WO2011012369A3 - Coating agent for the dip coating of capsule halves - Google Patents

Coating agent for the dip coating of capsule halves Download PDF

Info

Publication number
WO2011012369A3
WO2011012369A3 PCT/EP2010/058370 EP2010058370W WO2011012369A3 WO 2011012369 A3 WO2011012369 A3 WO 2011012369A3 EP 2010058370 W EP2010058370 W EP 2010058370W WO 2011012369 A3 WO2011012369 A3 WO 2011012369A3
Authority
WO
WIPO (PCT)
Prior art keywords
dispersion
solution
capsule halves
coating
dip coating
Prior art date
Application number
PCT/EP2010/058370
Other languages
German (de)
French (fr)
Other versions
WO2011012369A2 (en
Inventor
Brigitte Skalsky
Manfred Assmus
Odette Hensel
Hans-Ulrich Petereit
Original Assignee
Evonik Röhm Gmbh
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 Evonik Röhm Gmbh filed Critical Evonik Röhm Gmbh
Priority to CA2769046A priority Critical patent/CA2769046A1/en
Priority to EP10724857A priority patent/EP2459178A2/en
Priority to CN201080022662.9A priority patent/CN102448446B/en
Priority to JP2012522057A priority patent/JP5686802B2/en
Publication of WO2011012369A2 publication Critical patent/WO2011012369A2/en
Publication of WO2011012369A3 publication Critical patent/WO2011012369A3/en
Priority to HK12105568.7A priority patent/HK1164726A1/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
    • A61K9/4891—Coated capsules; Multilayered drug free capsule shells
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone

Abstract

The invention relates to a coating agent for the gastric juice-resistant coating of capsule halves, which are made of a water-soluble or water-swellable polymer material, in a dip coating process, in the form of an aqueous dispersion or solution, containing a polymer mixture of at least an initial (meth)acrylate copolymer that is gastric juice-resistant, as well as auxiliary materials that influence the viscosity of the dispersion and the elasticity of the dried polymer film, characterized in that the solids content of the dispersion or solution is more than 25 percent by weight and the viscosity is 150 to 1,500 mPas, wherein a film generated by the dispersion or solution and dried has an ultimate elongation of at least 200 percent and a capsule composed of two capsule halves coated with the dispersion or solution in the dip coating process does not dissolve in 0.1 N HCl at a pH of 1.2 after two hours, but does completely dissolve subsequently in a buffer at a pH of 6.8 in less than 30 minutes.
PCT/EP2010/058370 2009-07-29 2010-06-15 Coating agent for the dip coating of capsule halves WO2011012369A2 (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
CA2769046A CA2769046A1 (en) 2009-07-29 2010-06-15 Coating agent for the dip coating of capsule halves
EP10724857A EP2459178A2 (en) 2009-07-29 2010-06-15 Coating agent for the dip coating of capsule halves
CN201080022662.9A CN102448446B (en) 2009-07-29 2010-06-15 Coating agent for the dip coating of capsule halves
JP2012522057A JP5686802B2 (en) 2009-07-29 2010-06-15 Coating agent for dip coating of capsule pieces
HK12105568.7A HK1164726A1 (en) 2009-07-29 2012-06-07 Coating agent for the dip coating of capsule halves

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102009028076A DE102009028076A1 (en) 2009-07-29 2009-07-29 Coating composition for dip coating of capsule halves
DE102009028076.6 2009-07-29

Publications (2)

Publication Number Publication Date
WO2011012369A2 WO2011012369A2 (en) 2011-02-03
WO2011012369A3 true WO2011012369A3 (en) 2011-09-15

Family

ID=42635497

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2010/058370 WO2011012369A2 (en) 2009-07-29 2010-06-15 Coating agent for the dip coating of capsule halves

Country Status (7)

Country Link
EP (1) EP2459178A2 (en)
JP (1) JP5686802B2 (en)
CN (1) CN102448446B (en)
CA (1) CA2769046A1 (en)
DE (1) DE102009028076A1 (en)
HK (1) HK1164726A1 (en)
WO (1) WO2011012369A2 (en)

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9968561B2 (en) * 2013-03-15 2018-05-15 Patheon Softgels Inc. Silk-based capsules
CA2951884A1 (en) 2014-06-11 2015-12-17 Massachusetts Institute Of Technology Residence structures and related methods
CA3002916A1 (en) 2015-10-23 2017-04-27 Lyndra, Inc. Gastric residence systems for sustained release of therapeutic agents and methods of use thereof
JP2019532947A (en) 2016-09-30 2019-11-14 リンドラ，インコーポレイティド Gastric retention system for sustained delivery of adamantane drugs
KR20200026901A (en) 2017-07-11 2020-03-11 쿠오리카프스 가부시키가이샤 Enteric hard capsules
CA3084219A1 (en) 2017-11-17 2019-05-23 Evonik Operations Gmbh Process for preparing a coated hard shell capsule
KR20210022716A (en) 2018-06-22 2021-03-03 쿠오리카프스 가부시키가이샤 Enteric hard capsule
CN113677331A (en) 2019-03-14 2021-11-19 赢创运营有限公司 Capsule shell comprising core-shell polymer and cellulose
KR20220008817A (en) * 2019-05-15 2022-01-21 에보닉 오퍼레이션스 게엠베하 Process for the preparation of filled hard shell capsules with a coating based on (meth)acrylate copolymers using a capsule filling machine
US20220241155A1 (en) 2019-05-15 2022-08-04 Evonik Operations Gmbh Process for preparing filled hard-shell capsules with cellulose or starch-based coatings with a capsule-filling machine
IL308701A (en) * 2021-05-25 2024-01-01 Evonik Operations Gmbh Hard shell capsules with modified release coating

