WO1999013864A3 - Solid solution beadlet - Google Patents

Solid solution beadlet Download PDF

Info

Publication number
WO1999013864A3
WO1999013864A3 PCT/US1998/019658 US9819658W WO9913864A3 WO 1999013864 A3 WO1999013864 A3 WO 1999013864A3 US 9819658 W US9819658 W US 9819658W WO 9913864 A3 WO9913864 A3 WO 9913864A3
Authority
WO
WIPO (PCT)
Prior art keywords
beadlet
solid solution
surfactant
polyoxyethylene
hydrophobic
Prior art date
Application number
PCT/US1998/019658
Other languages
French (fr)
Other versions
WO1999013864A2 (en
Inventor
Beth A Burnside
Guinness Charlotte M Mc
Edward M Rudnic
Richard A Couch
Xiaodi Guo
Alexander K Tustian
Original Assignee
Shire Lab Inc
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 Shire Lab Inc filed Critical Shire Lab Inc
Priority to JP2000511488A priority Critical patent/JP2002522354A/en
Priority to AT98948383T priority patent/ATE286721T1/en
Priority to AU94967/98A priority patent/AU9496798A/en
Priority to CA002302275A priority patent/CA2302275C/en
Priority to DE69828635T priority patent/DE69828635T2/en
Priority to EP98948383A priority patent/EP1028712B1/en
Publication of WO1999013864A2 publication Critical patent/WO1999013864A2/en
Publication of WO1999013864A3 publication Critical patent/WO1999013864A3/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
    • A61K9/48—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
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A61K9/5047—Cellulose ethers containing no ester groups, 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
    • A61K9/14—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
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/06—Antimigraine agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • 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

Abstract

Disclosed is a beadlet comprising (i) a hydrophobic long chain fatty acid or ester material; (ii) a surfactant; and (iii) a therapeutic agent, which in admixture form a solid solution at room temperature. The hydrophobic material preferably has a melting point of about 40 to about 100 °C, and is most preferably glyceryl behenate. The surfactant is preferably a polyglycolyzed glyceride, polyoxyethylene sorbate, ethylene or propylene block copolymer or combinations thereof, and is most preferably polyoxyethylene 20 sorbitan monolaurate.
PCT/US1998/019658 1997-09-19 1998-09-18 Solid solution beadlet WO1999013864A2 (en)

Priority Applications (6)

Application Number Priority Date Filing Date Title
JP2000511488A JP2002522354A (en) 1997-09-19 1998-09-18 Solid solution beadlets
AT98948383T ATE286721T1 (en) 1997-09-19 1998-09-18 SOLID SOLUTION BEADS
AU94967/98A AU9496798A (en) 1997-09-19 1998-09-18 Solid solution beadlet
CA002302275A CA2302275C (en) 1997-09-19 1998-09-18 Solid solution beadlet
DE69828635T DE69828635T2 (en) 1997-09-19 1998-09-18 SOLID SOLUTION BEADS
EP98948383A EP1028712B1 (en) 1997-09-19 1998-09-18 Solid solution beadlet

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US5940897P 1997-09-19 1997-09-19
US60/059,408 1997-09-19

Publications (2)

Publication Number Publication Date
WO1999013864A2 WO1999013864A2 (en) 1999-03-25
WO1999013864A3 true WO1999013864A3 (en) 1999-08-12

Family

ID=22022768

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1998/019658 WO1999013864A2 (en) 1997-09-19 1998-09-18 Solid solution beadlet

Country Status (9)

Country Link
US (1) US6692767B2 (en)
EP (1) EP1028712B1 (en)
JP (1) JP2002522354A (en)
AT (1) ATE286721T1 (en)
AU (1) AU9496798A (en)
CA (1) CA2302275C (en)
DE (1) DE69828635T2 (en)
ES (1) ES2236943T3 (en)
WO (1) WO1999013864A2 (en)

Cited By (1)

* Cited by examiner, † Cited by third party
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US9598469B2 (en) 2001-07-05 2017-03-21 Novartis Vaccines And Diagnostics, Inc. HIV-1 south african subtype C env proteins

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Also Published As

Publication number Publication date
CA2302275C (en) 2009-12-08
US20010006650A1 (en) 2001-07-05
DE69828635T2 (en) 2005-06-16
JP2002522354A (en) 2002-07-23
EP1028712B1 (en) 2005-01-12
ATE286721T1 (en) 2005-01-15
WO1999013864A2 (en) 1999-03-25
EP1028712A2 (en) 2000-08-23
AU9496798A (en) 1999-04-05
ES2236943T3 (en) 2005-07-16
CA2302275A1 (en) 1999-03-25
DE69828635D1 (en) 2005-02-17
US6692767B2 (en) 2004-02-17

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