DK2914599T3 - Fast saltform af alpha-6-mPEG6-O-hydroxycodon som opioidagonister og anvendelser deraf - Google Patents
Fast saltform af alpha-6-mPEG6-O-hydroxycodon som opioidagonister og anvendelser deraf Download PDFInfo
- Publication number
- DK2914599T3 DK2914599T3 DK13796178.5T DK13796178T DK2914599T3 DK 2914599 T3 DK2914599 T3 DK 2914599T3 DK 13796178 T DK13796178 T DK 13796178T DK 2914599 T3 DK2914599 T3 DK 2914599T3
- Authority
- DK
- Denmark
- Prior art keywords
- mpeg6
- hydroxycodone
- certain embodiments
- salt
- solid
- Prior art date
Links
Classifications
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D489/00—Heterocyclic compounds containing 4aH-8, 9 c- Iminoethano-phenanthro [4, 5-b, c, d] furan ring systems, e.g. derivatives of [4, 5-epoxy]-morphinan of the formula:
- C07D489/02—Heterocyclic compounds containing 4aH-8, 9 c- Iminoethano-phenanthro [4, 5-b, c, d] furan ring systems, e.g. derivatives of [4, 5-epoxy]-morphinan of the formula: with oxygen atoms attached in positions 3 and 6, e.g. morphine, morphinone
- C07D489/04—Salts; Organic complexes
-
- 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
- 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
- A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
- A61K47/56—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
- A61K47/59—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
- A61K47/60—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
-
- 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
- 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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07B—GENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
- C07B2200/00—Indexing scheme relating to specific properties of organic compounds
- C07B2200/13—Crystalline forms, e.g. polymorphs
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Emergency Medicine (AREA)
- Biomedical Technology (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Pain & Pain Management (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Dermatology (AREA)
Claims (16)
1. Fast phosphat- eller D-tartrat salt form af CC-6-mPEG6-0-hydroxycodon.
2. Saltform ifølge krav 1, hvori saltformen er en uordnet krystallinsk form.
3. Saltform ifølge krav 1, hvori saltformen er en krystallinsk form.
4. Saltform ifølge et hvilket som helst af de foregående krav, hvori saltformen er CC-6-mPEG6-0-hydroxycodonphosphatsalt.
5. Saltform ifølge krav 4, hvori CC-6-mPEG6-0-hydroxycodonphosphatsaltet er et monophosphatsalt.
6. Saltform ifølge krav 1, hvori saltformen er CC-6-mPEG6-0-hydroxycodon-D-tartratsalt.
7. Fast saltform ifølge krav 6, hvori a-6-mPEG6-0-hydroxycodon-D-tartratsaltet er et monotartratsalt.
8. Saltform ifølge et hvilket som helst af de foregående krav til anvendelse ved behandling af smerte hos en patient.
9. Saltform til anvendelse ifølge krav 8, hvori smerten er moderat til alvorlig smerte.
10. Farmaceutisk sammensætning omfattende saltformen ifølge et hvilket som helst af de foregående krav og mindst et farmaceutisk acceptabelt excipiens.
11. Farmaceutisk sammensætning ifølge krav 10, hvori den farmaceutiske sammensætning er en tablet.
12. Farmaceutisk sammensætning ifølge krav 11, hvori tabletten har en fyldning af saltformen fra 10% til 50%.
13. Farmaceutisk sammensætning ifølge et hvilket som helst af kravene 10 til 12, hvori sammensætningen omfatter 5 mg til 1000 mg af saltformen.
14. Farmaceutisk sammensætning ifølge et hvilket som helst af kravene 10 til 13, hvori sammensætningen omfatter et af flere excipienser valgt fra gruppen omfattende dibasisk calciumphosphat, mikrokrystallinsk cellulose, natriumcroscarmellose, kolloidt siliciumdioxid og magnesiumstearat.
15. Farmaceutisk sammensætning ifølge et hvilket som helst af kravene 10 til 14 til anvendelse ved behandling af smerte hos en patient.
