WO2018211336A3 - Solid dosage form containing sorafenib tosylate - Google Patents

Solid dosage form containing sorafenib tosylate Download PDF

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Publication number
WO2018211336A3
WO2018211336A3 PCT/IB2018/001009 IB2018001009W WO2018211336A3 WO 2018211336 A3 WO2018211336 A3 WO 2018211336A3 IB 2018001009 W IB2018001009 W IB 2018001009W WO 2018211336 A3 WO2018211336 A3 WO 2018211336A3
Authority
WO
WIPO (PCT)
Prior art keywords
dosage form
solid dosage
sorafenib tosylate
form containing
containing sorafenib
Prior art date
Application number
PCT/IB2018/001009
Other languages
French (fr)
Other versions
WO2018211336A2 (en
Inventor
Mohit Jaya ABRAHAM
S. Gattani YOGESH
He Yen FANG
Chieh Shan LAI
Original Assignee
Alvogen Malta Operations (Row) Ltd
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 Alvogen Malta Operations (Row) Ltd filed Critical Alvogen Malta Operations (Row) Ltd
Priority to PCT/IB2018/001009 priority Critical patent/WO2018211336A2/en
Publication of WO2018211336A2 publication Critical patent/WO2018211336A2/en
Publication of WO2018211336A3 publication Critical patent/WO2018211336A3/en

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
    • A61K9/2022—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
    • 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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Epidemiology (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)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

The invention relates to a solid dosage form containing Sorafenib tosylate which is used in pharmacy and medicine. An advantage of the composition according to the invention is improved bioavailability and tolerability, possibility of its applicable at lower optimal therapeutic doses that created balance between reduction of adverse drug reactions and abilility to overcome acquired resistance in the course of therapy. A solid dosage form, according to the invention, comprising Sorafenib tosylate, a precipitation inhibitor in an amount of 0.5 to 25% by weight, preferably from 0.5% to 15%, and most preferably from 1% to 10% and optionally other excipients.
PCT/IB2018/001009 2018-09-07 2018-09-07 Solid dosage form containing sorafenib tosylate WO2018211336A2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/IB2018/001009 WO2018211336A2 (en) 2018-09-07 2018-09-07 Solid dosage form containing sorafenib tosylate

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/IB2018/001009 WO2018211336A2 (en) 2018-09-07 2018-09-07 Solid dosage form containing sorafenib tosylate

Publications (2)

Publication Number Publication Date
WO2018211336A2 WO2018211336A2 (en) 2018-11-22
WO2018211336A3 true WO2018211336A3 (en) 2019-06-13

Family

ID=63683233

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2018/001009 WO2018211336A2 (en) 2018-09-07 2018-09-07 Solid dosage form containing sorafenib tosylate

Country Status (1)

Country Link
WO (1) WO2018211336A2 (en)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA3155855A1 (en) * 2020-12-07 2022-06-07 Tianjin Creatron Biotechnology Co., Ltd. Sorafenib pharmaceutical composition with high bioavailability and use thereof
WO2023155182A1 (en) 2022-02-21 2023-08-24 北京睿创康泰医药研究院有限公司 Low-dose, high-exposure sorafenib or donafenib oral formulation and use thereof

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006094626A1 (en) * 2005-03-07 2006-09-14 Bayer Healthcare Ag Pharmaceutical composition comprising an omega- carboxyaryl substituted diphenyl urea for the treatment of cancer

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1140840B1 (en) 1999-01-13 2006-03-22 Bayer Pharmaceuticals Corp. -g(v)-carboxyaryl substituted diphenyl ureas as raf kinase inhibitors
JP5215666B2 (en) 2004-09-29 2013-06-19 バイエル・ファルマ・アクチェンゲゼルシャフト Thermodynamically stable form of BAY 43-9006 tosylate
TW200820991A (en) 2006-07-10 2008-05-16 Elan Pharma Int Ltd Nanoparticulate sorafenib formulations

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006094626A1 (en) * 2005-03-07 2006-09-14 Bayer Healthcare Ag Pharmaceutical composition comprising an omega- carboxyaryl substituted diphenyl urea for the treatment of cancer

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
DR T MANGILAL: "Formulation and evaluation of sorafenib tosylate immediate release", WORLD JOURNAL OF PHARMACEUTICAL RESEARCH, WORLD JOURNAL OF PHARMACEUTICAL RESEARCH, IN, vol. 4, June 2015 (2015-06-01), pages 841 - 858, XP009512848, ISSN: 2277-7105 *
MALLIKARJUN V: "In-vitro and kinetic studies of immediate release sorafenib tosylate film coated tablets", WORLD JOURNAL OF PHARMACEUTICAL RESEARCH, WORLD JOURNAL OF PHARMACEUTICAL RESEARCH, IN, vol. 7, May 2018 (2018-05-01), pages 931 - 944, XP009512849, ISSN: 2277-7105 *

Also Published As

Publication number Publication date
WO2018211336A2 (en) 2018-11-22

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