ES2564936T3 - Aerosol nasal líquido que contiene naltrexona a dosis baja - Google Patents
Aerosol nasal líquido que contiene naltrexona a dosis baja Download PDFInfo
- Publication number
- ES2564936T3 ES2564936T3 ES11726367.3T ES11726367T ES2564936T3 ES 2564936 T3 ES2564936 T3 ES 2564936T3 ES 11726367 T ES11726367 T ES 11726367T ES 2564936 T3 ES2564936 T3 ES 2564936T3
- Authority
- ES
- Spain
- Prior art keywords
- naltrexone
- low dose
- nasal spray
- spray containing
- liquid nasal
- 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.)
- Active
Links
Classifications
-
- 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
- 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
- A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0043—Nose
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Neurology (AREA)
- Emergency Medicine (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Neurosurgery (AREA)
- Biomedical Technology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Otolaryngology (AREA)
- Addiction (AREA)
- Pain & Pain Management (AREA)
- Psychiatry (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
Formulaciones farmacéuticas en forma de solución líquida para administración en aerosol por vía nasal que contienen naltrexona en cantidades de entre 0,005-0,02 % p/v.
Description
[0028] La solución obtenida tiene las siguientes características:
pH = 4,8; Densidad = 1,008 g/ml; 5 Osmolalidad = 292 mOsmol/kg; Viscosidad = 2,27 mPa•s.
[0029] Las formulaciones de acuerdo con la invención se pueden administrar, por ejemplo, en forma de un aerosol usando aplicadores adecuados capaces de nebulizar una cantidad definida de solución en las cavidades nasales. La 10 cantidad es normalmente de entre 50 y 100 µΙ y, opcionalmente, se puede repetir si es necesario.
Diseño experimental
[0030] A continuación, se presentan un protocolo experimental y los resultados obtenidos en un estudio clínico en 15 el que se administró naltrexona a pacientes que estaban siendo tratados con morfina.
- Incidencia de efectos adversos de la morfina en pacientes (número total 80) antes del tratamiento con Naltrexona
- Estreñimiento
- 70 % Mareo 13,3 %
- Náuseas
- 53,3 % Somnolencia 30 %
- Vómitos
- 53,3 % Prurito 30 %
- Inapetencia
- 46,7 % Astenia 43,3 %
- Retención urinaria
- 40 %
- Dolor de cabeza
- 6,7 %
- Pacientes oncológicos que reciben tratamiento con morfina por vía oral (dosis media de 40 mg ± 10 mg) tratados con Naltrexona -Dosis cada 12 horas: usada 1/2 hora antes de la morfina. Pacientes totales: 75.
- Dosis de Naltrexona
- Beneficio (%)1 Analgesia (%)2
- 2,5 µg
- 25 % 45 %
- 2,5 µg
- 90 % 60 %
- 0,125 µg
- 100 % 60 %
- 5 µg
- 40 % 55 %
- 1 mg
- 90 % 100 %
- 1 mg
- 65 % 90 %
- 1 mg
- 40 % 100 %
- 1 mg
- 70 % 65 %
- 1 mg
- 65 % 60 %
- 1 mg
- 100 % 70 %
- 5 µg
- 60 % 45 %
- 5 µg
- 60 % 55 %
- 5 µg
- 0 % 70 %
- 5 µg
- 70 % 100 %
- 5 µg
- 50 % 90 %
- 5 µg
- 45 % 60 %
- 5 µg
- 85 % 90 %
- 5 µg
- 45 % 65 %
- Dosis de Naltrexona
- Beneficio (%)1 Analgesia (%)2
- 2,5 µg
- 100 % 0 %
- 1 mg
- 100 % 100 %
- 2,5 µg
- 80 % 45 %
- 2,5 µg
- 80 % 45 %
- 1 mg
- 65 % 65 %**
- 2,5 µg
- 70 % 55 %
- 2,5 µg
- 50 % 60 %**
- 2,5 µg
- 80 % 45 %
- 0,125 µg
- 65 % 45 %
- 1 mg
- 90 % 100 %
- 2,5 µg
- 65 % 100 %
5
- Dosis de Naltrexona
- Beneficio (%)1 Analgesia (%)2
- 2,5 µg
- 100 % 0 %
- 2,5 µg
- 100 % 100 %
- 2,5 µg
- 80 % 45 %
- 2,5 µg
- 80 % 85 %
- 5 µg
- 65 % 35 %
- 5 µg
- 70 % 85 %
- 1 mg
- 50 % 60 %
- 2,5 µg
- 80 % 55 %
- 1 mg
- 65 % 65 %
- 2,5 µg
- 95 % 100 %
- 2,5 µg
- 60 % 100 %
- 5 µg
- 50 % 60 %
- 1 µg
- 100 % 45 %
- Dosis de Naltrexona
- Beneficio (%)1 Analgesia (%)2
- 5 µg
- 30 % 15 %
- 5 µg
- 50 % 60 %
- 2,5 µg
- 45 % 45 %
- 2,5 µg
- 80 % 75 %
- 1 µg
- 65 % 65 %
- 5 µg
- 70 % 45 %
- 2,5 µg
- 45 % 60 %
- 2,5 µg
- 60 % 55 %
- 1 mg
- 65 % 95 %
- 5 µg
- 95 % 100 %
- 2,5 µg
- 60 % 90 %
- 5 µg
- 50 % 60 %
- 1 µg
- 70 % 45 %
- Leyenda: 1: Porcentaje de reducción de los efectos adversos. 2: Eficacia analgésica tras la administración de naltrexona. ** Reducción de la eficacia tras la naltrexona.
