MX2009008951A - Microesferas que comprenden una matriz de sustancia activa y un revestimiento polimerico, y un metodo para producir dichas microesferas. - Google Patents
Microesferas que comprenden una matriz de sustancia activa y un revestimiento polimerico, y un metodo para producir dichas microesferas.Info
- Publication number
- MX2009008951A MX2009008951A MX2009008951A MX2009008951A MX2009008951A MX 2009008951 A MX2009008951 A MX 2009008951A MX 2009008951 A MX2009008951 A MX 2009008951A MX 2009008951 A MX2009008951 A MX 2009008951A MX 2009008951 A MX2009008951 A MX 2009008951A
- Authority
- MX
- Mexico
- Prior art keywords
- pellets
- active substance
- polymer coating
- polymer
- producing
- Prior art date
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
- A61K9/14—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
- A61K9/14—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
- 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
-
- 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
- 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
- A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Inorganic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
La invención trata de microesferas que contienen compuesto activo que tienen un revestimiento polimérico y un tamaño de partícula promedio que varía entre 300 a 1100 pm, que comprende una sustancia farmacéuticamente activa, incrustada en una matriz polimérica de uno o más polímeros que se caracterizan porque las microesferas tienen una friabilidad de máximo 0.1 %, medida utilizando 200 g de microesferas en una máquina cribadora que tiene un tamiz de 200 pm, un diámetro de tamiz de 20 cm y 1.5 mm de amplitud de agitación en una frecuencia de agitación de 50 1/segundos durante 10 minutos en la presencia de seis cubos de goma que tienen longitud de borde de 1.8 cm y se recubren con un revestimiento polimérico de un copolímero de metacrilato aniónico, con la condición de que las microesferas no liberan más del 10% del compuesto activo contenido en la prueba de liberación de acuerdo con USP en el jugo gástrico artificial que tiene pH 1.2 después de 120 minutos.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE102007009243A DE102007009243A1 (de) | 2007-02-22 | 2007-02-22 | Pellets mit einer Wirkstoff-Matrix und einem Polymerüberzug, sowie ein Verfahren zur Herstellung der Pellets |
PCT/EP2007/062603 WO2008101554A1 (de) | 2007-02-22 | 2007-11-21 | Pellets mit einer wirkstoff-matrix und einem polymerüberzug, sowie ein verfahren zur herstellung der pellets |
Publications (1)
Publication Number | Publication Date |
---|---|
MX2009008951A true MX2009008951A (es) | 2009-08-31 |
Family
ID=38983907
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
MX2009008951A MX2009008951A (es) | 2007-02-22 | 2007-11-21 | Microesferas que comprenden una matriz de sustancia activa y un revestimiento polimerico, y un metodo para producir dichas microesferas. |
Country Status (11)
Country | Link |