16. Sammensætning til anvendelse ifølge krav 15, hvori smerten er moderat til alvorlig smerte.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201261720259P | 2012-10-30 | 2012-10-30 | |
US201361791894P | 2013-03-15 | 2013-03-15 | |
PCT/US2013/067273 WO2014070745A1 (en) | 2012-10-30 | 2013-10-29 | Solid salt form of alpha-6-mpeg6-o-hydroxycodone as opioid agonists and uses thereof |
Publications (1)
Publication Number | Publication Date |
---|---|
DK2914599T3 true DK2914599T3 (da) | 2017-12-18 |
Family
ID=49674367
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DK13796178.5T DK2914599T3 (da) | 2012-10-30 | 2013-10-29 | Fast saltform af alpha-6-mPEG6-O-hydroxycodon som opioidagonister og anvendelser deraf |
Country Status (23)
Country | Link |
---|---|
US (2) | US9682988B2 (da) |
EP (2) | EP2914599B1 (da) |
JP (2) | JP6384964B2 (da) |
KR (1) | KR20150076175A (da) |
CN (2) | CN104755481A (da) |
AU (2) | AU2013338098B2 (da) |
CA (1) | CA2886276A1 (da) |
CY (1) | CY1119871T1 (da) |
DK (1) | DK2914599T3 (da) |
EA (1) | EA029512B1 (da) |
ES (1) | ES2651689T3 (da) |
HK (2) | HK1213549A1 (da) |
HR (1) | HRP20180315T1 (da) |
HU (1) | HUE038161T2 (da) |
IL (1) | IL238529A0 (da) |
LT (1) | LT2914599T (da) |
ME (1) | ME02971B (da) |
MX (1) | MX367773B (da) |
PL (1) | PL2914599T3 (da) |
PT (1) | PT2914599T (da) |
RS (1) | RS56898B1 (da) |
SI (1) | SI2914599T1 (da) |
WO (1) | WO2014070745A1 (da) |
Families Citing this family (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US10512644B2 (en) * | 2007-03-12 | 2019-12-24 | Inheris Pharmaceuticals, Inc. | Oligomer-opioid agonist conjugates |
ES2651689T3 (es) * | 2012-10-30 | 2018-01-29 | Nektar Therapeutics | Forma salina de alfa-6-mPEG6-O-hidroxicodona sólida como antagonista opioide y usos de la misma |
EP3658121A1 (en) * | 2017-07-27 | 2020-06-03 | Inheris Biopharma, Inc. | Oral tablet formulations |
Family Cites Families (18)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5800334A (en) | 1993-06-17 | 1998-09-01 | Wilk; Peter J. | Intrapericardial assist device and associated method |
US6096337A (en) | 1996-06-10 | 2000-08-01 | Spireas; Spiridon | Liquisolid systems and methods of preparing same |
EP2127642A3 (en) | 1998-08-13 | 2010-02-24 | Cima Labs, Inc. | Microemulsions as solid dosage forms for oral administration |
US6342249B1 (en) | 1998-12-23 | 2002-01-29 | Alza Corporation | Controlled release liquid active agent formulation dosage forms |
WO2002081477A1 (fr) * | 2001-03-30 | 2002-10-17 | Toray Industries, Inc. | Derives morphinane 7-substitues et leur utilisation medicinale |
WO2002080918A1 (fr) * | 2001-04-02 | 2002-10-17 | Toray Industries, Inc. | Agent therapeutique ou prophylactique en cas de miction frequente ou d'incontinence urinaire |
EP2236161A1 (en) | 2001-10-18 | 2010-10-06 | Nektar Therapeutics | Polymer conjugates of opioid antagonists |
JP2005053744A (ja) | 2003-08-05 | 2005-03-03 | Dsl Japan Co Ltd | 高吸油性非晶質シリカ粒子 |
US20050245557A1 (en) * | 2003-10-15 | 2005-11-03 | Pain Therapeutics, Inc. | Methods and materials useful for the treatment of arthritic conditions, inflammation associated with a chronic condition or chronic pain |
