BR112013028453B8 - Uso de uma composição de revestimento, formas de dosagem farmacêuticas ou nutracêuticas gastrorresistentes, e composição do polímero do núcleo/invólucro - Google Patents
Uso de uma composição de revestimento, formas de dosagem farmacêuticas ou nutracêuticas gastrorresistentes, e composição do polímero do núcleo/invólucroInfo
- Publication number
- BR112013028453B8 BR112013028453B8 BR112013028453A BR112013028453A BR112013028453B8 BR 112013028453 B8 BR112013028453 B8 BR 112013028453B8 BR 112013028453 A BR112013028453 A BR 112013028453A BR 112013028453 A BR112013028453 A BR 112013028453A BR 112013028453 B8 BR112013028453 B8 BR 112013028453B8
- Authority
- BR
- Brazil
- Prior art keywords
- core
- coating composition
- dosage forms
- polymer composition
- pharmaceutical
- Prior art date
Links
- 229920000642 polymer Polymers 0.000 title abstract 5
- 239000008199 coating composition Substances 0.000 title abstract 4
- 239000000203 mixture Substances 0.000 title abstract 4
- 239000002417 nutraceutical Substances 0.000 title abstract 4
- 235000021436 nutraceutical agent Nutrition 0.000 title abstract 4
- 239000002552 dosage form Substances 0.000 title abstract 3
- 229920001577 copolymer Polymers 0.000 abstract 2
- 229920006318 anionic polymer Polymers 0.000 abstract 1
- 239000011248 coating agent Substances 0.000 abstract 1
- 238000000576 coating method Methods 0.000 abstract 1
- 238000007720 emulsion polymerization reaction Methods 0.000 abstract 1
- 239000004615 ingredient Substances 0.000 abstract 1
- 238000000034 method Methods 0.000 abstract 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 abstract 1
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
- A61K9/14—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
-
- 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
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1635—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
- A61K9/5026—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
- 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
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
- A61K31/52—Purines, e.g. adenine
- A61K31/522—Purines, e.g. adenine having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
-
- 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
-
- 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
-
- 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
- A61K9/2004—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
- 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
- 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
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08F—MACROMOLECULAR COMPOUNDS OBTAINED BY REACTIONS ONLY INVOLVING CARBON-TO-CARBON UNSATURATED BONDS
- C08F2/00—Processes of polymerisation
- C08F2/12—Polymerisation in non-solvents
- C08F2/16—Aqueous medium
- C08F2/22—Emulsion polymerisation
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08F—MACROMOLECULAR COMPOUNDS OBTAINED BY REACTIONS ONLY INVOLVING CARBON-TO-CARBON UNSATURATED BONDS
- C08F220/00—Copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and only one being terminated by only one carboxyl radical or a salt, anhydride ester, amide, imide or nitrile thereof
- C08F220/02—Monocarboxylic acids having less than ten carbon atoms; Derivatives thereof
- C08F220/10—Esters
- C08F220/12—Esters of monohydric alcohols or phenols
- C08F220/16—Esters of monohydric alcohols or phenols of phenols or of alcohols containing two or more carbon atoms
- C08F220/18—Esters of monohydric alcohols or phenols of phenols or of alcohols containing two or more carbon atoms with acrylic or methacrylic acids
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08F—MACROMOLECULAR COMPOUNDS OBTAINED BY REACTIONS ONLY INVOLVING CARBON-TO-CARBON UNSATURATED BONDS
- C08F265/00—Macromolecular compounds obtained by polymerising monomers on to polymers of unsaturated monocarboxylic acids or derivatives thereof as defined in group C08F20/00
- C08F265/04—Macromolecular compounds obtained by polymerising monomers on to polymers of unsaturated monocarboxylic acids or derivatives thereof as defined in group C08F20/00 on to polymers of esters
- C08F265/06—Polymerisation of acrylate or methacrylate esters on to polymers thereof
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L2207/00—Properties characterising the ingredient of the composition
- C08L2207/53—Core-shell polymer
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Polymers & Plastics (AREA)
- Organic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
COMPOSIÇÃO DE REVESTIMENTO ADEQUADA PARA FORMAS DE DOSAGEM FARMACÊUTICAS OU NUTRACÊUTICAS. A presente invenção refere-se a uma composição de revestimento adequada para o revestimento da forma de dosagem farmacêutica ou nutracêutica, que compreende um núcleo que compreende um ou mais ingredientes ativos farmacêuticos ou nutracêuticos, em que a composição de revestimento é composta por, pelo menos, 20% em peso de uma composição do polímero do núcleo/invólucro entérico derivada a partir de um processo de polimerização em emulsão, em que o núcleo da composição do polímero do núcleo/invólucro é formado por um copolímero ou um polímero reticulado, insolúvel em água e o invólucro da composição do polímero do núcleo/invólucro é formado por meio de um polímero ou copolímero aniônico.
