WO2001087272A3 - Encapsulating a toxic core within a non-toxic region in an oral dosage form - Google Patents

Encapsulating a toxic core within a non-toxic region in an oral dosage form Download PDF

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Publication number
WO2001087272A3
WO2001087272A3 PCT/US2001/040763 US0140763W WO0187272A3 WO 2001087272 A3 WO2001087272 A3 WO 2001087272A3 US 0140763 W US0140763 W US 0140763W WO 0187272 A3 WO0187272 A3 WO 0187272A3
Authority
WO
WIPO (PCT)
Prior art keywords
toxic
drug
region
dosage form
core
Prior art date
Application number
PCT/US2001/040763
Other languages
French (fr)
Other versions
WO2001087272A2 (en
Inventor
Francis C Payumo
Chen-Chao Wang
Jill K Sherwood
Michael J Cima
Christopher M Gaylo
Donald C Monkhouse
Jaedeok Yoo
Original Assignee
Therics Inc
Massachusetts Inst Technology
Francis C Payumo
Wang Chen Chao
Jill K Sherwood
Michael J Cima
Christopher M Gaylo
Donald C Monkhouse
Jaedeok Yoo
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 Therics Inc, Massachusetts Inst Technology, Francis C Payumo, Wang Chen Chao, Jill K Sherwood, Michael J Cima, Christopher M Gaylo, Donald C Monkhouse, Jaedeok Yoo filed Critical Therics Inc
Priority to EP01937808A priority Critical patent/EP1286663B1/en
Priority to DE60116758T priority patent/DE60116758T2/en
Priority to JP2001583741A priority patent/JP5178982B2/en
Priority to AU2001263506A priority patent/AU2001263506A1/en
Priority to CA2408956A priority patent/CA2408956C/en
Publication of WO2001087272A2 publication Critical patent/WO2001087272A2/en
Publication of WO2001087272A3 publication Critical patent/WO2001087272A3/en

Links

Classifications

    • 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
    • A61K9/2893Tablet coating processes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • 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
    • A61P5/14Drugs for disorders of the endocrine system of the thyroid hormones, e.g. T3, T4
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B33ADDITIVE MANUFACTURING TECHNOLOGY
    • B33YADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y10/00Processes of additive manufacturing
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B33ADDITIVE MANUFACTURING TECHNOLOGY
    • B33YADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y70/00Materials specially adapted for additive manufacturing
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B33ADDITIVE MANUFACTURING TECHNOLOGY
    • B33YADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y80/00Products made by additive manufacturing
    • 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
    • A61K9/2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209Layered 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
    • 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
    • A61K9/2886Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Materials Engineering (AREA)
  • Manufacturing & Machinery (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)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Diabetes (AREA)
  • Endocrinology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

A drug delivery device such as an oral dosage form (ODF) with a toxic or potent core encapsulated by a non-toxic region. The non-toxic region may be a region including multiple layers, coatings, shells, and combinations thereof, which provides protection to and isolation from the toxic or potent core. The drug in the toxic or potent core is incorporated into the dosage form via, for example, three-dimensional printing, as a solution, solubilization or suspension of solid particles in liquid, rather than by the more conventional handling and compressing of dry powder. This minimizes the likelihood of creating airborne particles of the toxic drug during manufacturing, hence controlling and minimizing the exposure of manufacturing personnel to the hazardous substance. Wet dispensing of the toxic or potent drug further provides greater bioavailability of the drug to the patient.
PCT/US2001/040763 2000-05-18 2001-05-18 Encapsulating a toxic core within a non-toxic region in an oral dosage form WO2001087272A2 (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
EP01937808A EP1286663B1 (en) 2000-05-18 2001-05-18 Encapsulating a toxic core within a non-toxic region in an oral dosage form
DE60116758T DE60116758T2 (en) 2000-05-18 2001-05-18 Encapsulation of a toxic to a non-toxic region in an oral formulation
JP2001583741A JP5178982B2 (en) 2000-05-18 2001-05-18 Encapsulation of the toxic core in a non-toxic region in an oral dosage form
AU2001263506A AU2001263506A1 (en) 2000-05-18 2001-05-18 Encapsulating a toxic core within a non-toxic region in an oral dosage form
CA2408956A CA2408956C (en) 2000-05-18 2001-05-18 Method and form of a drug delivery device,such as encapsulating a toxic core within a non-toxic region in an oral dosage form

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US20589600P 2000-05-18 2000-05-18
US60/205,896 2000-05-18

Publications (2)

Publication Number Publication Date
WO2001087272A2 WO2001087272A2 (en) 2001-11-22
WO2001087272A3 true WO2001087272A3 (en) 2002-04-18

Family

ID=22764098

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2001/040763 WO2001087272A2 (en) 2000-05-18 2001-05-18 Encapsulating a toxic core within a non-toxic region in an oral dosage form

Country Status (9)

Country Link
US (2) US7276252B2 (en)
EP (1) EP1286663B1 (en)
JP (2) JP5178982B2 (en)
AT (1) ATE315930T1 (en)
AU (1) AU2001263506A1 (en)
CA (1) CA2408956C (en)
DE (1) DE60116758T2 (en)
ES (1) ES2257412T3 (en)
WO (1) WO2001087272A2 (en)

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Also Published As

Publication number Publication date
JP2012082224A (en) 2012-04-26
CA2408956C (en) 2011-07-12
US20020015728A1 (en) 2002-02-07
EP1286663B1 (en) 2006-01-18
DE60116758T2 (en) 2006-11-02
JP5178982B2 (en) 2013-04-10
CA2408956A1 (en) 2001-11-22
DE60116758D1 (en) 2006-04-06
US20060110443A1 (en) 2006-05-25
US7875290B2 (en) 2011-01-25
US7276252B2 (en) 2007-10-02
ES2257412T3 (en) 2006-08-01
WO2001087272A2 (en) 2001-11-22
ATE315930T1 (en) 2006-02-15
JP2003533470A (en) 2003-11-11
AU2001263506A1 (en) 2001-11-26
EP1286663A2 (en) 2003-03-05

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