DK3003268T3 - Stabile orale opløsninger til kombineret api - Google Patents
Stabile orale opløsninger til kombineret api Download PDFInfo
- Publication number
- DK3003268T3 DK3003268T3 DK14727848.5T DK14727848T DK3003268T3 DK 3003268 T3 DK3003268 T3 DK 3003268T3 DK 14727848 T DK14727848 T DK 14727848T DK 3003268 T3 DK3003268 T3 DK 3003268T3
- Authority
- DK
- Denmark
- Prior art keywords
- naltrexone
- baclofen
- composition
- sorbitol
- solution
- Prior art date
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- 239000000243 solution Substances 0.000 claims description 69
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- 229960003086 naltrexone Drugs 0.000 claims description 57
- KPYSYYIEGFHWSV-UHFFFAOYSA-N Baclofen Chemical compound OC(=O)CC(CN)C1=CC=C(Cl)C=C1 KPYSYYIEGFHWSV-UHFFFAOYSA-N 0.000 claims description 54
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
-
- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
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- 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
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- A—HUMAN NECESSITIES
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- A—HUMAN NECESSITIES
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
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- A61P25/16—Anti-Parkinson drugs
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- A—HUMAN NECESSITIES
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- A—HUMAN NECESSITIES
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- Health & Medical Sciences (AREA)
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- Public Health (AREA)
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Claims (16)
1. Farmaceutisk sammensætning omfattende, i formen afen opløsning: - baclofen, sorbitol og naltrexon som aktive ingredienser, - en acetat- eller citratbuffer med en pH omfattet mellem 4 og 7, fortrinsvis mellem 4,5 og 5,5, og - eventuelt, mindst ét konserveringsmiddel og/eller mindst ét aromastof.
2. Sammensætningen ifølge krav 1, hvor sorbitol og naltrexon er til stede i et relativt vægtforhold (sorbitol/naltrexon) omfattet mellem 100 og 500, fortrinsvis mellem 200 og 400.
3. Sammensætningen ifølge et hvilket som helst af de foregående krav, hvor baclofen og naltrexon er til stede i et relativt vægtforhold (baclofen/naltrexon) omfattet mellem 2 og 20, fortrinsvis mellem 5 og 10.
4. Sammensætningen ifølge et hvilket som helst af de foregående krav, hvor baclofen, sorbitol og naltrexon er til stede i det relative vægtforhold på omkring 8,6/300/1.
5. Sammensætningen ifølge et hvilket som helst af de foregående krav, hvor pH'en af bufferen er omkring 5,5.
6. Sammensætningen ifølge et hvilket som helst af de foregående krav, hvor det mindst ene aromastof er isoamylacetat eller vanillin.
7. Sammensætningen ifølge et hvilket som helst af de foregående krav, hvor det mindst ene konserveringsmiddel er et paraben.
8. Sammensætningen ifølge et hvilket som helst af de foregående krav, hvor det mindst ene konserveringsmiddel omfatter methylparaben og/eller propylparaben.
9. Sammensætningen ifølge krav 8, hvor methylparabenet og/eller propylparabenet er anvendt i en koncentration på henholdsvis omkring 0,18 % w/v og omkring 0,02 % w/v.
10. Sammensætningen ifølge et hvilket som helst af de foregående krav, omfattende: - baclofen, sorbitol og naltrexon som aktive ingredienser i et relativt vægtforhold på omkring 8,6/300/1, - en acetatbuffer med en pH på omkring 5,5, - omkring 0,18 % w/v af methylparahydroxybenzoat og 0,02 % w/v propyl parahydroxybenzoat, og - omkring 0,04 % w/v af isoamylacetat.
11. Sammensætningen ifølge et hvilket som helst af kravene 1-6, hvilken er fri for paraben og hvor bufferen er en acetatbuffer.
12. Sammensætningen ifølge et hvilket som helst af de foregående krav, omfattende mindst én yderligere forbindelse valgt fra antioxidant(er), emulgeringsmiddel(-midler), viskositetsmodifikator(er), sødemiddel(-midler), smagsforstærker(e), farvestof (fer), co-solvent(er), og/eller opløsningsmiddel-midler).