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
PCT/EP2011/060097 WO2012171576A1 (en) | 2011-06-17 | 2011-06-17 | Coating composition suitable for pharmaceutical or nutraceutical dosage forms |
Publications (3)
Publication Number | Publication Date |
---|---|
BR112013028453A2 BR112013028453A2 (pt) | 2017-01-24 |
BR112013028453B1 BR112013028453B1 (pt) | 2021-10-19 |
BR112013028453B8 true BR112013028453B8 (pt) | 2022-07-05 |
Family
ID=44627081
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
BR112013028453A BR112013028453B8 (pt) | 2011-06-17 | 2011-06-17 | Uso de uma composição de revestimento, formas de dosagem farmacêuticas ou nutracêuticas gastrorresistentes, e composição do polímero do núcleo/invólucro |
Country Status (16)
Country | Link |
---|---|
US (1) | US9668977B2 (pt) |
EP (1) | EP2720681B1 (pt) |
JP (1) | JP5832645B2 (pt) |
KR (1) | KR101799625B1 (pt) |
CN (1) | CN103501767A (pt) |
AU (1) | AU2011370763A1 (pt) |
BR (1) | BR112013028453B8 (pt) |
CA (1) | CA2839494C (pt) |
ES (1) | ES2617402T3 (pt) |
HU (1) | HUE033117T2 (pt) |
IL (1) | IL228397A (pt) |
MX (1) | MX353426B (pt) |
PL (1) | PL2720681T3 (pt) |
RU (1) | RU2599023C2 (pt) |
SI (1) | SI2720681T1 (pt) |
WO (1) | WO2012171576A1 (pt) |
Families Citing this family (13)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
KR101902602B1 (ko) * | 2011-06-17 | 2018-09-28 | 에보니크 룀 게엠베하 | 에탄올의 영향에 대해 내성을 갖는 위 내성 제약 또는 기능식품 조성물 |
CN105943519A (zh) * | 2016-06-22 | 2016-09-21 | 福建省微生物研究所 | 一种苯磺贝他斯汀掩味颗粒 |
RU2749905C2 (ru) * | 2016-08-15 | 2021-06-18 | Эвоник Оперейшнс Гмбх | Содержащие функциональные группы полиалкил(мет)акрилаты, обладающие улучшенной деэмульгирующей способностью |
CN111936121A (zh) | 2017-11-17 | 2020-11-13 | 赢创运营有限公司 | 制备包衣硬壳胶囊的方法 |
SG11202005947RA (en) | 2018-05-24 | 2020-07-29 | Celanese Eva Performance Polymers Corp | Implantable device for sustained release of a macromolecular drug compound |
AU2019275409A1 (en) | 2018-05-24 | 2020-07-16 | Celanese Eva Performance Polymers Llc | Implantable device for sustained release of a macromolecular drug compound |
CN109232795A (zh) * | 2018-09-21 | 2019-01-18 | 佛山市森昂生物科技有限公司 | 一种防水型高韧性包衣材料的制备方法 |
EP3962465A1 (en) | 2019-04-30 | 2022-03-09 | Evonik Operations GmbH | Pellet and multi-unit pellet system (mups) |
KR20240012433A (ko) | 2021-05-25 | 2024-01-29 | 에보니크 오퍼레이션즈 게엠베하 | 변형 방출 코팅을 갖는 경질 쉘 캡슐 |
CN117377466A (zh) | 2021-05-25 | 2024-01-09 | 赢创运营有限公司 | 防止胃液流入的硬壳胶囊 |
EP4176874A1 (en) | 2021-11-09 | 2023-05-10 | Evonik Operations GmbH | Pharmaceutical or nutraceutical composition with an alcohol resistant single layer coating system |
WO2023174722A1 (en) | 2022-03-15 | 2023-09-21 | Evonik Operations Gmbh | Pre-functionalized hard shell capsule with accelerated drug release at ph value 5 to 5.5 |
WO2023214016A1 (en) | 2022-05-06 | 2023-11-09 | Evonik Operations Gmbh | Dosage form with drug release at ph 3 to 6 using double coating system with at least one release acceleration agent |
