HRP20110049T2 - Opioidi za liječenje nemirnosti kod donjih ekstremiteta - Google Patents
Opioidi za liječenje nemirnosti kod donjih ekstremiteta Download PDFInfo
- Publication number
- HRP20110049T2 HRP20110049T2 HR20110049A HRP20110049A HRP20110049T2 HR P20110049 T2 HRP20110049 T2 HR P20110049T2 HR 20110049 A HR20110049 A HR 20110049A HR P20110049 A HRP20110049 A HR P20110049A HR P20110049 T2 HRP20110049 T2 HR P20110049T2
- Authority
- HR
- Croatia
- Prior art keywords
- dosage form
- oral dosage
- oxycodone
- pharmaceutically acceptable
- use according
- Prior art date
Links
- 208000001431 Psychomotor Agitation Diseases 0.000 title 1
- 206010038743 Restlessness Diseases 0.000 title 1
- 210000003141 lower extremity Anatomy 0.000 title 1
- 229940005483 opioid analgesics Drugs 0.000 title 1
- 239000006186 oral dosage form Substances 0.000 claims abstract 12
- 208000005793 Restless legs syndrome Diseases 0.000 claims abstract 6
- BRUQQQPBMZOVGD-XFKAJCMBSA-N Oxycodone Chemical compound O=C([C@@H]1O2)CC[C@@]3(O)[C@H]4CC5=CC=C(OC)C2=C5[C@@]13CCN4C BRUQQQPBMZOVGD-XFKAJCMBSA-N 0.000 claims 9
- 229960002085 oxycodone Drugs 0.000 claims 9
- 150000003839 salts Chemical class 0.000 claims 9
- BQJCRHHNABKAKU-KBQPJGBKSA-N morphine Chemical compound O([C@H]1[C@H](C=C[C@H]23)O)C4=C5[C@@]12CCN(C)[C@@H]3CC5=CC=C4O BQJCRHHNABKAKU-KBQPJGBKSA-N 0.000 claims 8
- UZHSEJADLWPNLE-GRGSLBFTSA-N naloxone Chemical compound O=C([C@@H]1O2)CC[C@@]3(O)[C@H]4CC5=CC=C(O)C2=C5[C@@]13CCN4CC=C UZHSEJADLWPNLE-GRGSLBFTSA-N 0.000 claims 8
- 229960004127 naloxone Drugs 0.000 claims 8
- 239000012458 free base Substances 0.000 claims 7
- 239000000203 mixture Substances 0.000 claims 4
- 229960005181 morphine Drugs 0.000 claims 4
- USSIQXCVUWKGNF-UHFFFAOYSA-N 6-(dimethylamino)-4,4-diphenylheptan-3-one Chemical compound C=1C=CC=CC=1C(CC(C)N(C)C)(C(=O)CC)C1=CC=CC=C1 USSIQXCVUWKGNF-UHFFFAOYSA-N 0.000 claims 3
- WJBLNOPPDWQMCH-MBPVOVBZSA-N Nalmefene Chemical compound N1([C@@H]2CC3=CC=C(C=4O[C@@H]5[C@](C3=4)([C@]2(CCC5=C)O)CC1)O)CC1CC1 WJBLNOPPDWQMCH-MBPVOVBZSA-N 0.000 claims 3
- UQCNKQCJZOAFTQ-ISWURRPUSA-N Oxymorphone Chemical compound O([C@H]1C(CC[C@]23O)=O)C4=C5[C@@]12CCN(C)[C@@H]3CC5=CC=C4O UQCNKQCJZOAFTQ-ISWURRPUSA-N 0.000 claims 3
- XYYVYLMBEZUESM-UHFFFAOYSA-N dihydrocodeine Natural products C1C(N(CCC234)C)C2C=CC(=O)C3OC2=C4C1=CC=C2OC XYYVYLMBEZUESM-UHFFFAOYSA-N 0.000 claims 3
- 229960002428 fentanyl Drugs 0.000 claims 3
- PJMPHNIQZUBGLI-UHFFFAOYSA-N fentanyl Chemical compound C=1C=CC=CC=1N(C(=O)CC)C(CC1)CCN1CCC1=CC=CC=C1 PJMPHNIQZUBGLI-UHFFFAOYSA-N 0.000 claims 3
- LLPOLZWFYMWNKH-CMKMFDCUSA-N hydrocodone Chemical compound C([C@H]1[C@H](N(CC[C@@]112)C)C3)CC(=O)[C@@H]1OC1=C2C3=CC=C1OC LLPOLZWFYMWNKH-CMKMFDCUSA-N 0.000 claims 3
- 229960000240 hydrocodone Drugs 0.000 claims 3
- OROGSEYTTFOCAN-UHFFFAOYSA-N hydrocodone Natural products C1C(N(CCC234)C)C2C=CC(O)C3OC2=C4C1=CC=C2OC OROGSEYTTFOCAN-UHFFFAOYSA-N 0.000 claims 3
- WVLOADHCBXTIJK-YNHQPCIGSA-N hydromorphone Chemical compound O([C@H]1C(CC[C@H]23)=O)C4=C5[C@@]12CCN(C)[C@@H]3CC5=CC=C4O WVLOADHCBXTIJK-YNHQPCIGSA-N 0.000 claims 3
