ES2425559T5 - Composiciones farmacéuticas que comprenden las exendinas y los agonistas de las mismas - Google Patents
Composiciones farmacéuticas que comprenden las exendinas y los agonistas de las mismas Download PDFInfo
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- ES2425559T5 ES2425559T5 ES05011978.3T ES05011978T ES2425559T5 ES 2425559 T5 ES2425559 T5 ES 2425559T5 ES 05011978 T ES05011978 T ES 05011978T ES 2425559 T5 ES2425559 T5 ES 2425559T5
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- food
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- exendin
- exendins
- agonists
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- 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
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/22—Hormones
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/22—Hormones
- A61K38/2207—Gastrins; Cholecystokinins [CCK]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/22—Hormones
- A61K38/2264—Obesity-gene products, e.g. leptin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/22—Hormones
- A61K38/23—Calcitonins
-
- 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
- A61K47/02—Inorganic compounds
-
- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- 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
-
- 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
- A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/04—Anorexiants; Antiobesity agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/06—Antihyperlipidemics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- C07K14/575—Hormones
- C07K14/57563—Vasoactive intestinal peptide [VIP]; Related peptides
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
Description
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EJEMPLO DE REFERENCIA 1: Las inyecciones de exendina redujeron la ingesta alimenticia en ratones normales
Se alojaron todos los ratones (ratones suizos NIH) en un ambiente estable de 22 (± 2) ºC, y un 60 (± 10) % de humedad y con un ciclo de luz: oscuridad de 12:12, encendiéndose las luces a las 06:00. Los ratones se alojaron en grupos de cuatro en jaulas estándar con acceso a la comida (Teklad: LM 485; Madison, WI) y agua a discreción excepto cuando se indica lo contrario, durante por lo menos dos semanas antes de los experimentos.
Todos los experimentos se realizaron entre las 07:00 h y las 09:00 h. Se privó de alimentos a los ratones (se quitó la comida a las 16:00 h a todos los animales el día anterior al experimento) y se los alojó por separado. Todos los ratones recibieron una inyección intraperitoneal (5 µl/kg) de una disolución salina o de exendina-4 a unas dosis de 0,1, 1,0, 10 y 100 µg/kg e inmediatamente se presentó a los animales la comida en forma de bolita pesada previamente (Teklad LM 485). La bolita de alimento se pesó a intervalos de 30 minutos, 1 h, 2 h y 6 h para determinar la cantidad de comida consumida.
La Figura 1 representa la ingesta alimenticia acumulativa en períodos de 0,5, 1, 2 y 6 h en ratones normales suizos NIH tras ayunar toda la noche a continuación de una inyección intraperitoneal de disolución salina, 2 dosis de GLP1, o 4 dosis de exendina-4. Con las dosis de hasta 100 µg/kg, el GLP-1 no produjo efecto alguno en la ingesta alimenticia determinada con cualquier tipo de período, un resultado coherente con las publicaciones anteriores (Bhavsar, S.P., et al., Soc. Neurosci. Abstr. 21:460 (188.8) (1995); y Turton, M.D., Nature, 379:69-72, (1996)).
En cambio, las inyecciones de exendina-4 inhibieron la ingesta alimenticia de forma eficaz y dependiente de la dosis. La DE50 para la inhibición de la ingesta alimenticia durante 30 minutos fue de 1 µg/kg, que es un nivel aproximadamente tan eficaz como el de la amilina (DE50 de 3,6 µg/kg) o el agente de la saciedad periférico prototípico, CCK, (DE50 de 0,97 µg/kg) tal como se determinó en esta preparación. Sin embargo, a diferencia de los efectos de la amilina o la CCK, que disminuyen después de 1 – 2 horas, la inhibición de la ingesta alimenticia con la exendina-4 aún tenía lugar por lo menos 6 horas después de la inyección.
EJEMPLO DE REFERENCIA 2: las inyecciones de exendina redujeron la ingesta alimenticia en ratones obesos
Se alojaron todos los ratones (hembras de ratones ob/ob) en un ambiente estable de 22 (± 2) ºC, y un 60 (± 10) % de humedad y con un ciclo de luz: oscuridad de 12:12, encendiéndose las luces a las 06:00. Los ratones se alojaron en grupos de cuatro en jaulas estándar con acceso a la comida (Teklad: LM 485) y agua a discreción excepto cuando se indica lo contrario, durante por lo menos dos semanas antes de los experimentos.
