WO2007092718A3 - Coating process to produce controlled release coatings - Google Patents

Coating process to produce controlled release coatings Download PDF

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Publication number
WO2007092718A3
WO2007092718A3 PCT/US2007/061385 US2007061385W WO2007092718A3 WO 2007092718 A3 WO2007092718 A3 WO 2007092718A3 US 2007061385 W US2007061385 W US 2007061385W WO 2007092718 A3 WO2007092718 A3 WO 2007092718A3
Authority
WO
WIPO (PCT)
Prior art keywords
coating
coating process
coated
humidity
high humidity
Prior art date
Application number
PCT/US2007/061385
Other languages
French (fr)
Other versions
WO2007092718A2 (en
Inventor
Jian-Xin Li
Brian A C Carlin
Original Assignee
Fmc Corp
Jian-Xin Li
Brian A C Carlin
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 Fmc Corp, Jian-Xin Li, Brian A C Carlin filed Critical Fmc Corp
Priority to JP2008553480A priority Critical patent/JP2009526096A/en
Publication of WO2007092718A2 publication Critical patent/WO2007092718A2/en
Publication of WO2007092718A3 publication Critical patent/WO2007092718A3/en

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05D—PROCESSES FOR APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05D3/00—Pretreatment of surfaces to which liquids or other fluent materials are to be applied; After-treatment of applied coatings, e.g. intermediate treating of an applied coating preparatory to subsequent applications of liquids or other fluent materials
    • B05D3/04—Pretreatment of surfaces to which liquids or other fluent materials are to be applied; After-treatment of applied coatings, e.g. intermediate treating of an applied coating preparatory to subsequent applications of liquids or other fluent materials by exposure to gases
    • B05D3/0486—Operating the coating or treatment in a controlled atmosphere
    • 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
    • A61K9/2806—Coating materials
    • A61K9/282—Organic compounds, e.g. 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2893—Tablet coating processes
    • 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
    • A61K9/5026—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • 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
    • A61K9/48—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
    • A61K9/5089—Processes
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J2/00—Processes or devices for granulating materials, e.g. fertilisers in general; Rendering particulate materials free flowing in general, e.g. making them hydrophobic
    • B01J2/006—Coating of the granules without description of the process or the device by which the granules are obtained
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J2/00—Processes or devices for granulating materials, e.g. fertilisers in general; Rendering particulate materials free flowing in general, e.g. making them hydrophobic
    • B01J2/30—Processes or devices for granulating materials, e.g. fertilisers in general; Rendering particulate materials free flowing in general, e.g. making them hydrophobic using agents to prevent the granules sticking together; Rendering particulate materials free flowing in general, e.g. making them hydrophobic
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05D—PROCESSES FOR APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05D3/00—Pretreatment of surfaces to which liquids or other fluent materials are to be applied; After-treatment of applied coatings, e.g. intermediate treating of an applied coating preparatory to subsequent applications of liquids or other fluent materials
    • B05D3/02—Pretreatment of surfaces to which liquids or other fluent materials are to be applied; After-treatment of applied coatings, e.g. intermediate treating of an applied coating preparatory to subsequent applications of liquids or other fluent materials by baking
    • B05D3/0254—After-treatment
    • 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
    • A61K9/2806—Coating materials
    • A61K9/2813—Inorganic compounds
    • 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
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • 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
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846—Poly(meth)acrylates
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B05—SPRAYING OR ATOMISING IN GENERAL; APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05D—PROCESSES FOR APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL
    • B05D2401/00—Form of the coating product, e.g. solution, water dispersion, powders or the like
    • B05D2401/20—Aqueous dispersion or solution

Abstract

An aqueous polymer coating composition containing at least one latex or pseudolatex is coated on a substrate in a high humidity coating process followed by heat treatment of the coated substrate above the film forming temperature of the coating at low humidity. The coated substrate gives a stable reproducible dissolution profile substantially insensitive to temperature or humidity conditions upon storage. The high humidity coating process is achieved by addition of water to the coating chamber through dilution of the coating formulation or humidification of inlet air. Contrary to the conventional low humidity coating process, residual water is retained in the coating layer of the coated substrates in the coating step. When the coated substrates are heat treated at a temperature greater than the minimum film forming temperature, the residual water in the coating layer will ensure adequate capillary force for the completion of film coalescence. High humidity heat treatment is not needed.
PCT/US2007/061385 2006-02-07 2007-01-31 Coating process to produce controlled release coatings WO2007092718A2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2008553480A JP2009526096A (en) 2006-02-07 2007-01-31 Coating method for making sustained release coatings

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US76585806P 2006-02-07 2006-02-07
US60/765,858 2006-02-07
US83236406P 2006-07-21 2006-07-21
US60/832,364 2006-07-21

Publications (2)

Publication Number Publication Date
WO2007092718A2 WO2007092718A2 (en) 2007-08-16
WO2007092718A3 true WO2007092718A3 (en) 2007-11-22