- 229960001410 hydromorphone Drugs 0.000 claims 3
- 229960001797 methadone Drugs 0.000 claims 3
- 229960005297 nalmefene Drugs 0.000 claims 3
- 229960003086 naltrexone Drugs 0.000 claims 3
- DQCKKXVULJGBQN-XFWGSAIBSA-N naltrexone Chemical compound N1([C@@H]2CC3=CC=C(C=4O[C@@H]5[C@](C3=4)([C@]2(CCC5=O)O)CC1)O)CC1CC1 DQCKKXVULJGBQN-XFWGSAIBSA-N 0.000 claims 3
- 239000003402 opiate agonist Substances 0.000 claims 3
- 239000003401 opiate antagonist Substances 0.000 claims 3
- 229960005118 oxymorphone Drugs 0.000 claims 3
- GGCSSNBKKAUURC-UHFFFAOYSA-N sufentanil Chemical compound C1CN(CCC=2SC=CC=2)CCC1(COC)N(C(=O)CC)C1=CC=CC=C1 GGCSSNBKKAUURC-UHFFFAOYSA-N 0.000 claims 3
- 229960004739 sufentanil Drugs 0.000 claims 3
- 238000013268 sustained release Methods 0.000 claims 3
- 239000012730 sustained-release form Substances 0.000 claims 3
- LLPOLZWFYMWNKH-UHFFFAOYSA-N trans-dihydrocodeinone Natural products C1C(N(CCC234)C)C2CCC(=O)C3OC2=C4C1=CC=C2OC LLPOLZWFYMWNKH-UHFFFAOYSA-N 0.000 claims 3
- 239000013543 active substance Substances 0.000 claims 1
- 239000002552 dosage form Substances 0.000 claims 1
- 239000000825 pharmaceutical preparation Substances 0.000 claims 1
- 230000002035 prolonged effect Effects 0.000 claims 1
- 238000013270 controlled release Methods 0.000 abstract 1
- 239000003814 drug Substances 0.000 abstract 1
- 238000004519 manufacturing process Methods 0.000 abstract 1
Classifications
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- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
-
- 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
- A61P25/02—Drugs for disorders of the nervous system for peripheral neuropathies
-
- 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
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
-
- 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
- A61P25/20—Hypnotics; Sedatives
-
- 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)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Epidemiology (AREA)
- Emergency Medicine (AREA)
- Anesthesiology (AREA)
- Psychology (AREA)
- Pain & Pain Management (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Transition And Organic Metals Composition Catalysts For Addition Polymerization (AREA)
- Solid-Sorbent Or Filter-Aiding Compositions (AREA)
- Disintegrating Or Milling (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Compounds Of Alkaline-Earth Elements, Aluminum Or Rare-Earth Metals (AREA)
Abstract
Upotreba oralnog oblika doziranja opioida s produljenim oslobađanjem koji sadrži smjesu opioidnog agonista odabranog iz grupe koja sadrži oksikodon, hidrokodon, hidromorfon, morfij, metadon, oksimorfon, fentanil i sufentanil, u obliku slobodne baze ili farmaceutski prihvatljive soli, i opioidnog antagonista odabranog iz grupe koja sadrži naltrekson, nalmefen i nalokson, u obliku slobodne baze ili farmaceutski prihvatljive soli, za proizvodnju lijeka za liječenje pacijenata sa sindromom nemirnih nogu (restless legs syndrome - RLS). Patent sadrži još 10 patentnih zahtjeva.