7
Claims (1)
-
imagen1
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| ITFI20100113 | 2010-05-21 | ||
| ITFI2010A000113A IT1400067B1 (it) | 2010-05-21 | 2010-05-21 | Spray nasale liquido contenente naltrexone a bassi dosaggi. |
| PCT/EP2011/058284 WO2011144746A2 (en) | 2010-05-21 | 2011-05-20 | Liquid nasal spray containing low-dose naltrexone |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ES2564936T3 true ES2564936T3 (es) | 2016-03-30 |
Family
ID=43431069
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ES11726367.3T Active ES2564936T3 (es) | 2010-05-21 | 2011-05-20 | Aerosol nasal líquido que contiene naltrexona a dosis baja |
Country Status (17)
| Country | Link |
|---|---|
| US (1) | US20130059876A1 (es) |
| EP (1) | EP2574167B1 (es) |
| CN (1) | CN102905689A (es) |
| BR (1) | BR112012029595A2 (es) |
| CA (1) | CA2800094C (es) |
| DK (1) | DK2574167T3 (es) |
| ES (1) | ES2564936T3 (es) |
| HR (1) | HRP20160187T1 (es) |
| HU (1) | HUE026994T2 (es) |
| IT (1) | IT1400067B1 (es) |
| MX (1) | MX2012013380A (es) |
| NZ (1) | NZ604417A (es) |
| PL (1) | PL2574167T3 (es) |
| RS (1) | RS54588B1 (es) |
| RU (1) | RU2552786C2 (es) |
| SI (1) | SI2574167T1 (es) |
| WO (1) | WO2011144746A2 (es) |
Families Citing this family (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2065038A1 (en) | 2007-11-30 | 2009-06-03 | Pharnext | New therapeutic approaches for treating Charcot-Marie-Tooth disease |
| EP2263665A1 (en) | 2009-06-02 | 2010-12-22 | Pharnext | New compositions for treating CMT and related disorders |
| US9393241B2 (en) | 2009-06-02 | 2016-07-19 | Pharnext | Compositions for treating CMT and related disorders |
| LT3003268T (lt) | 2013-06-05 | 2018-12-10 | Pharnext | Stabilūs peroraliniai tirpalai, skirti kompleksiniam aktyviam farmaciniam ingredientui (api) |
| EP3082816B1 (en) | 2013-12-20 | 2019-03-20 | Indivior UK Limited | Intranasal naloxone compositions and methods of making and using same |
| US10722510B2 (en) | 2014-07-08 | 2020-07-28 | Hikma Pharmaceuticals Usa Inc. | Liquid naloxone spray |
| CA2954637A1 (en) * | 2014-07-09 | 2016-01-14 | Opiant Pharmaceuticals, Inc. | Co-packaged drug products |
| EP3416619A2 (en) * | 2016-02-18 | 2018-12-26 | Immune Therapeutics, Inc. | Method for inducing a sustained immune response |
| US10383870B2 (en) | 2016-06-10 | 2019-08-20 | Pharnext | Early treatment of CMT disease |
| US20180092839A1 (en) * | 2016-10-03 | 2018-04-05 | Lance L. Gooberman | Medicated spray for treatment of substance abuse, overdose, addiction and impulse control disorders |
| EP3906934A1 (en) * | 2020-05-06 | 2021-11-10 | PVP Labs PTE. Ltd. | Application of dalargin for the prevention of viral respiratory infections and prevention of the development of complications during viral respiratory infections |
| US11752143B2 (en) | 2020-12-31 | 2023-09-12 | Soin Therapeutics Llc | Methods of using low dose naltrexone to treat chronic pain |
| CN118021709A (zh) * | 2022-11-07 | 2024-05-14 | 深圳善康医药科技股份有限公司 | 纳曲酮原位凝胶鼻喷剂及其制备方法和应用 |
