CA2938071A1 - Assisted particle size reduction process - Google Patents
Assisted particle size reduction process Download PDFInfo
- Publication number
- CA2938071A1 CA2938071A1 CA2938071A CA2938071A CA2938071A1 CA 2938071 A1 CA2938071 A1 CA 2938071A1 CA 2938071 A CA2938071 A CA 2938071A CA 2938071 A CA2938071 A CA 2938071A CA 2938071 A1 CA2938071 A1 CA 2938071A1
- Authority
- CA
- Canada
- Prior art keywords
- solvent
- apis
- process according
- particle size
- excipients
- 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.)
- Abandoned
Links
- 238000010951 particle size reduction Methods 0.000 title claims abstract description 20
- 238000000034 method Methods 0.000 title claims description 82
- 230000008569 process Effects 0.000 title claims description 78
- 239000002245 particle Substances 0.000 claims abstract description 132
- 239000008186 active pharmaceutical agent Substances 0.000 claims abstract description 99
- 239000002904 solvent Substances 0.000 claims abstract description 78
- 239000000546 pharmaceutical excipient Substances 0.000 claims abstract description 54
- 239000000725 suspension Substances 0.000 claims abstract description 50
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- 238000001016 Ostwald ripening Methods 0.000 claims description 14
- 238000001035 drying Methods 0.000 claims description 13
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- IMNFDUFMRHMDMM-UHFFFAOYSA-N N-Heptane Chemical compound CCCCCCC IMNFDUFMRHMDMM-UHFFFAOYSA-N 0.000 claims description 10
- 150000002148 esters Chemical class 0.000 claims description 9
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- 229920001577 copolymer Polymers 0.000 description 1
- 230000008878 coupling Effects 0.000 description 1
- 238000010168 coupling process Methods 0.000 description 1
- 238000005859 coupling reaction Methods 0.000 description 1
- 238000006731 degradation reaction Methods 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 230000018109 developmental process Effects 0.000 description 1
- 229940088679 drug related substance Drugs 0.000 description 1
- 229940112141 dry powder inhaler Drugs 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 229960001469 fluticasone furoate Drugs 0.000 description 1
- XTULMSXFIHGYFS-VLSRWLAYSA-N fluticasone furoate Chemical compound O([C@]1([C@@]2(C)C[C@H](O)[C@]3(F)[C@@]4(C)C=CC(=O)C=C4[C@@H](F)C[C@H]3[C@@H]2C[C@H]1C)C(=O)SCF)C(=O)C1=CC=CO1 XTULMSXFIHGYFS-VLSRWLAYSA-N 0.000 description 1
- 239000008103 glucose Substances 0.000 description 1
- 229960004078 indacaterol Drugs 0.000 description 1
- QZZUEBNBZAPZLX-QFIPXVFZSA-N indacaterol Chemical compound N1C(=O)C=CC2=C1C(O)=CC=C2[C@@H](O)CNC1CC(C=C(C(=C2)CC)CC)=C2C1 QZZUEBNBZAPZLX-QFIPXVFZSA-N 0.000 description 1
- 230000006698 induction Effects 0.000 description 1
- 229910010272 inorganic material Inorganic materials 0.000 description 1
- 239000011147 inorganic material Substances 0.000 description 1
- 229910052500 inorganic mineral Inorganic materials 0.000 description 1
- 238000010902 jet-milling Methods 0.000 description 1
- 239000008101 lactose Substances 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 239000000594 mannitol Substances 0.000 description 1
- 235000010355 mannitol Nutrition 0.000 description 1
- 230000007246 mechanism Effects 0.000 description 1
- 239000011707 mineral Substances 0.000 description 1
- 229960004123 mometasone furoate monohydrate Drugs 0.000 description 1
- 239000006199 nebulizer Substances 0.000 description 1
- 239000006186 oral dosage form Substances 0.000 description 1
