HRP20110775T1 - Oblik doziranja koji sadrži oksikodon i nalokson - Google Patents
Oblik doziranja koji sadrži oksikodon i nalokson Download PDFInfo
- Publication number
- HRP20110775T1 HRP20110775T1 HR20110775T HRP20110775T HRP20110775T1 HR P20110775 T1 HRP20110775 T1 HR P20110775T1 HR 20110775 T HR20110775 T HR 20110775T HR P20110775 T HRP20110775 T HR P20110775T HR P20110775 T1 HRP20110775 T1 HR P20110775T1
- Authority
- HR
- Croatia
- Prior art keywords
- side effects
- naloxone
- opioid
- induced
- dosage form
- Prior art date
Links
- 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 title claims abstract 7
- 229960004127 naloxone Drugs 0.000 title claims abstract 7
- 239000002552 dosage form Substances 0.000 title 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 title claims abstract 4
- 229960002085 oxycodone Drugs 0.000 title claims abstract 4
- 230000000694 effects Effects 0.000 claims 9
- 208000030053 Opioid-Induced Constipation Diseases 0.000 claims 6
- 208000002193 Pain Diseases 0.000 claims 6
- 208000011580 syndromic disease Diseases 0.000 claims 6
- 208000004998 Abdominal Pain Diseases 0.000 claims 5
- 150000003839 salts Chemical class 0.000 claims 4
- 206010010774 Constipation Diseases 0.000 claims 3
- 206010012735 Diarrhoea Diseases 0.000 claims 3
- 238000002560 therapeutic procedure Methods 0.000 claims 3
- 208000002881 Colic Diseases 0.000 claims 2
- VZCYOOQTPOCHFL-UHFFFAOYSA-N trans-butenedioic acid Natural products OC(=O)C=CC(O)=O VZCYOOQTPOCHFL-UHFFFAOYSA-N 0.000 claims 2
- KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 claims 1
- FEWJPZIEWOKRBE-JCYAYHJZSA-N Dextrotartaric acid Chemical compound OC(=O)[C@H](O)[C@@H](O)C(O)=O FEWJPZIEWOKRBE-JCYAYHJZSA-N 0.000 claims 1
- VZCYOOQTPOCHFL-OWOJBTEDSA-N Fumaric acid Chemical compound OC(=O)\C=C\C(O)=O VZCYOOQTPOCHFL-OWOJBTEDSA-N 0.000 claims 1
- CPELXLSAUQHCOX-UHFFFAOYSA-N Hydrogen bromide Chemical compound Br CPELXLSAUQHCOX-UHFFFAOYSA-N 0.000 claims 1
- 229910002651 NO3 Inorganic materials 0.000 claims 1
- NHNBFGGVMKEFGY-UHFFFAOYSA-N Nitrate Chemical compound [O-][N+]([O-])=O NHNBFGGVMKEFGY-UHFFFAOYSA-N 0.000 claims 1
- 229910019142 PO4 Inorganic materials 0.000 claims 1
- QAOWNCQODCNURD-UHFFFAOYSA-L Sulfate Chemical compound [O-]S([O-])(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-L 0.000 claims 1
- XMBWDFGMSWQBCA-UHFFFAOYSA-N hydrogen iodide Chemical compound I XMBWDFGMSWQBCA-UHFFFAOYSA-N 0.000 claims 1
- QAOWNCQODCNURD-UHFFFAOYSA-M hydrogensulfate Chemical compound OS([O-])(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-M 0.000 claims 1
- 229940049920 malate Drugs 0.000 claims 1
- VZCYOOQTPOCHFL-UPHRSURJSA-N maleic acid Chemical compound OC(=O)\C=C/C(O)=O VZCYOOQTPOCHFL-UPHRSURJSA-N 0.000 claims 1
- BJEPYKJPYRNKOW-UHFFFAOYSA-N malic acid Chemical compound OC(=O)C(O)CC(O)=O BJEPYKJPYRNKOW-UHFFFAOYSA-N 0.000 claims 1
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 claims 1
- 239000010452 phosphate Substances 0.000 claims 1
- -1 salt hydrochloride Chemical class 0.000 claims 1
- KDYFGRWQOYBRFD-UHFFFAOYSA-L succinate(2-) Chemical compound [O-]C(=O)CCC([O-])=O KDYFGRWQOYBRFD-UHFFFAOYSA-L 0.000 claims 1
- 238000013268 sustained release Methods 0.000 claims 1