Claims (11)
1. Oralni oblik doziranja opioida s produljenim oslobađanjem koji sadrži smjesu opioidnog agonista odabranog iz grupe koja sadrži oksikodon, hidrokodon, hidromorfon, morfij, metadon, oksimorfon, fentanil i sufentanil, u obliku slobodne baze ili farmaceutski prihvatljive soli, i opioidnog antagonista odabranog iz grupe koja sadrži naltrekson, nalmefen i nalokson, u obliku slobodne baze ili farmaceutski prihvatljive soli, za upotrebu u liječenju pacijenata sa sindromom nemirnih nogu (restless leg svndrome - RLS).
2. Oralni oblik doziranja opioida s produljenim oslobađanjem koji sadrži smjesu opioidnog agonista odabranog iz grupe koja sadrži oksikodon, hidrokodon, hidromorfon, morfij, metadon, oksimorfon, fentanil i sufentanil, u obliku slobodne baze ili farmaceutski prihvatljive soli, i opioidnog antagonista odabranog iz grupe koja sadrži naltrekson, nalmefen i nalokson, u obliku slobodne baze ili farmaceutski prihvatljive soli, za upotrebu u liječenju pacijenata sa sindromom nemirnih nogu, koja pruža učinkovito liječenje kada se primjenjuje svakih 12 sati u stalnom režimu.
3. Oralni oblik doziranja opioida s produljenim oslobađanjem koji sadrži smjesu opioidnog agonista odabranog iz grupe koja sadrži oksikodon, hidrokodon, hidromorfon, morfij, metadon, oksimorfon, fentanil i sufentanil, u obliku slobodne baze ili farmaceutski prihvatljive soli, i opioidnog antagonista odabranog iz grupe koja sadrži naltrekson, nalmefen i nalokson, u obliku slobodne baze ili farmaceutski prihvatljive soli, za upotrebu u liječenju pacijenata sa sindromom nemirnih nogu koja pruža učinkovito liječenje kada se primjenjuje svakih 24 sata u stalnom režimu.
4. Oralni oblik doziranja koji sadrži oksikodon ili njegovu farmaceutski prihvatljivu sol, naznačen time daje za upotrebu prema bilo kojem od prethodnih zahtjeva.
5. Oralni oblik doziranja koji sadrži morfij ili njegovu farmaceutski prihvatljivu sol, naznačen time da je za upotrebu prema zahtjevima od 1 do 3.
6. Oralni oblik doziranja koji sadrži smjesu oksikodona i naloksona, u obliku slobodne baze ili kao njihovih farmaceutski prihvatljivih soli, naznačen time daje za upotrebu prema zahtjevima od 1 do 4.
7. Oralni oblik doziranja koji je farmaceutski pripravak stabilan pri skladištenju i gdje se aktivne supstance otpuštaju iz pripravka na produljeni, nepromijenjeni i neovisni način, naznačen time da je za upotrebu prema zahtjevu 6. 8. Oralni oblik doziranja za upotrebu prema zahtjevu 6 ili 7, naznačen time da je oksikodon prisutan u suvišku u odnosu na količinu naloksona u jediničnom doziranju.
8. Oralni oblik doziranja za upotrebu prema zahtjevima od 6 do 8, naznačen time da je nalokson prisutan u količinskom rasponu od 1 do 50 mg.
