WO2004034959A3 - Multiparticulate modified release composition comprising beraprost - Google Patents

Multiparticulate modified release composition comprising beraprost Download PDF

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Publication number
WO2004034959A3
WO2004034959A3 PCT/IB2003/006415 IB0306415W WO2004034959A3 WO 2004034959 A3 WO2004034959 A3 WO 2004034959A3 IB 0306415 W IB0306415 W IB 0306415W WO 2004034959 A3 WO2004034959 A3 WO 2004034959A3
Authority
WO
WIPO (PCT)
Prior art keywords
release
component
beraprost sodium
ingestion
beraprost
Prior art date
Application number
PCT/IB2003/006415
Other languages
French (fr)
Other versions
WO2004034959A2 (en
Inventor
Paul Stark
Theresa Jeary
Fiona Palmer
Jackie Butler
Janet Codd
Original Assignee
Elan Corp Plc
Paul Stark
Theresa Jeary
Fiona Palmer
Jackie Butler
Janet Codd
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 Elan Corp Plc, Paul Stark, Theresa Jeary, Fiona Palmer, Jackie Butler, Janet Codd filed Critical Elan Corp Plc
Priority to AU2003296852A priority Critical patent/AU2003296852A1/en
Publication of WO2004034959A2 publication Critical patent/WO2004034959A2/en
Publication of WO2004034959A3 publication Critical patent/WO2004034959A3/en

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    • 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
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/34—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide
    • A61K31/343—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide condensed with a carbocyclic ring, e.g. coumaran, bufuralol, befunolol, clobenfurol, amiodarone
    • 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
    • A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • 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
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
    • 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
    • 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
    • A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • A61K9/1676—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
    • 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
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5026—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
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings with drug-free core

Landscapes

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

Abstract

A formulation which is capable of being taken orally for the delivery of beraprost sodium and which comprises the following components, each of which includes the beraprost sodium: (A) an instant-release (IR) component which releases substantially all of the beraprost sodium thereof in the stomach within about 15 minutes after ingestion; (B) a sustained-release (SR) component which has associated therewith a material that is effective in controlling the release of beraprost sodium in the body over a period of time of about 6 hours after ingestion; and (C) a delayed­release (DR) component which includes: (i) a sub-component which has associated therewith a material that is effective in controlling the release of beraprost sodium in the body in a period of time of about 6 to about 12 hours after ingestion; and (ii) another sub-component which has associated therewith a material that is effective in controlling the release of beraprost sodium in the body in a period of time of about 12 to about 18 hours after ingestion, and the use of the formulation in therapeutically effective amounts to treat various types of conditions, for example, peripheral vascular disease, thrombosis, pulmonary ischemia, pulmonary hypertension, diabetes, and neuropathy.
PCT/IB2003/006415 2002-09-18 2003-09-18 Multiparticulate modified release composition comprising beraprost WO2004034959A2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2003296852A AU2003296852A1 (en) 2002-09-18 2003-09-18 Multiparticulate modified release composition comprising beraprost

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US41212402P 2002-09-18 2002-09-18
US60/412,124 2002-09-18

Publications (2)

Publication Number Publication Date
WO2004034959A2 WO2004034959A2 (en) 2004-04-29
WO2004034959A3 true WO2004034959A3 (en) 2004-07-29

Family

ID=32107869

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2003/006415 WO2004034959A2 (en) 2002-09-18 2003-09-18 Multiparticulate modified release composition comprising beraprost

Country Status (2)

Country Link
AU (1) AU2003296852A1 (en)
WO (1) WO2004034959A2 (en)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116270515B (en) * 2023-02-09 2023-08-18 北京诚济制药股份有限公司 Preparation method for improving quality of beraprost sodium tablet product

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0947196A1 (en) * 1997-03-14 1999-10-06 Toray Industries, Inc. Sustained-release prostaglandin i derivative preparation
WO2000025752A1 (en) * 1998-11-02 2000-05-11 Church, Marla, J. Multiparticulate modified release composition
WO2001013898A2 (en) * 1999-08-26 2001-03-01 Elan Corporation, Plc. Pharmaceutical formulations with different release times

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0947196A1 (en) * 1997-03-14 1999-10-06 Toray Industries, Inc. Sustained-release prostaglandin i derivative preparation
WO2000025752A1 (en) * 1998-11-02 2000-05-11 Church, Marla, J. Multiparticulate modified release composition
WO2001013898A2 (en) * 1999-08-26 2001-03-01 Elan Corporation, Plc. Pharmaceutical formulations with different release times

Also Published As

Publication number Publication date
AU2003296852A8 (en) 2004-05-04
WO2004034959A2 (en) 2004-04-29
AU2003296852A1 (en) 2004-05-04

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