AU2021212258B2 - Amorphous nilotinib microparticles and uses thereof - Google Patents
Amorphous nilotinib microparticles and uses thereofInfo
- Publication number
- AU2021212258B2 AU2021212258B2 AU2021212258A AU2021212258A AU2021212258B2 AU 2021212258 B2 AU2021212258 B2 AU 2021212258B2 AU 2021212258 A AU2021212258 A AU 2021212258A AU 2021212258 A AU2021212258 A AU 2021212258A AU 2021212258 B2 AU2021212258 B2 AU 2021212258B2
- Authority
- AU
- Australia
- Prior art keywords
- nilotinib
- asd
- pharmaceutical composition
- fasted
- administration
- 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.)
- Active
Links
Classifications
-
- 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
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/506—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
-
- 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
- A61K47/30—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
- A61K47/38—Cellulose; Derivatives thereof
-
- 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
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
-
- 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
- A61K9/10—Dispersions; Emulsions
-
- 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
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
-
- 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
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
- A61P35/02—Antineoplastic agents specific for leukemia
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Inorganic Chemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Dispersion Chemistry (AREA)
- Oncology (AREA)
- Hematology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Dental Preparations (AREA)
- Paints Or Removers (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US202062968749P | 2020-01-31 | 2020-01-31 | |
| US62/968,749 | 2020-01-31 | ||
| PCT/US2021/015864 WO2021155254A1 (en) | 2020-01-31 | 2021-01-29 | Amorphous nilotinib microparticles and uses thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| AU2021212258A1 AU2021212258A1 (en) | 2022-09-29 |
| AU2021212258B2 true AU2021212258B2 (en) | 2026-03-05 |
Family
ID=74759481
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| AU2021212258A Active AU2021212258B2 (en) | 2020-01-31 | 2021-01-29 | Amorphous nilotinib microparticles and uses thereof |
Country Status (7)
| Country | Link |
|---|---|
| US (6) | US11389450B2 (enExample) |
| EP (1) | EP4096791A1 (enExample) |
| JP (2) | JP2023513045A (enExample) |
| AU (1) | AU2021212258B2 (enExample) |
| CA (1) | CA3168680A1 (enExample) |
| IL (1) | IL295007A (enExample) |
| WO (1) | WO2021155254A1 (enExample) |
Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP4096791A1 (en) | 2020-01-31 | 2022-12-07 | Nanocopoeia LLC | Amorphous nilotinib microparticles and uses thereof |
| CN112294971B (zh) * | 2020-02-20 | 2022-02-01 | 深圳市泰力生物医药有限公司 | 具有改进的溶解性的尼洛替尼组合物 |
| MX2023003556A (es) | 2020-09-29 | 2023-06-13 | Shenzhen Pharmacin Co Ltd | Composiciones farmaceuticas. |
| CA3202761A1 (en) | 2020-11-25 | 2022-06-02 | Nanocopoeia, Llc | Amorphous cabozantinib particles and uses thereof |
| WO2025099249A1 (en) * | 2023-11-08 | 2025-05-15 | Xspray Pharma Ab | Pharmaceutical compositions comprising nilotinib |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2013105894A1 (en) * | 2012-01-13 | 2013-07-18 | Xspray Microparticles Ab | A method for producing stable, amorphous hybrid nanoparticles comprising at least one protein kinase inhibitor and at least one polymeric stabilizing and matrix- forming component. |
| WO2016016665A1 (en) * | 2014-08-01 | 2016-02-04 | Hovione International Ltd | A method of preparing amorphous solid dispersion in submicron range by co-precipitation |
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| CN113573712A (zh) * | 2019-02-18 | 2021-10-29 | 斯莱班克制药有限责任公司 | 尼洛替尼的药物组合物 |
| EP4096791A1 (en) | 2020-01-31 | 2022-12-07 | Nanocopoeia LLC | Amorphous nilotinib microparticles and uses thereof |
| EP4101015A4 (en) * | 2020-02-06 | 2024-10-30 | Briggs & Stratton (Shanghai) International Trading Co., Ltd. | BATTERY PACK FOR BATTERY-OPERATED DEVICE |
| IL297776A (en) | 2020-04-30 | 2022-12-01 | Nanocopoeia Llc | Orally disintegrating tablets containing an amorphous solid dispersion of nalotinib |
| US20220378788A1 (en) | 2020-04-30 | 2022-12-01 | Nanocopoeia, Llc | Orally disintegrating tablet comprising amorphous solid dispersion of nilotinib and in vitro characterization thereof |
-
2021
- 2021-01-29 EP EP21708444.1A patent/EP4096791A1/en active Pending
- 2021-01-29 IL IL295007A patent/IL295007A/en unknown
- 2021-01-29 AU AU2021212258A patent/AU2021212258B2/en active Active
- 2021-01-29 WO PCT/US2021/015864 patent/WO2021155254A1/en not_active Ceased
- 2021-01-29 CA CA3168680A patent/CA3168680A1/en active Pending
- 2021-01-29 JP JP2022546499A patent/JP2023513045A/ja active Pending
- 2021-04-23 US US17/238,869 patent/US11389450B2/en active Active
-
2022
- 2022-07-18 US US17/866,939 patent/US12029740B2/en active Active
- 2022-12-27 US US18/089,338 patent/US12016861B2/en active Active
- 2022-12-29 US US18/090,582 patent/US11998548B2/en active Active
-
2023
- 2023-01-06 US US18/094,050 patent/US12053471B2/en active Active
-
2024
- 2024-07-31 US US18/791,209 patent/US20250032491A1/en active Pending
-
2025
- 2025-12-04 JP JP2025232279A patent/JP2026053379A/ja active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2013105894A1 (en) * | 2012-01-13 | 2013-07-18 | Xspray Microparticles Ab | A method for producing stable, amorphous hybrid nanoparticles comprising at least one protein kinase inhibitor and at least one polymeric stabilizing and matrix- forming component. |
| WO2016016665A1 (en) * | 2014-08-01 | 2016-02-04 | Hovione International Ltd | A method of preparing amorphous solid dispersion in submicron range by co-precipitation |
Also Published As
| Publication number | Publication date |
|---|---|
| US11998548B2 (en) | 2024-06-04 |
| US11389450B2 (en) | 2022-07-19 |
| US12016861B2 (en) | 2024-06-25 |
| US20230181585A1 (en) | 2023-06-15 |
| US20230172931A1 (en) | 2023-06-08 |
| JP2026053379A (ja) | 2026-03-25 |
| IL295007A (en) | 2022-09-01 |
| JP2023513045A (ja) | 2023-03-30 |
| US20210267975A1 (en) | 2021-09-02 |
| US12029740B2 (en) | 2024-07-09 |
| EP4096791A1 (en) | 2022-12-07 |
| CA3168680A1 (en) | 2021-08-05 |
| US12053471B2 (en) | 2024-08-06 |
| AU2021212258A1 (en) | 2022-09-29 |
| US20250032491A1 (en) | 2025-01-30 |
| WO2021155254A1 (en) | 2021-08-05 |
| US20230158026A1 (en) | 2023-05-25 |
| US20220362246A1 (en) | 2022-11-17 |
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