ECSP055960A - Formulaciones parenterales de un péptido para el tratamiento de lupus sistémico eritematoso - Google Patents
Formulaciones parenterales de un péptido para el tratamiento de lupus sistémico eritematosoInfo
- Publication number
- ECSP055960A ECSP055960A EC2005005960A ECSP055960A ECSP055960A EC SP055960 A ECSP055960 A EC SP055960A EC 2005005960 A EC2005005960 A EC 2005005960A EC SP055960 A ECSP055960 A EC SP055960A EC SP055960 A ECSP055960 A EC SP055960A
- Authority
- EC
- Ecuador
- Prior art keywords
- pharmaceutical composition
- solution
- temperature
- peptide
- provides
- Prior art date
Links
Classifications
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B82—NANOTECHNOLOGY
- B82Y—SPECIFIC USES OR APPLICATIONS OF NANOSTRUCTURES; MEASUREMENT OR ANALYSIS OF NANOSTRUCTURES; MANUFACTURE OR TREATMENT OF NANOSTRUCTURES
- B82Y5/00—Nanobiotechnology or nanomedicine, e.g. protein engineering or drug delivery
-
- 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
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K31/716—Glucans
- A61K31/724—Cyclodextrins
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
- A61K38/10—Peptides having 12 to 20 amino acids
-
- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/40—Cyclodextrins; Derivatives 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
- A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/69—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
- A61K47/6949—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes
- A61K47/6951—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes using cyclodextrin
-
- 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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
- A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Epidemiology (AREA)
- Immunology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Molecular Biology (AREA)
- Nanotechnology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Gastroenterology & Hepatology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Crystallography & Structural Chemistry (AREA)
- General Engineering & Computer Science (AREA)
- Biotechnology (AREA)
- Dermatology (AREA)
- Medical Informatics (AREA)
- Biophysics (AREA)
- Transplantation (AREA)
- Inorganic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Peptides Or Proteins (AREA)
Abstract
SUMARIO DE LA INVENCIÓN La presente invención provee una composición farmacéutica que comprende: Un vehículo acuoso; de 0.1 mg/ml a 20 mg/ml de la composición de una sal farmacéuticamente aceptable de un péptido que tiene la fórmula estructural NH2-Gly Tyr Tyr Trp Ser Trp Ile Arg Gln Pro Pro Gly Lys Gly Glu Glu Trp Ile Gly-cooh (SEC ID NO:1). Una ß ciclodextrina sustituída en una cantidad efectiva para disolver el péptido en el vehículo acuoso, en donde la composición tiene un pH entre 4 y 9. La invención sujeto también provee una composición farmacéutica que también comprende: Un vehículo acuoso; de 0.1 mg/ml a 20 mg/ml de la composición de la sal de acetato de un péptido que tiene la fórmula estructural NH2-Gly Tyr Tyr Trp Ser Trp Ile Arg Gln Pro Pro Gly Lys Gly Glu Glu Trp Ile Gly-cooh (SEC ID NO:1); y de 70 mg/ml a 170 mg/ml de la composición de hepta-sulfobutileter-ß-ciclodextrina, en donde el péptido y el hepta-sulfobutileter-ß-ciclodextrina se disuelven en el vehículo acuoso; y en