AU2014362999B2 - Pharmaceutical dosage forms - Google Patents

Pharmaceutical dosage forms Download PDF

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Publication number
AU2014362999B2
AU2014362999B2 AU2014362999A AU2014362999A AU2014362999B2 AU 2014362999 B2 AU2014362999 B2 AU 2014362999B2 AU 2014362999 A AU2014362999 A AU 2014362999A AU 2014362999 A AU2014362999 A AU 2014362999A AU 2014362999 B2 AU2014362999 B2 AU 2014362999B2
Authority
AU
Australia
Prior art keywords
capsule
blend
weight
pharmaceutical
drug substance
Prior art date
Legal status (The legal status 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 status listed.)
Active, expires
Application number
AU2014362999A
Other languages
English (en)
Other versions
AU2014362999A1 (en
Inventor
Suzie RIBEIRO
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Novartis AG
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
Application filed by Novartis AG filed Critical Novartis AG
Publication of AU2014362999A1 publication Critical patent/AU2014362999A1/en
Application granted granted Critical
Publication of AU2014362999B2 publication Critical patent/AU2014362999B2/en
Active legal-status Critical Current
Adjusted expiration legal-status Critical

Links

Classifications

    • 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
    • A61K31/495Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/506Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
    • 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
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • 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
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38Cellulose; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • 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
    • A61K9/4833Encapsulating processes; Filling of capsules
    • 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
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4858Organic 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
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4866Organic macromolecular compounds
    • 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
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Inorganic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
AU2014362999A 2013-12-13 2014-12-11 Pharmaceutical dosage forms Active 2036-11-05 AU2014362999B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201361915606P 2013-12-13 2013-12-13
US61/915,606 2013-12-13
PCT/IB2014/066820 WO2015087283A1 (en) 2013-12-13 2014-12-11 Pharmaceutical dosage forms

Publications (2)

Publication Number Publication Date
AU2014362999A1 AU2014362999A1 (en) 2016-05-26
AU2014362999B2 true AU2014362999B2 (en) 2017-10-12

Family

ID=52146563

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2014362999A Active 2036-11-05 AU2014362999B2 (en) 2013-12-13 2014-12-11 Pharmaceutical dosage forms

Country Status (33)

Country Link
US (3) US10278969B2 (enExample)
EP (2) EP3079667B1 (enExample)
JP (2) JP6522619B2 (enExample)
KR (1) KR102349893B1 (enExample)
CN (2) CN105813635A (enExample)
AR (1) AR098716A1 (enExample)
AU (1) AU2014362999B2 (enExample)
CA (1) CA2930055C (enExample)
CL (1) CL2016001436A1 (enExample)
CY (1) CY1122063T1 (enExample)
DK (1) DK3079667T3 (enExample)
EA (1) EA036288B1 (enExample)
EC (1) ECSP16060194A (enExample)
ES (1) ES2745983T3 (enExample)
HR (1) HRP20191691T1 (enExample)
HU (1) HUE045156T2 (enExample)
IL (1) IL245705B (enExample)
LT (1) LT3079667T (enExample)
MA (1) MA39175A1 (enExample)
MX (1) MX2016007652A (enExample)
MY (1) MY194303A (enExample)
NZ (2) NZ719865A (enExample)
PE (1) PE20160851A1 (enExample)
PH (1) PH12016501039B1 (enExample)
PL (1) PL3079667T3 (enExample)
PT (1) PT3079667T (enExample)
RS (1) RS59270B1 (enExample)
SG (1) SG10202104627UA (enExample)
SI (1) SI3079667T1 (enExample)
TN (1) TN2016000207A1 (enExample)
TW (2) TWI721938B (enExample)
WO (1) WO2015087283A1 (enExample)
ZA (1) ZA201603064B (enExample)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2014362999B2 (en) 2013-12-13 2017-10-12 Novartis Ag Pharmaceutical dosage forms
MA41611A (fr) * 2015-02-23 2018-01-02 Omthera Pharmaceuticals Inc Préparations en milli-capsules comprenant des acides gras polyinsaturés libres
EP3675827A1 (en) 2017-08-30 2020-07-08 Acadia Pharmaceuticals Inc. Formulations of pimavanserin
EP4262774A4 (en) * 2020-12-18 2024-11-13 QED Therapeutics, Inc. METHODS FOR TREATING ACHINDROPLASIA
CN117042738A (zh) * 2021-03-17 2023-11-10 埃科特莱茵药品有限公司 药物剂量系统

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006000420A1 (en) * 2004-06-24 2006-01-05 Novartis Ag Pyrimidine urea derivatives as kinase inhibitors
WO2011071821A1 (en) * 2009-12-07 2011-06-16 Novartis Ag Crystalline forms of 3-(2,6-dichloro-3,5-dimethoxy-phenyl)-1-{6-[4-(4-ethyl-piperazin-1-yl)-phenylamino]-pyrimidin-4-yl}-1-methyl-urea and salts thereof.

