MX2022016265A - Composiciones terapeuticas de liberacion sostenida estable en solventes polares aproticos y metodos de preparacion de los mismos. - Google Patents
Composiciones terapeuticas de liberacion sostenida estable en solventes polares aproticos y metodos de preparacion de los mismos.Info
- Publication number
- MX2022016265A MX2022016265A MX2022016265A MX2022016265A MX2022016265A MX 2022016265 A MX2022016265 A MX 2022016265A MX 2022016265 A MX2022016265 A MX 2022016265A MX 2022016265 A MX2022016265 A MX 2022016265A MX 2022016265 A MX2022016265 A MX 2022016265A
- Authority
- MX
- Mexico
- Prior art keywords
- sustained release
- methods
- formulations
- aprotic polar
- therapeutic
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title abstract 8
- 238000013268 sustained release Methods 0.000 title abstract 6
- 239000012730 sustained-release form Substances 0.000 title abstract 6
- 238000000034 method Methods 0.000 title abstract 4
- 239000002798 polar solvent Substances 0.000 title abstract 4
- 230000001225 therapeutic effect Effects 0.000 title abstract 4
- 238000004519 manufacturing process Methods 0.000 title 1
- 238000009472 formulation Methods 0.000 abstract 7
- 239000003814 drug Substances 0.000 abstract 5
- 229940124597 therapeutic agent Drugs 0.000 abstract 5
- IAZDPXIOMUYVGZ-UHFFFAOYSA-N Dimethylsulphoxide Chemical compound CS(C)=O IAZDPXIOMUYVGZ-UHFFFAOYSA-N 0.000 abstract 3
- 208000013016 Hypoglycemia Diseases 0.000 abstract 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 abstract 2
- 230000002218 hypoglycaemic effect Effects 0.000 abstract 2
- 239000002253 acid Substances 0.000 abstract 1
- 239000004480 active ingredient Substances 0.000 abstract 1
- 150000001875 compounds Chemical class 0.000 abstract 1
- 229910052500 inorganic mineral Inorganic materials 0.000 abstract 1
- 239000011707 mineral Substances 0.000 abstract 1
- 239000003607 modifier Substances 0.000 abstract 1
- 239000000546 pharmaceutical excipient Substances 0.000 abstract 1
- 229920001606 poly(lactic acid-co-glycolic acid) Polymers 0.000 abstract 1
- 229920000642 polymer Polymers 0.000 abstract 1
- 239000003381 stabilizer Substances 0.000 abstract 1
- 230000000087 stabilizing effect Effects 0.000 abstract 1
- 239000000126 substance Substances 0.000 abstract 1
- 150000003751 zinc Chemical class 0.000 abstract 1
Classifications
-
- 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
- A61K38/26—Glucagons
-
- 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
- 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
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic 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
- A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Diabetes (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Endocrinology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Inorganic Chemistry (AREA)
- Immunology (AREA)
- Zoology (AREA)
- Gastroenterology & Hepatology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Obesity (AREA)
- Emergency Medicine (AREA)
- Hematology (AREA)
- Dermatology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
La presente invención se refiere al uso de solventes polares apróticos y un agente estabilizador de ionización para preparar formulaciones terapéuticas de liberación sostenida de almacenamiento estables al disover un agente terapéutico (ingrediente activo) en un sistema de solvente polar aprótico que entonces se puede administrar a pacientes que padecen de o están predispuestos a una variedad de condiciones físicas o trastornos, notablemente hipoglucemia. En ciertas modalidades, la invención se refiere a formulaciones que comprenden uno o más agentes terapéuticos, así como métodos para producir estas formulaciones, que comprenden al menos un agente terapéutico disuelto en un solvente polar aprótico tal como DMSO, que comprende al menos un excipiente estabilizador de ionización (adecuadamente, un ácido mineral) y al menos un modificador de liberación sostenida (adecuadamente, un compuesto de donación de cationes divalente tal como una sal de zinc y/o un polímero tal como un PLGA) en concentraciones suficientes para impartir estabilidad física y química al agente terapéutico y para producir una formulación que da por resultado una liberación sostenida del agente terapéutico en el torrente sanguíneo de un animal al que se le ha administrado la formulación. La invención también se refiere a métodos de producción de estas formulaciones terapéuticas de liberación sostenida de almacenamiento estable y a métodos de tratamiento, prevención y diagnóstico de ciertas condiciones y trastornos físicos, en particular hipoglucemia, mediante la administración de estas formulaciones terapéuticas de liberación sostenida estables en almacenamiento a un paciente.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US202063044973P | 2020-06-26 | 2020-06-26 | |