---|---|
US (1) | US20080206324A1 (es) |
EP (1) | EP2120955A1 (es) |
JP (1) | JP5345557B2 (es) |
KR (1) | KR101465819B1 (es) |
CN (1) | CN101626769A (es) |
BR (1) | BRPI0721369A2 (es) |
CA (1) | CA2677727A1 (es) |
DE (1) | DE102007009243A1 (es) |
IL (1) | IL199817A0 (es) |
MX (1) | MX2009008951A (es) |
WO (1) | WO2008101554A1 (es) |
Families Citing this family (24)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CA2359812C (en) | 2000-11-20 | 2004-02-10 | The Procter & Gamble Company | Pharmaceutical dosage form with multiple coatings for reduced impact of coating fractures |
SI2230932T1 (sl) * | 2008-01-10 | 2017-07-31 | Evonik Roehm Gmbh | Oplaščeni farmacevtski ali nutracevtski pripravek s povečanim sproščanjem aktivne učinkovine v črevesu |
MX2010007579A (es) * | 2008-01-10 | 2010-08-03 | Evonik Roehm Gmbh | Preparacion nutriceutica o farmaceutica revestida con una liberacion de sustancia activa de impulsion mejorada. |
WO2009086942A1 (en) * | 2008-01-10 | 2009-07-16 | Evonik Röhm Gmbh | Coated pharmaceutical or nutraceutical preparation with accelerated controlled active substance release |
AR070863A1 (es) | 2008-03-11 | 2010-05-12 | Takeda Pharmaceutical | Preparacion solida de desintegracion oral y metodo para suprimir la ruptura de los granulos finos durante la produccion de un comprimido |
CN101897674B (zh) * | 2009-05-25 | 2012-12-19 | 范敏华 | L-半胱氨酸片及其制备方法 |
EA025735B1 (ru) | 2009-06-08 | 2017-01-30 | ЮСиЭл БИЗНЕС ПиЭлСи | Способ лечения портальной гипертензии с использованием l-орнитина в сочетании по меньшей мере с одним из соединений, выбранных из фенилацетата и фенилбутирата |
WO2011126733A2 (en) * | 2010-03-28 | 2011-10-13 | Children's Medical Center Corporation | Combination therapies: inhibitors of gaba transaminase and nkcc1 |
ITPN20100027A1 (it) * | 2010-05-12 | 2011-11-13 | Friulchem S P A | Processo per la preparazione di cilindri e granuli utilizzabili nell'industria veterinaria e mangimistica contenenti principi farmacologicamente attivi, integratori, nutrienti, vitamine o microorganismi |
CN101961324A (zh) * | 2010-09-10 | 2011-02-02 | 武汉药谷生物工程有限公司 | 一种依托贝特缓释胶囊的处方及制备方法 |
JP5631500B2 (ja) * | 2010-10-13 | 2014-11-26 | エボニック レーム ゲゼルシャフト ミット ベシュレンクテル ハフツングEvonik Roehm GmbH | 溶液中フリーラジカル重合により第四級アンモニウム基を含む(メタ)アクリレートコポリマーを製造する方法 |
CN102258478B (zh) * | 2011-04-29 | 2013-02-27 | 武汉华扬动物药业有限责任公司 | 一种兽用甲磺酸培氟沙星微丸及其制备方法 |
CA2936746C (en) | 2014-10-31 | 2017-06-27 | Purdue Pharma | Methods and compositions particularly for treatment of attention deficit disorder |
IL255343B1 (en) | 2015-05-04 | 2024-06-01 | Confluence Pharmaceuticals Llc | Essay formulations of acamprosate |
BR112017025148A2 (pt) | 2015-06-05 | 2018-08-07 | Evonik Röhm Gmbh | composição farmacêutica ou nutracêutica com resistência contra a influência do etanol |
CN104983692A (zh) * | 2015-07-17 | 2015-10-21 | 江西博莱大药厂有限公司 | 一种阿莫西林缓释微丸及其制备方法 |
US11219611B2 (en) | 2015-11-13 | 2022-01-11 | Ocera Therapeutics, Inc. | Formulations of L-ornithine phenylacetate |
