PL3881833T3 - Tabletki o natychmiastowym uwalnianiu zawierające lek i sposoby wytwarzania tabletek - Google Patents

Tabletki o natychmiastowym uwalnianiu zawierające lek i sposoby wytwarzania tabletek

Info

Publication number
PL3881833T3
PL3881833T3 PL21160939.1T PL21160939T PL3881833T3 PL 3881833 T3 PL3881833 T3 PL 3881833T3 PL 21160939 T PL21160939 T PL 21160939T PL 3881833 T3 PL3881833 T3 PL 3881833T3
Authority
PL
Poland
Prior art keywords
tablets
methods
immediate release
containing drug
manufacturing
Prior art date
Application number
PL21160939.1T
Other languages
English (en)
Inventor
Sanjeev Kothari
Priscilla MANTIK
Alexander MAUERER
Hamid REZAEI
Original Assignee
Genentech, Inc.
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 Genentech, Inc. filed Critical Genentech, Inc.
Publication of PL3881833T3 publication Critical patent/PL3881833T3/pl

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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/10—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of compressed tablets
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/4353—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/437—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a five-membered ring having nitrogen as a ring hetero atom, e.g. indolizine, beta-carboline
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • A61K31/4523—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2095—Tabletting processes
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2813—Inorganic compounds
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/2853—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)
    • 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
    • A61P35/04—Antineoplastic agents specific for metastasis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oncology (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
PL21160939.1T 2015-06-30 2016-06-29 Tabletki o natychmiastowym uwalnianiu zawierające lek i sposoby wytwarzania tabletek PL3881833T3 (pl)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US201562186556P 2015-06-30 2015-06-30

Publications (1)

Publication Number Publication Date
PL3881833T3 true PL3881833T3 (pl) 2024-05-13

Family

ID=56373188

Family Applications (3)

Application Number Title Priority Date Filing Date
PL21160939.1T PL3881833T3 (pl) 2015-06-30 2016-06-29 Tabletki o natychmiastowym uwalnianiu zawierające lek i sposoby wytwarzania tabletek
PL23198295.0T PL4272735T3 (pl) 2015-06-30 2016-06-29 Tabletki o natychmiastowym uwalnianiu zawierające lek i sposoby wytwarzania tabletek
PL16736730T PL3316867T3 (pl) 2015-06-30 2016-06-29 Tabletki o natychmiastowym uwalnianiu zawierające lek i sposoby wytwarzania tabletek

Family Applications After (2)

Application Number Title Priority Date Filing Date
PL23198295.0T PL4272735T3 (pl) 2015-06-30 2016-06-29 Tabletki o natychmiastowym uwalnianiu zawierające lek i sposoby wytwarzania tabletek
PL16736730T PL3316867T3 (pl) 2015-06-30 2016-06-29 Tabletki o natychmiastowym uwalnianiu zawierające lek i sposoby wytwarzania tabletek

Country Status (17)

Country Link
US (3) US10478400B2 (pl)
EP (3) EP3316867B1 (pl)
JP (3) JP6914202B2 (pl)
KR (2) KR102881659B1 (pl)
CN (2) CN114177157B (pl)
AR (2) AR105184A1 (pl)
AU (2) AU2016287422B2 (pl)
BR (1) BR112017028218A2 (pl)
CA (1) CA2987912C (pl)
ES (3) ES2871175T3 (pl)
HR (2) HRP20210828T1 (pl)
IL (2) IL303352B2 (pl)
MX (3) MX377955B (pl)
PL (3) PL3881833T3 (pl)
SI (2) SI3316867T1 (pl)
TW (3) TWI804919B (pl)
WO (1) WO2017004122A1 (pl)

