EP3893878A4 - AMORPHOUS SOLID DISPERSIONS - Google Patents
AMORPHOUS SOLID DISPERSIONS Download PDFInfo
- Publication number
- EP3893878A4 EP3893878A4 EP19897052.7A EP19897052A EP3893878A4 EP 3893878 A4 EP3893878 A4 EP 3893878A4 EP 19897052 A EP19897052 A EP 19897052A EP 3893878 A4 EP3893878 A4 EP 3893878A4
- Authority
- EP
- European Patent Office
- Prior art keywords
- amorphous solid
- solid dispersions
- dispersions
- amorphous
- solid
- 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
Links
Classifications
-
- 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
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
-
- 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
- A61K31/4985—Pyrazines or piperazines ortho- or peri-condensed with heterocyclic ring systems
-
- 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
- A61K9/14—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
-
- 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
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
-
- 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
-
- 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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D471/00—Heterocyclic compounds containing nitrogen atoms as the only ring hetero atoms in the condensed system, at least one ring being a six-membered ring with one nitrogen atom, not provided for by groups C07D451/00 - C07D463/00
- C07D471/12—Heterocyclic compounds containing nitrogen atoms as the only ring hetero atoms in the condensed system, at least one ring being a six-membered ring with one nitrogen atom, not provided for by groups C07D451/00 - C07D463/00 in which the condensed system contains three hetero rings
- C07D471/16—Peri-condensed systems
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Organic Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Epidemiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Diabetes (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Obesity (AREA)
- Hematology (AREA)
- Endocrinology (AREA)
- Emergency Medicine (AREA)
- Inorganic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Nitrogen Condensed Heterocyclic Rings (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201862779930P | 2018-12-14 | 2018-12-14 | |
| PCT/US2019/066247 WO2020123952A1 (en) | 2018-12-14 | 2019-12-13 | Amorphous solid dispersions |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| EP3893878A1 EP3893878A1 (en) | 2021-10-20 |
| EP3893878A4 true EP3893878A4 (en) | 2022-08-17 |
Family
ID=71077112
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EP19897052.7A Pending EP3893878A4 (en) | 2018-12-14 | 2019-12-13 | AMORPHOUS SOLID DISPERSIONS |
Country Status (9)
| Country | Link |
|---|---|
| EP (1) | EP3893878A4 (https=) |
| JP (1) | JP7523440B2 (https=) |
| KR (1) | KR20210103501A (https=) |
| CN (1) | CN113473988A (https=) |
| AU (1) | AU2019398451B2 (https=) |
| CA (1) | CA3123085A1 (https=) |
| IL (1) | IL283927A (https=) |
| MX (1) | MX2021006886A (https=) |
| WO (1) | WO2020123952A1 (https=) |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112584837A (zh) * | 2018-08-31 | 2021-03-30 | 细胞内治疗公司 | 新方法 |
| CN115671057A (zh) | 2022-10-19 | 2023-02-03 | 四川迈可隆生物科技有限公司 | 一种卢美哌隆药物组合物、长效微球缓释制剂及其制备方法 |
| CN118566395B (zh) * | 2024-08-02 | 2024-10-25 | 则正(济南)生物科技有限公司 | 测定甲苯磺酸卢美哌隆口崩片中杂质含量的方法、应用和系统 |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2018071233A1 (en) * | 2016-10-12 | 2018-04-19 | Intra-Cellular Therapies, Inc. | Amorphous solid dispersions |
