AR110269A1 - Preparación de nanopartículas de ciclodextrina para la administración de fármacos oftálmicos - Google Patents
Preparación de nanopartículas de ciclodextrina para la administración de fármacos oftálmicosInfo
- Publication number
- AR110269A1 AR110269A1 ARP170103327A ARP170103327A AR110269A1 AR 110269 A1 AR110269 A1 AR 110269A1 AR P170103327 A ARP170103327 A AR P170103327A AR P170103327 A ARP170103327 A AR P170103327A AR 110269 A1 AR110269 A1 AR 110269A1
- Authority
- AR
- Argentina
- Prior art keywords
- cyclodextrin
- ophthalmic
- active agent
- complex
- microsuspension
- Prior art date
Links
- 229920000858 Cyclodextrin Polymers 0.000 title abstract 7
- HFHDHCJBZVLPGP-UHFFFAOYSA-N schardinger α-dextrin Chemical compound O1C(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(O)C2O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC2C(O)C(O)C1OC2CO HFHDHCJBZVLPGP-UHFFFAOYSA-N 0.000 title abstract 7
- 239000002105 nanoparticle Substances 0.000 title 1
- 229940023490 ophthalmic product Drugs 0.000 title 1
- 239000000203 mixture Substances 0.000 abstract 9
- 239000013543 active substance Substances 0.000 abstract 6
- 239000008135 aqueous vehicle Substances 0.000 abstract 3
- 239000000725 suspension Substances 0.000 abstract 3
- 239000007857 degradation product Substances 0.000 abstract 2
- 238000000034 method Methods 0.000 abstract 2
- RVGRUAULSDPKGF-UHFFFAOYSA-N Poloxamer Chemical group C1CO1.CC1CO1 RVGRUAULSDPKGF-UHFFFAOYSA-N 0.000 abstract 1
- 239000006227 byproduct Substances 0.000 abstract 1
- 238000001816 cooling Methods 0.000 abstract 1
- 239000003814 drug Substances 0.000 abstract 1
- 229940079593 drug Drugs 0.000 abstract 1
- 229940012356 eye drops Drugs 0.000 abstract 1
- GDSRMADSINPKSL-HSEONFRVSA-N gamma-cyclodextrin Chemical compound OC[C@H]([C@H]([C@@H]([C@H]1O)O)O[C@H]2O[C@@H]([C@@H](O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O3)[C@H](O)[C@H]2O)CO)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@@H]3O[C@@H]1CO GDSRMADSINPKSL-HSEONFRVSA-N 0.000 abstract 1
- 238000010438 heat treatment Methods 0.000 abstract 1
- 238000004519 manufacturing process Methods 0.000 abstract 1
- 229960000502 poloxamer Drugs 0.000 abstract 1
- 229920001983 poloxamer Polymers 0.000 abstract 1
- 239000003381 stabilizer Substances 0.000 abstract 1
- 239000003981 vehicle Substances 0.000 abstract 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
- A61K9/0012—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
- 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
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/4164—1,3-Diazoles
- A61K31/4184—1,3-Diazoles condensed with carbocyclic rings, e.g. benzimidazoles
-
- 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
- A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
- A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
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- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
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- 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
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- A—HUMAN NECESSITIES
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- 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
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- 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
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- 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
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- 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
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- A—HUMAN NECESSITIES
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- 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
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- 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
- A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
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- 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
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- 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
