CN101052379A - 优选阿片样物质的多颗粒以及使用挤出的制造方法 - Google Patents
优选阿片样物质的多颗粒以及使用挤出的制造方法 Download PDFInfo
- Publication number
- CN101052379A CN101052379A CNA2005800377469A CN200580037746A CN101052379A CN 101052379 A CN101052379 A CN 101052379A CN A2005800377469 A CNA2005800377469 A CN A2005800377469A CN 200580037746 A CN200580037746 A CN 200580037746A CN 101052379 A CN101052379 A CN 101052379A
- Authority
- CN
- China
- Prior art keywords
- oxycodone
- multiparticulates
- pharmaceutically active
- active agents
- release
- 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.)
- Pending
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Classifications
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- 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
- A61K9/1617—Organic compounds, e.g. phospholipids, 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
- A61K9/14—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
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/47—Quinolines; Isoquinolines
- A61K31/485—Morphinan derivatives, e.g. morphine, codeine
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
-
- 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
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4866—Organic macromolecular compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/04—Centrally acting analgesics, e.g. opioids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P29/02—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID] without antiinflammatory effect
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
- B29C48/03—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor characterised by the shape of the extruded material at extrusion
- B29C48/04—Particle-shaped
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
- B29C48/25—Component parts, details or accessories; Auxiliary operations
- B29C48/36—Means for plasticising or homogenising the moulding material or forcing it through the nozzle or die
- B29C48/50—Details of extruders
- B29C48/505—Screws
- B29C48/63—Screws having sections without mixing elements or threads, i.e. having cylinder shaped sections
-
- 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
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Mechanical Engineering (AREA)
- Emergency Medicine (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Pain & Pain Management (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Rheumatology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GB0419296A GB2418854B (en) | 2004-08-31 | 2004-08-31 | Multiparticulates |
| GB0419296.9 | 2004-08-31 |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2013104365518A Division CN103462904A (zh) | 2004-08-31 | 2005-08-31 | 优选阿片样物质的多颗粒以及使用挤出的制造方法 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN101052379A true CN101052379A (zh) | 2007-10-10 |
Family
ID=33104837
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNA2005800377469A Pending CN101052379A (zh) | 2004-08-31 | 2005-08-31 | 优选阿片样物质的多颗粒以及使用挤出的制造方法 |
| CN2013104365518A Pending CN103462904A (zh) | 2004-08-31 | 2005-08-31 | 优选阿片样物质的多颗粒以及使用挤出的制造方法 |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2013104365518A Pending CN103462904A (zh) | 2004-08-31 | 2005-08-31 | 优选阿片样物质的多颗粒以及使用挤出的制造方法 |
Country Status (17)
| Country | Link |
|---|---|
| US (1) | US9259872B2 (enExample) |
| EP (2) | EP1809249A2 (enExample) |
| JP (3) | JP2008511604A (enExample) |
| KR (2) | KR101306500B1 (enExample) |
| CN (2) | CN101052379A (enExample) |
| AU (1) | AU2005278919B2 (enExample) |
| BR (1) | BRPI0514474B1 (enExample) |
| CA (1) | CA2576275C (enExample) |
| EA (1) | EA017435B1 (enExample) |
| GB (1) | GB2418854B (enExample) |
| IL (1) | IL180928A (enExample) |
| MX (1) | MX2007001904A (enExample) |
| NO (1) | NO20070871L (enExample) |
| NZ (1) | NZ552845A (enExample) |
| SG (1) | SG155880A1 (enExample) |
| WO (1) | WO2006024881A2 (enExample) |
