MX2021002441A - 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.

Info

Publication number
MX2021002441A
MX2021002441A MX2021002441A MX2021002441A MX2021002441A MX 2021002441 A MX2021002441 A MX 2021002441A MX 2021002441 A MX2021002441 A MX 2021002441A MX 2021002441 A MX2021002441 A MX 2021002441A MX 2021002441 A MX2021002441 A MX 2021002441A
Authority
MX
Mexico
Prior art keywords
dosage form
pharmaceutical composition
lapatinib
pharmaceutically acceptable
present
Prior art date
Application number
MX2021002441A
Other languages
Spanish (es)
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
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 MX2021002441A publication Critical patent/MX2021002441A/en

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)

Abstract

The present invention discloses a novel pharmaceutical composition of lapatinib or a pharmaceutically acceptable salt thereof preferably oral solid dosage form of a tablet with pharmaceutically acceptable excipients and method of preparation thereof. The pharmaceutical composition of present invention comprises lapatinib ditosylate monohydrate with one or more pharmaceutically acceptable excipients selected from the group comprising of at least one diluent, at least one disintegrant, at least one binder, at least one lubricant, wherein the composition does not comprise microcrystalline cellulose and sodium starch glycolate. The pharmaceutical composition according to the present invention is economical and advanced dosage form over existing dosage form, with less side effects and time efficient, especially for large scale production, whereby the pharmaceutical composition shows a desired dissolution profile and higher stability with minimum use of excipients.
MX2021002441A 2018-09-03 2019-08-30 Novel composition of lapatinib of oral solid dosage form and method of manufacturing thereof. MX2021002441A (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 (1)

Publication Number Publication Date
MX2021002441A true MX2021002441A (en) 2021-03-25

Family

ID=69723001

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2021002441A MX2021002441A (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)

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2158913A1 (en) * 2008-08-25 2010-03-03 Ratiopharm GmbH Pharmaceutical composition comprising N-[3-chhloro-4-[(3-fluorophenyl)methoxy]phenyl]6-(5[[[2-(methylsulfonyl)ethyl]amino]methyl]-2-furyl]-4-quinazolinamine
EP2158912A1 (en) * 2008-08-25 2010-03-03 Ratiopharm GmbH Pharmaceutical composition comprising N-[3-chhloro-4-[3-fluorophenyl)methoxy)phenyl]6-[5[[[2-(methylsulfonyl)ethyl]amino]methyl]-2-furyl]-4-quinazolinamine
EP2572199B1 (en) * 2010-05-21 2017-03-08 Novartis AG Combination
WO2012017448A2 (en) * 2010-08-03 2012-02-09 Hetero Research Foundation Salts of lapatinib
WO2015145145A1 (en) * 2014-03-24 2015-10-01 Cipla Limited Pharmaceutical composition comprising lapatinib
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

Also Published As

Publication number Publication date
CL2021000512A1 (en) 2021-11-26
EP3846787A1 (en) 2021-07-14
BR112021004047A2 (en) 2021-05-25
PH12021550451A1 (en) 2021-09-27
ZA202101538B (en) 2022-07-27
WO2020049429A1 (en) 2020-03-12
EP3846787A4 (en) 2022-05-25

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