- 230000003647 oxidation Effects 0.000 description 1
- 238000007254 oxidation reaction Methods 0.000 description 1
- 239000013500 performance material Substances 0.000 description 1
- 239000008194 pharmaceutical composition Substances 0.000 description 1
- 230000000704 physical effect Effects 0.000 description 1
- 231100000572 poisoning Toxicity 0.000 description 1
- 230000000607 poisoning effect Effects 0.000 description 1
- 230000002685 pulmonary effect Effects 0.000 description 1
- 150000003248 quinolines Chemical class 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 238000012552 review Methods 0.000 description 1
- CVHZOJJKTDOEJC-UHFFFAOYSA-N saccharin Chemical compound C1=CC=C2C(=O)NS(=O)(=O)C2=C1 CVHZOJJKTDOEJC-UHFFFAOYSA-N 0.000 description 1
- 235000019204 saccharin Nutrition 0.000 description 1
- 150000003839 salts Chemical class 0.000 description 1
- 239000002002 slurry Substances 0.000 description 1
- 230000007928 solubilization Effects 0.000 description 1
- 238000005063 solubilization Methods 0.000 description 1
- 230000006641 stabilisation Effects 0.000 description 1
- 238000011105 stabilization Methods 0.000 description 1
- 239000003381 stabilizer Substances 0.000 description 1
- 230000035882 stress Effects 0.000 description 1
- 238000003786 synthesis reaction Methods 0.000 description 1
- 230000008685 targeting Effects 0.000 description 1
- 229960000278 theophylline Drugs 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- MQLXPRBEAHBZTK-SEINRUQRSA-M tiotropium bromide hydrate Chemical compound O.[Br-].C[N+]1(C)[C@H]2C[C@@H](C[C@@H]1[C@H]1O[C@@H]21)OC(=O)C(O)(c1cccs1)c1cccs1 MQLXPRBEAHBZTK-SEINRUQRSA-M 0.000 description 1
- 230000009466 transformation Effects 0.000 description 1
- PEJHHXHHNGORMP-AVADPIKZSA-M umeclidinium bromide Chemical compound [Br-].C=1C=CC=CC=1C([C@@]12CC[N@@+](CCOCC=3C=CC=CC=3)(CC1)CC2)(O)C1=CC=CC=C1 PEJHHXHHNGORMP-AVADPIKZSA-M 0.000 description 1
- 229960004541 umeclidinium bromide Drugs 0.000 description 1
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
-
- 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
- A61K31/439—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 the ring forming part of a bridged ring system, e.g. quinuclidine
-
- 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
- A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
- A61K31/52—Purines, e.g. adenine
- A61K31/522—Purines, e.g. adenine having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
-
- 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
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
-
- 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
- A61K9/007—Pulmonary tract; Aromatherapy
- A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
- A61K9/0075—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
-
- 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
- A61K9/145—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 compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
Landscapes
- Health & Medical Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Life Sciences & Earth Sciences (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pulmonology (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Otolaryngology (AREA)
- Pain & Pain Management (AREA)
- Rheumatology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Thermistors And Varistors (AREA)
- Nitrogen Condensed Heterocyclic Rings (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PT107433 | 2014-01-28 | ||
| PT10743314A PT107433B (pt) | 2014-01-28 | 2014-01-28 | Processo de redução e controlo do tamanho de partícula |