| ZA (1) | ZA200701056B (enExample) |
Families Citing this family (47)
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| US6375957B1 (en) | 1997-12-22 | 2002-04-23 | Euro-Celtique, S.A. | Opioid agonist/opioid antagonist/acetaminophen combinations |
| ES2412409T3 (es) | 1997-12-22 | 2013-07-11 | Euro-Celtique S.A. | Forma farmacéutica para dosificación oral que comprende una combinación de un agonista opiáceo y un antagonista opiáceo |
| US20030065002A1 (en) | 2001-05-11 | 2003-04-03 | Endo Pharmaceuticals, Inc. | Abuse-resistant controlled-release opioid dosage form |
| US20030068375A1 (en) | 2001-08-06 | 2003-04-10 | Curtis Wright | Pharmaceutical formulation containing gelling agent |
| EP1492505B1 (en) | 2002-04-05 | 2015-06-03 | Euro-Celtique S.A. | Pharmaceutical preparation containing oxycodone and naloxone |
| DE10361596A1 (de) | 2003-12-24 | 2005-09-29 | Grünenthal GmbH | Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform |
| DE102005005446A1 (de) | 2005-02-04 | 2006-08-10 | Grünenthal GmbH | Bruchfeste Darreichungsformen mit retardierter Freisetzung |
| CA2569958C (en) | 2004-06-12 | 2016-03-22 | Jane C. Hirsh | Abuse-deterrent drug formulations |
| DE102004032049A1 (de) * | 2004-07-01 | 2006-01-19 | Grünenthal GmbH | Gegen Missbrauch gesicherte, orale Darreichungsform |
| GB2418854B (en) * | 2004-08-31 | 2009-12-23 | Euro Celtique Sa | Multiparticulates |
| DE102005005449A1 (de) | 2005-02-04 | 2006-08-10 | Grünenthal GmbH | Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform |
| EP1702558A1 (en) | 2005-02-28 | 2006-09-20 | Euro-Celtique S.A. | Method and device for the assessment of bowel function |
| US8852638B2 (en) | 2005-09-30 | 2014-10-07 | Durect Corporation | Sustained release small molecule drug formulation |
| EP1832281A1 (en) * | 2006-03-10 | 2007-09-12 | Abbott GmbH & Co. KG | Process for producing a solid dispersion of an active ingredient |
| EP2907524A1 (en) | 2007-05-25 | 2015-08-19 | RB Pharmaceuticals Limited | Sustained delivery formulations of risperidone compounds |
| DE102007026550A1 (de) * | 2007-06-08 | 2008-12-11 | Bayer Healthcare Ag | Extrudate mit verbesserter Geschmacksmaskierung |
| WO2009051022A2 (en) * | 2007-10-19 | 2009-04-23 | Otsuka Pharmaceutical Co., Ltd. | Matrix-type pharmaceutical solid preparation |
| JP2011511782A (ja) | 2008-02-12 | 2011-04-14 | アボット・ラボラトリーズ | 長期放出性ヒドロコドンアセトアミノフェンならびにその関連方法および用途 |
| BRPI1006186A2 (pt) | 2009-03-10 | 2016-08-23 | Euro Celtique Sa | composições farmaceuticas de liberação imediata compreedendo oxicodona e naloxona |
| GB0909680D0 (en) | 2009-06-05 | 2009-07-22 | Euro Celtique Sa | Dosage form |
| US10668060B2 (en) | 2009-12-10 | 2020-06-02 | Collegium Pharmaceutical, Inc. | Tamper-resistant pharmaceutical compositions of opioids and other drugs |
| JP5749247B2 (ja) | 2010-02-22 | 2015-07-15 | 第一三共株式会社 | 経口用徐放性固形製剤 |
| WO2011102505A1 (ja) * | 2010-02-22 | 2011-08-25 | 第一三共株式会社 | 経口用徐放性固形製剤 |
| MX344846B (es) | 2010-05-10 | 2017-01-10 | Euro-Celtique S A * | Combinacion de granulos cargados activos con activos adicionales. |
| AU2011252040C1 (en) | 2010-05-10 | 2015-04-02 | Euro-Celtique S.A. | Manufacturing of active-free granules and tablets comprising the same |
| US9700508B2 (en) | 2010-05-10 | 2017-07-11 | Euro-Celtique S.A. | Pharmaceutical compositions comprising hydromorphone and naloxone |
| US9272044B2 (en) | 2010-06-08 | 2016-03-01 | Indivior Uk Limited | Injectable flowable composition buprenorphine |
| GB2513060B (en) | 2010-06-08 | 2015-01-07 | Rb Pharmaceuticals Ltd | Microparticle buprenorphine suspension |
| CN104873455B (zh) | 2010-12-22 | 2023-09-12 | 普渡制药公司 | 包覆的抗篡改控制释放剂型 |
| PH12013501345A1 (en) | 2010-12-23 | 2022-10-24 | Purdue Pharma Lp | Tamper resistant solid oral dosage forms |
| NO2736497T3 (enExample) | 2011-07-29 | 2018-01-20 | ||
| CA2839123A1 (en) | 2011-07-29 | 2013-02-07 | Grunenthal Gmbh | Tamper-resistant tablet providing immediate drug release |
