WO2003026615A3 - Modified release dosage forms - Google Patents

Modified release dosage forms Download PDF

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Publication number
WO2003026615A3
WO2003026615A3 PCT/US2002/031116 US0231116W WO03026615A3 WO 2003026615 A3 WO2003026615 A3 WO 2003026615A3 US 0231116 W US0231116 W US 0231116W WO 03026615 A3 WO03026615 A3 WO 03026615A3
Authority
WO
WIPO (PCT)
Prior art keywords
dosage form
modified release
active ingredient
dosage forms
release dosage
Prior art date
Application number
PCT/US2002/031116
Other languages
French (fr)
Other versions
WO2003026615A2 (en
Inventor
Der-Yang Lee
Shun-Por Li
Narendra Parikh
Dan Mcteigue
Harry S Sowden
Martin Thomas
David Wynn
Original Assignee
Mcneil Ppc Inc
Der-Yang Lee
Shun-Por Li
Narendra Parikh
Dan Mcteigue
Harry S Sowden
Martin Thomas
David Wynn
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
Priority claimed from US09/966,450 external-priority patent/US6982094B2/en
Priority claimed from US09/966,497 external-priority patent/US7122143B2/en
Priority claimed from US09/966,509 external-priority patent/US6767200B2/en
Priority claimed from US09/966,939 external-priority patent/US6837696B2/en
Priority claimed from US09/967,414 external-priority patent/US6742646B2/en
Priority to US10/476,504 priority Critical patent/US20040213848A1/en
Priority to EP02766427A priority patent/EP1429742B1/en
Priority to CA002461870A priority patent/CA2461870A1/en
Application filed by Mcneil Ppc Inc, Der-Yang Lee, Shun-Por Li, Narendra Parikh, Dan Mcteigue, Harry S Sowden, Martin Thomas, David Wynn filed Critical Mcneil Ppc Inc
Priority to AU2002330164A priority patent/AU2002330164A1/en
Priority to JP2003530252A priority patent/JP2005508326A/en
Priority to BR0212946-9A priority patent/BR0212946A/en
Priority to KR10-2004-7004663A priority patent/KR20040045034A/en
Priority to MXPA04002978A priority patent/MXPA04002978A/en
Priority to AT02766427T priority patent/ATE507823T1/en
Priority to DE60239945T priority patent/DE60239945D1/en
Publication of WO2003026615A2 publication Critical patent/WO2003026615A2/en
Publication of WO2003026615A3 publication Critical patent/WO2003026615A3/en
Priority to US12/360,579 priority patent/US20090186082A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
    • A23G3/00—Sweetmeats; Confectionery; Marzipan; Coated or filled products
    • A23G3/02—Apparatus specially adapted for manufacture or treatment of sweetmeats or confectionery; Accessories therefor
    • A23G3/04—Sugar-cookers
    • 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
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
    • A23G1/00—Cocoa; Cocoa products, e.g. chocolate; Substitutes therefor
    • A23G1/30—Cocoa products, e.g. chocolate; Substitutes therefor
    • A23G1/50—Cocoa products, e.g. chocolate; Substitutes therefor characterised by shape, structure or physical form, e.g. products with an inedible support
    • A23G1/54—Composite products, e.g. layered laminated, coated, filled
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
    • A23G3/00—Sweetmeats; Confectionery; Marzipan; Coated or filled products
    • A23G3/0002—Processes of manufacture not relating to composition and compounding ingredients
    • A23G3/0004—Processes specially adapted for manufacture or treatment of sweetmeats or confectionery
    • A23G3/0019—Shaping of liquid, paste, powder; Manufacture of moulded articles, e.g. modelling, moulding, calendering
    • A23G3/0025—Processes in which the material is shaped at least partially in a mould in the hollows of a surface, a drum, an endless band, or by a drop-by-drop casting or dispensing of the material on a surface, e.g. injection moulding, transfer moulding
    • A23G3/0029—Moulding processes for hollow products, e.g. opened shell
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
    • A23G3/00—Sweetmeats; Confectionery; Marzipan; Coated or filled products
    • A23G3/34—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof
    • A23G3/36—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof characterised by the composition containing organic or inorganic compounds
    • A23G3/364—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof characterised by the composition containing organic or inorganic compounds containing microorganisms or enzymes; containing paramedical or dietetical agents, e.g. vitamins
    • A23G3/368—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof characterised by the composition containing organic or inorganic compounds containing microorganisms or enzymes; containing paramedical or dietetical agents, e.g. vitamins containing vitamins, antibiotics
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
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    • A23G3/00—Sweetmeats; Confectionery; Marzipan; Coated or filled products
    • A23G3/34—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof
    • A23G3/50—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof characterised by shape, structure or physical form, e.g. products with supported structure
    • A23G3/54—Composite products, e.g. layered, coated, filled
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L29/00—Foods or foodstuffs containing additives; Preparation or treatment thereof
    • A23L29/30—Foods or foodstuffs containing additives; Preparation or treatment thereof containing carbohydrate syrups; containing sugars; containing sugar alcohols, e.g. xylitol; containing starch hydrolysates, e.g. dextrin
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    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
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    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/10—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of compressed tablets
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K9/0004—Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
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    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A—HUMAN NECESSITIES
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    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
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    • 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
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • A—HUMAN NECESSITIES
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    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
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    • 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
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    • 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
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    • 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
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered 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
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    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
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    • A—HUMAN NECESSITIES
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    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
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    • B30B11/02—Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses using a ram exerting pressure on the material in a moulding space
    • B30B11/08—Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses using a ram exerting pressure on the material in a moulding space co-operating with moulds carried by a turntable
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    • 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
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
    • Y10T428/1352—Polymer or resin containing [i.e., natural or synthetic]

