DK3769753T3 - Fremgangsmåde til fremstilling af sterile oftalmiske vandige suspensioner af nanokrystaller af fluticasonpropionat-form A - Google Patents
Fremgangsmåde til fremstilling af sterile oftalmiske vandige suspensioner af nanokrystaller af fluticasonpropionat-form A Download PDFInfo
- Publication number
- DK3769753T3 DK3769753T3 DK20186965.8T DK20186965T DK3769753T3 DK 3769753 T3 DK3769753 T3 DK 3769753T3 DK 20186965 T DK20186965 T DK 20186965T DK 3769753 T3 DK3769753 T3 DK 3769753T3
- Authority
- DK
- Denmark
- Prior art keywords
- nanocrystals
- preparation
- aqueous suspensions
- fluticasone propionate
- ophthalmic aqueous
- Prior art date
Links
- 239000007900 aqueous suspension Substances 0.000 title 1
- WMWTYOKRWGGJOA-CENSZEJFSA-N fluticasone propionate Chemical group C1([C@@H](F)C2)=CC(=O)C=C[C@]1(C)[C@]1(F)[C@@H]2[C@@H]2C[C@@H](C)[C@@](C(=O)SCF)(OC(=O)CC)[C@@]2(C)C[C@@H]1O WMWTYOKRWGGJOA-CENSZEJFSA-N 0.000 title 1
- 239000002159 nanocrystal Substances 0.000 title 1
Classifications
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- 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
- A61K9/08—Solutions
-
- 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
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
- A61K31/567—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in position 17 alpha, e.g. mestranol, norethandrolone
-
- 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
- A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
- A61K31/568—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
- A61K31/569—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone substituted in position 17 alpha, e.g. ethisterone
-
- 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
- A61K47/08—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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
-
- 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
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/186—Quaternary ammonium compounds, e.g. benzalkonium chloride or cetrimide
-
- 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
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- 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
- A61K9/0048—Eye, e.g. artificial tears
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
- A61P27/04—Artificial tears; Irrigation solutions
-
- 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]
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B82—NANOTECHNOLOGY
- B82Y—SPECIFIC USES OR APPLICATIONS OF NANOSTRUCTURES; MEASUREMENT OR ANALYSIS OF NANOSTRUCTURES; MANUFACTURE OR TREATMENT OF NANOSTRUCTURES
- B82Y5/00—Nanobiotechnology or nanomedicine, e.g. protein engineering or drug delivery
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07B—GENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
- C07B2200/00—Indexing scheme relating to specific properties of organic compounds
- C07B2200/13—Crystalline forms, e.g. polymorphs
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07J—STEROIDS
- C07J31/00—Normal steroids containing one or more sulfur atoms not belonging to a hetero ring
- C07J31/006—Normal steroids containing one or more sulfur atoms not belonging to a hetero ring not covered by C07J31/003
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Ophthalmology & Optometry (AREA)
- Inorganic Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Dispersion Chemistry (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Nanotechnology (AREA)
- Rheumatology (AREA)
- Biophysics (AREA)
- Biotechnology (AREA)
- General Engineering & Computer Science (AREA)
- Medical Informatics (AREA)
- Crystallography & Structural Chemistry (AREA)
- Pain & Pain Management (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Steroid Compounds (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201962877599P | 2019-07-23 | 2019-07-23 | |
| US201962942551P | 2019-12-02 | 2019-12-02 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK3769753T3 true DK3769753T3 (da) | 2022-01-31 |
Family
ID=71738074
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK20186965.8T DK3769753T3 (da) | 2019-07-23 | 2020-07-21 | Fremgangsmåde til fremstilling af sterile oftalmiske vandige suspensioner af nanokrystaller af fluticasonpropionat-form A |
Country Status (23)
| Country | Link |
|---|---|
| US (3) | US20220241296A1 (enExample) |
| EP (1) | EP3769753B1 (enExample) |
| JP (2) | JP7021301B2 (enExample) |
| KR (1) | KR20220038443A (enExample) |