13. Sammensætning ifølge et hvilket som helst af kravene 1 til 12 til anvendelse i behandling af Charcot-Marie-Tooth-sygdom hos et individ.
14. Beholder omfattende en sammensætning ifølge et hvilket som helst af de foregående krav.
15. Kit omfattende en beholder ifølge krav 14 og instruktioner.
16. Fremgangsmåde til fremstilling af en sammensætning ifølge et hvilket som helst af kravene 1 til 12, omfattende tilvejebringelse af baclofen, sorbitol og naltrexon og blanding af nævnte aktive ingredienser i opløsning i en citrat- eller acetatbuffer med en pH omfattet mellem 4 og 7.
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|---|---|---|---|
| EP13170583 | 2013-06-05 | ||
| PCT/EP2014/061664 WO2014195394A1 (en) | 2013-06-05 | 2014-06-05 | Stable oral solutions for combined api |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK3003268T3 true DK3003268T3 (da) | 2018-11-05 |
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| DK14727848.5T DK3003268T3 (da) | 2013-06-05 | 2014-06-05 | Stabile orale opløsninger til kombineret api |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| EP2065038A1 (en) | 2007-11-30 | 2009-06-03 | Pharnext | New therapeutic approaches for treating Charcot-Marie-Tooth disease |
| US9393241B2 (en) | 2009-06-02 | 2016-07-19 | Pharnext | Compositions for treating CMT and related disorders |
| EP2263665A1 (en) | 2009-06-02 | 2010-12-22 | Pharnext | New compositions for treating CMT and related disorders |
| HUE040023T2 (hu) | 2013-06-05 | 2019-02-28 | Pharnext | Stabil orális oldatok kombinált API-hoz |
| CA2938361A1 (en) | 2014-02-11 | 2015-08-20 | Pharnext | Combination of baclofen, acamprosate and medium chain triglycerides for the treatment of neurological disorders |
| US10383870B2 (en) | 2016-06-10 | 2019-08-20 | Pharnext | Early treatment of CMT disease |
| WO2018049184A1 (en) * | 2016-09-09 | 2018-03-15 | Cutispharma, Inc. | Suspensions and diluents for metronidazole and baclofen |
| CN106389313A (zh) * | 2016-10-08 | 2017-02-15 | 安徽省逸欣铭医药科技有限公司 | 一种巴氯芬口服液组合物 |
| EP3582765B1 (en) * | 2017-10-10 | 2021-04-28 | Vertice Pharma, LLC | Midodrine hydrochloride oral solution and uses thereof |
| US10952981B2 (en) * | 2019-05-27 | 2021-03-23 | Slayback Pharma Llc | Liquid pharmaceutical compositions of baclofen for oral administration |
| US10792262B1 (en) * | 2019-07-29 | 2020-10-06 | Saol International Limited | Stabilized formulations of 4-amino-3-substituted butanoic acid derivatives |
| US10610502B1 (en) | 2019-08-30 | 2020-04-07 | Metacel Pharmaceuticals, LLC | Oral baclofen solutions |
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| TW427904B (en) | 1995-12-07 | 2001-04-01 | American Home Prod | Neuroprotective agents |
| AU9187598A (en) | 1997-09-30 | 1999-04-23 | Daiichi Pharmaceutical Co., Ltd. | Oral preparation |
| CA2345642A1 (en) | 1998-10-02 | 2000-04-13 | Celtrix Pharmaceuticals, Inc. | Methods for the treatment of non-thyroid disorders |
| WO2002049607A2 (en) * | 2000-12-20 | 2002-06-27 | Firmenich Sa | Flavoured oral drug delivery system |
| JP3805646B2 (ja) | 2001-05-25 | 2006-08-02 | 久光メディカル株式会社 | 医薬液剤 |
| IL163911A0 (en) | 2002-03-14 | 2005-12-18 | Euro Celtique Sa | Naltrexone hydrochloride compositions |
| FR2842422B1 (fr) | 2002-07-16 | 2006-06-30 | Univ Aix Marseille Ii | Compositions destinees au traitement des neuropathies peripheriques, preparation et utilisations |
