WO2006124047A3 - Pharmaceutical formulations containing microparticles or nanoparticles of a delivery agent - Google Patents

Pharmaceutical formulations containing microparticles or nanoparticles of a delivery agent Download PDF

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Publication number
WO2006124047A3
WO2006124047A3 PCT/US2005/028991 US2005028991W WO2006124047A3 WO 2006124047 A3 WO2006124047 A3 WO 2006124047A3 US 2005028991 W US2005028991 W US 2005028991W WO 2006124047 A3 WO2006124047 A3 WO 2006124047A3
Authority
WO
WIPO (PCT)
Prior art keywords
delivery agent
pharmaceutical formulations
nanoparticles
formulations containing
containing microparticles
Prior art date
Application number
PCT/US2005/028991
Other languages
French (fr)
Other versions
WO2006124047A9 (en
WO2006124047A2 (en
Inventor
Shingai Majuru
Puchun Liu
Steve Dinh
Jun Liao
Jongbin Lee
Ehud Arbit
Nikhill Dhoot
Halina Levchik
Jamila Harris
Nai Fang Wang
George F Klein
Original Assignee
Emisphere Tech Inc
Shingai Majuru
Puchun Liu
Steve Dinh
Jun Liao
Jongbin Lee
Ehud Arbit
Nikhill Dhoot
Halina Levchik
Jamila Harris
Nai Fang Wang
George F Klein
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 Emisphere Tech Inc, Shingai Majuru, Puchun Liu, Steve Dinh, Jun Liao, Jongbin Lee, Ehud Arbit, Nikhill Dhoot, Halina Levchik, Jamila Harris, Nai Fang Wang, George F Klein filed Critical Emisphere Tech Inc
Priority to JP2007525876A priority Critical patent/JP2008509933A/en
Priority to EP05857913.7A priority patent/EP1781257B1/en
Publication of WO2006124047A2 publication Critical patent/WO2006124047A2/en
Publication of WO2006124047A3 publication Critical patent/WO2006124047A3/en
Publication of WO2006124047A9 publication Critical patent/WO2006124047A9/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22Hormones
    • A61K38/28Insulins
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141Intimate 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
    • A61K9/145Intimate 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/2072Pills, 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
    • A61K9/2077Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • 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
    • A61K9/2072Pills, 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
    • A61K9/2077Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A61K9/2081Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • 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
    • A61K9/2846Poly(meth)acrylates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4858Organic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/08Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/48Drugs for disorders of the endocrine system of the pancreatic hormones
    • A61P5/50Drugs for disorders of the endocrine system of the pancreatic hormones for increasing or potentiating the activity of insulin

Abstract

This invention relates to microparticles and/or nanoparticles containing a delivery agent and /or an active agent. This invention also relates to pharmaceutical formulations and solid dosage forms, including controlled release solid dosage forms of active agent and a delivery agent
PCT/US2005/028991 2004-08-13 2005-08-15 Pharmaceutical formulations containing microparticles or nanoparticles of a delivery agent WO2006124047A2 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
JP2007525876A JP2008509933A (en) 2004-08-13 2005-08-15 Pharmaceutical formulation comprising microparticles or nanoparticles of a delivery agent
EP05857913.7A EP1781257B1 (en) 2004-08-13 2005-08-15 Pharmaceutical formulations containing microparticles or nanoparticles of a delivery agent

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US60125804P 2004-08-13 2004-08-13
US60/601,258 2004-08-13
US61281004P 2004-09-23 2004-09-23
US60/612,810 2004-09-23

Publications (3)

Publication Number Publication Date
WO2006124047A2 WO2006124047A2 (en) 2006-11-23
WO2006124047A3 true WO2006124047A3 (en) 2007-02-22
WO2006124047A9 WO2006124047A9 (en) 2007-06-21

Family

ID=37431701

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2005/028991 WO2006124047A2 (en) 2004-08-13 2005-08-15 Pharmaceutical formulations containing microparticles or nanoparticles of a delivery agent

Country Status (4)

Country Link
US (5) US20060078623A1 (en)
EP (1) EP1781257B1 (en)
JP (3) JP2008509933A (en)
WO (1) WO2006124047A2 (en)

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US20090124639A1 (en) * 2007-11-06 2009-05-14 Emisphere Technologies Inc. valacyclovir formulations
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Also Published As

Publication number Publication date
JP6085093B2 (en) 2017-02-22
EP1781257B1 (en) 2018-12-19
EP1781257A2 (en) 2007-05-09
JP2012121924A (en) 2012-06-28
JP2012121923A (en) 2012-06-28
JP2008509933A (en) 2008-04-03
EP1781257A4 (en) 2012-06-20
US20060078622A1 (en) 2006-04-13
US20190022228A1 (en) 2019-01-24
JP5931520B2 (en) 2016-06-08
US20100055194A1 (en) 2010-03-04
US20120189666A1 (en) 2012-07-26
WO2006124047A9 (en) 2007-06-21
US20060078623A1 (en) 2006-04-13
WO2006124047A2 (en) 2006-11-23

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