WO2016153222A3 - Pharmaceutical composition comprising potassium salt of telmisartan, and preparation method therefor - Google Patents

Pharmaceutical composition comprising potassium salt of telmisartan, and preparation method therefor Download PDF

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Publication number
WO2016153222A3
WO2016153222A3 PCT/KR2016/002743 KR2016002743W WO2016153222A3 WO 2016153222 A3 WO2016153222 A3 WO 2016153222A3 KR 2016002743 W KR2016002743 W KR 2016002743W WO 2016153222 A3 WO2016153222 A3 WO 2016153222A3
Authority
WO
WIPO (PCT)
Prior art keywords
telmisartan
preparation
present
formulation
pharmaceutical composition
Prior art date
Application number
PCT/KR2016/002743
Other languages
French (fr)
Korean (ko)
Other versions
WO2016153222A2 (en
Inventor
박영준
박상미
조중명
노성구
Original Assignee
크리스탈지노믹스(주)
아주대학교산학협력단
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 크리스탈지노믹스(주), 아주대학교산학협력단 filed Critical 크리스탈지노믹스(주)
Publication of WO2016153222A2 publication Critical patent/WO2016153222A2/en
Publication of WO2016153222A3 publication Critical patent/WO2016153222A3/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
    • 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
    • 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
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4164—1,3-Diazoles
    • A61K31/4184—1,3-Diazoles condensed with carbocyclic rings, e.g. benzimidazoles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • 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
    • A61K9/2009—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
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • 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
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/12—Antihypertensives

Landscapes

  • Health & Medical Sciences (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)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Inorganic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)

Abstract

The present invention relates to a pharmaceutical composition containing a potassium salt of telmisartan, which is an angiotensin II receptor antagonist, and a preparation method therefor. The present invention can provide a granule or powder form of a solid formulation with improved drug dissolution and stability of a telmisartan-containing formulation, and a method for preparing capsules and tablets containing the same. Also, the composition and preparation method according to the present invention are industrially advanced techniques which allow for very easier preparation of telmisartan as a single component or a composite agent combined with other diuretics or high blood pressure-related components compared to a pharmaceutical composition containing telmisartan or salts thereof, thereby achieving significant improvements in terms of production time and cost. The size of a dosage formulation can also be significantly reduced compared to conventional formulations, thereby enhancing medication compliance of patients taking the formulation for a long period of time. In addition, the present invention can provide a composition containing a potassium salt of telmisartan which is capable of significantly improving hygroscopicity of a product, which has been a problem of existing formulations, and maintaining stability in typical packing materials.
PCT/KR2016/002743 2015-03-20 2016-03-18 Pharmaceutical composition comprising potassium salt of telmisartan, and preparation method therefor WO2016153222A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR10-2015-0038969 2015-03-20
KR1020150038969A KR20160112732A (en) 2015-03-20 2015-03-20 Pharmaceutical compositions comprising potassium salt of telmisartan and Preparation methods thereof

Publications (2)

Publication Number Publication Date
WO2016153222A2 WO2016153222A2 (en) 2016-09-29
WO2016153222A3 true WO2016153222A3 (en) 2016-11-17

Family

ID=56978240

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/KR2016/002743 WO2016153222A2 (en) 2015-03-20 2016-03-18 Pharmaceutical composition comprising potassium salt of telmisartan, and preparation method therefor

Country Status (2)

Country Link
KR (1) KR20160112732A (en)
WO (1) WO2016153222A2 (en)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021148347A1 (en) * 2020-01-20 2021-07-29 Zakłady Farmaceutyczne POLPHARMA S.A. Bilayer tablet comprising telmisartan and amlodipine

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20070061583A (en) * 2004-10-15 2007-06-13 테바 파마슈티컬 인더스트리즈 리미티드 Process for preparing telmisartan
WO2007147889A2 (en) * 2006-06-23 2007-12-27 Krka, Tovarna Zdravil, D.D., Novo Mesto Preparation of telmisartan salts
KR20100128247A (en) * 2009-05-27 2010-12-07 (주)다산메디켐 Multi-layer tablet comprising effervescent layer
KR20110085307A (en) * 2010-01-20 2011-07-27 한올바이오파마주식회사 Oral solid dosage form comprising poorly soluble drugs
KR101302883B1 (en) * 2012-07-23 2013-09-05 삼일제약주식회사 Pharmaceutical composition comprising telmisartan with improved stability and preparation method thereof

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20070061583A (en) * 2004-10-15 2007-06-13 테바 파마슈티컬 인더스트리즈 리미티드 Process for preparing telmisartan
WO2007147889A2 (en) * 2006-06-23 2007-12-27 Krka, Tovarna Zdravil, D.D., Novo Mesto Preparation of telmisartan salts
KR20100128247A (en) * 2009-05-27 2010-12-07 (주)다산메디켐 Multi-layer tablet comprising effervescent layer
KR20110085307A (en) * 2010-01-20 2011-07-27 한올바이오파마주식회사 Oral solid dosage form comprising poorly soluble drugs
KR101302883B1 (en) * 2012-07-23 2013-09-05 삼일제약주식회사 Pharmaceutical composition comprising telmisartan with improved stability and preparation method thereof

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
REDDY, K. S. ET AL.: "An Efficient and Impurity-Free Process for Telmisartan: An Antihypertensive Drug", ORGANIC PROCESS RESEARCH & DEVELOPMENT, vol. 11, no. 1, 2007, pages 81 - 85, XP002548424 *

Also Published As

Publication number Publication date
KR20160112732A (en) 2016-09-28
WO2016153222A2 (en) 2016-09-29

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