 (pt) 2019-02-26
BR112018010743B1 BR112018010743B1 (pt) 2024-02-15

Family

ID=57708873

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112018010743-3A BR112018010743B1 (pt) 2015-12-16 2016-12-16 Método para fabricação de um pó farmacêutico formulado, e, pó farmacêutico formulado

Country Status (22)

Country Link
US (1) US20200022917A1 (pt)
EP (2) EP4059492B1 (pt)
JP (2) JP7185526B2 (pt)
KR (1) KR102714544B1 (pt)
CN (2) CN114404371A (pt)
AU (2) AU2016369557B2 (pt)
BR (1) BR112018010743B1 (pt)
CA (1) CA3003654A1 (pt)
CL (2) CL2018001623A1 (pt)
CO (1) CO2018005920A2 (pt)
DK (1) DK3389636T3 (pt)
EA (2) EA201891164A1 (pt)
ES (2) ES2927348T3 (pt)
HK (1) HK1251461A1 (pt)
HU (1) HUE060148T2 (pt)
IL (3) IL302211A (pt)
MX (2) MX2018005384A (pt)
PH (2) PH12018500830A1 (pt)
PL (1) PL3389636T3 (pt)
SG (2) SG10202007834VA (pt)
WO (1) WO2017106716A1 (pt)
ZA (2) ZA201802706B (pt)

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US11291636B2 (en) 2011-11-18 2022-04-05 Regeneron Pharmaceuticals, Inc. Polymer protein microparticles

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JP2022523510A (ja) 2019-01-31 2022-04-25 エレクトロフィ,インコーポレイテッド 粒子形成及び形態構造
EP4027978A1 (en) 2019-09-13 2022-07-20 Elektrofi, Inc. Compositions and methods for the delivery of therapeutic biologics for treatment of disease
JP2023502591A (ja) * 2019-11-15 2023-01-25 シルク テクノロジーズ、リミテッド 絹由来タンパク質の安定した配合物
MX2022006236A (es) * 2019-11-25 2022-06-22 Regeneron Pharma Formulaciones de liberacion sostenida con emulsiones no acuosas.
WO2021158959A2 (en) * 2020-02-07 2021-08-12 Elektrofi, Inc. Peptide particles and methods of formation
AU2021385363A1 (en) * 2020-11-25 2023-06-08 Regeneron Pharmaceuticals, Inc. Sustained release formulations using non-aqueous membrane emulsification

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11291636B2 (en) 2011-11-18 2022-04-05 Regeneron Pharmaceuticals, Inc. Polymer protein microparticles
US11951216B2 (en) 2011-11-18 2024-04-09 Regeneron Pharmaceuticals, Inc. Polymer protein microparticles

Also Published As

Publication number Publication date
PH12021550603A1 (en) 2021-11-03
KR20180088836A (ko) 2018-08-07
AU2016369557A1 (en) 2018-06-07
ES2927348T3 (es) 2022-11-04
AU2016369557B2 (en) 2022-10-20
PL3389636T3 (pl) 2022-11-28
IL259204A (en) 2018-07-31
CN108366968A (zh) 2018-08-03
EP3389636B1 (en) 2022-07-20
US20200022917A1 (en) 2020-01-23
SG10202007834VA (en) 2020-09-29
EP3389636A1 (en) 2018-10-24
JP7554243B2 (ja) 2024-09-19
IL259204B (en) 2021-10-31
ES2981791T3 (es) 2024-10-10
BR112018010743B1 (pt) 2024-02-15
WO2017106716A1 (en) 2017-06-22
IL286601B2 (en) 2023-09-01
JP2022185057A (ja) 2022-12-13
AU2022291549B2 (en) 2024-08-08
JP7185526B2 (ja) 2022-12-07
CO2018005920A2 (es) 2018-06-20
CL2023002345A1 (es) 2024-03-15
AU2022291549A1 (en) 2023-02-02
ZA201802706B (en) 2023-12-20
BR112018010743A8 (pt) 2019-02-26
IL302211A (en) 2023-06-01
EP4059492A1 (en) 2022-09-21
EP4059492B1 (en) 2024-04-17
CN108366968B (zh) 2022-02-18
CA3003654A1 (en) 2017-06-22
MX2024000362A (es) 2024-01-26
CN114404371A (zh) 2022-04-29
EA201891164A1 (ru) 2018-11-30
EA202192290A1 (ru) 2022-02-28
ZA202304376B (en) 2024-08-28
CL2018001623A1 (es) 2018-07-20
HUE060148T2 (hu) 2023-02-28
PH12018500830A1 (en) 2018-10-29
JP2019504825A (ja) 2019-02-21
IL286601A (en) 2021-10-31
DK3389636T3 (da) 2022-09-19
SG11201803197UA (en) 2018-05-30
IL286601B1 (en) 2023-05-01
KR102714544B1 (ko) 2024-10-10
MX2018005384A (es) 2018-08-16
HK1251461A1 (zh) 2019-02-01

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