MX2015013403A - Composiciones farmaceuticas que comprenden everolimus. - Google Patents

Composiciones farmaceuticas que comprenden everolimus.

Info

Publication number
MX2015013403A
MX2015013403A MX2015013403A MX2015013403A MX2015013403A MX 2015013403 A MX2015013403 A MX 2015013403A MX 2015013403 A MX2015013403 A MX 2015013403A MX 2015013403 A MX2015013403 A MX 2015013403A MX 2015013403 A MX2015013403 A MX 2015013403A
Authority
MX
Mexico
Prior art keywords
everolimus
pharmaceutical compositions
layer
rapamycin
hydroxy
Prior art date
Application number
MX2015013403A
Other languages
English (en)
Inventor
Anke Diederich
Hans-Ulrich Kunzler
Olivier Graner
Original Assignee
Novartis Ag
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=50483409&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=MX2015013403(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Novartis Ag filed Critical Novartis Ag
Publication of MX2015013403A publication Critical patent/MX2015013403A/es

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/284Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846Poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/03Containers specially adapted for medical or pharmaceutical purposes for pills or tablets
    • A61J1/035Blister-type containers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic 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
    • A61K31/4353Heterocyclic 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
    • A61K31/436Heterocyclic 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 six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
    • 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
    • A61K9/1635Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/167Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, 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
    • A61K9/2077Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/286Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2893Tablet coating processes
    • 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
    • A61K9/501Inorganic compounds
    • 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
    • A61K9/5026Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/5036Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A61K9/5047Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
    • 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
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/06Immunosuppressants, e.g. drugs for graft rejection
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D65/00Wrappers or flexible covers; Packaging materials of special type or form
    • B65D65/38Packaging materials of special type or form
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D75/00Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes, or webs of flexible sheet material, e.g. in folded wrappers
    • B65D75/28Articles or materials wholly enclosed in composite wrappers, i.e. wrappers formed by associating or interconnecting two or more sheets or blanks
    • B65D75/30Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding
    • B65D75/32Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents
    • B65D75/36Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents one sheet or blank being recessed and the other formed of relatively stiff flat sheet material, e.g. blister packages, the recess or recesses being preformed
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D2565/00Wrappers or flexible covers; Packaging materials of special type or form
    • B65D2565/38Packaging materials of special type or form
    • B65D2565/381Details of packaging materials of special type or form
    • B65D2565/387Materials used as gas barriers

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Mechanical Engineering (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Composite Materials (AREA)
  • Inorganic Chemistry (AREA)
  • Transplantation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Nitrogen And Oxygen Or Sulfur-Condensed Heterocyclic Ring Systems (AREA)

Abstract

La invención se relaciona con una formulación farmacéutica que comprende 40-O-(2-hidroxi)etil-rapamicina en una parte de alta carga de fármaco y una parte de liberación inmediata. Además, la invención se relaciona con una formulación farmacéutica que comprende 40-O-(2-hidroxi) etil-rapamicina en una primera capa y un surfactante en una capa debajo de la primera capa. La composición farmacéutica es particularmente adecuada para utilizar como un medicamento.
MX2015013403A 2013-03-19 2014-03-19 Composiciones farmaceuticas que comprenden everolimus. MX2015013403A (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201361803300P 2013-03-19 2013-03-19
PCT/IB2014/059965 WO2014147567A1 (en) 2013-03-19 2014-03-19 Pharmaceutical compositions comprising everolimus

Publications (1)

Publication Number Publication Date
MX2015013403A true MX2015013403A (es) 2016-01-08

Family

ID=50483409

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2015013403A MX2015013403A (es) 2013-03-19 2014-03-19 Composiciones farmaceuticas que comprenden everolimus.

Country Status (21)

Country Link
US (2) US20160045441A1 (es)
EP (1) EP2976064B1 (es)
JP (1) JP6356215B2 (es)
KR (1) KR20150132399A (es)
CN (1) CN105307640A (es)
AR (1) AR095672A1 (es)
AU (1) AU2014233799A1 (es)
BR (1) BR112015021112A2 (es)
CA (1) CA2907500A1 (es)
EA (1) EA201591830A1 (es)
ES (1) ES2633496T3 (es)
HK (1) HK1212899A1 (es)
IL (1) IL241254A0 (es)
MA (1) MA38430A1 (es)
MX (1) MX2015013403A (es)
PE (1) PE20151810A1 (es)
PH (1) PH12015501982A1 (es)
SG (1) SG11201506466WA (es)
TN (1) TN2015000394A1 (es)
TW (1) TW201503912A (es)
WO (1) WO2014147567A1 (es)