- A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/69—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
- A61K47/6949—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes
- A61K47/6951—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes using cyclodextrin
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- A—HUMAN NECESSITIES
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- 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
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- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/51—Nanocapsules; Nanoparticles
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- 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
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- 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
- A61K47/40—Cyclodextrins; Derivatives thereof
Abstract
Composiciones oftálmicas y a métodos de elaboración de las composiciones. Las composiciones incluyen un complejo de fármaco agente activo / ciclodextrina sustancialmente disuelto en un vehículo de gotas oftálmicas acuosas. La composición oftálmica está generalmente en forma de microsuspensión que incluye un complejo de agente activo que tiene un diámetro de menos de aproximadamente 100 mm. Reivindicación 1: Una composición oftálmica que comprende: un complejo con un diámetro de menos de aproximadamente 100 mm, caracterizado porque el complejo comprende un agente activo y al menos una ciclodextrina disuelta en un vehículo acuoso, y caracterizada porque un subproducto o producto de degradación se mantiene por debajo de 0,5% durante su fabricación y almacenamiento durante al menos aproximadamente 2 años cuando se almacena a 25ºC. Reivindicación 2: La composición oftálmica según la reivindicación 1, caracterizada porque la composición es una microsuspensión o gotas oftálmicas. Reivindicación 6: Una composición oftálmica según cualquiera de las reivindicaciones precedentes, caracterizada porque la ciclodextrina es g-ciclodextrina. Reivindicación 17: Una composición oftálmica según la reivindicación 15 ó 16, caracterizada porque el agente estabilizante polimérico es un poloxámero. Reivindicación 19: Un método para preparar una microsuspensión oftálmica, que comprende los pasos de: a) suspender un agente activo y al menos una ciclodextrina en un vehículo acuoso para formar una suspensión de aspecto lechoso; b) calentar la suspensión hasta que el agente activo y la ciclodextrina se disuelvan en el vehículo acuoso, donde la suspensión se calienta durante un tiempo suficiente a una temperatura suficiente para limitar sustancialmente la generación de un producto de degradación y proporcionar una solución sustancialmente clara; y c) enfriar la solución clara resultante a una velocidad suficiente para producir una microsuspensión que comprende un complejo de agente activo / ciclodextrina que tiene un diámetro de menos de aproximadamente 100 mm.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201662427737P | 2016-11-29 | 2016-11-29 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| AR110269A1 true AR110269A1 (es) | 2019-03-13 |
Family
ID=61656066
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ARP170103328A AR110270A1 (es) | 2016-11-29 | 2017-11-29 | Preparación de complejos sólidos de ciclodextrina para la administración de ingredientes farmacéuticos activos oftálmicos |
| ARP170103327A AR110269A1 (es) | 2016-11-29 | 2017-11-29 | Preparación de nanopartículas de ciclodextrina para la administración de fármacos oftálmicos |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ARP170103328A AR110270A1 (es) | 2016-11-29 | 2017-11-29 | Preparación de complejos sólidos de ciclodextrina para la administración de ingredientes farmacéuticos activos oftálmicos |
Country Status (31)
| Country | Link |
|---|---|
| US (6) | US20190343846A1 (es) |
| EP (2) | EP3548091B1 (es) |
| JP (2) | JP7138103B2 (es) |
| KR (3) | KR20240036731A (es) |
| CN (2) | CN110177576B (es) |
| AR (2) | AR110270A1 (es) |
| AU (1) | AU2017369971B2 (es) |
| BR (1) | BR112019011067A2 (es) |
| CA (1) | CA3045226A1 (es) |
| CL (1) | CL2019001447A1 (es) |
| CO (1) | CO2019005729A2 (es) |
| CY (1) | CY1124917T1 (es) |
| DK (1) | DK3548091T3 (es) |
