EP4378454A1 - Composition pharmaceutique solide comprenant de l'apixaban et de la beta-lactoglobuline et procédé de préparation de la composition - Google Patents
Composition pharmaceutique solide comprenant de l'apixaban et de la beta-lactoglobuline et procédé de préparation de la composition Download PDFInfo
- Publication number
- EP4378454A1 EP4378454A1 EP22211107.2A EP22211107A EP4378454A1 EP 4378454 A1 EP4378454 A1 EP 4378454A1 EP 22211107 A EP22211107 A EP 22211107A EP 4378454 A1 EP4378454 A1 EP 4378454A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- apixaban
- lactoglobulin
- beta
- pharmaceutical composition
- solid pharmaceutical
- 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.)
- Pending
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- 229960003886 apixaban Drugs 0.000 title claims abstract description 88
- 108010060630 Lactoglobulins Proteins 0.000 title claims abstract description 76
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Images
Classifications
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- 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
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1658—Proteins, e.g. albumin, gelatin
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- 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
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/445—Non condensed piperidines, e.g. piperocaine
- A61K31/4523—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
- A61K31/4545—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a six-membered ring with nitrogen as a ring hetero atom, e.g. pipamperone, anabasine
-
- 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
- A61K38/1703—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates
- A61K38/1709—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from mammals
- A61K38/1722—Plasma globulins, lactoglobulins
-
- 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
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1682—Processes
- A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2063—Proteins, e.g. gelatin
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Medicinal Chemistry (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Marine Sciences & Fisheries (AREA)
- Zoology (AREA)
- Gastroenterology & Hepatology (AREA)
- Immunology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Medicinal Preparation (AREA)
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP22211107.2A EP4378454A1 (fr) | 2022-12-02 | 2022-12-02 | Composition pharmaceutique solide comprenant de l'apixaban et de la beta-lactoglobuline et procédé de préparation de la composition |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP22211107.2A EP4378454A1 (fr) | 2022-12-02 | 2022-12-02 | Composition pharmaceutique solide comprenant de l'apixaban et de la beta-lactoglobuline et procédé de préparation de la composition |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| EP4378454A1 true EP4378454A1 (fr) | 2024-06-05 |
Family
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EP22211107.2A Pending EP4378454A1 (fr) | 2022-12-02 | 2022-12-02 | Composition pharmaceutique solide comprenant de l'apixaban et de la beta-lactoglobuline et procédé de préparation de la composition |
Country Status (1)
| Country | Link |
|---|---|
| EP (1) | EP4378454A1 (fr) |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20150018386A1 (en) | 2012-03-06 | 2015-01-15 | Cadila Healthcare Limited | Amorphous form of apixaban, process of preparation and compositions thereof |
| US9326945B2 (en) | 2010-02-25 | 2016-05-03 | Bristol-Myers Squibb Company | Apixaban formulations |
| EP3243505A1 (fr) * | 2016-05-13 | 2017-11-15 | Zaklady Farmaceutyczne Polpharma SA | Composition pharmaceutique comprenant de l'apixaban amorphe |
| WO2021110983A1 (fr) * | 2019-12-05 | 2021-06-10 | Zerion Aps | Formes co-amorphes de bêta-lactoglobuline et d'une substance médicamenteuse |
-
2022
- 2022-12-02 EP EP22211107.2A patent/EP4378454A1/fr active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US9326945B2 (en) | 2010-02-25 | 2016-05-03 | Bristol-Myers Squibb Company | Apixaban formulations |
| US20150018386A1 (en) | 2012-03-06 | 2015-01-15 | Cadila Healthcare Limited | Amorphous form of apixaban, process of preparation and compositions thereof |
| EP3243505A1 (fr) * | 2016-05-13 | 2017-11-15 | Zaklady Farmaceutyczne Polpharma SA | Composition pharmaceutique comprenant de l'apixaban amorphe |
| WO2021110983A1 (fr) * | 2019-12-05 | 2021-06-10 | Zerion Aps | Formes co-amorphes de bêta-lactoglobuline et d'une substance médicamenteuse |
Non-Patent Citations (1)
| Title |
|---|
| BHUJBAL SONAL V. ET AL: "Pharmaceutical amorphous solid dispersion: A review of manufacturing strategies", ACTA PHARMACEUTICA SINICA B, vol. 11, no. 8, 1 August 2021 (2021-08-01), pages 2505 - 2536, XP055881096, ISSN: 2211-3835, DOI: 10.1016/j.apsb.2021.05.014 * |
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