9. Oralni oblik doziranja za upotrebu prema zahtjevima od 6 do 9, naznačen time da je oksikodon prisutan u količinskom rasponu od 10 do 150 mg, poželjno od 10 do 80 mg.
10. Oralni oblik doziranja za upotrebu prema zahtjevima od 6 do 10, naznačen time da su oksikodon i nalokson prisutni u rasponu težinskih omjera od maksimalno 25 : 1, poželjno od maksimalno 20:1, 15:1, posebno poželjno od 5:1, 4:1, 3:1, 2:1 ili 1:1.
11. Oralni oblik doziranja za upotrebu prema zahtjevima od 6 do 10, naznačen time da su oksikodon i nalokson prisutni u rasponu težinkih omjera od maksimalno 25 : 1, poželjno od maksimalno 20:1, 15:1, posebno poželjno od 5:1, 4:1, 3:1, 2:1 ili 1:1.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP04013469A EP1604667A1 (en) | 2004-06-08 | 2004-06-08 | Opioids for the treatment of the restless leg syndrome |
PCT/EP2005/005888 WO2005120506A1 (en) | 2004-06-08 | 2005-06-01 | Opioids for the treatment of the restless leg syndrome |
Publications (2)
Publication Number | Publication Date |
---|---|
HRP20110049T1 HRP20110049T1 (hr) | 2011-02-28 |
HRP20110049T2 true HRP20110049T2 (hr) | 2011-10-31 |
Family
ID=34925286
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HR20110049A HRP20110049T2 (hr) | 2004-06-08 | 2011-01-24 | Opioidi za liječenje nemirnosti kod donjih ekstremiteta |
Country Status (25)
Country | Link |
---|---|
US (2) | US20070185147A1 (hr) |
EP (3) | EP1604667A1 (hr) |
JP (2) | JP2008501742A (hr) |
KR (2) | KR101200869B1 (hr) |
CN (2) | CN103394090A (hr) |
AT (1) | ATE486603T1 (hr) |
AU (1) | AU2005251445C1 (hr) |
BR (1) | BRPI0511300A (hr) |
CA (1) | CA2569742C (hr) |
CY (1) | CY1111512T1 (hr) |
DE (1) | DE602005024571D1 (hr) |
DK (1) | DK1781291T3 (hr) |
ES (1) | ES2355247T3 (hr) |
HR (1) | HRP20110049T2 (hr) |
IL (1) | IL179896A (hr) |
ME (1) | ME01238B (hr) |
MX (1) | MXPA06014391A (hr) |
NO (1) | NO337890B1 (hr) |
NZ (1) | NZ552430A (hr) |
PL (1) | PL1781291T3 (hr) |
PT (1) | PT1781291E (hr) |
RS (1) | RS51573B (hr) |
SI (1) | SI1781291T1 (hr) |
WO (1) | WO2005120506A1 (hr) |
ZA (1) | ZA200610477B (hr) |
Families Citing this family (17)
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HU1500214D0 (hu) | 1997-12-22 | 2002-03-28 | Euro Celtique Sa | Opioid agonista és antagonista hatóanyagot tartalmazó gyógyszerkészítmény |
US6375957B1 (en) | 1997-12-22 | 2002-04-23 | Euro-Celtique, S.A. | Opioid agonist/opioid antagonist/acetaminophen combinations |
ES2361148T3 (es) | 2001-05-11 | 2011-06-14 | Endo Pharmaceuticals Inc. | Forma de dosificación de opioides de liberación controlada resistente al abuso. |
EP2425823A1 (en) | 2002-04-05 | 2012-03-07 | Euro-Celtique S.A. | Pharmaceutical preparation containing oxycodone and naloxone |
EP1604666A1 (en) | 2004-06-08 | 2005-12-14 | Euro-Celtique S.A. | Opioids for the treatment of the Chronic Obstructive Pulmonary Disease (COPD) |
EP1702558A1 (en) | 2005-02-28 | 2006-09-20 | Euro-Celtique S.A. | Method and device for the assessment of bowel function |
US8445018B2 (en) | 2006-09-15 | 2013-05-21 | Cima Labs Inc. | Abuse resistant drug formulation |