| WO2018189646A1 (en) * | 2017-04-10 | 2018-10-18 | Dr. Reddy's Laboratories Limited | AMORPHOUS FORM AND SOLID DISPERSIONS OF LUMATEPERONE p-TOSYLATE |
| WO2020047407A1 (en) * | 2018-08-31 | 2020-03-05 | Intra-Cellular Therapies, Inc. | Novel methods |
Family Cites Families (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP4001281A1 (en) * | 2016-08-09 | 2022-05-25 | Teva Pharmaceuticals International GmbH | Solid state forms of lumateperone ditosylate salt and preparation thereof |
| US11655251B2 (en) * | 2017-11-27 | 2023-05-23 | Egis Gyogyszergyar Zrt. | Method for the production of lumateperone and its salts |
-
2019
- 2019-12-13 MX MX2021006886A patent/MX2021006886A/es unknown
- 2019-12-13 CN CN201980092118.2A patent/CN113473988A/zh active Pending
- 2019-12-13 JP JP2021533470A patent/JP7523440B2/ja active Active
- 2019-12-13 AU AU2019398451A patent/AU2019398451B2/en active Active
- 2019-12-13 KR KR1020217021918A patent/KR20210103501A/ko active Pending
- 2019-12-13 EP EP19897052.7A patent/EP3893878A4/en active Pending
- 2019-12-13 CA CA3123085A patent/CA3123085A1/en active Pending
- 2019-12-13 WO PCT/US2019/066247 patent/WO2020123952A1/en not_active Ceased
-
2021
- 2021-06-13 IL IL283927A patent/IL283927A/en unknown
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2018071233A1 (en) * | 2016-10-12 | 2018-04-19 | Intra-Cellular Therapies, Inc. | Amorphous solid dispersions |
| WO2018189646A1 (en) * | 2017-04-10 | 2018-10-18 | Dr. Reddy's Laboratories Limited | AMORPHOUS FORM AND SOLID DISPERSIONS OF LUMATEPERONE p-TOSYLATE |
| WO2020047407A1 (en) * | 2018-08-31 | 2020-03-05 | Intra-Cellular Therapies, Inc. | Novel methods |
Non-Patent Citations (1)
| Title |
|---|
| See also references of WO2020123952A1 * |
Also Published As
| Publication number | Publication date |
|---|---|
| EP3893878A1 (en) | 2021-10-20 |
| IL283927A (en) | 2021-07-29 |
| JP7523440B2 (ja) | 2024-07-26 |
| JP2022512239A (ja) | 2022-02-02 |
| AU2019398451B2 (en) | 2024-12-05 |
| MX2021006886A (es) | 2021-09-14 |
| CA3123085A1 (en) | 2020-06-18 |
| KR20210103501A (ko) | 2021-08-23 |
| WO2020123952A1 (en) | 2020-06-18 |
| AU2019398451A1 (en) | 2021-07-15 |
| CN113473988A (zh) | 2021-10-01 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| STAA | Information on the status of an ep patent application or granted ep patent |
Free format text: STATUS: THE INTERNATIONAL PUBLICATION HAS BEEN MADE |
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| PUAI | Public reference made under article 153(3) epc to a published international application that has entered the european phase |
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| A4 | Supplementary search report drawn up and despatched |
Effective date: 20220715 |
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| RIC1 | Information provided on ipc code assigned before grant |
Ipc: A61P 25/00 20060101ALI20220711BHEP Ipc: A61P 1/00 20060101ALI20220711BHEP Ipc: C07D 471/16 20060101ALI20220711BHEP Ipc: A61K 31/4985 20060101ALI20220711BHEP Ipc: A61K 9/48 20060101ALI20220711BHEP Ipc: A61K 9/20 20060101ALI20220711BHEP Ipc: A61K 31/495 20060101ALI20220711BHEP Ipc: A61K 9/14 20060101AFI20220711BHEP |
|
| P01 | Opt-out of the competence of the unified patent court (upc) registered |
Effective date: 20230517 |
|
| RAP3 | Party data changed (applicant data changed or rights of an application transferred) |
Owner name: INTRA-CELLULAR THERAPIES, INC. |
|
| STAA | Information on the status of an ep patent application or granted ep patent |
Free format text: STATUS: EXAMINATION IS IN PROGRESS |
|
| 17Q | First examination report despatched |
Effective date: 20260320 |