CA3037328C - Tofacitinib oral sustained release dosage forms - Google Patents

Tofacitinib oral sustained release dosage forms Download PDF

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Publication number
CA3037328C
CA3037328C CA3037328A CA3037328A CA3037328C CA 3037328 C CA3037328 C CA 3037328C CA 3037328 A CA3037328 A CA 3037328A CA 3037328 A CA3037328 A CA 3037328A CA 3037328 C CA3037328 C CA 3037328C
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CA
Canada
Prior art keywords
tofacitinib
coating
dosage form
water
pharmaceutically acceptable
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
Application number
CA3037328A
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English (en)
French (fr)
Other versions
CA3037328A1 (en
Inventor
Scott Max Herbig
Sriram Krishnaswami
Joseph Kushner, Iv
Manisha LAMBA
Thomas C. STOCK
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.)
Pfizer Corp SRL
Original Assignee
Pfizer Corp SRL
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=50819757&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA3037328(C) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Pfizer Corp SRL filed Critical Pfizer Corp SRL
Publication of CA3037328A1 publication Critical patent/CA3037328A1/en
Application granted granted Critical
Publication of CA3037328C publication Critical patent/CA3037328C/en
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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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • 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
    • A61K31/495—Heterocyclic 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
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic 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
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A61K31/52—Purines, e.g. adenine
    • 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
    • A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0004—Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
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    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • A—HUMAN NECESSITIES
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    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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    • 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
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    • 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
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    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • 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
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    • A61K9/00—Medicinal preparations characterised by special physical form
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    • A61K9/4891—Coated capsules; Multilayered drug free capsule shells
    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
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    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • A—HUMAN NECESSITIES
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Diabetes (AREA)
  • Rheumatology (AREA)
  • Endocrinology (AREA)
  • Pulmonology (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Dermatology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Hematology (AREA)
  • Pain & Pain Management (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Transplantation (AREA)
  • Obesity (AREA)
  • Emergency Medicine (AREA)
  • Hospice & Palliative Care (AREA)
  • Oncology (AREA)
  • Psychiatry (AREA)
  • Urology & Nephrology (AREA)
CA3037328A 2013-03-16 2014-03-12 Tofacitinib oral sustained release dosage forms Active CA3037328C (en)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US201361802479P 2013-03-16 2013-03-16
US61/802479 2013-03-16
US201361864059P 2013-08-09 2013-08-09
US61/864059 2013-08-09
US201461934428P 2014-01-31 2014-01-31
US61/934428 2014-01-31
CA2905604A CA2905604C (en) 2013-03-16 2014-03-12 Tofacitinib oral sustained release dosage forms

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
CA2905604A Division CA2905604C (en) 2013-03-16 2014-03-12 Tofacitinib oral sustained release dosage forms

Publications (2)

Publication Number Publication Date
CA3037328A1 CA3037328A1 (en) 2014-09-25
CA3037328C true CA3037328C (en) 2023-01-24

Family

ID=50819757

Family Applications (2)

Application Number Title Priority Date Filing Date
CA3037328A Active CA3037328C (en) 2013-03-16 2014-03-12 Tofacitinib oral sustained release dosage forms
CA2905604A Active CA2905604C (en) 2013-03-16 2014-03-12 Tofacitinib oral sustained release dosage forms

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Application Number Title Priority Date Filing Date
CA2905604A Active CA2905604C (en) 2013-03-16 2014-03-12 Tofacitinib oral sustained release dosage forms

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US (4) US9937181B2 (cg-RX-API-DMAC7.html)
EP (3) EP2968155B1 (cg-RX-API-DMAC7.html)
JP (3) JP6041823B2 (cg-RX-API-DMAC7.html)
KR (5) KR20150131238A (cg-RX-API-DMAC7.html)
CN (2) CN105101952B (cg-RX-API-DMAC7.html)
AU (2) AU2014233850B2 (cg-RX-API-DMAC7.html)
BR (1) BR112015020453B1 (cg-RX-API-DMAC7.html)
CA (2) CA3037328C (cg-RX-API-DMAC7.html)
CY (1) CY1124007T1 (cg-RX-API-DMAC7.html)
DK (1) DK2968155T3 (cg-RX-API-DMAC7.html)
ES (1) ES2865134T3 (cg-RX-API-DMAC7.html)
HU (1) HUE053911T2 (cg-RX-API-DMAC7.html)
IL (3) IL241400B (cg-RX-API-DMAC7.html)
MX (1) MX2021000550A (cg-RX-API-DMAC7.html)
NZ (2) NZ710792A (cg-RX-API-DMAC7.html)
PL (1) PL2968155T3 (cg-RX-API-DMAC7.html)
PT (1) PT2968155T (cg-RX-API-DMAC7.html)
SG (2) SG11201506103UA (cg-RX-API-DMAC7.html)
SI (1) SI2968155T1 (cg-RX-API-DMAC7.html)
TW (1) TWI619516B (cg-RX-API-DMAC7.html)
WO (1) WO2014147526A1 (cg-RX-API-DMAC7.html)
ZA (2) ZA201505468B (cg-RX-API-DMAC7.html)

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JP2759924B2 (ja) 1995-08-11 1998-05-28 株式会社ゼクセル 燃料噴射装置の噴射時期検出装置
JP6041823B2 (ja) 2013-03-16 2016-12-14 ファイザー・インク トファシチニブの経口持続放出剤形
GB201402070D0 (en) * 2014-02-07 2014-03-26 Galapagos Nv Pharmaceutical compositions for the treatment of inflammatory disorders
WO2015198225A1 (en) * 2014-06-23 2015-12-30 Sun Pharmaceutical Industries Limited Oral pharmaceutical composition of tofacitinib
WO2016020901A1 (en) 2014-08-07 2016-02-11 Acerta Pharma B.V. Methods of treating cancers, immune and autoimmune diseases, and inflammatory diseases based on btk occupancy and btk resynthesis rate
CN104622827A (zh) * 2015-03-05 2015-05-20 重庆华邦制药有限公司 托法替布片剂及其制备方法
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JP6796083B2 (ja) * 2015-06-09 2020-12-02 カプスゲル・ベルギウム・ナムローゼ・フェンノートシャップＣａｐｓｕｇｅｌ Ｂｅｌｇｉｕｍ ＮＶ カプセル中の薬剤の噴霧乾燥ディスパーションからの迅速な溶解を達成するための製剤
US20180214383A1 (en) * 2015-07-16 2018-08-02 National University Of Singapore Printing drug tablets with fully customizable release profiles for personalized medicine
BR112017013253A2 (pt) * 2015-07-27 2018-02-27 Unichem Laboratories Limited comprimidos de desintegração oral, processo para produzir comprimido de desintegração oral contendo tofacitinibe ou seus sais farmaceuticamente aceitáveis, processo para produzir comprimido de desintegração oral, desintegrante, e edulcorantes
WO2017029587A1 (en) * 2015-08-19 2017-02-23 Sun Pharmaceutical Industries Limited Sustained release oral pharmaceutical compositions of tofacitinib
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