US7794750B2 (en) * | 2008-06-20 | 2010-09-14 | Mutual Pharmaceutical Company, Inc. | Controlled-release formulations, method of manufacture, and use thereof |
US8632805B2 (en) * | 2008-06-20 | 2014-01-21 | Mutual Pharmaceutical Company, Inc. | Controlled-release formulations, method of manufacture, and use thereof |
MX347106B (es) | 2009-03-10 | 2017-04-12 | Euro-Celtique S A * | Coposiciones farmacéuticas de liberación inmediata que comprenden oxicodona y naloxona. |
CA2798884C (en) | 2010-05-10 | 2016-09-13 | Euro-Celtique S.A. | Manufacturing of active-free granules and tablets comprising the same |
US9901540B2 (en) | 2010-05-10 | 2018-02-27 | Euro-Celtique S.A. | Combination of active loaded granules with additional actives |
SE1251371A1 (sv) | 2010-05-10 | 2012-12-27 | Euro Celtique Sa | Farmaceutiska kompositioner innefattande hydromorfon och naloxon |
US20180264013A1 (en) * | 2010-07-08 | 2018-09-20 | Wellesley Pharmaceuticals, Llc | Composition and methods for treating sleep disorders |
BR112013003150B1 (pt) * | 2010-08-13 | 2022-01-18 | Euro-Celtique S.A. | Uso de hidroxipropil celulose para a fabricação de formulações estáveis em armazenagem |
CN105517551A (zh) | 2013-07-23 | 2016-04-20 | 欧洲凯尔特公司 | 用于在患有疼痛和导致肠生态失调和/或提高肠细菌移位风险之疾病的患者中治疗疼痛的羟考酮与纳洛酮的组合 |
BR112016009749A8 (pt) | 2013-11-13 | 2018-01-30 | Euro Celtique Sa | hidromorfona e naloxona para tratamento de dor e síndrome de disfunção intestinal opioide |
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2004
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2005
- 2005-06-01 NZ NZ552430A patent/NZ552430A/en unknown
- 2005-06-01 US US11/570,222 patent/US20070185147A1/en not_active Abandoned
- 2005-06-01 ME MEP-2011-18A patent/ME01238B/me unknown
- 2005-06-01 EP EP10175878A patent/EP2255808A3/en not_active Withdrawn
- 2005-06-01 AT AT05754710T patent/ATE486603T1/de active
- 2005-06-01 EP EP05754710A patent/EP1781291B9/en active Active
- 2005-06-01 JP JP2007526247A patent/JP2008501742A/ja not_active Withdrawn
- 2005-06-01 ES ES05754710T patent/ES2355247T3/es active Active
- 2005-06-01 AU AU2005251445A patent/AU2005251445C1/en active Active
- 2005-06-01 CA CA2569742A patent/CA2569742C/en not_active Expired - Fee Related
- 2005-06-01 RS RS20110030A patent/RS51573B/en unknown
- 2005-06-01 CN CN2013102699069A patent/CN103394090A/zh active Pending
- 2005-06-01 KR KR1020097016692A patent/KR101200869B1/ko active IP Right Grant
- 2005-06-01 WO PCT/EP2005/005888 patent/WO2005120506A1/en active Application Filing
- 2005-06-01 BR BRPI0511300-8A patent/BRPI0511300A/pt not_active Application Discontinuation
- 2005-06-01 SI SI200531198T patent/SI1781291T1/sl unknown
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- 2005-06-01 KR KR1020077000489A patent/KR20070037485A/ko not_active Application Discontinuation
- 2005-06-01 DK DK05754710.1T patent/DK1781291T3/da active
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- 2011-02-18 JP JP2011033064A patent/JP5774865B2/ja not_active Expired - Fee Related
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