SG11201802987UA (en) * | 2015-11-13 | 2018-05-30 | Ocera Therapeutics Inc | Formulation of l-ornithine phenylacetate |
EP3624788A4 (en) | 2017-05-17 | 2021-03-03 | Confluence Pharmaceuticals, LLC | FORMULATIONS OF HOMOTAURINS AND THEIR SALTS |
CN108338978B (zh) * | 2018-04-20 | 2020-09-18 | 广州白云山医药集团股份有限公司白云山制药总厂 | 一种s-羧甲基-l-半胱氨酸肠溶微丸胶囊 |
US10722473B2 (en) | 2018-11-19 | 2020-07-28 | Purdue Pharma L.P. | Methods and compositions particularly for treatment of attention deficit disorder |
JP2022533610A (ja) * | 2019-05-15 | 2022-07-25 | エボニック オペレーションズ ゲーエムベーハー | カプセル充填機を用いて、(メタ)アクリレートコポリマー系のコーティングを有する、充填されたハードシェルカプセルを製造する方法 |
US10792262B1 (en) | 2019-07-29 | 2020-10-06 | Saol International Limited | Stabilized formulations of 4-amino-3-substituted butanoic acid derivatives |
US11654124B2 (en) | 2019-07-29 | 2023-05-23 | Amneal Pharmaceuticals Llc | Stabilized formulations of 4-amino-3-substituted butanoic acid derivatives |
Family Cites Families (30)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE2135073C3 (de) | 1971-07-14 | 1974-07-11 | Roehm Gmbh | Überzugsmittel für Arzneiformen |
DE3106449A1 (de) | 1981-02-20 | 1982-09-09 | Röhm GmbH, 6100 Darmstadt | "in magensaft loesliche oder quellbare ueberzugsmasse und ihre verwendung in einem verfahren zum ueberziehen von arzneiformen" |
DE3581428D1 (de) | 1984-06-13 | 1991-02-28 | Roehm Gmbh | Verfahren zum ueberziehen von arzneiformen. |
DE3438291A1 (de) | 1984-10-19 | 1986-04-24 | Röhm GmbH, 6100 Darmstadt | Verfahren zur herstellung einer waessrigen ueberzugsmitteldispersion und ihre verwendung zum ueberziehen von arzneimitteln |
JP2536876B2 (ja) * | 1987-07-31 | 1996-09-25 | 寛治 高田 | シクロスポリンの溶解性粉末状製剤 |
JP2542122B2 (ja) * | 1990-04-18 | 1996-10-09 | 旭化成工業株式会社 | 球状核、球形顆粒およびその製造方法 |
TW209174B (es) * | 1991-04-19 | 1993-07-11 | Takeda Pharm Industry Co Ltd | |
DE9414066U1 (de) | 1994-08-31 | 1994-11-03 | Röhm GmbH & Co. KG, 64293 Darmstadt | Überzugs- und Bindemittel für Arzneiformen sowie damit hergestellte Arzneiform |
DE9414065U1 (de) | 1994-08-31 | 1994-11-03 | Röhm GmbH & Co. KG, 64293 Darmstadt | Thermoplastischer Kunststoff für darmsaftlösliche Arznei-Umhüllungen |
US5965161A (en) * | 1994-11-04 | 1999-10-12 | Euro-Celtique, S.A. | Extruded multi-particulates |
ES2200158T3 (es) * | 1996-03-08 | 2004-03-01 | Nycomed Danmark Aps | Cmpuesto de dosificacion de unidades multiples, de liberacion modificada. |
DE10011447A1 (de) | 2000-03-10 | 2001-09-20 | Roehm Gmbh | Dispersion mit nichtionischem Emulgator |
DE10013029A1 (de) | 2000-03-17 | 2001-09-20 | Roehm Gmbh | Mehrschichtige Arzneiform für die Colonfreigabe |
JP2001270821A (ja) * | 2000-03-23 | 2001-10-02 | Eisai Co Ltd | 服用感が優れた散剤 |
AU2002226098A1 (en) * | 2000-10-30 | 2002-05-15 | The Board Of Regents, The University Of Texas System | Spherical particles produced by a hot-melt extrusion/spheronization process |
DE10208335A1 (de) | 2002-02-27 | 2003-09-04 | Roehm Gmbh | Arzneiform und Verfahren zu ihrer Herstellung |