- 239000012730 sustained-release form Substances 0.000 claims 1
- 229940095064 tartrate Drugs 0.000 claims 1
- 230000000202 analgesic effect Effects 0.000 abstract 1
- 230000003871 intestinal function Effects 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
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/10—Laxatives
-
- 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
- A61P25/04—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
- A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
-
- 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
- A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
- A61P25/36—Opioid-abuse
-
- 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]
-
- 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)
- Public Health (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Epidemiology (AREA)
- Neurology (AREA)
- Biomedical Technology (AREA)
- Neurosurgery (AREA)
- Emergency Medicine (AREA)
- Addiction (AREA)
- Pain & Pain Management (AREA)
- Psychiatry (AREA)
- Rheumatology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
Farmaceutski oblik doziranja s produljenim oslobađanjem koji sadrži 40 mg oksikodona ili njegove farmaceutski prihvatljive soli i 20 mg naloksona ili njegove farmaceutski prihvatljive soli, gdje su oksikodon ili njegova farmaceutski prihvatljiva sol i nalokson ili njegova farmaceutski prihvatljiva sol prisutni u težinskom omjeru od 2:1, za upotrebu u liječenju umjerene do jake boli i opioidom izazvanih sindroma crijevne disfunkcije koji se javljaju tijekom terapije protiv bolova, gdje je navedeni opioidom izazvani sindrom crijevne disfunkcije zatvor, i neželjenih efekata, gdje su navedeni neželjeni efekti tipični naloksonom izazvani neželjeni efekti odabrani iz skupine koja se sastoji od bolova u trbuhu, grčeva i dijareje. Patent sadrži još 2 patentna zahtjeva.
Claims (3)
1. Farmaceutski oblik doziranja s produljenim oslobađanjem koji sadrži 40 mg oksikodona ili njegove farmaceutski prihvatljive soli i 20 mg naloksona ili njegove farmaceutski prihvatljive soli, gdje su oksikodon ili njegova farmaceutski prihvatljiva sol i nalokson ili njegova farmaceutski prihvatljiva sol prisutni u težinskom omjeru od 2:1, za upotrebu u liječenju umjerene do jake boli i opioidom izazvanih sindroma crijevne disfunkcije koji se javljaju tijekom terapije protiv bolova, gdje je navedeni opioidom izazvani sindrom crijevne disfunkcije zatvor, i neželjenih efekata, gdje su navedeni neželjeni efekti tipični naloksonom izazvani neželjeni efekti odabrani iz skupine koja se sastoji od bolova u trbuhu, grčeva i dijareje.
2. Farmaceutski oblik doziranja prema patentnom zahtjevu 1 za upotrebu u liječenju umjerene do jake boli i opioidom izazvanih sindroma crijevne disfunkcije koji se javljaju tijekom terapije protiv bolova, gdje je navedeni opioidom izazvani sindrom crijevne disfunkcije zatvor, i neželjenih efekata, gdje su navedeni neželjeni efekti tipični naloksonom izazvani neželjeni efekti odabrani iz skupine koja se sastoji od bolova u trbuhu, grčeva i dijareje, gdje je navedena farmaceutski prihvatljiva sol hidroklorid, sulfat, bisulfat, tartrat, nitrat, citrat, bitatrat, fosfat, malat, maleat, hidrobromid, hidroiodid, fumarat ili sucinat.