Todos los experimentos se realizaron entre las 07:00 h y las 09:00 h. Se privó de alimentos a los ratones (se quitó la comida a las 16:00 h a todos los animales el día anterior al experimento) y se los alojó por separado. Todos los ratones recibieron una inyección intraperitoneal (5 µl/kg) de una disolución salina o de exendina-4 a unas dosis de 0,1, 1,0 y 10 µg/kg (ratones hembra ob/ob) e inmediatamente se presentó a los animales la comida en forma de bolita pesada previamente (Teklad LM 485). La bolita de alimento se pesó a intervalos de 30 minutos, 1 h, 2 h y 6 h para determinar la cantidad de comida consumida.
La Figura 2 representa el efecto de la exendina-4 en el ratón con el modelo de obesidad ob/ob. Dichos ratones obesos presentaron una respuesta relacionada con la ingesta alimenticia similar a la de la exendina en los ratones normales. Además, dichos ratones obesos no resultaron hipersensibles a la exendina, tal como se ha observado con la amilina y con la leptina (Young, A.A., et al., Program and Abstracts, 10º Congreso Internacional de Endocrinología, 12 a 15 de junio de 1996, San Francisco, p. 419 (P2-58)).
EJEMPLO DE REFERENCIA 3: las inyecciones de exendina intracerebroventriculares redujeron la ingesta alimenticia en ratas
Se alojaron todas las ratas (Harlan Sprague-Dawley) en un ambiente estable de 22 (± 2) ºC, y un 60 (± 10) % de humedad y con un ciclo de luz: oscuridad de 12:12, encendiéndose las luces a las 06:00. Las ratas se obtuvieron de Zivic Miller con una cánula intracerebroventricular (cánula ICV) implantada (las coordenadas determinadas por el peso real de los animales y haciendo referencia a Paxinos, G. y Watson, C. "The Rat Brain in stereotaxic coordinates (“El encéfalo de la rata en coordenadas estereotáxicas”)", segunda edición. Academic Press) y se alojaron por separado en jaulas estándar con acceso a la comida (Teklad: LM 485) y agua a discreción durante por lo menos una semana antes de los experimentos.
Todas las inyecciones se administraron entre las 17:00 h y las 18:00 h. Se habituó a las ratas al procedimiento de la inyección ICV por lo menos una vez antes de la administración ICV del compuesto. Todas las ratas recibieron una inyección ICV (2 µl/30 segundos) de una disolución salina o de exendina-4 a unas dosis de 0,01, 0,03, 0,1, 0,3 y 1,0 µg. Posteriormente se presentó a los animales la comida en forma de bolita pesada previamente (Teklad LM 485) a las 18:00, cuando se apagaron las luces. La bolita de alimento se pesó a intervalos de 2 h, 12 h y 24 h para determinar la cantidad de comida consumida por cada animal.
La Figura 3 representa la inhibición de la ingesta dependiente de la dosis en las ratas que recibieron dosis
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Claims (1)
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imagen1
Applications Claiming Priority (8)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US3490597P | 1997-01-07 | 1997-01-07 | |
US34905P | 1997-01-07 | ||
US5540497P | 1997-08-08 | 1997-08-08 | |
US55404P | 1997-08-08 | ||
US6602997P | 1997-11-14 | 1997-11-14 | |
US6544297P | 1997-11-14 | 1997-11-14 | |
US65442P | 1997-11-14 | ||
US66029P | 1997-11-14 |
Publications (2)
Publication Number | Publication Date |
---|---|
ES2425559T3 ES2425559T3 (es) | 2013-10-16 |
ES2425559T5 true ES2425559T5 (es) | 2018-02-02 |
Family
ID=27488253
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
ES98904545T Expired - Lifetime ES2247676T3 (es) | 1997-01-07 | 1998-01-07 | Uso de las exendinas y de los agonistas de las mismas para la reduccion de la ingesta alimenticia. |
ES05011978.3T Expired - Lifetime ES2425559T5 (es) | 1997-01-07 | 1998-01-07 | Composiciones farmacéuticas que comprenden las exendinas y los agonistas de las mismas |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
