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IN2014DN07898A - - Google Patents

Info

Publication number
IN2014DN07898A
IN2014DN07898A IN7898DEN2014A IN2014DN07898A IN 2014DN07898 A IN2014DN07898 A IN 2014DN07898A IN 7898DEN2014 A IN7898DEN2014 A IN 7898DEN2014A IN 2014DN07898 A IN2014DN07898 A IN 2014DN07898A
Authority
IN
India
Prior art keywords
dosage form
relates
pharmaceutical dosage
oral pharmaceutical
imatinib
Prior art date
Application number
Inventor
Ravi Kochhar
Annavarapu Ramesh
Suneel Kumar Vasireddy
Roshan Lal Sandal
Original Assignee
Ranbaxy Lab 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 Ranbaxy Lab Ltd filed Critical Ranbaxy Lab Ltd
Priority to IN7898DEN2014 priority Critical patent/IN2014DN07898A/en
Publication of IN2014DN07898A publication Critical patent/IN2014DN07898A/en

Links

Classifications

    • 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
    • A61K31/506—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/03—Containers specially adapted for medical or pharmaceutical purposes for pills or tablets
    • A61J1/035—Blister-type containers
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • A61K9/1688—Processes resulting in pure drug agglomerate optionally containing up to 5% of excipient
    • 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
    • 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
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • 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
    • 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
    • A61K9/2893—Tablet coating processes
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4833—Encapsulating processes; Filling of capsules
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
    • B65D81/24—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants
    • B65D81/26—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants with provision for draining away, or absorbing, or removing by ventilation, fluids, e.g. exuded by contents; Applications of corrosion inhibitors or desiccators
    • B65D81/264—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants with provision for draining away, or absorbing, or removing by ventilation, fluids, e.g. exuded by contents; Applications of corrosion inhibitors or desiccators for absorbing liquids
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1611—Inorganic compounds
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds

Landscapes

  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Food Science & Technology (AREA)
  • Mechanical Engineering (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

The present invention relates to a stable oral pharmaceutical dosage form comprising imatinib mesylate and one or more pharmaceutically acceptable excipients wherein the amount of imatinib calculated as free base is more than 80% by weight based on the total weight of the oral pharmaceutical dosage form, and wherein the oral dosage form does not show polymorphic conversion after storage at 40°C and 75% relative humidity for three months. It also relates to processes for the preparation thereof.
IN7898DEN2014 2012-02-21 2013-02-15 IN2014DN07898A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
IN7898DEN2014 IN2014DN07898A (en) 2012-02-21 2013-02-15

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
IN499DE2012 2012-02-21
IN498DE2012 2012-02-21
IN7898DEN2014 IN2014DN07898A (en) 2012-02-21 2013-02-15
PCT/IB2013/051261 WO2013124774A1 (en) 2012-02-21 2013-02-15 Stable dosage forms of imatinib mesylate

Publications (1)

Publication Number Publication Date
IN2014DN07898A true IN2014DN07898A (en) 2015-04-24

Family

ID=48093035

Family Applications (1)

Application Number Title Priority Date Filing Date
IN7898DEN2014 IN2014DN07898A (en) 2012-02-21 2013-02-15

Country Status (7)

Country Link
US (1) US20160015708A1 (en)
EP (1) EP2817030A1 (en)
AU (1) AU2013223749A1 (en)
IN (1) IN2014DN07898A (en)
SG (1) SG11201405099UA (en)
WO (1) WO2013124774A1 (en)
ZA (1) ZA201406139B (en)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2803353B1 (en) * 2013-05-14 2018-05-23 Hetero Research Foundation Compositions of Imatinib
WO2019229648A1 (en) * 2018-05-28 2019-12-05 Shivalik Rasayan Limited Oral compositions of imatinib mesylate

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5521184A (en) 1992-04-03 1996-05-28 Ciba-Geigy Corporation Pyrimidine derivatives and processes for the preparation thereof
CO4940418A1 (en) 1997-07-18 2000-07-24 Novartis Ag MODIFICATION OF A CRYSTAL OF A DERIVATIVE OF N-PHENYL-2-PIRIMIDINAMINE, PROCESSES FOR ITS MANUFACTURE AND USE
ITMI992711A1 (en) 1999-12-27 2001-06-27 Novartis Ag ORGANIC COMPOUNDS
SK287335B6 (en) 2000-10-27 2010-07-07 Novartis Ag Use of 4-(4-methylpiperazin-1-ylmethyl)-N-[4-methyl-3-(4-pyridin- 3-yl)pyrimidin-2-ylamino)phenyl]-benzamide for the preparation of pharmaceutical compositions for the treatment of gastrointestinal stromal tumours
EP1243524A3 (en) * 2001-03-16 2004-04-07 Pfizer Products Inc. Pharmaceutical kit for oxygen-sensitive drugs
GB0209265D0 (en) 2002-04-23 2002-06-05 Novartis Ag Organic compounds
EP1720853B2 (en) 2004-02-11 2023-06-28 Natco Pharma Limited Pharmaceutical compositions of the 2 crystalline form of imatinib mesylate for use in the treatment of chronic myelogenous leukemia
ATE459341T1 (en) 2005-06-03 2010-03-15 Elan Pharma Int Ltd NANOPARTICLE SHAPED IMATINIB MESYLATE FORMULATIONS
KR20070096729A (en) 2006-03-24 2007-10-02 고쿠리츠다이가쿠호진 규슈다이가쿠 Organic compounds
BRPI0817946A2 (en) 2007-09-25 2015-05-05 Teva Pharma Stable imatinib compositions
EP2552447A4 (en) 2010-03-29 2013-09-11 Hetero Research Foundation Stable pharmaceutical composition of imatinib
WO2011158255A1 (en) * 2010-06-16 2011-12-22 Aptuit Laurus Private Limited Process for preparation of stable imatintb mesylate alpha form
RU2013110058A (en) * 2010-08-11 2014-09-20 Синтон Б.В. PHARMACEUTICAL GRANULATE CONTAINING IMATINIB MESILATE

Also Published As

Publication number Publication date
ZA201406139B (en) 2015-05-27
EP2817030A1 (en) 2014-12-31
AU2013223749A1 (en) 2014-09-11
SG11201405099UA (en) 2014-10-30
WO2013124774A1 (en) 2013-08-29
US20160015708A1 (en) 2016-01-21

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