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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
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.)
Ceased
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
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.)
Roehm GmbH Darmstadt
Original Assignee
Evonik Roehm 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 Roehm GmbH filed Critical Evonik Roehm GmbH
Priority to CN201080022662.9A priority Critical patent/CN102448446B/en
Priority to HK12105568.7A priority patent/HK1164726B/en
Priority to EP10724857A priority patent/EP2459178A2/en
Priority to CA2769046A priority patent/CA2769046A1/en
Priority to JP2012522057A priority patent/JP5686802B2/en
Publication of WO2011012369A2 publication Critical patent/WO2011012369A2/en
Publication of WO2011012369A3 publication Critical patent/WO2011012369A3/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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

Landscapes

  • Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Preparation (AREA)

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 Ceased WO2011012369A2 (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
CN201080022662.9A CN102448446B (en) 2009-07-29 2010-06-15 Coating agent for dip coating of capsule halves
HK12105568.7A HK1164726B (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
CA2769046A CA2769046A1 (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

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 Ceased WO2011012369A2 (en) 2009-07-29 2010-06-15 Coating agent for the dip coating of capsule halves

Country Status (6)

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

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11576866B2 (en) 2016-09-30 2023-02-14 Lyndra Therapeutics, Inc. Gastric residence systems for sustained delivery of adamantane-class drugs
US11576859B2 (en) 2015-10-23 2023-02-14 Lyndra Therapeutics, Inc. Gastric residence systems for sustained release of therapeutic agents and methods of use thereof
US11992552B2 (en) 2015-12-08 2024-05-28 Lyndra Therapeutics, Inc. Geometric configurations for gastric residence systems
US12023406B2 (en) 2017-06-09 2024-07-02 Lyndra Therapeutics, Inc. Gastric residence systems with release rate-modulating films
US12109305B2 (en) 2016-05-27 2024-10-08 Lyndra Therapeutics, Inc. Materials architecture for gastric residence systems

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014152097A1 (en) * 2013-03-15 2014-09-25 Banner Pharmacaps Inc. Silk-based capsules
AU2015274453A1 (en) 2014-06-11 2017-01-12 Massachusetts Institute Of Technology Enteric elastomers
JP7198205B2 (en) 2017-07-11 2022-12-28 クオリカプス株式会社 Enteric coated hard capsule
IL274579B2 (en) 2017-11-17 2025-04-01 Evonik Operations Gmbh Process for preparing a coated hard shell capsule
ES2976714T3 (en) 2018-06-22 2024-08-07 Qualicaps Co Ltd Hard enteric capsule
MX2021010913A (en) 2019-03-14 2021-10-01 Evonik Operations Gmbh CAPSULE SHELL COMPRISING A CORE-SHELL POLYMER AND A CELLULOSE.
CN120346175A (en) * 2019-05-15 2025-07-22 赢创运营有限公司 Method for preparing filled hard shell capsules with cellulose or starch based coating using capsule filling machine
WO2020229178A1 (en) 2019-05-15 2020-11-19 Evonik Operations Gmbh Process for preparing filled hard-shell capsules with (meth)acrylate copolymer based coatings with a capsule-filling machine
WO2022248334A1 (en) * 2021-05-25 2022-12-01 Evonik Operations Gmbh Hard shell capsules with modified release coating
TW202412746A (en) 2022-07-22 2024-04-01 日商快力膠囊股份有限公司 Multilayered enteric rigid capsule

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)

* Cited by examiner, † Cited by third party
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.
DE69940769D1 (en) * 1998-01-20 2009-06-04 Applied Analytical Ind 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 *

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11576859B2 (en) 2015-10-23 2023-02-14 Lyndra Therapeutics, Inc. Gastric residence systems for sustained release of therapeutic agents and methods of use thereof
US11992552B2 (en) 2015-12-08 2024-05-28 Lyndra Therapeutics, Inc. Geometric configurations for gastric residence systems
US12109305B2 (en) 2016-05-27 2024-10-08 Lyndra Therapeutics, Inc. Materials architecture for gastric residence systems
US11576866B2 (en) 2016-09-30 2023-02-14 Lyndra Therapeutics, Inc. Gastric residence systems for sustained delivery of adamantane-class drugs
US12023406B2 (en) 2017-06-09 2024-07-02 Lyndra Therapeutics, Inc. Gastric residence systems with release rate-modulating films

Also Published As

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

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