Family Cites Families (26)
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DE2135073C3 (de) | 1971-07-14 | 1974-07-11 | Roehm Gmbh | Überzugsmittel für Arzneiformen |
US4876313A (en) * | 1986-08-29 | 1989-10-24 | Rohm And Haas Company | Grafted core-shell polymer compositions using polyfunctional compounds |
DE9414065U1 (de) | 1994-08-31 | 1994-11-03 | Roehm Gmbh | Thermoplastischer Kunststoff für darmsaftlösliche Arznei-Umhüllungen |
DE9414066U1 (de) | 1994-08-31 | 1994-11-03 | Roehm Gmbh | Überzugs- und Bindemittel für Arzneiformen sowie damit hergestellte Arzneiform |
DE19615812A1 (de) | 1996-04-20 | 1997-10-23 | Boehringer Mannheim Gmbh | Pharmazeutische Zubereitung enthaltend Diphosphonsäuren zur oralen Applikation |
AU771383B2 (en) | 1998-12-08 | 2004-03-18 | Rohm And Haas Company | Dirt pickup resistant coating binder and coatings |
AUPQ164299A0 (en) | 1999-07-14 | 1999-08-05 | Orica Australia Pty Ltd | Aqueous polymer dispersion |
DE10208335A1 (de) | 2002-02-27 | 2003-09-04 | Roehm Gmbh | Arzneiform und Verfahren zu ihrer Herstellung |
MXPA04010956A (es) | 2003-01-30 | 2005-01-25 | Roehm Gmbh | Forma de dosis farmaceutica y metodo para la produccion de la misma. |
AU2003903838A0 (en) * | 2003-07-23 | 2003-08-07 | Orica Australia Pty Ltd | Aqueous polymer dispersion |
TWI350762B (en) | 2004-02-12 | 2011-10-21 | Euro Celtique Sa | Particulates |
US7501475B2 (en) | 2004-05-07 | 2009-03-10 | Asahi Kasei Chemicals Corporation | Aqueous resin dispersion for adhesive and composition thereof |
DE102004036437A1 (de) * | 2004-07-27 | 2006-03-23 | Röhm GmbH & Co. KG | Multipartikuläre Arzneiform für wenig lösliche Wirkstoffe, sowie ein Verfahren zur Herstellung der Arzneiform |
WO2006044202A2 (en) * | 2004-10-19 | 2006-04-27 | State Of Oregon Acting By And Through The State Board Of Higher Education On Behalf Of Oregon State University | Enteric coated compositions that release active ingredient(s) in gastric fluid and intestinal fluid |
ITBO20050123A1 (it) * | 2005-03-07 | 2005-06-06 | Alfa Wassermann Spa | Formulazioni farmaceutiche gastroresistenti contenenti rifaximina |
WO2006132471A1 (en) | 2005-06-07 | 2006-12-14 | Lg Chem, Ltd. | Polymeric lubricant having multi layer structure and manufacturing method thereof |
US20080014257A1 (en) * | 2006-07-14 | 2008-01-17 | Par Pharmaceutical, Inc. | Oral dosage forms |
US20080058473A1 (en) * | 2006-08-31 | 2008-03-06 | Yakov Freidzon | Latex for low VOC paint having improved block resistance, open time and water-softening resistance |
DE102006051020A1 (de) | 2006-10-26 | 2008-04-30 | Evonik Röhm Gmbh | Verwendung von (Meth)acrylat-Copolymeren in Retard-Arzneiformen zur Verringerung des Einflusses von Ethanol auf die Wirkstofffreisetzung |
CN101801356B (zh) * | 2007-09-21 | 2016-10-19 | 赢创罗姆有限公司 | 耐受乙醇影响的非阿片类的pH依赖性受控释放的药物组合物 |
SI2187876T1 (sl) | 2007-09-21 | 2012-12-31 | Evonik Roehm Gmbh | Od pH odvisen opioidni farmacevtski sestavek z nadzorovanim sproščanjem z odpornostjo na vpliv etanola |