3. Farmaceutski oblik doziranja prema patentnom zahtjevu 1 ili 2 za upotrebu u liječenju umjerene do jake boli i opioidom izazvanih sindroma crijevne disfunkcije koji se javljaju tijekom terapije protiv bolova, gdje je navedeni opioidom izazvani sindrom crijevne disfunkcije zatvor, i neželjenih efekata, gdje su navedeni neželjeni efekti tipični naloksonom izazvani neželjeni efekti odabrani iz skupine koja se sastoji od bolova u trbuhu, grčeva i dijareje, gdje je oblik doziranja formuliran za oralnu primjenu.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP05004377A EP1695700A1 (en) | 2005-02-28 | 2005-02-28 | Dosage form containing oxycodone and naloxone |
| PCT/EP2006/060341 WO2006089973A2 (en) | 2005-02-28 | 2006-02-28 | Dosage form containing oxycodone and naloxone |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20110775T1 true HRP20110775T1 (hr) | 2011-11-30 |
Family
ID=34933990
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HR20110775T HRP20110775T1 (hr) | 2005-02-28 | 2011-10-25 | Oblik doziranja koji sadrži oksikodon i nalokson |
Country Status (27)
| Country | Link |
|---|---|
| US (5) | US20080145429A1 (hr) |
| EP (5) | EP1695700A1 (hr) |
| JP (2) | JP2008531650A (hr) |
| KR (1) | KR20070107805A (hr) |
| CN (2) | CN101128191A (hr) |
| AT (1) | ATE517611T1 (hr) |
| AU (2) | AU2006217870B2 (hr) |
| BR (1) | BRPI0607975A2 (hr) |
| CA (3) | CA2768075A1 (hr) |
| CY (1) | CY1111967T1 (hr) |
| DE (2) | DE19167974T1 (hr) |
| DK (2) | DK1855657T3 (hr) |
| ES (1) | ES2370409T3 (hr) |
| FI (1) | FI7750U1 (hr) |
| HK (1) | HK1111604A1 (hr) |
| HR (1) | HRP20110775T1 (hr) |
| IL (2) | IL185514A0 (hr) |
| ME (1) | ME01262B (hr) |
| MX (1) | MX2007010494A (hr) |
| NZ (1) | NZ588875A (hr) |
| PL (1) | PL1855657T3 (hr) |
| PT (1) | PT1855657E (hr) |
| RS (1) | RS51984B (hr) |
| RU (1) | RU2428985C2 (hr) |
| SI (1) | SI1855657T1 (hr) |
| UA (1) | UA93543C2 (hr) |
| WO (1) | WO2006089973A2 (hr) |
Families Citing this family (69)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6375957B1 (en) | 1997-12-22 | 2002-04-23 | Euro-Celtique, S.A. | Opioid agonist/opioid antagonist/acetaminophen combinations |
| PT2266564E (pt) | 1997-12-22 | 2013-06-20 | Euro Celtique Sa | Forma de dosagem farmacêutica por via oral compreendendo uma combinação de um agonista opióide e de um antagonista opióide |
| WO2002092060A1 (en) | 2001-05-11 | 2002-11-21 | Endo Pharmaceuticals, Inc. | Abuse-resistant controlled-release opioid dosage form |
| JP4814488B2 (ja) | 2001-10-18 | 2011-11-16 | ネクター セラピューティックス | 重合体共役物オピオイドアンタゴニスト |
| PT2425821T (pt) * | 2002-04-05 | 2017-08-23 | Mundipharma Farmacêutica Lda | Preparação farmacêutica contendo oxicodona e naloxona |
| US7776314B2 (en) | 2002-06-17 | 2010-08-17 | Grunenthal Gmbh | Abuse-proofed dosage system |
| US20070048228A1 (en) | 2003-08-06 | 2007-03-01 | Elisabeth Arkenau-Maric | Abuse-proofed dosage form |
| DE102005005446A1 (de) | 2005-02-04 | 2006-08-10 | Grünenthal GmbH | Bruchfeste Darreichungsformen mit retardierter Freisetzung |