JP5586223B2 (ja) | 2006-04-21 | 2014-09-10 | ネクター セラピューティクス | モルヒノンの立体選択的還元 |
US8173666B2 (en) | 2007-03-12 | 2012-05-08 | Nektar Therapeutics | Oligomer-opioid agonist conjugates |
CN101646464B (zh) * | 2007-03-12 | 2013-05-29 | 尼克塔治疗公司 | 低聚物-阿片样激动剂偶联物 |
JP5827123B2 (ja) | 2008-09-16 | 2015-12-02 | ウェルズ ファーゴ バンク ナショナル アソシエイション | 乱用の可能性が低いpeg化オピオイド |
MX2012000980A (es) * | 2009-07-21 | 2012-06-12 | Nektar Therapeutics | Conjugados de agonistas de oligómeros-opioides. |
US20130023553A1 (en) | 2010-01-12 | 2013-01-24 | Nektar Therapeutics | Pegylated opioids with low potential for abuse and side effects |
ES2562643T5 (es) * | 2010-09-30 | 2019-05-24 | Astrazeneca Ab | Conjugado de naloxol-peg cristalino |
EP2606879A1 (en) * | 2011-12-21 | 2013-06-26 | Hexal AG | Multiple unit pellet tablet formulation comprising an opioid |
ES2651689T3 (es) * | 2012-10-30 | 2018-01-29 | Nektar Therapeutics | Forma salina de alfa-6-mPEG6-O-hidroxicodona sólida como antagonista opioide y usos de la misma |
-
2013
- 2013-10-29 ES ES13796178.5T patent/ES2651689T3/es active Active
- 2013-10-29 US US14/439,473 patent/US9682988B2/en active Active
- 2013-10-29 PL PL13796178T patent/PL2914599T3/pl unknown
- 2013-10-29 PT PT137961785T patent/PT2914599T/pt unknown
- 2013-10-29 KR KR1020157010866A patent/KR20150076175A/ko not_active Application Discontinuation
- 2013-10-29 CA CA 2886276 patent/CA2886276A1/en not_active Abandoned
- 2013-10-29 EA EA201590853A patent/EA029512B1/ru not_active IP Right Cessation
- 2013-10-29 AU AU2013338098A patent/AU2013338098B2/en not_active Ceased
- 2013-10-29 RS RS20180190A patent/RS56898B1/sr unknown
- 2013-10-29 EP EP13796178.5A patent/EP2914599B1/en active Active
- 2013-10-29 LT LTEP13796178.5T patent/LT2914599T/lt unknown
- 2013-10-29 CN CN201380056619.8A patent/CN104755481A/zh active Pending
- 2013-10-29 DK DK13796178.5T patent/DK2914599T3/da active
- 2013-10-29 MX MX2015005510A patent/MX367773B/es active IP Right Grant
- 2013-10-29 SI SI201330875T patent/SI2914599T1/en unknown
- 2013-10-29 CN CN201910553996.1A patent/CN110615796A/zh active Pending
- 2013-10-29 HU HUE13796178A patent/HUE038161T2/hu unknown
- 2013-10-29 EP EP17186401.0A patent/EP3327022A1/en not_active Withdrawn
- 2013-10-29 ME MEP-2018-48A patent/ME02971B/me unknown
- 2013-10-29 WO PCT/US2013/067273 patent/WO2014070745A1/en active Application Filing
- 2013-10-29 JP JP2015539912A patent/JP6384964B2/ja not_active Expired - Fee Related
-
2015
- 2015-04-29 IL IL238529A patent/IL238529A0/en unknown
-
2016
- 2016-02-05 HK HK16101433.5A patent/HK1213549A1/zh not_active IP Right Cessation
-
2017
- 2017-04-26 US US15/498,308 patent/US20170226119A1/en not_active Abandoned
-
2018
- 2018-02-01 CY CY20181100121T patent/CY1119871T1/el unknown
- 2018-02-21 HR HRP20180315TT patent/HRP20180315T1/hr unknown
- 2018-02-22 AU AU2018201297A patent/AU2018201297A1/en not_active Abandoned
- 2018-03-26 JP JP2018058310A patent/JP2018111718A/ja active Pending
- 2018-06-12 HK HK18107623.0A patent/HK1248224A1/zh unknown
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