donde la solución tiene un pH entre 6.5 y 8.5. La invención sujeto también provee un método para aliviar los síntomas del lupus sistémico eritematoso (SLE) en un sujeto humano que comprende administrar al sujeto humano cualquiera de las composiciones farmacéuticas anteriores en una cantidad efectiva para aliviar los síntomas del SLE en el sujeto humano. La invención sujeto también provee un procedimiento de fabricación de la composición farmacéutica anterior que comprende los siguientes pasos: a) Preparación de una solución de un ß-ciclodextrina sustituída en un vehículo acuoso a una concentración predeterminante; b) Agregar una cantidad predeterminante de una sal farmacéuticamente aceptable del péptido NH2-Gly Tyr Tyr Trp Ser Trp Ile Arg Gln Pro Pro Gly Lys Gly Glu Glu Trp Ile Gly-cooh (SEC ID NO:1)a la solución del paso a); c) Ajustar el pH de la solución del paso b) hasta que el péptido se disuelva en la solución; y d) si es necesario, ajustar el pH de la solución del paso c) a un pH de 4-9, de esa manera fabricar la composición farmacéutica. La invención sujeto también provee un procedimiento de liofilización de la composición farmacéutica anterior, que comprende los pasos de: a) Reducir la temperatura de una composición farmacéutica a -40°C; b) Sostener la temperatura a -40°C por un tiempo predeterminado; c) Elevar la temperatura de la solución a 20°C; d) Sostener la temperatura a 20°C por un tiempo predeterminado; y e) Reducir la presión a 10µbarias, de esa manera liofilizar la composición farmacéutica. La invención sujeto también provee un procedimiento de liofilización de la composición farmacéutica anterior, que comprende los pasos de: a) Reducir la temperatura de la composición farmacéutica a -45°C; b) Sostener la temperatura a -45°C por un tiempo predeterminado; c) Elevar la temperatura de la solución a -20°C; d) Elevar la temperatura de la solución a 25°C; y e) Sostener la temperatura a 25°C por un tiempo predeterminado, de esa manera liofilizar la composición farmacéutica.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US43995003P | 2003-01-14 | 2003-01-14 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ECSP055960A true ECSP055960A (es) | 2006-04-19 |
Family
ID=32771763
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EC2005005960A ECSP055960A (es) | 2003-01-14 | 2005-08-11 | Formulaciones parenterales de un péptido para el tratamiento de lupus sistémico eritematoso |
Country Status (18)
| Country | Link |
|---|---|
| US (2) | US7294687B2 (es) |
| EP (1) | EP1587525A4 (es) |
| JP (1) | JP2006516034A (es) |
| KR (1) | KR20050100616A (es) |
| CN (1) | CN1761477A (es) |
| AU (1) | AU2004206844A1 (es) |
| BR (1) | BRPI0406737A (es) |
| CA (1) | CA2513331A1 (es) |
| CO (1) | CO5640149A2 (es) |
| CR (1) | CR7936A (es) |
| EA (1) | EA008438B1 (es) |
| EC (1) | ECSP055960A (es) |
| MX (1) | MXPA05007552A (es) |
| NO (1) | NO20053761L (es) |
| NZ (1) | NZ541659A (es) |
| UA (1) | UA83816C2 (es) |
| WO (1) | WO2004064788A2 (es) |
| ZA (1) | ZA200506205B (es) |
Families Citing this family (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| IL141647A0 (en) * | 2001-02-26 | 2002-03-10 | Yeda Res & Dev | Synthetic human peptides and pharmaceutical compositions comprising them for the treatment of systemic lupus erythematosus |