Abstract

In one embodiment, a dosage form comprises: (a) at least one active ingredient; (b) a molded core which is solid at room temperature; and (c) a shell which is in contact with at least a portion of the core, wherein the dosage form provides modified release of the active ingredient upon contacting of the dosage form with a liquid medium. In another embodiment of this invention, a dosage form comprises: (a) at least one active ingredient; (b) a molded core comprising a plurality of particles; and (c) a shell which is in contact with at least a portion of the core, wherein the dosage form provides modified release of the active ingredient upon contacting of the dosage form with a liquid medium.
PCT/US2002/031116 2001-09-28 2002-09-28 Modified release dosage forms WO2003026615A2 (en)

Priority Applications (11)

Application Number Priority Date Filing Date Title
BR0212946-9A BR0212946A (en) 2001-09-28 2002-09-28 Modified Release Dosage Forms
KR10-2004-7004663A KR20040045034A (en) 2001-09-28 2002-09-28 Modified release dosage forms
MXPA04002978A MXPA04002978A (en) 2001-09-28 2002-09-28 Modified release dosage forms.
EP02766427A EP1429742B1 (en) 2001-09-28 2002-09-28 Modified release dosage forms
AT02766427T ATE507823T1 (en) 2001-09-28 2002-09-28 MODIFIED RELEASE PHARMACEUTICAL FORMS
DE60239945T DE60239945D1 (en) 2001-09-28 2002-09-28 PHARMACEUTICAL FORMS FOR MODIFIED RELEASE
CA002461870A CA2461870A1 (en) 2001-09-28 2002-09-28 Modified release dosage forms
US10/476,504 US20040213848A1 (en) 2001-09-28 2002-09-28 Modified release dosage forms
AU2002330164A AU2002330164A1 (en) 2001-09-28 2002-09-28 Modified release dosage forms
JP2003530252A JP2005508326A (en) 2001-09-28 2002-09-28 Modified release dosage form
US12/360,579 US20090186082A1 (en) 2001-09-28 2009-01-27 Method of manufacturing modified release dosage forms

Applications Claiming Priority (10)

Application Number Priority Date Filing Date Title
US09/966,509 2001-09-28
US09/966,497 2001-09-28
US09/966,450 US6982094B2 (en) 2001-09-28 2001-09-28 Systems, methods and apparatuses for manufacturing dosage forms
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US09/967,414 US6742646B2 (en) 2001-09-28 2001-09-28 Systems, methods and apparatuses for manufacturing dosage forms
US09/966,939 US6837696B2 (en) 2001-09-28 2001-09-28 Apparatus for manufacturing dosage forms
US09/966,509 US6767200B2 (en) 2001-09-28 2001-09-28 Systems, methods and apparatuses for manufacturing dosage forms
US09/966,497 US7122143B2 (en) 2001-09-28 2001-09-28 Methods for manufacturing dosage forms
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WO2003026628A3 (en) 2003-05-01
KR20040045032A (en) 2004-05-31
US20030235616A1 (en) 2003-12-25
US20040241236A1 (en) 2004-12-02
EP1429724A1 (en) 2004-06-23
CN1638740A (en) 2005-07-13
CN1592612A (en) 2005-03-09
EP1429737A1 (en) 2004-06-23
MXPA04002978A (en) 2005-06-20
EP1429746B1 (en) 2008-08-13
KR20040045031A (en) 2004-05-31
CA2446760A1 (en) 2003-04-03
DE60223269D1 (en) 2007-12-13
KR20040045034A (en) 2004-05-31
EP1438030A2 (en) 2004-07-21
NO20032363D0 (en) 2003-05-26
MXPA04002977A (en) 2005-06-20
PL369134A1 (en) 2005-04-18
WO2003026630A1 (en) 2003-04-03
MXPA04002891A (en) 2005-06-20
EP1429724B1 (en) 2013-11-06
EP1463489A1 (en) 2004-10-06
JP2005509604A (en) 2005-04-14
KR20040045033A (en) 2004-05-31
BR0212950A (en) 2004-10-26
WO2003026629A3 (en) 2004-03-04
EP1429745A2 (en) 2004-06-23
US20040213848A1 (en) 2004-10-28
KR20040045030A (en) 2004-05-31
KR20040037206A (en) 2004-05-04
KR20040066094A (en) 2004-07-23
ES2444549T3 (en) 2014-02-25
US7416738B2 (en) 2008-08-26
WO2003026624A1 (en) 2003-04-03
MXPA04002980A (en) 2005-06-20
US20030219484A1 (en) 2003-11-27
ATE376826T1 (en) 2007-11-15
CA2461659C (en) 2010-12-07
EP1429743A1 (en) 2004-06-23
US7968120B2 (en) 2011-06-28
CN100364515C (en) 2008-01-30
KR20040037207A (en) 2004-05-04
ATE507823T1 (en) 2011-05-15
CA2461653A1 (en) 2003-04-03
CN1596102A (en) 2005-03-16
ES2295427T3 (en) 2008-04-16
EP1438018B1 (en) 2010-08-11
NZ532096A (en) 2006-10-27
US20040213849A1 (en) 2004-10-28
CA2461870A1 (en) 2003-04-03
CA2461656A1 (en) 2003-04-03
CA2446759A1 (en) 2003-04-03
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WO2003026612A2 (en) 2003-04-03
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ATE404179T1 (en) 2008-08-15
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CN1592613A (en) 2005-03-09

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