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EA201792314A1 (ru) 2015-05-20 2018-05-31 Новартис Аг Фармацевтическая комбинация эверолимуса и дактолисиба
CN106361717A (zh) * 2016-08-31 2017-02-01 佛山市弘泰药物研发有限公司 一种依维莫司胃溶型微丸片及其制备方法
CN106265569A (zh) * 2016-08-31 2017-01-04 佛山市弘泰药物研发有限公司 一种依维莫司口崩片及其制备方法
CN110114070A (zh) 2016-11-23 2019-08-09 诺华公司 使用依维莫司(everolimus)、达托里昔布(dactolisib)或二者增强免疫反应的方法
GB201704547D0 (en) * 2017-03-22 2017-05-03 Skipping Rocks Lab Ltd Method of encapsulating liquid products
KR102051806B1 (ko) * 2018-01-12 2019-12-04 주식회사 종근당 에베로리무스를 포함하는 안정화된 약제학적 제제
US10596165B2 (en) 2018-02-12 2020-03-24 resTORbio, Inc. Combination therapies
CN109431997B (zh) * 2018-12-20 2021-06-04 武汉科福新药有限责任公司 一种雷帕霉素局部注射制剂及其制备方法
KR102285886B1 (ko) * 2019-10-22 2021-08-05 한국유나이티드제약 주식회사 콜린알포세레이트를 함유하는 서방성 소형 경구 투여 제제
CN114557966B (zh) * 2022-03-09 2023-07-04 上海方予健康医药科技有限公司 真空履带式烘箱生产依维莫司固体分散体的方法
WO2024058093A1 (ja) * 2022-09-16 2024-03-21 東和薬品株式会社 時限放出型顆粒およびその用途

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GB9221220D0 (en) 1992-10-09 1992-11-25 Sandoz Ag Organic componds
FR2736550B1 (fr) * 1995-07-14 1998-07-24 Sandoz Sa Composition pharmaceutique sous la forme d'une dispersion solide comprenant un macrolide et un vehicule
GB0008785D0 (en) * 2000-04-10 2000-05-31 Novartis Ag Organic compounds
GB0123400D0 (en) * 2001-09-28 2001-11-21 Novartis Ag Organic compounds
US20030203027A1 (en) * 2002-04-26 2003-10-30 Ethicon, Inc. Coating technique for deposition of drug substance on a substrate
AR045957A1 (es) 2003-10-03 2005-11-16 Novartis Ag Composicion farmaceutica y combinacion
US8758816B2 (en) * 2004-11-24 2014-06-24 Meda Pharmaceuticals Inc. Compositions comprising azelastine and methods of use thereof
WO2008016633A2 (en) * 2006-08-02 2008-02-07 Ariad Gene Therapeutics, Inc. Combination therapy
EA201071035A1 (ru) * 2008-03-05 2011-04-29 Панацеа Биотек Лимитед Фармацевтические композиции модифицированного высвобождения, содержащие микофенолат, и способ их получения
US20120064143A1 (en) * 2008-11-11 2012-03-15 The Board Of Regents Of The University Of Texas System Inhibition of mammalian target of rapamycin
EP2416782A1 (en) * 2009-04-09 2012-02-15 Alkermes Pharma Ireland Limited Controlled-release clozapine compositions
CN102138903B (zh) * 2011-03-17 2012-12-12 苏州特瑞药业有限公司 一种依维莫司固体口服药物组合物
KR101643219B1 (ko) * 2011-10-06 2016-07-27 노파르티스 아게 40-o-(2-히드록시)에틸-라파마이신을 포함하는 제약 조성물

Also Published As

Publication number Publication date
HK1212899A1 (zh) 2016-06-24
EA201591830A1 (ru) 2016-02-29
US20160045441A1 (en) 2016-02-18
SG11201506466WA (en) 2015-10-29
IL241254A0 (en) 2015-11-30
CN105307640A (zh) 2016-02-03
BR112015021112A2 (pt) 2017-07-18
EP2976064B1 (en) 2017-04-19
US20180161280A1 (en) 2018-06-14
TW201503912A (zh) 2015-02-01
MA38430A1 (fr) 2017-03-31
PH12015501982A1 (en) 2016-01-18
EP2976064A1 (en) 2016-01-27
AR095672A1 (es) 2015-11-04
JP6356215B2 (ja) 2018-07-11
KR20150132399A (ko) 2015-11-25
TN2015000394A1 (en) 2017-01-03
ES2633496T3 (es) 2017-09-21
CA2907500A1 (en) 2014-09-25
AU2014233799A1 (en) 2015-09-10
JP2016515543A (ja) 2016-05-30
PE20151810A1 (es) 2015-12-04
WO2014147567A1 (en) 2014-09-25

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