| PCT/GB2015/050186 WO2015114320A1 (en) | 2014-01-28 | 2015-01-27 | Assisted particle size reduction process |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2938071A1 true CA2938071A1 (en) | 2015-08-06 |
Family
ID=52450514
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA2938071A Abandoned CA2938071A1 (en) | 2014-01-28 | 2015-01-27 | Assisted particle size reduction process |
Country Status (11)
| Country | Link |
|---|---|
| US (1) | US10328027B2 (enExample) |
| EP (1) | EP3096738B1 (enExample) |
| JP (1) | JP6499187B2 (enExample) |
| AU (1) | AU2015212618B2 (enExample) |
| CA (1) | CA2938071A1 (enExample) |
| DK (1) | DK3096738T3 (enExample) |
| ES (1) | ES2702643T3 (enExample) |
| HU (1) | HUE041329T2 (enExample) |
| IL (1) | IL246989A0 (enExample) |
| PT (1) | PT107433B (enExample) |
| WO (1) | WO2015114320A1 (enExample) |
Families Citing this family (26)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| IL152486A0 (en) | 2002-10-25 | 2003-05-29 | Meir Eini | Alcohol-free cosmetic and pharmaceutical foam carrier |
| US20060140984A1 (en) | 2002-10-25 | 2006-06-29 | Foamix Ltd. | Cosmetic and pharmaceutical foam |
| US10117812B2 (en) | 2002-10-25 | 2018-11-06 | Foamix Pharmaceuticals Ltd. | Foamable composition combining a polar solvent and a hydrophobic carrier |
| US9668972B2 (en) | 2002-10-25 | 2017-06-06 | Foamix Pharmaceuticals Ltd. | Nonsteroidal immunomodulating kit and composition and uses thereof |
| US9265725B2 (en) | 2002-10-25 | 2016-02-23 | Foamix Pharmaceuticals Ltd. | Dicarboxylic acid foamable vehicle and pharmaceutical compositions thereof |
| US7704518B2 (en) | 2003-08-04 | 2010-04-27 | Foamix, Ltd. | Foamable vehicle and pharmaceutical compositions thereof |
| US20080138296A1 (en) | 2002-10-25 | 2008-06-12 | Foamix Ltd. | Foam prepared from nanoemulsions and uses |
| US7700076B2 (en) | 2002-10-25 | 2010-04-20 | Foamix, Ltd. | Penetrating pharmaceutical foam |
| US20080260655A1 (en) | 2006-11-14 | 2008-10-23 | Dov Tamarkin | Substantially non-aqueous foamable petrolatum based pharmaceutical and cosmetic compositions and their uses |
| US8636982B2 (en) | 2007-08-07 | 2014-01-28 | Foamix Ltd. | Wax foamable vehicle and pharmaceutical compositions thereof |
| US9439857B2 (en) | 2007-11-30 | 2016-09-13 | Foamix Pharmaceuticals Ltd. | Foam containing benzoyl peroxide |
| WO2009090495A2 (en) | 2007-12-07 | 2009-07-23 | Foamix Ltd. | Oil and liquid silicone foamable carriers and formulations |
| US20120087872A1 (en) | 2009-04-28 | 2012-04-12 | Foamix Ltd. | Foamable Vehicles and Pharmaceutical Compositions Comprising Aprotic Polar Solvents and Uses Thereof |
| WO2011013009A2 (en) | 2009-07-29 | 2011-02-03 | Foamix Ltd. | Non surfactant hydro-alcoholic foamable compositions, breakable foams and their uses |
| WO2011013008A2 (en) | 2009-07-29 | 2011-02-03 | Foamix Ltd. | Non surface active agent non polymeric agent hydro-alcoholic foamable compositions, breakable foams and their uses |
| EP2482788B1 (en) | 2009-10-02 | 2022-12-14 | Journey Medical Corporation | Topical tetracycline compositions |
| US9849142B2 (en) | 2009-10-02 | 2017-12-26 | Foamix Pharmaceuticals Ltd. | Methods for accelerated return of skin integrity and for the treatment of impetigo |
| PT108368B (pt) | 2015-03-31 | 2018-11-05 | Hovione Farm S A | Produção contínua de partículas |
| PT109117B (pt) * | 2016-01-28 | 2019-02-01 | Hovione Farm Sa | Complexação de ingredientes ativos farmacêuticos |
| IL285928B2 (en) | 2016-05-06 | 2025-06-01 | Eagle Pharmaceuticals Inc | Fulvestrant formulations and methods of their use |
