TW201622707A - 免疫抑制性調配物 - Google Patents

免疫抑制性調配物 Download PDF

Info

Publication number
TW201622707A
TW201622707A TW104111464A TW104111464A TW201622707A TW 201622707 A TW201622707 A TW 201622707A TW 104111464 A TW104111464 A TW 104111464A TW 104111464 A TW104111464 A TW 104111464A TW 201622707 A TW201622707 A TW 201622707A
Authority
TW
Taiwan
Prior art keywords
dosage form
weight
moisture barrier
mixture
pharmaceutical excipient
Prior art date
Application number
TW104111464A
Other languages
English (en)
Chinese (zh)
Inventor
菲利普 波洛特
愛默瑞克 瑞納奧德
Original Assignee
諾華公司
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 諾華公司 filed Critical 諾華公司
Publication of TW201622707A publication Critical patent/TW201622707A/zh

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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K31/397—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having four-membered rings, e.g. azetidine
    • 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
    • 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
    • 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
    • A61K9/2072—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
    • A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • 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
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • 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
    • 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
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2886—Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules 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
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules 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
    • A61K9/5089—Processes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • 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
    • 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
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Pain & Pain Management (AREA)
  • Transplantation (AREA)
  • Rheumatology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Nitrogen And Oxygen Or Sulfur-Condensed Heterocyclic Ring Systems (AREA)
TW104111464A 2014-04-10 2015-04-09 免疫抑制性調配物 TW201622707A (zh)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US201461977806P 2014-04-10 2014-04-10

Publications (1)

Publication Number Publication Date
TW201622707A true TW201622707A (zh) 2016-07-01

Family

ID=53525213

Family Applications (1)

Application Number Title Priority Date Filing Date
TW104111464A TW201622707A (zh) 2014-04-10 2015-04-09 免疫抑制性調配物

Country Status (23)

Country Link
US (5) US20170027906A1 (enExample)
EP (1) EP3129006B1 (enExample)
JP (2) JP6679495B2 (enExample)
KR (1) KR102466348B1 (enExample)
CN (1) CN106163502B (enExample)
AR (1) AR100002A1 (enExample)
AU (1) AU2015246038C1 (enExample)
CA (1) CA2942236C (enExample)
CL (1) CL2016002560A1 (enExample)
DK (1) DK3129006T3 (enExample)
EA (1) EA201692043A1 (enExample)
ES (1) ES2865451T3 (enExample)
HU (1) HUE054245T2 (enExample)
IL (1) IL247599B (enExample)
MX (1) MX2016013236A (enExample)
PE (1) PE20161385A1 (enExample)
PH (1) PH12016501841A1 (enExample)
PL (1) PL3129006T3 (enExample)
PT (1) PT3129006T (enExample)
SG (1) SG11201607354PA (enExample)
SI (1) SI3129006T1 (enExample)
TW (1) TW201622707A (enExample)
WO (1) WO2015155711A1 (enExample)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SG191286A1 (en) 2011-01-07 2013-07-31 Novartis Ag Immunosuppressant formulations
KR102466348B1 (ko) * 2014-04-10 2022-11-10 노파르티스 아게 면역억제제 제제
US11434200B2 (en) 2017-03-09 2022-09-06 Novartis Ag Solid forms comprising an oxime ether compound and a coformer, compositions and methods of use thereof
US11629124B2 (en) 2017-03-09 2023-04-18 Novartis Ag Solid forms comprising an oxime ether compound, compositions and methods of use thereof
ES3024636T3 (en) 2017-09-27 2025-06-04 Novartis Ag Parenteral formulation comprising siponimod
AU2018343239A1 (en) 2017-09-29 2020-03-12 Novartis Ag Dosing regimen of siponimod
WO2019064212A1 (en) 2017-09-29 2019-04-04 Novartis Ag DOSAGE DIAGRAM OF SIPONIMOD
US11673860B2 (en) 2018-01-22 2023-06-13 Teva Pharmaceuticals International Gmbh Crystalline siponimod fumaric acid and polymorphs thereof
CN109908095A (zh) * 2019-04-08 2019-06-21 肇庆学院 一种西尼莫德片剂及制备方法
WO2021214717A1 (en) 2020-04-23 2021-10-28 Novartis Ag Dosing regimen for the use of siponimod for the treatment of acute respiratory distress syndrome
CN113633632A (zh) * 2021-09-09 2021-11-12 暨南大学附属第一医院（广州华侨医院） siponimod在制备抗肿瘤转移药物中的应用
US20260207513A1 (en) 2022-12-12 2026-07-23 Synthon B.V. Pharmaceutical composition of siponimod