ES98904545T Expired - Lifetime ES2247676T3 (es) | 1997-01-07 | 1998-01-07 | Uso de las exendinas y de los agonistas de las mismas para la reduccion de la ingesta alimenticia. |
Country Status (16)
Country | Link |
---|---|
US (10) | US6956026B2 (es) |
EP (2) | EP1629849B2 (es) |
JP (1) | JP4798814B2 (es) |
AT (1) | ATE304864T1 (es) |
AU (1) | AU739020B2 (es) |
BE (1) | BE2007C038I2 (es) |
CA (1) | CA2277112C (es) |
DE (2) | DE69831673C5 (es) |
DK (2) | DK1629849T4 (es) |
ES (2) | ES2247676T3 (es) |
FR (1) | FR07C0031I2 (es) |
HK (1) | HK1025252A1 (es) |
LU (1) | LU91342I2 (es) |
NL (1) | NL300281I2 (es) |
PT (1) | PT1629849E (es) |
WO (1) | WO1998030231A1 (es) |
Families Citing this family (213)
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WO1998005351A1 (en) | 1996-08-08 | 1998-02-12 | Amylin Pharmaceuticals, Inc. | Methods for regulating gastrointestinal motility |
ATE366584T1 (de) * | 1996-11-12 | 2007-08-15 | Novo Nordisk As | Verwendung von glp-1 peptiden |
EP1629849B2 (en) | 1997-01-07 | 2017-10-04 | Amylin Pharmaceuticals, LLC | Pharmaceutical compositions comprising exendins and agonists thereof |
US7910548B2 (en) * | 1997-06-06 | 2011-03-22 | Amylin Pharmaceuticals, Inc. | Methods for treating obesity |
US20040022807A1 (en) * | 1998-06-05 | 2004-02-05 | Duft Bradford J | Methods for treating obesity |
DE69838791T3 (de) * | 1997-08-08 | 2011-06-22 | Amylin Pharmaceuticals, Inc., Calif. | Neue exendinagonist verbindungen |
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1998
- 1998-01-07 EP EP05011978.3A patent/EP1629849B2/en not_active Expired - Lifetime
- 1998-01-07 DE DE69831673.8T patent/DE69831673C5/de not_active Expired - Lifetime
- 1998-01-07 ES ES98904545T patent/ES2247676T3/es not_active Expired - Lifetime
- 1998-01-07 DE DE122007000044C patent/DE122007000044I2/de active Active
- 1998-01-07 AU AU62394/98A patent/AU739020B2/en not_active Expired
- 1998-01-07 DK DK05011978.3T patent/DK1629849T4/en active
- 1998-01-07 EP EP98904545A patent/EP0996459B1/en not_active Expired - Lifetime
- 1998-01-07 PT PT50119783T patent/PT1629849E/pt unknown
- 1998-01-07 DK DK98904545T patent/DK0996459T3/da active
- 1998-01-07 AT AT98904545T patent/ATE304864T1/de active
- 1998-01-07 US US09/003,869 patent/US6956026B2/en not_active Expired - Lifetime
- 1998-01-07 JP JP53114798A patent/JP4798814B2/ja not_active Expired - Lifetime
- 1998-01-07 ES ES05011978.3T patent/ES2425559T5/es not_active Expired - Lifetime
- 1998-01-07 CA CA002277112A patent/CA2277112C/en not_active Expired - Lifetime
- 1998-01-07 WO PCT/US1998/000449 patent/WO1998030231A1/en active IP Right Grant
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2000
- 2000-07-21 HK HK00104513A patent/HK1025252A1/xx not_active IP Right Cessation
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2002
- 2002-06-28 US US10/187,051 patent/US6989366B2/en not_active Expired - Fee Related
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- 2004-07-19 US US10/894,999 patent/US7297761B2/en not_active Expired - Fee Related
- 2004-07-20 US US10/895,909 patent/US7741269B2/en not_active Expired - Fee Related
- 2004-10-14 US US10/966,337 patent/US7138375B2/en not_active Expired - Fee Related
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- 2006-03-03 US US11/368,225 patent/US7419952B2/en not_active Expired - Fee Related
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- 2007-05-16 BE BE2007C038C patent/BE2007C038I2/fr unknown
- 2007-05-16 FR FR07C0031C patent/FR07C0031I2/fr active Active
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- 2008-08-29 US US12/201,918 patent/US7700549B2/en not_active Expired - Fee Related
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