| EA (1) | EA201991299A1 (es) |
| ES (1) | ES2903383T3 (es) |
| HR (1) | HRP20220046T1 (es) |
| HU (1) | HUE057221T2 (es) |
| IL (2) | IL266964B1 (es) |
| LT (1) | LT3548091T (es) |
| MA (1) | MA46997B1 (es) |
| MD (1) | MD3548091T2 (es) |
| MX (1) | MX2019006221A (es) |
| PH (1) | PH12019550088A1 (es) |
| PL (1) | PL3548091T3 (es) |
| PT (1) | PT3548091T (es) |
| RS (1) | RS62845B1 (es) |
| SI (1) | SI3548091T1 (es) |
| TW (2) | TWI773706B (es) |
| UA (1) | UA124774C2 (es) |
| WO (1) | WO2018100434A1 (es) |
| ZA (1) | ZA201903307B (es) |
Families Citing this family (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| HRP20220046T1 (hr) * | 2016-11-29 | 2022-04-15 | Oculis SA | Priprema čvrstih kompleksa ciklodekstrina za uporabu oftalmološki aktivnih farmaceutskih sastojka |
| IT201900000561A1 (it) * | 2019-01-14 | 2020-07-14 | Medivis S R L | Formulazioni topiche oftalmiche chimicamente e fisicamente stabili a base di Nepafenac |
| CN110051859B (zh) * | 2019-06-06 | 2020-06-12 | 鲁南制药集团股份有限公司 | 一种阿昔替尼环糊精包合物 |
| US20220354869A1 (en) * | 2019-07-01 | 2022-11-10 | Oculis SA | Method for stabilizing the ph of an aqueous composition comprising a drug |
| TWI756547B (zh) * | 2019-07-15 | 2022-03-01 | 高雄榮民總醫院 | 奈米眼藥水及其製造方法 |
| EP4171507A1 (en) * | 2020-06-30 | 2023-05-03 | Oculis SA | Preparation of solid cyclodextrin complexes for ophthalmic active pharmaceutical ingredient delivery |
| CN111728953B (zh) * | 2020-07-29 | 2023-08-08 | 中国科学院上海药物研究所 | 一种托法替布或其盐的缓释制剂及其制备方法 |
| WO2022158893A2 (ko) * | 2021-01-21 | 2022-07-28 | 주식회사태준제약 | 점안 조성물 |
| US20220233564A1 (en) * | 2021-01-25 | 2022-07-28 | University Of South Florida | Ophthalmological formulations for the prevention of a coronavirus infection |
| WO2023132947A1 (en) * | 2022-01-05 | 2023-07-13 | The Regents Of The University Of California | Closo-dodecaiododecaborate complexes and methods of use for same |
| WO2023148231A1 (en) | 2022-02-02 | 2023-08-10 | Oculis SA | Multidose ophthalmic compositions |
Family Cites Families (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5472954A (en) * | 1992-07-14 | 1995-12-05 | Cyclops H.F. | Cyclodextrin complexation |
| EP0938896A1 (en) | 1998-01-15 | 1999-09-01 | Novartis AG | Autoclavable pharmaceutical compositions containing a chelating agent |
| US20020198174A1 (en) * | 2001-05-07 | 2002-12-26 | Allergan Sales, Inc. | Disinfecting and solubilizing steroid compositions |
| MXPA03004241A (es) * | 2000-11-15 | 2004-12-03 | Chandavarkar Mohan A | Preparaciones farmaceuticas que comprenden corticosteroides y agentes antiinfecciosos. |
| WO2004069280A1 (en) | 2003-02-06 | 2004-08-19 | Cipla Ltd | Pharmaceutical inclusion complexes containing a steroid and optionally an antibacterial agent |
| MXPA05008913A (es) * | 2003-02-21 | 2005-10-05 | Sun Pharmaceutical Ind Ltd | Formulacion oftalmica estable que contiene antibiotico y corticoesteroide. |
| US7893040B2 (en) | 2005-07-22 | 2011-02-22 | Oculis Ehf | Cyclodextrin nanotechnology for ophthalmic drug delivery |
| US20140163080A1 (en) * | 2011-02-03 | 2014-06-12 | Gnt, Llc | Compositions and Methods for Treatment of Glaucoma |
| EP2662094B1 (en) | 2012-05-08 | 2024-04-17 | Onyx Therapeutics, Inc. | Cylodextrin Complexation Methods for Formulating Peptide Proteasome Inhibitors |
| SI2887923T1 (sl) * | 2012-08-24 | 2023-09-29 | Sun Pharmaceutical Industries Limited | Oftalmična formulacija polioksilnega lipida ali polioksilne maščobne kisline in zdravljenje očesnih stanj |
| HRP20220046T1 (hr) * | 2016-11-29 | 2022-04-15 | Oculis SA | Priprema čvrstih kompleksa ciklodekstrina za uporabu oftalmološki aktivnih farmaceutskih sastojka |
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2017
- 2017-11-29 HR HRP20220046TT patent/HRP20220046T1/hr unknown
- 2017-11-29 UA UAA201907103A patent/UA124774C2/uk unknown
- 2017-11-29 KR KR1020247008223A patent/KR20240036731A/ko active Search and Examination
- 2017-11-29 TW TW106141577A patent/TWI773706B/zh active
- 2017-11-29 EA EA201991299A patent/EA201991299A1/ru unknown
- 2017-11-29 MA MA46997A patent/MA46997B1/fr unknown
- 2017-11-29 US US16/465,138 patent/US20190343846A1/en not_active Abandoned
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