JP6713483B2 - ミューオピオイド受容体アンタゴニストとオピオイド剤との組み合わせ剤形 - Google Patents
ミューオピオイド受容体アンタゴニストとオピオイド剤との組み合わせ剤形 Download PDFInfo
- Publication number
- JP6713483B2 JP6713483B2 JP2017550832A JP2017550832A JP6713483B2 JP 6713483 B2 JP6713483 B2 JP 6713483B2 JP 2017550832 A JP2017550832 A JP 2017550832A JP 2017550832 A JP2017550832 A JP 2017550832A JP 6713483 B2 JP6713483 B2 JP 6713483B2
- Authority
- JP
- Japan
- Prior art keywords
- weight
- sulfate
- opioid
- formulation
- combination
- 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.)
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
- A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
-
- 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
- A61K31/439—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 the ring forming part of a bridged ring system, e.g. quinuclidine
-
- 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
- A61K31/46—8-Azabicyclo [3.2.1] octane; Derivatives thereof, e.g. atropine, cocaine
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/282—Organic compounds, e.g. 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
-
- 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
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/2853—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)
-
- 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
- A61K9/2893—Tablet coating processes
-
- 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
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Emergency Medicine (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Pain & Pain Management (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Nitrogen Condensed Heterocyclic Rings (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201562141981P | 2015-04-02 | 2015-04-02 | |
| US62/141,981 | 2015-04-02 | ||
| PCT/US2016/025176 WO2016161069A1 (en) | 2015-04-02 | 2016-03-31 | Combination dosage form of a mu opioid receptor antagonist and an opioid agent |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2020016858A Division JP2020073583A (ja) | 2015-04-02 | 2020-02-04 | ミューオピオイド受容体アンタゴニストとオピオイド剤との組み合わせ剤形 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2018513138A JP2018513138A (ja) | 2018-05-24 |
| JP2018513138A5 JP2018513138A5 (enExample) | 2019-03-14 |
| JP6713483B2 true JP6713483B2 (ja) | 2020-06-24 |
Family
ID=55806767
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2017550832A Active JP6713483B2 (ja) | 2015-04-02 | 2016-03-31 | ミューオピオイド受容体アンタゴニストとオピオイド剤との組み合わせ剤形 |
| JP2020016858A Withdrawn JP2020073583A (ja) | 2015-04-02 | 2020-02-04 | ミューオピオイド受容体アンタゴニストとオピオイド剤との組み合わせ剤形 |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2020016858A Withdrawn JP2020073583A (ja) | 2015-04-02 | 2020-02-04 | ミューオピオイド受容体アンタゴニストとオピオイド剤との組み合わせ剤形 |
Country Status (27)
| Country | Link |
|---|---|
| US (4) | US20160287573A1 (enExample) |
| EP (1) | EP3277278B1 (enExample) |
| JP (2) | JP6713483B2 (enExample) |
| KR (1) | KR20170132325A (enExample) |
| CN (1) | CN107820424B (enExample) |
| AU (1) | AU2016243691A1 (enExample) |
| BR (1) | BR112017021120A2 (enExample) |
| CA (1) | CA2980328A1 (enExample) |
| CY (1) | CY1122828T1 (enExample) |