| WO2013191668A1 (en) * | 2012-06-22 | 2013-12-27 | Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi | Compositions preventing hypertension comprising soluplus |
| RU2665372C2 (ru) | 2012-09-03 | 2018-08-29 | Дайити Санкио Компани, Лимитед | Пероральная фармацевтическая композиция замедленного высвобождения, содержащая гидрохлорид гидроморфона |
| SG11201506064UA (en) | 2013-02-05 | 2015-08-28 | Purdue Pharma Lp | Tamper resistant pharmaceutical formulations |
| US10751287B2 (en) | 2013-03-15 | 2020-08-25 | Purdue Pharma L.P. | Tamper resistant pharmaceutical formulations |
| BR112016000194A8 (pt) | 2013-07-12 | 2019-12-31 | Gruenenthal Gmbh | forma de dosagem resistente à violação contendo o polímero de acetato de etileno-vinila |
| JP2016525138A (ja) | 2013-07-23 | 2016-08-22 | ユーロ−セルティーク エス.エイ. | 疼痛および腸内ディスバイオシスをもたらす疾患および/または腸内細菌移行に対するリスクを高める疾患に罹患している患者における痛みの治療への使用のためのオキシコドンおよびナロキソンの組み合わせ |
| AU2014306759B2 (en) | 2013-08-12 | 2018-04-26 | Pharmaceutical Manufacturing Research Services, Inc. | Extruded immediate release abuse deterrent pill |
| EP3068397A1 (en) | 2013-11-13 | 2016-09-21 | Euro-Celtique S.A. | Hydromorphone and naloxone for treatment of pain and opioid bowel dysfunction syndrome |
| WO2015095391A1 (en) | 2013-12-17 | 2015-06-25 | Pharmaceutical Manufacturing Research Services, Inc. | Extruded extended release abuse deterrent pill |
| US9492444B2 (en) | 2013-12-17 | 2016-11-15 | Pharmaceutical Manufacturing Research Services, Inc. | Extruded extended release abuse deterrent pill |
| GB201404139D0 (en) | 2014-03-10 | 2014-04-23 | Rb Pharmaceuticals Ltd | Sustained release buprenorphine solution formulations |
| WO2016010771A1 (en) | 2014-07-17 | 2016-01-21 | Pharmaceutical Manufacturing Research Services, Inc. | Immediate release abuse deterrent liquid fill dosage form |
| CA2964628A1 (en) | 2014-10-20 | 2016-04-28 | Pharmaceutical Manufacturing Research Services, Inc. | Extended release abuse deterrent liquid fill dosage form |
| CA2998259A1 (en) | 2015-09-10 | 2017-03-16 | Grunenthal Gmbh | Protecting oral overdose with abuse deterrent immediate release formulations |
| WO2017222575A1 (en) | 2016-06-23 | 2017-12-28 | Collegium Pharmaceutical, Inc. | Process of making more stable abuse-deterrent oral formulations |
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| AU3404997A (en) | 1996-05-31 | 1998-01-05 | Euro-Celtique S.A. | Sustained release oxycodone formulations with no fed/fast effect |
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| UA81224C2 (uk) * | 2001-05-02 | 2007-12-25 | Euro Celtic S A | Дозована форма оксикодону та її застосування |
| AU2002324624A1 (en) | 2001-08-06 | 2003-02-24 | Euro-Celtique S.A. | Sequestered antagonist formulations |
| WO2003020241A2 (en) | 2001-09-05 | 2003-03-13 | Vectura Limited | Functional powders for oral delivery |
| US7939102B2 (en) | 2002-06-07 | 2011-05-10 | Torrent Pharmaceuticals Ltd. | Controlled release formulation of lamotrigine |
| AU2003272601B2 (en) | 2002-09-20 | 2009-05-07 | Alpharma Pharmaceuticals, Llc | Sustained-release opioid formulations and methods of use |
| MY135852A (en) * | 2003-04-21 | 2008-07-31 | Euro Celtique Sa | Pharmaceutical products |
| TWI357815B (en) * | 2003-06-27 | 2012-02-11 | Euro Celtique Sa | Multiparticulates |
| US20060165790A1 (en) | 2003-06-27 | 2006-07-27 | Malcolm Walden | Multiparticulates |
| TWI350762B (en) * | 2004-02-12 | 2011-10-21 | Euro Celtique Sa | Particulates |
| GB2418854B (en) * | 2004-08-31 | 2009-12-23 | Euro Celtique Sa | Multiparticulates |
| CN102888347B (zh) * | 2011-07-22 | 2014-03-26 | 中国科学院烟台海岸带研究所 | 小球藻突变株及其应用 |
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- 2005-08-31 EP EP05781628A patent/EP1809249A2/en not_active Withdrawn
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Application publication date: 20071010 |