| US7294687B2 (en) * | 2003-01-14 | 2007-11-13 | Teva Pharmaceutical Industries, Ltd. | Parenteral formulations of a peptide for the treatment of systemic lupus erythematosus |
| NZ541658A (en) * | 2003-01-14 | 2008-04-30 | Teva Pharma | Parenteral formulations of peptides for the treatment of systemic lupus erythematosus |
| DE102004043750A1 (de) * | 2004-09-10 | 2006-03-30 | Sanofi-Aventis Deutschland Gmbh | Formulierungen des Peptids p277 oder dessen Varianten mit optimierter Stabilität |
| US20100160442A1 (en) * | 2006-07-18 | 2010-06-24 | Ossovskaya Valeria S | Formulations for cancer treatment |
| US20100168011A1 (en) * | 2006-12-12 | 2010-07-01 | Amylin Pharmaceuticals, Inc. | Pharmaceutical Formulations and Methods for Making the Same |
| CN101668561A (zh) * | 2007-01-16 | 2010-03-10 | 彼帕科学公司 | 癌症治疗制剂 |
| US7635773B2 (en) | 2008-04-28 | 2009-12-22 | Cydex Pharmaceuticals, Inc. | Sulfoalkyl ether cyclodextrin compositions |
| RU2526804C2 (ru) | 2008-08-06 | 2014-08-27 | Ново Нордиск Хелс Кеа Аг | Конъюгированные белки с пролонгированным действием in vivo |
| DK2814849T3 (da) | 2012-02-15 | 2020-03-09 | Cydex Pharmaceuticals Inc | Fremgangsmåde til fremstilling af cyclodextrin-derivater |
| CA2888822C (en) | 2012-10-22 | 2021-01-26 | Cydex Pharmaceuticals, Inc. | Alkylated cyclodextrin compositions and processes for preparing and using the same |
| JP6914188B2 (ja) | 2014-08-22 | 2021-08-04 | サイデックス・ファーマシューティカルズ・インコーポレイテッド | 分画アルキル化シクロデキストリン組成物ならびにその調製方法および使用方法 |
| JP7242059B2 (ja) | 2017-01-05 | 2023-03-20 | イエダ リサーチ アンド ディベロプメント カンパニー リミテッド | シェーグレン症候群の治療用ペプチド |
| CN110960442B (zh) * | 2019-12-17 | 2023-03-31 | 珠海冀百康生物科技有限公司 | 一种多肽包封物的制备方法 |
Family Cites Families (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS60184098A (ja) * | 1984-03-02 | 1985-09-19 | Suntory Ltd | 新規なペプチド及びこれを有効成分とする利尿剤 |
| US6407079B1 (en) * | 1985-07-03 | 2002-06-18 | Janssen Pharmaceutica N.V. | Pharmaceutical compositions containing drugs which are instable or sparingly soluble in water and methods for their preparation |
| US5997856A (en) * | 1988-10-05 | 1999-12-07 | Chiron Corporation | Method and compositions for solubilization and stabilization of polypeptides, especially proteins |
| US5126249A (en) | 1989-05-09 | 1992-06-30 | Eli Lilly And Company | Enzymatic removal of a protein amino-terminal sequence |
| US5376645A (en) | 1990-01-23 | 1994-12-27 | University Of Kansas | Derivatives of cyclodextrins exhibiting enhanced aqueous solubility and the use thereof |
| KR0166088B1 (ko) * | 1990-01-23 | 1999-01-15 | . | 수용해도가 증가된 시클로덱스트린 유도체 및 이의 용도 |
| GB9017008D0 (en) | 1990-08-02 | 1990-09-19 | Erba Carlo Spa | Process for the enzymatic preparation of basic fibroblast growth factor |
| US5646131A (en) | 1994-02-22 | 1997-07-08 | The Arab Company For Drug Industries And Medical Applicances (Acdima) | Method for solubilizing drugs using cyclodextrins and carboxylic acids |
| IL113159A0 (en) * | 1995-03-28 | 1995-06-29 | Yeda Res & Dev | Synthetic peptides and pharmaceutical compositions comprising them |
| US6613536B1 (en) | 1995-03-28 | 2003-09-02 | Yeda Research And Development Co. Ltd. | Synthetic peptides and pharmaceutical compositions comprising them for the treatment of systemic lupus erythematosus |
| IL120503A0 (en) | 1997-03-20 | 1997-07-13 | Hadasit Med Res Service | Peptides for the treatment of systemic lupus erythematosis and pharmaceutical compositions containing them |