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
NZ591443A (en) 2005-09-22 2013-04-26 Intermune Inc Granule formation of pirfenidone and pharmaceutically acceptable excipients
CN101336237B (zh) 2005-12-21 2015-09-30 诺华股份有限公司 作为fgf抑制剂的嘧啶基芳基脲衍生物
FR2910813B1 (fr) * 2006-12-28 2009-02-06 Sanofi Aventis Sa Nouvelle utilisation therapeutique pour le traitement des leucemies
ES2610931T3 (es) 2011-07-01 2017-05-04 Novartis Ag Terapia de combinación
AU2014287209B2 (en) 2013-07-09 2019-01-24 Dana-Farber Cancer Institute, Inc. Kinase inhibitors for the treatment of disease
AU2014362999B2 (en) 2013-12-13 2017-10-12 Novartis Ag Pharmaceutical dosage forms
KR20170060042A (ko) 2014-09-13 2017-05-31 노파르티스 아게 Alk 억제제의 조합 요법
JP2018509448A (ja) 2015-03-25 2018-04-05 ノバルティス アーゲー 組合せ医薬
CA2986441A1 (en) 2015-06-12 2016-12-15 Dana-Farber Cancer Institute, Inc. Combination therapy of transcription inhibitors and kinase inhibitors

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006000420A1 (en) * 2004-06-24 2006-01-05 Novartis Ag Pyrimidine urea derivatives as kinase inhibitors
WO2011071821A1 (en) * 2009-12-07 2011-06-16 Novartis Ag Crystalline forms of 3-(2,6-dichloro-3,5-dimethoxy-phenyl)-1-{6-[4-(4-ethyl-piperazin-1-yl)-phenylamino]-pyrimidin-4-yl}-1-methyl-urea and salts thereof.

Also Published As

Publication number Publication date
KR102349893B1 (ko) 2022-01-10
TN2016000207A1 (en) 2017-10-06
IL245705B (en) 2021-05-31
US20200054632A1 (en) 2020-02-20
HUE045156T2 (hu) 2019-12-30
US20170007602A1 (en) 2017-01-12
JP2017502941A (ja) 2017-01-26
ECSP16060194A (es) 2019-07-31
CA2930055A1 (en) 2015-06-18
JP6522619B2 (ja) 2019-05-29
PH12016501039A1 (en) 2016-07-04
JP2019142927A (ja) 2019-08-29
US10278969B2 (en) 2019-05-07
PH12016501039B1 (en) 2024-01-19
EP3597179A1 (en) 2020-01-22
PE20160851A1 (es) 2016-09-14
HK1223833A1 (en) 2017-08-11
AU2014362999A1 (en) 2016-05-26
CL2016001436A1 (es) 2017-02-10
LT3079667T (lt) 2019-09-10
NZ760002A (en) 2022-07-29
CN116942629A (zh) 2023-10-27
NZ719865A (en) 2022-07-29
EP3079667A1 (en) 2016-10-19
MA39175A1 (fr) 2017-10-31
EA201691231A1 (ru) 2016-10-31
SI3079667T1 (sl) 2019-10-30
IL245705A0 (en) 2016-07-31
ES2745983T3 (es) 2020-03-04
HRP20191691T1 (hr) 2019-12-27
CY1122063T1 (el) 2020-11-25
PT3079667T (pt) 2019-10-10
DK3079667T3 (da) 2019-09-09
EA036288B1 (ru) 2020-10-22
US11160804B2 (en) 2021-11-02
TWI800759B (zh) 2023-05-01
WO2015087283A1 (en) 2015-06-18
TW202128137A (zh) 2021-08-01
TWI721938B (zh) 2021-03-21
TW201605494A (zh) 2016-02-16
AR098716A1 (es) 2016-06-08
EP3597179B1 (en) 2024-04-03
MX2016007652A (es) 2016-10-13
RS59270B1 (sr) 2019-10-31
ZA201603064B (en) 2017-07-26
KR20160096093A (ko) 2016-08-12
JP6804585B2 (ja) 2020-12-23
SG10202104627UA (en) 2021-06-29
PL3079667T3 (pl) 2020-02-28
US20220265651A1 (en) 2022-08-25
CA2930055C (en) 2023-07-04
MY194303A (en) 2022-11-27
CN105813635A (zh) 2016-07-27
EP3079667B1 (en) 2019-06-26

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FGA Letters patent sealed or granted (standard patent)
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Filing date: 20211105

NDA Extension of term for standard patent accepted (sect.70)

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Extension date: 20361105