Family Cites Families (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB9908921D0 (en) * | 1999-04-19 | 1999-06-16 | Britannia Pharmaceuticals Ltd | Spray dispenser for opiod antagonists |
| AU2001262992A1 (en) * | 2000-05-10 | 2002-02-18 | University Of Kentucky Research Foundation | System and method for intranasal administration of opioids |
| AU2002303148A1 (en) * | 2001-06-29 | 2003-03-03 | Leon J. Lewandowski | Individualized addiction cessation therapy |
| RU2224518C1 (ru) * | 2003-02-10 | 2004-02-27 | Дулькис Мария Дмитриевна | Жидкая лекарственная форма налтрексона |
| US20070212307A1 (en) * | 2006-02-10 | 2007-09-13 | Daniel Wermeling | Pharmaceutical Compositions Comprising an Opioid Receptor Antagonist and Methods of Using Same |
| WO2009040595A1 (en) * | 2007-09-28 | 2009-04-02 | Wockhardt Research Centre | Multi-dose pharmaceutical composition of analgesic for nasal administration |
| EP2266563A1 (en) * | 2009-06-11 | 2010-12-29 | Charité-Universitätsmedizin Berlin (Charité) | Use of opioid receptor antagonists for acute treatment of paraphilic arousal states |
-
2010
- 2010-05-21 IT ITFI2010A000113A patent/IT1400067B1/it active
-
2011
- 2011-05-20 EP EP11726367.3A patent/EP2574167B1/en active Active
- 2011-05-20 DK DK11726367.3T patent/DK2574167T3/en active
- 2011-05-20 NZ NZ604417A patent/NZ604417A/en not_active IP Right Cessation
- 2011-05-20 CN CN2011800249945A patent/CN102905689A/zh active Pending
- 2011-05-20 US US13/698,128 patent/US20130059876A1/en not_active Abandoned
- 2011-05-20 SI SI201130746A patent/SI2574167T1/sl unknown
- 2011-05-20 ES ES11726367.3T patent/ES2564936T3/es active Active
- 2011-05-20 BR BR112012029595A patent/BR112012029595A2/pt active Search and Examination
- 2011-05-20 MX MX2012013380A patent/MX2012013380A/es not_active Application Discontinuation
- 2011-05-20 CA CA2800094A patent/CA2800094C/en not_active Expired - Fee Related
- 2011-05-20 RU RU2012155711/15A patent/RU2552786C2/ru active
- 2011-05-20 HU HUE11726367A patent/HUE026994T2/en unknown
- 2011-05-20 PL PL11726367T patent/PL2574167T3/pl unknown
- 2011-05-20 WO PCT/EP2011/058284 patent/WO2011144746A2/en active Application Filing
- 2011-05-20 RS RS20160104A patent/RS54588B1/en unknown
-
2016
- 2016-02-23 HR HRP20160187TT patent/HRP20160187T1/hr unknown
Also Published As
| Publication number | Publication date |
|---|---|
| AU2011254554A1 (en) | 2013-01-10 |
| IT1400067B1 (it) | 2013-05-17 |
| ITFI20100113A1 (it) | 2011-11-22 |
| WO2011144746A3 (en) | 2012-02-02 |
| RU2552786C2 (ru) | 2015-06-10 |
| EP2574167A2 (en) | 2013-04-03 |
| RU2012155711A (ru) | 2014-06-27 |
| BR112012029595A2 (pt) | 2016-12-13 |
| MX2012013380A (es) | 2013-02-11 |
| CA2800094A1 (en) | 2011-11-24 |
| SI2574167T1 (sl) | 2016-05-31 |
| RS54588B1 (en) | 2016-08-31 |
| HRP20160187T1 (hr) | 2016-04-08 |
| CN102905689A (zh) | 2013-01-30 |
| NZ604417A (en) | 2014-03-28 |
| WO2011144746A2 (en) | 2011-11-24 |
| PL2574167T3 (pl) | 2016-07-29 |
| HUE026994T2 (en) | 2016-08-29 |
| US20130059876A1 (en) | 2013-03-07 |
| DK2574167T3 (en) | 2016-03-07 |
| CA2800094C (en) | 2018-05-29 |
| EP2574167B1 (en) | 2015-12-16 |
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