| JP2006504679A (ja) | 2002-08-28 | 2006-02-09 | メルク フロスト カナダ アンド カンパニー | 緑内障の治療においてｅｐ４受容体作動薬として使用するためのオキサゾリジン−２−オンおよびチアゾリジン−２−オン誘導体 |
| WO2004091593A2 (en) | 2003-04-14 | 2004-10-28 | Pain Therapeutics, Inc. | Methods for the treatment of pain comprising opioid antagonists |
| WO2004103263A2 (en) | 2003-05-22 | 2004-12-02 | Yeda Research And Development Co. Ltd. | Dopamine and agonists and antagonists thereof for treatment of neurodegenerative diseases |
| WO2005032555A2 (en) | 2003-09-25 | 2005-04-14 | Euro-Celtique S.A. | Pharmaceutical combinations of hydrocodone and naltrexone |
| EP1706098A4 (en) | 2003-11-26 | 2012-08-15 | Supernus Pharmaceuticals Inc | MICELLAR SYSTEMS SUITABLE FOR THE DELIVERY OF LIPOPHILIC OR HYDROPHOBIC COMPOUNDS |
| FR2865648B1 (fr) | 2004-02-03 | 2006-06-30 | Philippe Perovitch | Procede de diffusion de molecules insolubles en milieu aqueux et composition mettant en oeuvre ce procede |
| US20050220863A1 (en) | 2004-04-02 | 2005-10-06 | Chien-Hsuan Han | Pharmaceutical dosage forms having controlled release properties that contain a GABAB receptor agonist |
| JP2006131545A (ja) | 2004-11-05 | 2006-05-25 | Japan Science & Technology Agency | 神経因性疼痛治療剤 |
| GB0509052D0 (en) | 2005-05-04 | 2005-06-08 | Aimsco Ltd | Combination therapy |
| US20070099947A1 (en) | 2005-11-03 | 2007-05-03 | Alkermes, Inc. | Methods and compositions for the treatment of brain reward system disorders by combination therapy |
| DE102006016990A1 (de) | 2006-04-11 | 2007-10-18 | Hermann, Holger Lars, Dr. | Verwendung von Baclofen und Baclofen-Derivaten zur Entzugs- und/oder Substitutionsbehandlung bei Abhängigkeit von GHB und/oder GHB-Analogen |
| EP2377531A2 (en) | 2006-05-09 | 2011-10-19 | Braincells, Inc. | Neurogenesis by modulating angiotensin |
| US7678808B2 (en) | 2006-05-09 | 2010-03-16 | Braincells, Inc. | 5 HT receptor mediated neurogenesis |
| ATE511392T1 (de) | 2007-01-11 | 2011-06-15 | Xenoport Inc | Verzögert freigesetzte orale dosierungsformen eines prodrugs von r-baclofen und behandlungsverfahren damit |
| US20080255062A1 (en) | 2007-02-13 | 2008-10-16 | University Of Manitoba | Axon regeneration from adult sensory neurons |
| EP2065038A1 (en) | 2007-11-30 | 2009-06-03 | Pharnext | New therapeutic approaches for treating Charcot-Marie-Tooth disease |
| EP2135607A1 (en) | 2008-06-18 | 2009-12-23 | Pharnext | Combination of pilocarpin and methimazol for treating Charcot-MarieTooth disease and related disorders |
| US9393241B2 (en) | 2009-06-02 | 2016-07-19 | Pharnext | Compositions for treating CMT and related disorders |
| EP2263665A1 (en) | 2009-06-02 | 2010-12-22 | Pharnext | New compositions for treating CMT and related disorders |
| EP2322163A1 (en) | 2009-11-03 | 2011-05-18 | Pharnext | New therapeutics approaches for treating alzheimer disease |
| IT1400067B1 (it) * | 2010-05-21 | 2013-05-17 | Molteni & C | Spray nasale liquido contenente naltrexone a bassi dosaggi. |
| LT2727588T (lt) | 2011-03-01 | 2019-01-25 | Pharnext | Neurologinių sutrikimų terapija baklofeno ir akamprozato pagrindu |
| HUE040023T2 (hu) | 2013-06-05 | 2019-02-28 | Pharnext | Stabil orális oldatok kombinált API-hoz |
| US10383870B2 (en) | 2016-06-10 | 2019-08-20 | Pharnext | Early treatment of CMT disease |
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- 2014-06-05 PT PT14727848T patent/PT3003268T/pt unknown
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