WO2013015599A3 - Pharmaceutical composition for oral administration comprising bisphosphonic acid or its salt - Google Patents

Pharmaceutical composition for oral administration comprising bisphosphonic acid or its salt Download PDF

Info

Publication number
WO2013015599A3
WO2013015599A3 PCT/KR2012/005898 KR2012005898W WO2013015599A3 WO 2013015599 A3 WO2013015599 A3 WO 2013015599A3 KR 2012005898 W KR2012005898 W KR 2012005898W WO 2013015599 A3 WO2013015599 A3 WO 2013015599A3
Authority
WO
WIPO (PCT)
Prior art keywords
pharmaceutical composition
salt
bisphosphonic acid
oral administration
present
Prior art date
Application number
PCT/KR2012/005898
Other languages
French (fr)
Other versions
WO2013015599A2 (en
Inventor
Min-Soo Kim
Chang-Yong SHIM
Myung-Young Park
Mi-Kyeong JU
Hyeon-Woo KANG
Gaya NOH
Original Assignee
Yuhan Corporation
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 Yuhan Corporation filed Critical Yuhan Corporation
Publication of WO2013015599A2 publication Critical patent/WO2013015599A2/en
Publication of WO2013015599A3 publication Critical patent/WO2013015599A3/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
    • A61K31/66—Phosphorus compounds
    • A61K31/675—Phosphorus compounds having nitrogen as a ring hetero atom, e.g. pyridoxal phosphate
    • 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
    • A61K31/66—Phosphorus compounds
    • A61K31/662—Phosphorus acids or esters thereof having P—C bonds, e.g. foscarnet, trichlorfon
    • A61K31/663—Compounds having two or more phosphorus acid groups or esters thereof, e.g. clodronic acid, pamidronic acid
    • 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
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • 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
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic 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
    • A61K9/14—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
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1635—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
    • A61K9/14—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
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1658—Proteins, e.g. albumin, gelatin
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2063—Proteins, e.g. gelatin
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846—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)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

The present invention provides a pharmaceutical composition for oral administration, comprising bisphosphonic acid or its pharmaceutically acceptable salt; and gelatin, polyvinylacetal diethylaminoacetate, or a mixture thereof as an absorption enhancer. The pharmaceutical composition according to the present invention remarkably increases gastrointestinal absorption of bisphosphonic acid or its salt, thereby accomplishing high bioavailability thereof. And also, because the pharmaceutical composition according to the present invention shows desired pharmacological effects at a significantly low dose of bisphosphonic acid or its salt, it can minimize any side effects originated from relatively high dose thereof.
PCT/KR2012/005898 2011-07-28 2012-07-24 Pharmaceutical composition for oral administration comprising bisphosphonic acid or its salt WO2013015599A2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR20110075051 2011-07-28
KR10-2011-0075051 2011-07-28

Publications (2)

Publication Number Publication Date
WO2013015599A2 WO2013015599A2 (en) 2013-01-31
WO2013015599A3 true WO2013015599A3 (en) 2013-04-11

Family

ID=47601645

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/KR2012/005898 WO2013015599A2 (en) 2011-07-28 2012-07-24 Pharmaceutical composition for oral administration comprising bisphosphonic acid or its salt

Country Status (2)

Country Link
KR (1) KR20130014376A (en)
WO (1) WO2013015599A2 (en)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR102011714B1 (en) * 2018-01-16 2019-08-19 동국제약 주식회사 Oral emulsion formulation comprising Risedronic acid or its salts and vitamin D and the method for preparation thereof

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR100400053B1 (en) * 1997-06-11 2003-09-29 더 프록터 앤드 갬블 캄파니 Film-coated tablet for improved upper gastrointestinal tract safety
US20040151774A1 (en) * 2002-10-31 2004-08-05 Pauletti Giovanni M. Therapeutic compositions for drug delivery to and through covering epithelia
US20070117781A1 (en) * 2003-09-29 2007-05-24 Koninklijke Philips Electronics, N.V. Pharmaceutical formulation with improved stability
JP2010275319A (en) * 2004-05-24 2010-12-09 Ajinomoto Co Inc Enteric solid oral dosage form of bisphosphonate containing chelating agent

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR100400053B1 (en) * 1997-06-11 2003-09-29 더 프록터 앤드 갬블 캄파니 Film-coated tablet for improved upper gastrointestinal tract safety
US20040151774A1 (en) * 2002-10-31 2004-08-05 Pauletti Giovanni M. Therapeutic compositions for drug delivery to and through covering epithelia
US20070117781A1 (en) * 2003-09-29 2007-05-24 Koninklijke Philips Electronics, N.V. Pharmaceutical formulation with improved stability
JP2010275319A (en) * 2004-05-24 2010-12-09 Ajinomoto Co Inc Enteric solid oral dosage form of bisphosphonate containing chelating agent

Also Published As

Publication number Publication date
KR20130014376A (en) 2013-02-07
WO2013015599A2 (en) 2013-01-31

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