| US10398641B2 (en) | 2016-09-08 | 2019-09-03 | Foamix Pharmaceuticals Ltd. | Compositions and methods for treating rosacea and acne |
| CN110361307B (zh) * | 2019-08-15 | 2022-04-01 | 安徽工程大学 | 一种利用粒度分布特征值判断稻米新陈度的方法 |
| EP3868842B1 (en) | 2020-02-19 | 2023-06-07 | University of Limerick | Particle coating method |
| GB202002325D0 (en) | 2020-02-19 | 2020-04-01 | Univ Limerick | Particle coating method |
| WO2022170027A1 (en) * | 2021-02-04 | 2022-08-11 | Edenbridge Pharmaceuticals, LLC | Inhaled ivermectin |
| IL309073A (en) | 2021-06-03 | 2024-02-01 | Arcadia Medicine Inc | Enantiomeric entactogen compounds and methods of their use. |
Family Cites Families (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB0008411D0 (en) * | 2000-04-05 | 2000-05-24 | Vectura Ltd | Pharmaceutical preparations and their manufacture |
| GB0016040D0 (en) | 2000-06-29 | 2000-08-23 | Glaxo Group Ltd | Novel process for preparing crystalline particles |
| US6379459B1 (en) * | 2000-10-24 | 2002-04-30 | The United States Of America As Represented By The Secretary Of The Interior | Crystallization of powders having uniform particle sizes by Ostwald ripening at large levels of supersaturation |
| CN101453986A (zh) | 2006-03-14 | 2009-06-10 | 默克公司 | 通过微研磨和在微晶种上结晶生产结晶有机微粒组合物的方法和设备及其应用 |
| EP2077903A2 (en) * | 2006-10-03 | 2009-07-15 | Ranbaxy Laboratories, Ltd. | Process for the preparation of form i and form ii of ritonavir |
| EP2050437A1 (en) * | 2007-10-15 | 2009-04-22 | Laboratoires SMB | Improved pharmaceutical dry powder compositions for inhalation. |
| CA2707594C (en) | 2007-12-13 | 2015-08-18 | Novartis Ag | Process for preparing particulates of crystalline drug substance |
| PT105058B (pt) * | 2010-04-21 | 2013-04-17 | Hovione Farmaciencia S A | Processo para processamento de partículas de ingredientes activos farmacêuticos |
| PT106237B (pt) * | 2012-03-30 | 2015-03-19 | Hovione Farmaci Ncia S A | Produção de partículas substancialmente monodispersas utilizando moagem e separação por membranas |
-
2014
- 2014-01-28 PT PT10743314A patent/PT107433B/pt active IP Right Grant
-
2015
- 2015-01-27 AU AU2015212618A patent/AU2015212618B2/en not_active Ceased
- 2015-01-27 WO PCT/GB2015/050186 patent/WO2015114320A1/en not_active Ceased
- 2015-01-27 US US15/115,193 patent/US10328027B2/en not_active Expired - Fee Related
- 2015-01-27 HU HUE15702834A patent/HUE041329T2/hu unknown
- 2015-01-27 ES ES15702834T patent/ES2702643T3/es active Active
- 2015-01-27 JP JP2016549143A patent/JP6499187B2/ja not_active Expired - Fee Related
- 2015-01-27 CA CA2938071A patent/CA2938071A1/en not_active Abandoned
- 2015-01-27 EP EP15702834.1A patent/EP3096738B1/en not_active Not-in-force
- 2015-01-27 DK DK15702834.1T patent/DK3096738T3/en active
-
2016
- 2016-07-28 IL IL246989A patent/IL246989A0/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| JP2017504637A (ja) | 2017-02-09 |
| PT107433B (pt) | 2018-12-04 |
| AU2015212618A1 (en) | 2016-09-15 |
| PT107433A (pt) | 2015-07-28 |
| US20160346206A1 (en) | 2016-12-01 |
| AU2015212618B2 (en) | 2018-08-02 |
| HUE041329T2 (hu) | 2019-05-28 |
| IL246989A0 (en) | 2016-09-29 |
| ES2702643T3 (es) | 2019-03-04 |
| JP6499187B2 (ja) | 2019-04-10 |
| DK3096738T3 (en) | 2019-01-21 |
| EP3096738A1 (en) | 2016-11-30 |
| EP3096738B1 (en) | 2018-09-26 |
| WO2015114320A1 (en) | 2015-08-06 |
| US10328027B2 (en) | 2019-06-25 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request |
Effective date: 20180807 |
|
| FZDE | Discontinued |
Effective date: 20201217 |