| DK (1) | DK3277278T3 (enExample) |
| ES (1) | ES2774473T3 (enExample) |
| HK (1) | HK1247105A1 (enExample) |
| HR (1) | HRP20200432T1 (enExample) |
| HU (1) | HUE048785T2 (enExample) |
| IL (1) | IL254593A0 (enExample) |
| LT (1) | LT3277278T (enExample) |
| ME (1) | ME03671B (enExample) |
| MX (1) | MX2017012474A (enExample) |
| PH (1) | PH12017501767A1 (enExample) |
| PL (1) | PL3277278T3 (enExample) |
| PT (1) | PT3277278T (enExample) |
| RS (1) | RS60074B1 (enExample) |
| RU (1) | RU2017134794A (enExample) |
| SI (1) | SI3277278T1 (enExample) |
| SM (1) | SMT202000157T1 (enExample) |
| TW (1) | TW201642856A (enExample) |
| WO (1) | WO2016161069A1 (enExample) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP3277278B1 (en) | 2015-04-02 | 2020-01-08 | Theravance Biopharma R&D IP, LLC | Combination dosage form of a mu opioid receptor antagonist and an opioid agent |
| WO2019031560A1 (ja) * | 2017-08-08 | 2019-02-14 | 日本合成化学工業株式会社 | 医薬錠剤、およびその製造方法 |
Family Cites Families (24)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| US6419960B1 (en) | 1998-12-17 | 2002-07-16 | Euro-Celtique S.A. | Controlled release formulations having rapid onset and rapid decline of effective plasma drug concentrations |
| US6451806B2 (en) | 1999-09-29 | 2002-09-17 | Adolor Corporation | Methods and compositions involving opioids and antagonists thereof |
| AR029538A1 (es) * | 2000-07-06 | 2003-07-02 | Wyeth Corp | Composiciones farmaceuticas de agentes estrogenicos |
| US7842307B2 (en) | 2001-08-06 | 2010-11-30 | Purdue Pharma L.P. | Pharmaceutical formulation containing opioid agonist, opioid antagonist and gelling agent |
| DK1414451T3 (da) * | 2001-08-06 | 2009-08-10 | Euro Celtique Sa | Opioidagonistformuleringer med frigivelig og sekvenstreret antagonist |
| AU2003301121A1 (en) * | 2002-12-18 | 2004-07-14 | Pain Therapeutics, Inc. | Oral dosage forms with therapeutically active agents in controlled release cores and immediate release gelatin capsule coats |
| US20050013863A1 (en) | 2003-07-18 | 2005-01-20 | Depomed, Inc., A Corporation Of The State Of California | Dual drug dosage forms with improved separation of drugs |
| AU2004314693B2 (en) | 2003-09-26 | 2011-04-07 | Alza Corporation | Drug coating providing high drug loading and methods for providing the same |
| TWI415635B (zh) | 2004-05-28 | 2013-11-21 | 必治妥施貴寶公司 | 加衣錠片調製物及製備彼之方法 |
| AU2006218603A1 (en) * | 2005-03-02 | 2006-09-08 | Theravance, Inc. | Quinolinone compounds as 5-HT4 receptor agonists |
| MY145633A (en) | 2006-03-01 | 2012-03-15 | Theravance Inc | 8-azabicyclo[3.2.1]octane compounds as mu opioid receptor antagonists |
| CN101395154B (zh) * | 2006-03-01 | 2011-01-19 | 施万制药 | 作为μ阿片受体拮抗剂的8-氮杂双环[3.2.1]辛烷化合物 |
| CN101500542A (zh) * | 2006-07-11 | 2009-08-05 | 共有药物有限公司 | 控释制剂 |
| TWI409067B (zh) | 2007-02-28 | 2013-09-21 | Theravance Inc | 8-氮雜雙環〔3.2.1〕辛烷化合物之結晶型 |
| TWI415850B (zh) | 2007-07-20 | 2013-11-21 | Theravance Inc | 製備mu類鴉片受體拮抗劑之中間物的方法 |
| AU2009244190B2 (en) * | 2008-05-07 | 2016-02-25 | Salix Pharmaceuticals, Ltd. | Methods of treating bowel disease by administering a bowel cleanser and an antibiotic |
