WO2011018185A3 - Pharmaceutical tablet comprising rosuvastatin calcium - Google Patents

Pharmaceutical tablet comprising rosuvastatin calcium Download PDF

Info

Publication number
WO2011018185A3
WO2011018185A3 PCT/EP2010/004796 EP2010004796W WO2011018185A3 WO 2011018185 A3 WO2011018185 A3 WO 2011018185A3 EP 2010004796 W EP2010004796 W EP 2010004796W WO 2011018185 A3 WO2011018185 A3 WO 2011018185A3
Authority
WO
WIPO (PCT)
Prior art keywords
rosuvastatin calcium
pharmaceutical tablet
tablet
core
polyvinylalcohol
Prior art date
Application number
PCT/EP2010/004796
Other languages
French (fr)
Other versions
WO2011018185A2 (en
Inventor
Marta Vivancos
Original Assignee
Synthon B.V.
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 Synthon B.V. filed Critical Synthon B.V.
Priority to EA201270269A priority Critical patent/EA201270269A1/en
Priority to AU2010281913A priority patent/AU2010281913A1/en
Priority to EP10739873A priority patent/EP2464344A2/en
Publication of WO2011018185A2 publication Critical patent/WO2011018185A2/en
Publication of WO2011018185A3 publication Critical patent/WO2011018185A3/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic 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
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2009Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/2027Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2095Tabletting 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/284Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/286Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose

Landscapes

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

Abstract

The invention relates to a tablet comprising: i) a compressed core, which comprises rosuvastatin calcium, a dibasic calcium phosphate, and at least one pharmaceutically acceptable excipient; and ii) moisture barrier layer around said core, which comprises a polyvinylalcohol, to a process for making the tablet and use in medicine.
PCT/EP2010/004796 2009-08-13 2010-07-29 Pharmaceutical tablet comprising rosuvastatin calcium WO2011018185A2 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
EA201270269A EA201270269A1 (en) 2009-08-13 2010-07-29 PHARMACEUTICAL TABLET CONTAINING ROSUVASTATIN CALCIUM
AU2010281913A AU2010281913A1 (en) 2009-08-13 2010-07-29 Pharmaceutical tablet comprising rosuvastatin calcium
EP10739873A EP2464344A2 (en) 2009-08-13 2010-07-29 Pharmaceutical tablet comprising rosuvastatin calcium

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US23354209P 2009-08-13 2009-08-13
US61/233,542 2009-08-13

Publications (2)

Publication Number Publication Date
WO2011018185A2 WO2011018185A2 (en) 2011-02-17
WO2011018185A3 true WO2011018185A3 (en) 2011-11-24

Family

ID=43334705

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2010/004796 WO2011018185A2 (en) 2009-08-13 2010-07-29 Pharmaceutical tablet comprising rosuvastatin calcium

Country Status (4)

Country Link
EP (1) EP2464344A2 (en)
AU (1) AU2010281913A1 (en)
EA (1) EA201270269A1 (en)
WO (1) WO2011018185A2 (en)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RO129060B1 (en) 2013-04-25 2014-11-28 Antibiotice S.A. Stable pharmaceutical composition with amorphous rosuvastatin calcium
CN104473899B (en) * 2014-12-19 2017-10-03 河南润弘制药股份有限公司 A kind of rosuvastatin calcium tablets agent and preparation method thereof
BR112019009709A2 (en) * 2016-11-15 2019-08-13 Lg Chemical Ltd combination preparation.
GB2622822A (en) 2022-09-28 2024-04-03 Novumgen Ltd A rapidly disintegrating tablet of rosuvastatin and its process of preparation

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040185102A1 (en) * 2002-12-20 2004-09-23 Pfizer Inc Dosage forms comprising a CETP inhibitor and an HMG-CoA reductase inhibitor
WO2006079611A1 (en) * 2005-01-31 2006-08-03 Ciba Specialty Chemicals Holding Inc. Crystalline forms of rosuvastatin calcium salt

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2648897B2 (en) 1991-07-01 1997-09-03 塩野義製薬株式会社 Pyrimidine derivatives
GB0001621D0 (en) 2000-01-26 2000-03-15 Astrazeneca Ab Pharmaceutical compositions
WO2008075320A2 (en) * 2006-12-21 2008-06-26 Ranbaxy Laboratories Limited Antilipidemic pharmaceutical compositions and process for preparation thereof

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040185102A1 (en) * 2002-12-20 2004-09-23 Pfizer Inc Dosage forms comprising a CETP inhibitor and an HMG-CoA reductase inhibitor
WO2006079611A1 (en) * 2005-01-31 2006-08-03 Ciba Specialty Chemicals Holding Inc. Crystalline forms of rosuvastatin calcium salt

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP2464344A2 *

Also Published As

Publication number Publication date
EP2464344A2 (en) 2012-06-20
EA201270269A1 (en) 2012-09-28
AU2010281913A1 (en) 2012-04-05
WO2011018185A2 (en) 2011-02-17

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