| PCT/US2021/039236 WO2021263197A1 (en) | 2020-06-26 | 2021-06-25 | Stable sustained release therapeutic compositions in aprotic polar solvents and methods of manufacturing the same |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| MX2022016265A true MX2022016265A (es) | 2023-02-09 |
Family
ID=77051133
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MX2022016265A MX2022016265A (es) | 2020-06-26 | 2021-06-25 | Composiciones terapeuticas de liberacion sostenida estable en solventes polares aproticos y metodos de preparacion de los mismos. |
Country Status (11)
| Country | Link |
|---|---|
| US (2) | US11964003B2 (es) |
| EP (1) | EP4171509A1 (es) |
| JP (1) | JP2023533129A (es) |
| KR (1) | KR20230026984A (es) |
| CN (1) | CN115916153A (es) |
| AU (1) | AU2021297529A1 (es) |
| BR (1) | BR112022017509A2 (es) |
| CA (1) | CA3174711A1 (es) |
| IL (1) | IL299337A (es) |
| MX (1) | MX2022016265A (es) |
| WO (1) | WO2021263197A1 (es) |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN115916153A (zh) * | 2020-06-26 | 2023-04-04 | Xeris药物公司 | 非质子极性溶剂中的稳定缓释治疗性组合物及其制备方法 |
| CN120152698A (zh) | 2022-10-19 | 2025-06-13 | Xeris药物公司 | 使用非质子极性溶剂的缓释可注射制剂 |
| KR20250111106A (ko) | 2022-10-19 | 2025-07-22 | 엑스에리스 파머수티클스, 인크. | 비양성자성 극성 용매에서 안정한 레보티록신 조성물 |
Family Cites Families (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4727041A (en) | 1986-04-16 | 1988-02-23 | Chaovanee Aroonsakul | Method of diagnosing Alzheimer's disease |
| US5065747A (en) | 1989-11-21 | 1991-11-19 | University Of South Florida | Method for improving the accuracy of diagnosis of growth hormone deficiency |
| US5656297A (en) * | 1992-03-12 | 1997-08-12 | Alkermes Controlled Therapeutics, Incorporated | Modulated release from biocompatible polymers |
| US6663899B2 (en) * | 1997-06-13 | 2003-12-16 | Genentech, Inc. | Controlled release microencapsulated NGF formulation |
| WO2003068805A2 (en) * | 2002-02-14 | 2003-08-21 | Bayer Pharmaceuticals Corporation | Formulation strategies in stabilizing peptides in organic solvents and in dried states |
| AU2003299795A1 (en) | 2002-12-20 | 2004-07-22 | Xeris Pharmaceuticals, Inc. | Intracutaneous injection |
| KR20070029276A (ko) * | 2004-06-29 | 2007-03-13 | 디오벡스, 인코포레이티드 | 인슐린으로 인한 저혈당증을 예방하고 조절하기 위한조성물 및 방법 |
| US7534763B2 (en) * | 2004-07-02 | 2009-05-19 | Bristol-Myers Squibb Company | Sustained release GLP-1 receptor modulators |
| KR101978527B1 (ko) | 2011-03-10 | 2019-09-03 | 엑스에리스 파머수티클스, 인크. | 펩티드 약물의 비경구 주입을 위한 안정한 제형 |
| US9649364B2 (en) * | 2015-09-25 | 2017-05-16 | Xeris Pharmaceuticals, Inc. | Methods for producing stable therapeutic formulations in aprotic polar solvents |
| US20190083578A1 (en) * | 2015-06-10 | 2019-03-21 | Xeris Pharmaceuticals, Inc. | Use of low dose glucagon |
| BR112020000447A2 (pt) | 2017-07-14 | 2020-07-21 | Xeris Pharmaceuticals, Inc. | métodos de tratamento de hiperinsulinismo congênito |
| CN115916153A (zh) * | 2020-06-26 | 2023-04-04 | Xeris药物公司 | 非质子极性溶剂中的稳定缓释治疗性组合物及其制备方法 |
-
2021
- 2021-06-25 CN CN202180039460.3A patent/CN115916153A/zh active Pending
- 2021-06-25 US US17/359,202 patent/US11964003B2/en active Active
- 2021-06-25 WO PCT/US2021/039236 patent/WO2021263197A1/en not_active Ceased
- 2021-06-25 KR KR1020227035088A patent/KR20230026984A/ko active Pending
- 2021-06-25 AU AU2021297529A patent/AU2021297529A1/en active Pending
- 2021-06-25 JP JP2022571780A patent/JP2023533129A/ja active Pending
- 2021-06-25 MX MX2022016265A patent/MX2022016265A/es unknown
- 2021-06-25 BR BR112022017509A patent/BR112022017509A2/pt unknown
- 2021-06-25 IL IL299337A patent/IL299337A/en unknown
- 2021-06-25 EP EP21746214.2A patent/EP4171509A1/en active Pending
- 2021-06-25 CA CA3174711A patent/CA3174711A1/en active Pending
-
2024
- 2024-03-26 US US18/617,015 patent/US20240238381A1/en active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| US11964003B2 (en) | 2024-04-23 |
| IL299337A (en) | 2023-02-01 |
| AU2021297529A1 (en) | 2022-09-22 |
| KR20230026984A (ko) | 2023-02-27 |
| WO2021263197A1 (en) | 2021-12-30 |
| US20240238381A1 (en) | 2024-07-18 |
| BR112022017509A2 (pt) | 2023-01-17 |
| CA3174711A1 (en) | 2021-12-30 |
| JP2023533129A (ja) | 2023-08-02 |
| US20210401945A1 (en) | 2021-12-30 |
| EP4171509A1 (en) | 2023-05-03 |
| CN115916153A (zh) | 2023-04-04 |
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