| CN (2) | CN111821261B (enExample) |
| AU (1) | AU2020317084A1 (enExample) |
| CA (1) | CA3145055A1 (enExample) |
| CY (1) | CY1124930T1 (enExample) |
| DK (1) | DK3769753T3 (enExample) |
| ES (1) | ES2905793T3 (enExample) |
| HR (1) | HRP20220165T1 (enExample) |
| HU (1) | HUE057416T2 (enExample) |
| LT (1) | LT3769753T (enExample) |
| MD (1) | MD3769753T2 (enExample) |
| MX (1) | MX420447B (enExample) |
| PH (1) | PH12022550003A1 (enExample) |
| PL (1) | PL3769753T3 (enExample) |
| PT (1) | PT3769753T (enExample) |
| RS (1) | RS62932B1 (enExample) |
| SI (1) | SI3769753T1 (enExample) |
| SM (1) | SMT202200082T1 (enExample) |
| TW (1) | TWI864053B (enExample) |
| WO (1) | WO2021014348A1 (enExample) |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| PL3769753T3 (pl) * | 2019-07-23 | 2022-04-04 | Nicox Ophthalmics, Inc. | Sposób wytwarzania sterylnych oftalmicznych zawiesin wodnych nanokryształów postaci A propionianu flutykazonu |
| CN115554238A (zh) * | 2022-10-25 | 2023-01-03 | 苏州欧康维视生物科技有限公司 | 眼用混悬液及其制备方法 |
| CN115887372A (zh) * | 2022-10-25 | 2023-04-04 | 苏州欧康维视生物科技有限公司 | 丙酸氟替卡松混悬液及其制备方法 |
Family Cites Families (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CA2132826C (en) * | 1992-05-06 | 1999-01-05 | Masood Chowhan | Use of borate-polyol complexes in ophthalmic compositions |
| JP3450805B2 (ja) * | 2000-08-08 | 2003-09-29 | わかもと製薬株式会社 | 水性医薬組成物 |
| US6900184B2 (en) * | 2003-04-14 | 2005-05-31 | Wyeth Holdings Corporation | Compositions containing pipercillin and tazobactam useful for injection |
| US20060229219A1 (en) | 2005-04-11 | 2006-10-12 | Advanced Medical Optics, Inc. | Borate-polyol mixtures as a buffering system |
| US8010032B2 (en) * | 2005-05-23 | 2011-08-30 | Xerox Corporation | Fuser member comprising deflocculated material |
| US20110105450A1 (en) | 2009-06-05 | 2011-05-05 | Aciex Therapeutics, Inc. | Ophthalmic formulations of fluticasone and methods of use |
| TWI489997B (zh) | 2009-06-19 | 2015-07-01 | Alcon Res Ltd | 含有硼酸－多元醇錯合物之水性藥學組成物 |
| WO2013025696A1 (en) | 2011-08-15 | 2013-02-21 | Teva Pharmaceutical Industries Ltd. | Ophthalmic formulations and processes for their preparation |
| EP3517541B1 (en) | 2012-05-08 | 2020-07-15 | Nicox Ophthalmics, Inc. | Polymorphic form of fluticasone propionate |
| CN104869980A (zh) * | 2012-12-17 | 2015-08-26 | 葛兰素集团有限公司 | 用于治疗炎症性病症和/或变应性病症的左卡巴斯汀和糠酸氟替卡松的组合 |
| TWI773641B (zh) * | 2015-05-08 | 2022-08-11 | 日商活效製藥股份有限公司 | 含有糖皮質類固醇（ｇｌｕｃｏｃｏｒｔｉｃｏｉｄｓ）之奈米微粒子之水性懸浮液劑 |
| PL3769753T3 (pl) * | 2019-07-23 | 2022-04-04 | Nicox Ophthalmics, Inc. | Sposób wytwarzania sterylnych oftalmicznych zawiesin wodnych nanokryształów postaci A propionianu flutykazonu |
-
2020
- 2020-07-21 PL PL20186965T patent/PL3769753T3/pl unknown
- 2020-07-21 US US17/629,267 patent/US20220241296A1/en not_active Abandoned
- 2020-07-21 KR KR1020227006020A patent/KR20220038443A/ko active Pending
- 2020-07-21 MX MX2022000928A patent/MX420447B/es unknown
- 2020-07-21 ES ES20186965T patent/ES2905793T3/es active Active
- 2020-07-21 MD MDE20210297T patent/MD3769753T2/ro unknown
- 2020-07-21 EP EP20186965.8A patent/EP3769753B1/en active Active
- 2020-07-21 US US16/934,807 patent/US11406596B2/en active Active
- 2020-07-21 HR HRP20220165TT patent/HRP20220165T1/hr unknown
- 2020-07-21 CN CN202010707466.0A patent/CN111821261B/zh active Active
- 2020-07-21 JP JP2020124238A patent/JP7021301B2/ja active Active
- 2020-07-21 HU HUE20186965A patent/HUE057416T2/hu unknown
- 2020-07-21 CN CN202210807241.1A patent/CN115120557B/zh active Active
- 2020-07-21 PH PH1/2022/550003A patent/PH12022550003A1/en unknown
- 2020-07-21 CA CA3145055A patent/CA3145055A1/en active Pending
- 2020-07-21 AU AU2020317084A patent/AU2020317084A1/en not_active Abandoned
- 2020-07-21 RS RS20220142A patent/RS62932B1/sr unknown
- 2020-07-21 LT LTEP20186965.8T patent/LT3769753T/lt unknown
- 2020-07-21 SI SI202030032T patent/SI3769753T1/sl unknown
- 2020-07-21 PT PT201869658T patent/PT3769753T/pt unknown
- 2020-07-21 SM SM20220082T patent/SMT202200082T1/it unknown
- 2020-07-21 TW TW109124497A patent/TWI864053B/zh active
- 2020-07-21 WO PCT/IB2020/056832 patent/WO2021014348A1/en not_active Ceased
- 2020-07-21 DK DK20186965.8T patent/DK3769753T3/da active
-
2022
- 2022-01-27 CY CY20221100069T patent/CY1124930T1/el unknown
- 2022-02-03 JP JP2022015508A patent/JP7494230B2/ja active Active
- 2022-06-27 US US17/850,515 patent/US20220323352A1/en active Pending
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