EP3846787A4 - Novel composition of lapatinib of oral solid dosage form and method of manufacturing thereof - Google Patents

Novel composition of lapatinib of oral solid dosage form and method of manufacturing thereof Download PDF

Info

Publication number
EP3846787A4
EP3846787A4 EP19857473.3A EP19857473A EP3846787A4 EP 3846787 A4 EP3846787 A4 EP 3846787A4 EP 19857473 A EP19857473 A EP 19857473A EP 3846787 A4 EP3846787 A4 EP 3846787A4
Authority
EP
European Patent Office
Prior art keywords
lapatinib
manufacturing
dosage form
solid dosage
oral solid
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.)
Pending
Application number
EP19857473.3A
Other languages
German (de)
French (fr)
Other versions
EP3846787A1 (en
Inventor
Dharmesh Mahendrabhai Shah
Aravind Manappa Badiger
Mukeshkumar Subhashchandra SHARMA
Madhavkumar Dilipbhai TRIVEDI
Harikrishnabhai Vinubhai PATEL
Prashant Karamshibhai PATEL
Prashant Kanaiyalal GANDHI
Nimitkumar Harishchandra PANCHAL
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.)
Bdr Pharmaceuticals International Private Ltd
Original Assignee
Bdr Pharmaceuticals International Private 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 Bdr Pharmaceuticals International Private Ltd filed Critical Bdr Pharmaceuticals International Private Ltd
Publication of EP3846787A1 publication Critical patent/EP3846787A1/en
Publication of EP3846787A4 publication Critical patent/EP3846787A4/en
Pending legal-status Critical Current

Links

Classifications

    • 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
    • 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
    • A61K31/517—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with carbocyclic ring systems, e.g. quinazoline, perimidine
    • 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
    • A61K9/2027—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
    • A61K9/20—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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
EP19857473.3A 2018-09-03 2019-08-30 Novel composition of lapatinib of oral solid dosage form and method of manufacturing thereof Pending EP3846787A4 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN201821032977 2018-09-03
PCT/IB2019/057324 WO2020049429A1 (en) 2018-09-03 2019-08-30 Novel composition of lapatinib of oral solid dosage form and method of manufacturing thereof

Publications (2)

Publication Number Publication Date
EP3846787A1 EP3846787A1 (en) 2021-07-14
EP3846787A4 true EP3846787A4 (en) 2022-05-25

Family

ID=69723001

Family Applications (1)

Application Number Title Priority Date Filing Date
EP19857473.3A Pending EP3846787A4 (en) 2018-09-03 2019-08-30 Novel composition of lapatinib of oral solid dosage form and method of manufacturing thereof

Country Status (7)

Country Link
EP (1) EP3846787A4 (en)
BR (1) BR112021004047A2 (en)
CL (1) CL2021000512A1 (en)
MX (1) MX2021002441A (en)
PH (1) PH12021550451A1 (en)
WO (1) WO2020049429A1 (en)
ZA (1) ZA202101538B (en)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010023188A1 (en) * 2008-08-25 2010-03-04 Ratiopharm Gmbh Pharmaceutical composition comprising n-[3-chloro-4-[(3- fluorophenyl)methoxy]phenyl]-6-[5[[[2-(methylsulfonyl)ethyl]amino]methyl]-2-furyl]-4- quinazolinamine
WO2010023187A1 (en) * 2008-08-25 2010-03-04 Ratiopharm Gmbh Pharmaceutical composition comprising n-[3-chloro-4-[(3- fluorophenyl)methoxy]phenyl]-6-[5[[[2-(methylsulfonyl)ethyl]amino]methyl]-2-furyl]-4- quinazolinamine
WO2011146710A1 (en) * 2010-05-21 2011-11-24 Glaxosmithkline Llc Combination
CN106511289A (en) * 2015-09-10 2017-03-22 湖北生物医药产业技术研究院有限公司 Benzenesulfonicacid lapatinib tablets and preparing method thereof

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2601178A4 (en) * 2010-08-03 2013-11-13 Hetero Research Foundation Salts of lapatinib
WO2015145145A1 (en) * 2014-03-24 2015-10-01 Cipla Limited Pharmaceutical composition comprising lapatinib

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010023188A1 (en) * 2008-08-25 2010-03-04 Ratiopharm Gmbh Pharmaceutical composition comprising n-[3-chloro-4-[(3- fluorophenyl)methoxy]phenyl]-6-[5[[[2-(methylsulfonyl)ethyl]amino]methyl]-2-furyl]-4- quinazolinamine
WO2010023187A1 (en) * 2008-08-25 2010-03-04 Ratiopharm Gmbh Pharmaceutical composition comprising n-[3-chloro-4-[(3- fluorophenyl)methoxy]phenyl]-6-[5[[[2-(methylsulfonyl)ethyl]amino]methyl]-2-furyl]-4- quinazolinamine
WO2011146710A1 (en) * 2010-05-21 2011-11-24 Glaxosmithkline Llc Combination
CN106511289A (en) * 2015-09-10 2017-03-22 湖北生物医药产业技术研究院有限公司 Benzenesulfonicacid lapatinib tablets and preparing method thereof

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of WO2020049429A1 *

Also Published As

Publication number Publication date
CL2021000512A1 (en) 2021-11-26
WO2020049429A1 (en) 2020-03-12
ZA202101538B (en) 2022-07-27
MX2021002441A (en) 2021-03-25
EP3846787A1 (en) 2021-07-14
BR112021004047A2 (en) 2021-05-25
PH12021550451A1 (en) 2021-09-27

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Designated state(s): AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR

DAV Request for validation of the european patent (deleted)
DAX Request for extension of the european patent (deleted)
A4 Supplementary search report drawn up and despatched

Effective date: 20220426

RIC1 Information provided on ipc code assigned before grant

Ipc: C07D 405/04 20060101ALI20220420BHEP

Ipc: A61K 31/517 20060101ALI20220420BHEP

Ipc: A61K 9/20 20060101AFI20220420BHEP