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0393747A2 (en) * 1989-04-20 1990-10-24 The Procter & Gamble Company Mebeverine dosage form
US20040142035A1 (en) * 2003-01-03 2004-07-22 Rong-Kun Chang Use of a mixture of two or more enteric materials to regulate drug release via membrane or matrix for systemic therapeutics
WO2009036812A1 (en) * 2007-09-21 2009-03-26 Evonik Röhm Gmbh Ph-dependent controlled release pharmaceutical opioid composition with resistance against the influence of ethanol
WO2009074811A2 (en) * 2007-12-12 2009-06-18 Photocure Asa Use of 5-aminolevulinic acid and derivatives in a solid form for photodynamic treatment and diagnosis

Family Cites Families (5)

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Publication number Priority date Publication date Assignee Title
JPS59155325A (en) * 1983-02-25 1984-09-04 Kohjin Co Ltd Preparation of water-based enteric coating agent
ES2130056B1 (en) * 1997-01-16 2000-02-01 Lipotec Sa A NEW PHARMACEUTICAL PREPARATION TO IMPROVE THE ORAL BIOAVAILABILITY OF DRUGS WITH HARD ABSORPTION.
WO1999036060A1 (en) * 1998-01-20 1999-07-22 Applied Analytical Industries, Inc. Oral liquid compositions
DE10208335A1 (en) 2002-02-27 2003-09-04 Roehm Gmbh Pharmaceutical form and process for its preparation
MXPA04010956A (en) * 2003-01-30 2005-01-25 Roehm Gmbh Pharmaceutical dosage form and method for the production thereof.

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0393747A2 (en) * 1989-04-20 1990-10-24 The Procter & Gamble Company Mebeverine dosage form
US20040142035A1 (en) * 2003-01-03 2004-07-22 Rong-Kun Chang Use of a mixture of two or more enteric materials to regulate drug release via membrane or matrix for systemic therapeutics
WO2009036812A1 (en) * 2007-09-21 2009-03-26 Evonik Röhm Gmbh Ph-dependent controlled release pharmaceutical opioid composition with resistance against the influence of ethanol
WO2009074811A2 (en) * 2007-12-12 2009-06-18 Photocure Asa Use of 5-aminolevulinic acid and derivatives in a solid form for photodynamic treatment and diagnosis

Non-Patent Citations (4)

* Cited by examiner, † Cited by third party
Title
ASSMUS M ET AL: "Accurate GI Targeting with Eudragit FS 30 D/ L 30 D-55 Mixtures", INTERNET CITATION, 2008, pages 1, XP002560459, Retrieved from the Internet <URL:http://www.pharma-polymers.com/pharmapolymers/MCMSbase/Pages/ProvideR esource.aspx?respath=/NR/rdonlyres/32DDD09C-18F5-47A0-AFFA-0030E84F9C 57/0/CRS2008_AccurateGITargetingwithEUDRAGITFS30DandL30D55mixtures.pdf> [retrieved on 20091214] *
EVONIK INDUSTRIES: "Guidelines for Formulation Development and Process Technology for Enteric Coatings", INTERNET CITATION, 1 March 2009 (2009-03-01), pages 1 - 3, XP002560458, Retrieved from the Internet <URL:http://www.pharma-polymers.com/NR/rdonlyres/1EA56E7C-0D38-4084-8DF9-5 3F9B484FD5D/0/31eGuidelinesforFormulationDevelopmentandProcessTechnologyforEntericCoatings.pdf> [retrieved on 20091214] *
HUYGHEBAERT N ET AL: "In vitro evaluation of coating polymers for enteric coating and human ileal targeting", INTERNATIONAL JOURNAL OF PHARMACEUTICS, ELSEVIER BV, NL, vol. 298, no. 1, 14 July 2005 (2005-07-14), pages 26 - 37, XP004943736, ISSN: 0378-5173, DOI: DOI:10.1016/J.IJPHARM.2005.03.032 *
See also references of EP2459178A2 *

Also Published As

Publication number Publication date
CN102448446A (en) 2012-05-09
JP5686802B2 (en) 2015-03-18
CN102448446B (en) 2015-04-01
DE102009028076A1 (en) 2011-02-03
EP2459178A2 (en) 2012-06-06
HK1164726A1 (en) 2012-09-28
JP2013500293A (en) 2013-01-07
CA2769046A1 (en) 2011-02-03
WO2011012369A2 (en) 2011-02-03

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