PL2326313T3 (pl) | 2008-09-24 | 2015-08-31 | Evonik Roehm Gmbh | Kompozycja farmaceutyczna o zależnym od pH kontrolowanym uwalnianiu dla nieopioidów z odpornością przed wpływem etanolu |
CN102164588B (zh) | 2008-09-24 | 2015-07-08 | 赢创罗姆有限公司 | 耐受乙醇影响的pH依赖性受控释放的药物组合物 |
CA2755808C (en) | 2009-03-18 | 2016-01-19 | Evonik Roehm Gmbh | Controlled release pharmaceutical composition with resistance against the influence of ethanol employing a coating comprising neutral vinyl polymers and excipients |
US20110311631A1 (en) | 2009-03-18 | 2011-12-22 | Evonik Röhm Gmbh | Controlled release pharmaceutical composition with resistance against the influence of ethanol employing a coating comprising a polymer mixture and excipients |
EP2591027B1 (en) * | 2010-07-09 | 2015-09-23 | Lubrizol Advanced Materials, Inc. | Structured acrylate copolymer thickeners |
-
2011
- 2011-06-17 JP JP2014515074A patent/JP5832645B2/ja not_active Expired - Fee Related
- 2011-06-17 KR KR1020137033078A patent/KR101799625B1/ko not_active Application Discontinuation
- 2011-06-17 BR BR112013028453A patent/BR112013028453B8/pt not_active IP Right Cessation
- 2011-06-17 ES ES11725757.6T patent/ES2617402T3/es active Active
- 2011-06-17 CA CA2839494A patent/CA2839494C/en active Active
- 2011-06-17 RU RU2014101228/15A patent/RU2599023C2/ru active
- 2011-06-17 US US14/115,632 patent/US9668977B2/en active Active
- 2011-06-17 SI SI201131105A patent/SI2720681T1/sl unknown
- 2011-06-17 PL PL11725757T patent/PL2720681T3/pl unknown
- 2011-06-17 MX MX2013014143A patent/MX353426B/es active IP Right Grant
- 2011-06-17 WO PCT/EP2011/060097 patent/WO2012171576A1/en active Application Filing
- 2011-06-17 CN CN201180070617.5A patent/CN103501767A/zh active Pending
- 2011-06-17 AU AU2011370763A patent/AU2011370763A1/en not_active Abandoned
- 2011-06-17 EP EP11725757.6A patent/EP2720681B1/en active Active
- 2011-06-17 HU HUE11725757A patent/HUE033117T2/en unknown
-
2013
- 2013-09-12 IL IL228397A patent/IL228397A/en active IP Right Grant
Also Published As
Publication number | Publication date |
---|---|
EP2720681B1 (en) | 2016-11-23 |
KR101799625B1 (ko) | 2017-11-20 |
AU2011370763A1 (en) | 2013-10-03 |
BR112013028453A2 (pt) | 2017-01-24 |
WO2012171576A1 (en) | 2012-12-20 |
PL2720681T3 (pl) | 2017-05-31 |
JP2014517018A (ja) | 2014-07-17 |
IL228397A0 (en) | 2013-12-31 |
RU2014101228A (ru) | 2015-07-27 |
CN103501767A (zh) | 2014-01-08 |
KR20140041545A (ko) | 2014-04-04 |
SI2720681T1 (sl) | 2017-03-31 |
JP5832645B2 (ja) | 2015-12-16 |
IL228397A (en) | 2017-07-31 |
EP2720681A1 (en) | 2014-04-23 |
CA2839494A1 (en) | 2012-12-20 |
MX353426B (es) | 2018-01-12 |
HUE033117T2 (en) | 2017-11-28 |
CA2839494C (en) | 2018-11-06 |
RU2599023C2 (ru) | 2016-10-10 |
US9668977B2 (en) | 2017-06-06 |
US20140079792A1 (en) | 2014-03-20 |
BR112013028453B1 (pt) | 2021-10-19 |
ES2617402T3 (es) | 2017-06-19 |
MX2013014143A (es) | 2014-01-23 |
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