DE10250543A1 (de) * | 2002-10-29 | 2004-05-19 | Röhm GmbH & Co. KG | Mehrschichtige Arzneiform |
MXPA04010956A (es) | 2003-01-30 | 2005-01-25 | Roehm Gmbh | Forma de dosis farmaceutica y metodo para la produccion de la misma. |
US20050106253A1 (en) * | 2003-11-13 | 2005-05-19 | Platteeuw Johannes J. | Pharmaceutical pellets comprising tamsulosin |
CN1909889B (zh) * | 2004-01-09 | 2010-06-02 | 韩美药品株式会社 | 头孢呋辛酯颗粒及其制备方法 |
GB0403098D0 (en) | 2004-02-12 | 2004-03-17 | Euro Celtique Sa | Extrusion |
DE102004007713A1 (de) | 2004-02-16 | 2005-09-01 | Leistritz Extrusionstechnik Gmbh | Vorrichtung zur Herstellung gerundeter Pellets |
DE102004011349A1 (de) | 2004-03-05 | 2005-09-22 | Basf Ag | Wässrige Polymerdispersion auf Basis von Alkyl(meth)-acrylaten |
DE102004027924A1 (de) * | 2004-06-09 | 2005-12-29 | Röhm GmbH & Co. KG | Arzneiform, enthaltend den Wirkstoff Cholylsarcosin |
WO2006014427A1 (en) * | 2004-07-02 | 2006-02-09 | Advancis Pharmaceutical Corporation | Tablet for pulsed delivery |
US20060159753A1 (en) * | 2004-12-27 | 2006-07-20 | Eisai Co. Ltd. | Matrix type sustained-release preparation containing basic drug or salt thereof |
WO2007056570A2 (en) * | 2005-11-07 | 2007-05-18 | Teva Pharmaceutical Industries Ltd. | Levodopa compositions |
EP2063876A1 (en) * | 2006-07-28 | 2009-06-03 | Farmaprojects, S.A. | Extended release pharmaceutical formulation of metoprolol and process for its preparation |
CN101484147B (zh) * | 2006-08-18 | 2015-07-08 | 赢创罗姆有限责任公司 | 对于具有水中良好溶解性的活性成分具有受控的活性成分释放性的药物组合物 |
DE102007009242A1 (de) * | 2007-02-22 | 2008-09-18 | Evonik Röhm Gmbh | Pellets mit magensaftresistenter Wirkstoff-Matix |
-
2007
- 2007-02-22 DE DE102007009243A patent/DE102007009243A1/de not_active Withdrawn
- 2007-11-21 WO PCT/EP2007/062603 patent/WO2008101554A1/de active Application Filing
- 2007-11-21 EP EP07847238A patent/EP2120955A1/de not_active Withdrawn
- 2007-11-21 BR BRPI0721369-7A2A patent/BRPI0721369A2/pt not_active IP Right Cessation
- 2007-11-21 KR KR1020097017448A patent/KR101465819B1/ko not_active IP Right Cessation
- 2007-11-21 CN CN200780051079A patent/CN101626769A/zh active Pending
- 2007-11-21 JP JP2009550210A patent/JP5345557B2/ja not_active Expired - Fee Related
- 2007-11-21 MX MX2009008951A patent/MX2009008951A/es unknown
- 2007-11-21 CA CA002677727A patent/CA2677727A1/en not_active Abandoned
-
2008
- 2008-02-13 US US12/030,377 patent/US20080206324A1/en not_active Abandoned
-
2009
- 2009-07-12 IL IL199817A patent/IL199817A0/en unknown
Also Published As
Publication number | Publication date |
---|---|
JP5345557B2 (ja) | 2013-11-20 |
BRPI0721369A2 (pt) | 2014-03-04 |
CN101626769A (zh) | 2010-01-13 |
JP2010519228A (ja) | 2010-06-03 |
CA2677727A1 (en) | 2008-08-28 |
DE102007009243A1 (de) | 2008-09-18 |
WO2008101554A1 (de) | 2008-08-28 |
US20080206324A1 (en) | 2008-08-28 |
KR20090112718A (ko) | 2009-10-28 |
KR101465819B1 (ko) | 2014-11-27 |
IL199817A0 (en) | 2010-04-15 |
EP2120955A1 (de) | 2009-11-25 |
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