| EP2210595A1 (en) | 2009-01-14 | 2010-07-28 | LEK Pharmaceuticals d.d. | Active coating of pharmaceutical dosage forms |
| MX2011011919A (es) * | 2009-05-12 | 2012-01-27 | Bpsi Holdings Llc | Sistemas de recubrimiento de pelicula de liberacion inmediata con barrera contra humedad mejorada y sustratos recubiertos con dichos sistemas. |
| IT1398930B1 (it) * | 2010-03-24 | 2013-03-28 | Molteni & C | Formulazioni farmaceutiche bistrato contenenti agonisti ed antagonisti oppioidi. |
| AU2011295837B2 (en) * | 2010-09-03 | 2015-06-18 | Astrazeneca Uk Limited | Drug formulations using water soluble antioxidants |
| ES2801725T3 (es) | 2011-02-01 | 2021-01-12 | Bristol Myers Squibb Co | Formulaciones farmacéuticas que incluyen un compuesto de amina |
| US9339489B2 (en) * | 2013-03-15 | 2016-05-17 | Aprecia Pharmaceuticals Company | Rapid disperse dosage form containing levetiracetam |
| EP3277278B1 (en) | 2015-04-02 | 2020-01-08 | Theravance Biopharma R&D IP, LLC | Combination dosage form of a mu opioid receptor antagonist and an opioid agent |
-
2016
- 2016-03-31 EP EP16718062.9A patent/EP3277278B1/en active Active
- 2016-03-31 RU RU2017134794A patent/RU2017134794A/ru not_active Application Discontinuation
- 2016-03-31 BR BR112017021120-3A patent/BR112017021120A2/pt not_active Application Discontinuation
- 2016-03-31 HR HRP20200432TT patent/HRP20200432T1/hr unknown
- 2016-03-31 TW TW105110406A patent/TW201642856A/zh unknown
- 2016-03-31 US US15/086,816 patent/US20160287573A1/en not_active Abandoned
- 2016-03-31 RS RS20200315A patent/RS60074B1/sr unknown
- 2016-03-31 CA CA2980328A patent/CA2980328A1/en not_active Abandoned
- 2016-03-31 KR KR1020177031800A patent/KR20170132325A/ko not_active Withdrawn
- 2016-03-31 DK DK16718062.9T patent/DK3277278T3/da active
- 2016-03-31 ME MEP-2020-48A patent/ME03671B/me unknown
- 2016-03-31 PL PL16718062T patent/PL3277278T3/pl unknown
- 2016-03-31 WO PCT/US2016/025176 patent/WO2016161069A1/en not_active Ceased
- 2016-03-31 SI SI201630671T patent/SI3277278T1/sl unknown
- 2016-03-31 SM SM20200157T patent/SMT202000157T1/it unknown
- 2016-03-31 LT LTEP16718062.9T patent/LT3277278T/lt unknown
- 2016-03-31 HK HK18106740.0A patent/HK1247105A1/zh unknown
- 2016-03-31 CN CN201680019821.7A patent/CN107820424B/zh active Active
- 2016-03-31 HU HUE16718062A patent/HUE048785T2/hu unknown
- 2016-03-31 MX MX2017012474A patent/MX2017012474A/es unknown
- 2016-03-31 JP JP2017550832A patent/JP6713483B2/ja active Active
- 2016-03-31 AU AU2016243691A patent/AU2016243691A1/en not_active Abandoned
- 2016-03-31 ES ES16718062T patent/ES2774473T3/es active Active
- 2016-03-31 PT PT167180629T patent/PT3277278T/pt unknown
-
2017
- 2017-09-19 IL IL254593A patent/IL254593A0/en unknown
- 2017-09-26 PH PH12017501767A patent/PH12017501767A1/en unknown
- 2017-10-31 US US15/798,647 patent/US10369142B2/en active Active
-
2019
- 2019-06-27 US US16/454,353 patent/US10946009B2/en active Active
-
2020
- 2020-02-04 JP JP2020016858A patent/JP2020073583A/ja not_active Withdrawn
- 2020-03-17 CY CY20201100246T patent/CY1122828T1/el unknown
-
2021
- 2021-02-08 US US17/248,787 patent/US11452723B2/en active Active
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