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TWI804919B (zh) * 2015-06-30 2023-06-11 美商建南德克公司 含藥物之立即釋放錠劑及形成該錠劑的方法
US10751288B2 (en) * 2016-08-23 2020-08-25 New Jersey Institute Of Technology Dry processed surface coated engineering excipients
US11040027B2 (en) 2017-01-17 2021-06-22 Heparegenix Gmbh Protein kinase inhibitors for promoting liver regeneration or reducing or preventing hepatocyte death
CA3077768A1 (en) * 2017-10-13 2019-04-18 Unichem Laboratories Ltd Pharmaceutical compositions of apremilast
CN110151763A (zh) * 2019-06-26 2019-08-23 深圳市第三人民医院 考比替尼作为制备治疗结核病药物中的应用
GB201913972D0 (en) 2019-09-27 2019-11-13 Univ Ulster Pharmaceutical Delivery Device and method of manufacture
CN115697307A (zh) * 2020-06-19 2023-02-03 葛兰素史密斯克莱知识产权（第2 号）有限公司 包含达普司他的制剂
WO2023145486A1 (ja) * 2022-01-28 2023-08-03 沢井製薬株式会社 フェソテロジンフマル酸塩含有製剤の製造方法
CA3254546A1 (en) * 2022-03-07 2023-09-14 Janssen Pharmaceuticals, Inc. COMPOSITIONS CONTAINING ATICAPRANT
US20250000802A1 (en) * 2023-06-09 2025-01-02 Hoffmann-La Roche Inc. Solid formulations comprising an inhibitor of the k-ras protein having a g12c mutation, and a process for preparing

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TWI415635B (zh) * 2004-05-28 2013-11-21 必治妥施貴寶公司 加衣錠片調製物及製備彼之方法
CN101222911A (zh) * 2005-07-15 2008-07-16 特瓦制药工业有限公司 新的制粒方法及由此制备的颗粒
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TWI804919B (zh) 2015-06-30 2023-06-11 美商建南德克公司 含藥物之立即釋放錠劑及形成該錠劑的方法

Also Published As

Publication number Publication date
PL4272735T3 (pl) 2025-10-06
CN108135854A (zh) 2018-06-08
JP6914202B2 (ja) 2021-08-04
KR20180021814A (ko) 2018-03-05
EP3881833B1 (en) 2023-11-01
AR105184A1 (es) 2017-09-13
MX2017016163A (es) 2018-08-15
IL256299B2 (en) 2023-11-01
CA2987912A1 (en) 2017-01-05
CA2987912C (en) 2023-01-24
JP2021138716A (ja) 2021-09-16
MX377955B (es) 2025-03-10
MX2022015606A (es) 2023-02-01
MX2020013162A (es) 2021-02-18
WO2017004122A1 (en) 2017-01-05
EP4272735A1 (en) 2023-11-08
JP7232284B2 (ja) 2023-03-02
AU2016287422A1 (en) 2018-01-04
EP4272735B1 (en) 2025-06-18
TW201705944A (zh) 2017-02-16
HK1254389A1 (zh) 2019-07-19
JP2018519305A (ja) 2018-07-19
HRP20240045T1 (hr) 2024-03-29
ES2969014T3 (es) 2024-05-16
CN108135854B (zh) 2022-03-11
EP3881833A1 (en) 2021-09-22
US20220339111A1 (en) 2022-10-27
IL303352A (en) 2023-08-01
SI3881833T1 (sl) 2024-03-29
IL303352B1 (en) 2025-06-01
AU2022201067A1 (en) 2022-03-10
CN114177157A (zh) 2022-03-15
US20180116966A1 (en) 2018-05-03
IL303352B2 (en) 2025-10-01
ES3036390T3 (en) 2025-09-18
KR102716253B1 (ko) 2024-10-11
TWI804919B (zh) 2023-06-11
TWI872459B (zh) 2025-02-11
CN114177157B (zh) 2024-08-02
PL3316867T3 (pl) 2021-10-11
ES2871175T3 (es) 2021-10-28
KR102881659B1 (ko) 2025-11-06
US10478400B2 (en) 2019-11-19
JP2023071769A (ja) 2023-05-23
KR20240152414A (ko) 2024-10-21
TWI795344B (zh) 2023-03-11
BR112017028218A2 (pt) 2018-08-28
SI3316867T1 (sl) 2021-08-31
TW202206068A (zh) 2022-02-16
HRP20210828T1 (hr) 2021-07-09
AR121624A2 (es) 2022-06-22
EP3316867B1 (en) 2021-03-10
AU2016287422B2 (en) 2021-11-18
IL256299A (en) 2018-02-28
EP3316867A1 (en) 2018-05-09
TW202337463A (zh) 2023-10-01
US20200085749A1 (en) 2020-03-19
JP7607062B2 (ja) 2024-12-26
IL256299B1 (en) 2023-07-01
EP4272735C0 (en) 2025-06-18

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