| US20020054872A1 (en) | 1997-03-20 | 2002-05-09 | Yaakov Naparstek | Peptides for the treatment of systemic lupus erythematosus and methods of treating systemic lupus erythematosus |
| ATE388139T1 (de) | 1997-12-18 | 2008-03-15 | Boehringer Ingelheim Pharma | Pyridone als hemmer der sh2-domäne der src- familie |
| IL141647A0 (en) * | 2001-02-26 | 2002-03-10 | Yeda Res & Dev | Synthetic human peptides and pharmaceutical compositions comprising them for the treatment of systemic lupus erythematosus |
| US7114005B2 (en) | 2002-02-05 | 2006-09-26 | Cisco Technology, Inc. | Address hopping of packet-based communications |
| US7294687B2 (en) * | 2003-01-14 | 2007-11-13 | Teva Pharmaceutical Industries, Ltd. | Parenteral formulations of a peptide for the treatment of systemic lupus erythematosus |
| NZ541658A (en) * | 2003-01-14 | 2008-04-30 | Teva Pharma | Parenteral formulations of peptides for the treatment of systemic lupus erythematosus |
-
2004
- 2004-01-14 US US10/758,572 patent/US7294687B2/en not_active Expired - Lifetime
- 2004-01-14 WO PCT/US2004/000955 patent/WO2004064788A2/en not_active Application Discontinuation
- 2004-01-14 NZ NZ541659A patent/NZ541659A/en unknown
- 2004-01-14 EA EA200501129A patent/EA008438B1/ru not_active IP Right Cessation
- 2004-01-14 EP EP04702214A patent/EP1587525A4/en not_active Withdrawn
- 2004-01-14 UA UAA200507998A patent/UA83816C2/ru unknown
- 2004-01-14 AU AU2004206844A patent/AU2004206844A1/en not_active Abandoned
- 2004-01-14 CN CNA2004800069919A patent/CN1761477A/zh active Pending
- 2004-01-14 MX MXPA05007552A patent/MXPA05007552A/es active IP Right Grant
- 2004-01-14 BR BR0406737-1A patent/BRPI0406737A/pt not_active IP Right Cessation
- 2004-01-14 CA CA002513331A patent/CA2513331A1/en not_active Abandoned
- 2004-01-14 KR KR1020057013097A patent/KR20050100616A/ko not_active Application Discontinuation
- 2004-01-14 JP JP2006500958A patent/JP2006516034A/ja not_active Withdrawn
-
2005
- 2005-08-03 ZA ZA200506205A patent/ZA200506205B/en unknown
- 2005-08-08 NO NO20053761A patent/NO20053761L/no not_active Application Discontinuation
- 2005-08-09 CR CR7936A patent/CR7936A/es unknown
- 2005-08-10 CO CO05079319A patent/CO5640149A2/es not_active Application Discontinuation
- 2005-08-11 EC EC2005005960A patent/ECSP055960A/es unknown
-
2007
- 2007-11-12 US US11/985,068 patent/US20080287366A1/en not_active Abandoned
Also Published As
| Publication number | Publication date |
|---|---|
| US7294687B2 (en) | 2007-11-13 |
| AU2004206844A1 (en) | 2004-08-05 |
| JP2006516034A (ja) | 2006-06-15 |
| NO20053761D0 (no) | 2005-08-08 |
| US20080287366A1 (en) | 2008-11-20 |
| WO2004064788A3 (en) | 2005-03-24 |
| KR20050100616A (ko) | 2005-10-19 |
| EP1587525A2 (en) | 2005-10-26 |
| BRPI0406737A (pt) | 2005-12-20 |
| EA008438B1 (ru) | 2007-06-29 |
| CA2513331A1 (en) | 2004-08-05 |
| WO2004064788A2 (en) | 2004-08-05 |
| MXPA05007552A (es) | 2006-05-19 |
| US20040180059A1 (en) | 2004-09-16 |
| EP1587525A4 (en) | 2008-09-10 |
| NZ541659A (en) | 2007-05-31 |
| CR7936A (es) | 2006-05-31 |
| CO5640149A2 (es) | 2006-05-31 |
| ZA200506205B (en) | 2006-12-27 |
| UA83816C2 (ru) | 2008-08-26 |
| CN1761477A (zh) | 2006-04-19 |
| EA200501129A1 (ru) | 2006-02-24 |
| NO20053761L (no) | 2005-10-12 |
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