| DE10336400A1 (de) | 2003-08-06 | 2005-03-24 | Grünenthal GmbH | Gegen Missbrauch gesicherte Darreichungsform |
| DE10361596A1 (de) | 2003-12-24 | 2005-09-29 | Grünenthal GmbH | Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform |
| EP1604666A1 (en) | 2004-06-08 | 2005-12-14 | Euro-Celtique S.A. | Opioids for the treatment of the Chronic Obstructive Pulmonary Disease (COPD) |
| EP1604667A1 (en) * | 2004-06-08 | 2005-12-14 | Euro-Celtique S.A. | Opioids for the treatment of the restless leg syndrome |
| DE102004032049A1 (de) | 2004-07-01 | 2006-01-19 | Grünenthal GmbH | Gegen Missbrauch gesicherte, orale Darreichungsform |
| EP3228308A1 (en) * | 2005-01-28 | 2017-10-11 | Euro-Celtique S.A. | Alcohol resistant dosage forms |
| 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 |
| EP1695700A1 (en) | 2005-02-28 | 2006-08-30 | Euro-Celtique S.A. | Dosage form containing oxycodone and naloxone |
| DE202006018609U1 (de) * | 2006-08-29 | 2007-05-16 | Euro-Celtique S.A. | Verwendung von Opioidformulierungen in nadellosen Vorrichtungen zur Medikamentenverabreichung |
| WO2008057579A2 (en) * | 2006-11-07 | 2008-05-15 | Nektar Therapeutics Al, Corporation | Dosage forms and co-administration of an opioid agonist and an opioid antagonist |
| US20090004231A1 (en) | 2007-06-30 | 2009-01-01 | Popp Shane M | Pharmaceutical dosage forms fabricated with nanomaterials for quality monitoring |
| EP2042176A1 (en) * | 2007-09-26 | 2009-04-01 | Euro-Celtique S.A. | Use of a combination of an opioid agonist and an opioid antagonist for the treatment of Crohn's disease |
| JP5651818B2 (ja) | 2007-12-17 | 2015-01-14 | パラディン ラブス インコーポレーテッド | 誤用を防止するための放出制御製剤 |
| EP2249811A1 (en) | 2008-01-25 | 2010-11-17 | Grünenthal GmbH | Pharmaceutical dosage form |
| CN102123701B (zh) | 2008-05-09 | 2013-03-27 | 格吕伦塔尔有限公司 | 使用喷雾冻凝步骤制备中间粉末制剂以及最终固体剂型的方法 |
| ES2635733T3 (es) * | 2008-07-07 | 2017-10-04 | Euro-Celtique S.A. | Uso de antagonistas opioideos para tratar la retención urinaria |
| EP2367541B1 (en) | 2008-12-16 | 2014-07-16 | Paladin Labs Inc. | Misuse preventative, controlled release formulation |
| ES2706407T3 (es) * | 2009-03-10 | 2019-03-28 | Euro Celtique Sa | Composiciones farmacéuticas de liberación inmediata que comprenden oxicodona y naloxona |
| JP2012533585A (ja) | 2009-07-22 | 2012-12-27 | グリュネンタール・ゲゼルシャフト・ミト・ベシュレンクテル・ハフツング | 酸化感受性オピオイドのための不正使用防止剤形 |
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| US9993433B2 (en) | 2010-05-10 | 2018-06-12 | Euro-Celtique S.A. | Manufacturing of active-free granules and tablets comprising the same |
| BR112012028773A2 (pt) | 2010-05-10 | 2016-07-19 | Euro Celtique Sa | composições farmacêuticas compreendendo hidromorfona e naloxona |
| CA2805974C (en) * | 2010-08-13 | 2019-11-26 | Euro-Celtique S.A. | Use of binders for manufacturing storage stable formulations |
| KR20130137627A (ko) | 2010-09-02 | 2013-12-17 | 그뤼넨탈 게엠베하 | 음이온성 중합체를 포함하는 내변조성 투여형 |
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