Family

ID=38345872

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2007/061385 WO2007092718A2 (en) 2006-02-07 2007-01-31 Coating process to produce controlled release coatings

Country Status (3)

Country Link
US (1) US7829148B2 (en)
JP (1) JP2009526096A (en)
WO (1) WO2007092718A2 (en)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1981487B1 (en) * 2006-02-07 2014-06-25 Fmc Corporation Latex or pseudolatex compositions coatings and coating processes
GB0701909D0 (en) * 2007-01-31 2007-03-14 Imp Innovations Ltd Deposition Of Organic Layers
GB2453766A (en) * 2007-10-18 2009-04-22 Novalia Ltd Method of fabricating an electronic device
WO2012166474A1 (en) 2011-06-01 2012-12-06 Fmc Corporation Controlled release solid dose forms
EP2606880A1 (en) * 2011-12-23 2013-06-26 LEK Pharmaceuticals d.d. Coating process with aqueous latex coating
US20150258033A1 (en) 2014-03-11 2015-09-17 Fmc Corporation Controlled release composition and method
CN110742873B (en) * 2018-08-22 2021-02-23 深圳善康医疗健康产业有限公司 Naltrexone implant coating process and application thereof

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4318944A (en) * 1975-08-29 1982-03-09 Amchem Products, Inc. Reducing the cracking of autodeposited coatings

Family Cites Families (21)

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US4330338A (en) * 1978-10-02 1982-05-18 Purdue Research Foundation Pharmaceutical coating composition, and preparation and dosages so coated
US4462839A (en) * 1983-06-16 1984-07-31 Fmc Corporation Enteric coating for pharmaceutical dosage forms
US4562098A (en) * 1983-07-25 1985-12-31 Amchem Products Inc. Water or steam cure of autodeposited resin coatings on metallic substrates
US4600645A (en) * 1985-01-31 1986-07-15 Warner-Lambert Company Process for treating dosage forms
US5326572A (en) * 1989-03-23 1994-07-05 Fmc Corporation Freeze-dried polymer dispersions and the use thereof in preparing sustained-release pharmaceutical compositions
US5681585A (en) * 1991-12-24 1997-10-28 Euro-Celtique, S.A. Stabilized controlled release substrate having a coating derived from an aqueous dispersion of hydrophobic polymer
US5286493A (en) * 1992-01-27 1994-02-15 Euroceltique, S.A. Stabilized controlled release formulations having acrylic polymer coating
US5580578A (en) * 1992-01-27 1996-12-03 Euro-Celtique, S.A. Controlled release formulations coated with aqueous dispersions of acrylic polymers
US5273760A (en) * 1991-12-24 1993-12-28 Euroceltigue, S.A. Stabilized controlled release substrate having a coating derived from an aqueous dispersion of hydrophobic polymer
US5472712A (en) * 1991-12-24 1995-12-05 Euroceltique, S.A. Controlled-release formulations coated with aqueous dispersions of ethylcellulose
US7070806B2 (en) * 1992-01-27 2006-07-04 Purdue Pharma Lp Controlled release formulations coated with aqueous dispersions of acrylic polymers
IL110014A (en) * 1993-07-01 1999-11-30 Euro Celtique Sa Solid controlled-release oral dosage forms of opioid analgesics
US5500227A (en) * 1993-11-23 1996-03-19 Euro-Celtique, S.A. Immediate release tablet cores of insoluble drugs having sustained-release coating
JP3985907B2 (en) 1996-01-18 2007-10-03 旭化成ケミカルズ株式会社 Method for producing film coating granules
KR101045144B1 (en) * 2000-10-30 2011-06-30 유로-셀티크 소시에떼 아노뉨 Controlled release hydrocodone formulations
US20030175342A1 (en) * 2002-03-14 2003-09-18 Karl Kolter Coated pharmaceutical single-unit delayed-release forms, based on polyvinyl acetate
US7097850B2 (en) * 2002-06-18 2006-08-29 Surmodics, Inc. Bioactive agent release coating and controlled humidity method
DE10353186A1 (en) * 2003-11-13 2005-06-16 Röhm GmbH & Co. KG Multilayer dosage form containing a modulatory substance in relation to the release of active ingredient
JP2005188540A (en) * 2003-12-24 2005-07-14 Kayaba Ind Co Ltd Hydraulic damper
JP2005188539A (en) * 2003-12-24 2005-07-14 Ricoh Co Ltd Plate member mounting structure
CA2610343A1 (en) * 2005-03-03 2006-09-08 Takeda Pharmaceutical Company Limited Release-control composition

Patent Citations (1)

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Publication number Priority date Publication date Assignee Title
US4318944A (en) * 1975-08-29 1982-03-09 Amchem Products, Inc. Reducing the cracking of autodeposited coatings

Also Published As

Publication number Publication date
WO2007092718A2 (en) 2007-08-16
JP2009526096A (en) 2009-07-16
US7829148B2 (en) 2010-11-09
US20070184198A1 (en) 2007-08-09

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