CA2281420A1 - Preparation of pharmaceutically-active granules - Google Patents

Preparation of pharmaceutically-active granules Download PDF

Info

Publication number
CA2281420A1
CA2281420A1 CA002281420A CA2281420A CA2281420A1 CA 2281420 A1 CA2281420 A1 CA 2281420A1 CA 002281420 A CA002281420 A CA 002281420A CA 2281420 A CA2281420 A CA 2281420A CA 2281420 A1 CA2281420 A1 CA 2281420A1
Authority
CA
Canada
Prior art keywords
pharmaceutically
preparation
coating
active granules
core
Prior art date
Legal status (The legal status 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 status listed.)
Granted
Application number
CA002281420A
Other languages
French (fr)
Other versions
CA2281420C (en
Inventor
Daniel Mcteigue
Indukumar G. Shah
Karen Swider
David W. Wynn
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Johnson and Johnson Consumer Inc
Original Assignee
McNeil PPC 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 McNeil PPC Inc filed Critical McNeil PPC Inc
Publication of CA2281420A1 publication Critical patent/CA2281420A1/en
Application granted granted Critical
Publication of CA2281420C publication Critical patent/CA2281420C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • 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
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • 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
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • 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
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/485—Morphinan derivatives, e.g. morphine, codeine
    • 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
    • A61K9/48—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
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals

Abstract

The present invention provides a core of predominately microcrystalline cellulose, on which an active drug is layered onto the core via solution coating. The coated particles have a narrower particle size distribution than coated granules provided by other processes. An optional final coating of a pharmaceutically acceptable polymeric coating is provided to provide tastemaking or controlled release, and protection of the drug-layered particles.
CA002281420A 1998-09-04 1999-09-03 Preparation of pharmaceutically-active granules Expired - Fee Related CA2281420C (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US09/148,251 1998-09-04
US09/148,251 US5997905A (en) 1998-09-04 1998-09-04 Preparation of pharmaceutically active particles

Publications (2)

Publication Number Publication Date
CA2281420A1 true CA2281420A1 (en) 2000-03-04
CA2281420C CA2281420C (en) 2008-11-18

Family

ID=22524956

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002281420A Expired - Fee Related CA2281420C (en) 1998-09-04 1999-09-03 Preparation of pharmaceutically-active granules

Country Status (9)

Country Link
US (2) US5997905A (en)
EP (1) EP1000615B1 (en)
JP (1) JP2000109426A (en)
CN (1) CN1151844C (en)
AU (1) AU773833B2 (en)
BR (1) BR9904039A (en)
CA (1) CA2281420C (en)
DE (1) DE69921941T2 (en)
ES (1) ES2233003T3 (en)

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Also Published As

Publication number Publication date
EP1000615A2 (en) 2000-05-17
CA2281420C (en) 2008-11-18
AU4735099A (en) 2000-03-16
EP1000615A3 (en) 2000-05-31
US5997905A (en) 1999-12-07
DE69921941D1 (en) 2004-12-23
US6149943A (en) 2000-11-21
ES2233003T3 (en) 2005-06-01
AU773833B2 (en) 2004-06-10
DE69921941T2 (en) 2005-12-01
EP1000615B1 (en) 2004-11-17
BR9904039A (en) 2001-01-16
JP2000109426A (en) 2000-04-18
CN1249950A (en) 2000-04-12
CN1151844C (en) 2004-06-02

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