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009048993A2 (en) * 2007-10-12 2009-04-16 Novartis Ag Compositions comprising sphingosine 1 phosphate (s1p) receptor modulators
JP5190815B2 (ja) 2008-07-16 2013-04-24 日本電気株式会社 Ｉｕ−ＵＰプロトコルのネゴシエーション結果情報の通知方法、プロトコル変換方法、通信ネットワークシステム、インターワーキング装置、ＩｕＵＰネゴシエーション結果情報取得装置及びコンピュータ読み取り可能な情報記録媒体
AU2009327405A1 (en) 2008-12-18 2011-06-30 Novartis Ag New polymorphic form of 1- (4- { l- [ (E) -4-cyclohexyl--3-trifluoromethyl-benzyloxyimino] -ethyl) -2-ethyl-benzy l) -azetidine-3-carboxylic
HRP20131106T1 (hr) 2008-12-18 2013-12-20 Novartis Ag Hemifumaratna sol od 1-[4-[1-(4-cikloheksil-3-trifluorometil-benziloksiimino)-etil]-2-etil-benzil]-azetidin-3-karboksilne kiseline
MX367667B (es) * 2008-12-22 2019-08-30 Novartis Ag Régimen de dosificación de un agonista de los receptores de s1p.
CN101480374A (zh) * 2009-01-20 2009-07-15 苏州中化药品工业有限公司 一种稳定的固体药物组合物
SG191286A1 (en) * 2011-01-07 2013-07-31 Novartis Ag Immunosuppressant formulations
WO2012095853A1 (en) * 2011-01-10 2012-07-19 Novartis Pharma Ag Modified release formulations comprising sip receptor modulators
KR102466348B1 (ko) * 2014-04-10 2022-11-10 노파르티스 아게 면역억제제 제제

Also Published As

Publication number Publication date
DK3129006T3 (da) 2021-04-19
SG11201607354PA (en) 2016-10-28
US20190328705A1 (en) 2019-10-31
US20170027906A1 (en) 2017-02-02
CL2016002560A1 (es) 2017-04-07
SI3129006T1 (sl) 2021-08-31
IL247599B (en) 2020-08-31
IL247599A0 (en) 2016-11-30
EP3129006A1 (en) 2017-02-15
US20250073203A1 (en) 2025-03-06
HUE054245T2 (hu) 2021-08-30
KR20160144366A (ko) 2016-12-16
AU2015246038B2 (en) 2017-11-30
KR102466348B1 (ko) 2022-11-10
JP2020097591A (ja) 2020-06-25
JP2017510602A (ja) 2017-04-13
MX2016013236A (es) 2017-01-16
WO2015155711A4 (en) 2015-12-10
CA2942236C (en) 2023-08-29
CN106163502B (zh) 2020-12-01
ES2865451T3 (es) 2021-10-15
AU2015246038A1 (en) 2016-09-22
PE20161385A1 (es) 2017-01-05
EP3129006B1 (en) 2021-01-27
US20180207128A1 (en) 2018-07-26
PH12016501841A1 (en) 2017-01-09
AR100002A1 (es) 2016-08-31
WO2015155711A1 (en) 2015-10-15
PT3129006T (pt) 2021-04-09
AU2015246038C1 (en) 2018-05-31
CA2942236A1 (en) 2015-10-15
CN106163502A (zh) 2016-11-23
PL3129006T3 (pl) 2021-07-05
US20210161860A1 (en) 2021-06-03
EA201692043A1 (ru) 2017-02-28
JP6679495B2 (ja) 2020-04-15

Similar Documents

Publication Publication Date Title
US20250073203A1 (en) Immunosuppressant formulation
AU2018326596B2 (en) High concentration dosage forms of pridopidine
JP2023055940A (ja) 改善されたブロモクリプチン製剤
JP2014224079A (ja) 打錠用顆粒とその製造方法、その打錠用顆粒を用いた口腔内崩壊錠
EP3027174B1 (en) Pharmaceutical compositions of fingolimod
EP2050436A1 (en) Pharmaceutical composition containing dutasteride
WO2016042493A1 (en) Pharmaceutical compositions of fingolimod
JP2010265211A (ja) 被覆カフェイン粒子及びこれを含有する内服固形製剤
WO2021106004A1 (en) Pharmaceutical composition of s-adenosylmethionine
CN121038782A (zh) 具有改善的生物利用度的仑伐替尼组合物
EP2101742A2 (en) Pharmaceutical composition containing clopidogrel hydrogenesulphate of polymorph 1 form
US20120121700A1 (en) Pharmaceutical formulations comprising valganciclovir
WO2005099698A1 (ja) 安定化された４－アミノ－５－クロロ－Ｎ－［（１Ｒ，３ｒ，５Ｓ）－８－メチル－８－アザビシクロ［３．２．１］オクタ－３－イル]－２－［１－メチルブタ－２－インイルオキシ］ベンズアミド含有組成物
HK1227758B (en) Immunosuppressant formulation
JP2016510787A (ja) クリゾチニブを含む剤形
JP6233911B2 (ja) 化学的な安定性が向上したイルベサルタン含有錠剤
EA033685B1 (ru) Фармацевтические лекарственные формы
JP6199922B2 (ja) 化学的な安定性が向上したイルベサルタン含有錠剤
JP7547723B2 (ja) アビラテロン酢酸エステル含有製剤
JP2024077631A (ja) エルトロンボパグ オラミンを有効成分とする医薬組成物とその製造方法及び類縁物質の増加を抑制する方法
WO2025027630A1 (en) Amifampridine compositions
Kestur et al. EXCIPIENTS ORAL SOLID FOR DOSAGE CONVENTIONAL FORMS
HK1198466B (en) Prasugrel-containing immediate release stable oral pharmaceutical compositions