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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- exendin
- exendins
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- 229960001519 exenatide Drugs 0.000 description 6
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- 102000036770 Islet Amyloid Polypeptide Human genes 0.000 description 3
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- 230000005764 inhibitory process Effects 0.000 description 3
- 238000000185 intracerebroventricular administration Methods 0.000 description 3
- 238000013116 obese mouse model Methods 0.000 description 3
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- 239000000243 solution Substances 0.000 description 3
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 3
- 102100025101 GATA-type zinc finger protein 1 Human genes 0.000 description 2
- 210000004556 brain Anatomy 0.000 description 2
- 239000007928 intraperitoneal injection Substances 0.000 description 2
- 101710198884 GATA-type zinc finger protein 1 Proteins 0.000 description 1
- DTHNMHAUYICORS-KTKZVXAJSA-N Glucagon-like peptide 1 Chemical compound C([C@@H](C(=O)N[C@@H]([C@@H](C)CC)C(=O)N[C@@H](C)C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CCCCN)C(=O)NCC(=O)N[C@@H](CCCNC(N)=N)C(N)=O)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CCCCN)NC(=O)[C@H](C)NC(=O)[C@H](C)NC(=O)[C@H](CCC(N)=O)NC(=O)CNC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC=1C=CC(O)=CC=1)NC(=O)[C@H](CO)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](CC=1C=CC=CC=1)NC(=O)[C@@H](NC(=O)CNC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](C)NC(=O)[C@@H](N)CC=1N=CNC=1)[C@@H](C)O)[C@@H](C)O)C(C)C)C1=CC=CC=C1 DTHNMHAUYICORS-KTKZVXAJSA-N 0.000 description 1
- 108091016366 Histone-lysine N-methyltransferase EHMT1 Proteins 0.000 description 1
- 206010020751 Hypersensitivity Diseases 0.000 description 1
- 102000016267 Leptin Human genes 0.000 description 1
- 108010092277 Leptin Proteins 0.000 description 1
- 241000699666 Mus <mouse, genus> Species 0.000 description 1
- 208000008589 Obesity Diseases 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
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- 230000001186 cumulative effect Effects 0.000 description 1
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- 235000012631 food intake Nutrition 0.000 description 1
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- 238000007912 intraperitoneal administration Methods 0.000 description 1
- NRYBAZVQPHGZNS-ZSOCWYAHSA-N leptin Chemical compound O=C([C@H](CO)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CC=1C2=CC=CC=C2NC=1)NC(=O)[C@H](CC(C)C)NC(=O)[C@@H](NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CO)NC(=O)CNC(=O)[C@H](CCC(N)=O)NC(=O)[C@@H](N)CC(C)C)CCSC)N1CCC[C@H]1C(=O)NCC(=O)N[C@@H](CS)C(O)=O NRYBAZVQPHGZNS-ZSOCWYAHSA-N 0.000 description 1
- 229940039781 leptin Drugs 0.000 description 1
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- 235000019627 satiety Nutrition 0.000 description 1
- 238000012453 sprague-dawley rat model Methods 0.000 description 1
Classifications
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- 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
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- 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
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- 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]
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- 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
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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
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- 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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- 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
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- C07K—PEPTIDES
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- C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- General Health & Medical Sciences (AREA)
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- Pharmacology & Pharmacy (AREA)
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- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Gastroenterology & Hepatology (AREA)
- General Chemical & Material Sciences (AREA)
- Endocrinology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Zoology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Organic Chemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Immunology (AREA)
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- Dermatology (AREA)
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- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Emergency Medicine (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Peptides Or Proteins (AREA)
- Medicinal Preparation (AREA)
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 | ||
| US6544297P | 1997-11-14 | 1997-11-14 | |
| US6602997P | 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 |
|---|---|---|---|
| ES05011978.3T Expired - Lifetime ES2425559T5 (es) | 1997-01-07 | 1998-01-07 | Composiciones farmacéuticas que comprenden las exendinas y los agonistas de las mismas |
| 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. |
Family Applications After (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 (15)
| Country | Link |
|---|---|
| US (10) | US6956026B2 (es) |
| EP (2) | EP0996459B1 (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) | ES2425559T5 (es) |
| FR (1) | FR07C0031I2 (es) |
| LU (1) | LU91342I2 (es) |
| NL (1) | NL300281I2 (es) |
| PT (1) | PT1629849E (es) |
| WO (1) | WO1998030231A1 (es) |
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2002
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2004
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2006
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2007
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2008
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