DK3307241T3 - Drypbar oftalmisk bimatoprost-gel - Google Patents
Drypbar oftalmisk bimatoprost-gel Download PDFInfo
- Publication number
- DK3307241T3 DK3307241T3 DK16729525.2T DK16729525T DK3307241T3 DK 3307241 T3 DK3307241 T3 DK 3307241T3 DK 16729525 T DK16729525 T DK 16729525T DK 3307241 T3 DK3307241 T3 DK 3307241T3
- Authority
- DK
- Denmark
- Prior art keywords
- weight
- amount
- gel according
- bimatoprost
- gel
- Prior art date
Links
Classifications
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- 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
-
- 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
- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
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- 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
- A61K31/557—Eicosanoids, e.g. leukotrienes or prostaglandins
- A61K31/5575—Eicosanoids, e.g. leukotrienes or prostaglandins having a cyclopentane, e.g. prostaglandin E2, prostaglandin F2-alpha
-
- 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
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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
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
-
- 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
- A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
-
- 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
- A61P27/06—Antiglaucoma agents or miotics
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)
- Ophthalmology & Optometry (AREA)
- General Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Inorganic Chemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
Claims (15)
1. Drypbar oftalmisk gel, hvilken gel omfatter 1) bimatoprost i en mængde på 0,003 til 0,03 vægtprocent, 2a) polyakrylat i en mængde på > 0,2 vægtprocent, 2b) povidon, dextran, polyethylenglycol, carboxymethylcellulose eller poly(vi-nylalkohol) i en mængde på 0,2 til 10,0 vægtprocent, 3) et isotoniseringsmiddel i en mængde til fremstilling af en osmolalitet på 200 til 400 mosmol/kg, fortrinsvis 270 til 330 mosmol/kg, 4) et salt til justering af viskositeten i en mængde på 0,05 til 0,4 vægtprocent, 5) en base i en mængde til justering af pH-værdien til 6 til 8, fortrinsvis en pH på 7,3, 6) excipienser, der normalt anvendes i oftalmiske geler, og 7) vand, og har en viskositet i området 200 til 2000 mPa s, målt med et Brookfield RVDV-ll-viskometer ved 25° C.
2. Drypbar oftalmisk gel ifølge krav 1, kendetegnet ved, at mængden af polyakrylat er i området > 0,2 til 3,0 vægtprocent, fortrinsvis i området > 0,2 til 0,7 vægtprocent.
3. Drypbar oftalmisk gel ifølge krav 1 eller 2, kendetegnet ved, at mængden af povidon er i området > 0,8 til 10 vægtprocent, fortrinsvis > 2,5 til 10 vægtprocent.
4. Gel ifølge krav 1 til 3, kendetegnet ved, at mængden af bimatoprost er mindre end 0,01 vægtprocent, fortrinsvis mindre end 0,0045 vægtprocent.
5. Gel ifølge et af de foregående krav, kendetegnet ved, at den omfatter sorbitol, mannitol eller glycerol som et isotoniseringsmiddel i en mængde på 1,2 til 5,5 vægtprocent.
6. Gel ifølge et af de foregående krav, kendetegnet ved, at den omfatter en base i en mængde på 0,1 til 0,8 vægtprocent.
7. Gel ifølge et af de foregående krav, kendetegnet ved, at basen er trometa-mol.
8. Gel ifølge et af de foregående krav, kendetegnet ved, at den som poly-akrylatet indeholder sådanne typer med en molekylvægt på mellem 1.000.000 og 4.000.000.
9. Gel ifølge et af de foregående krav, kendetegnet ved, at den ikke omfatter konserveringsmidler.
10. Gel ifølge krav 1 til 8, kendetegnet ved, at den omfatter benzalkonium-chlorid som et konserveringsmiddel.
11. Gel ifølge krav 10, kendetegnet ved, at mængden af benzalkoniumchlorid er i området 0,005 til 0,02 vægtprocent.
12. Enkeltdosisbeholder indeholdende den drypbare, konserveringsmiddelfri oftalmiske gel ifølge et af kravene 1 til 9.
13. Flerdosisplastbeholder indeholdende den drypbare, konserverede oftalmiske gel ifølge et af kravene 1 til 8, 10 eller 11.
14. Gel ifølge et af kravene 1 til 11 til anvendelse som et lægemiddel.
15. Gel ifølge et af kravene 1 til 11 til anvendelse ved behandling af forhøjet intraokulært tryk.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP15171233.8A EP3103439B1 (en) | 2015-06-09 | 2015-06-09 | Drippable ophthalmic bimatoprost gel |
| PCT/EP2016/062990 WO2016198434A1 (en) | 2015-06-09 | 2016-06-08 | Drippable ophthalmic bimatoprost gel |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK3307241T3 true DK3307241T3 (da) | 2018-11-05 |
Family
ID=53298285
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK16729525.2T DK3307241T3 (da) | 2015-06-09 | 2016-06-08 | Drypbar oftalmisk bimatoprost-gel |
Country Status (28)
| Country | Link |
|---|---|
| US (1) | US10314780B2 (da) |
| EP (2) | EP3103439B1 (da) |
| JP (1) | JP6342087B1 (da) |
| KR (1) | KR101889878B1 (da) |
| CN (1) | CN107771074B (da) |
| AU (1) | AU2016277336B2 (da) |
| BR (1) | BR112017026552B1 (da) |
| CA (1) | CA2985897C (da) |
| CY (1) | CY1120883T1 (da) |
| DK (1) | DK3307241T3 (da) |
| ES (2) | ES2747302T3 (da) |
| HK (1) | HK1247118A1 (da) |
| HR (1) | HRP20181840T1 (da) |
| IL (1) | IL256071B (da) |
| LT (1) | LT3307241T (da) |
| MA (1) | MA42290B1 (da) |
| MX (1) | MX2017015835A (da) |
| PL (2) | PL3103439T3 (da) |
| PT (1) | PT3307241T (da) |
| RS (1) | RS57948B1 (da) |
| RU (1) | RU2698456C2 (da) |
| SA (1) | SA517390480B1 (da) |
| SG (1) | SG11201708642VA (da) |
| SI (1) | SI3307241T1 (da) |
| TN (1) | TN2017000445A1 (da) |
| TR (1) | TR201815791T4 (da) |
| UA (1) | UA121139C2 (da) |
| WO (1) | WO2016198434A1 (da) |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CA3104468A1 (en) * | 2018-06-19 | 2019-12-26 | Cella Therapeutics, Llc | Sustained-release drug delivery systems comprising an intraocular pressure lowering agent, a c-type natriuretic peptide compound, an natriuretic peptide receptor-b compound, a tie-2 agonist, or neurotrophic agent for use for treating glaucoma or ocular hypertension |
| CN110200904B (zh) * | 2019-05-27 | 2021-07-23 | 上海昊海生物科技股份有限公司 | 一种降眼压缓释滴眼组合物及其制备方法 |
| US11400100B2 (en) | 2019-12-11 | 2022-08-02 | Somerset Therapeutics, Llc. | Effective benzalkonium chloride-free bimatoprost ophthalmic compositions |
Family Cites Families (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE4209722C3 (de) | 1992-03-25 | 1997-06-19 | Medproject Pharma Entwicklungs | Tropfbares Gel für die Augenheilkunde |
| DE10132876A1 (de) * | 2001-07-06 | 2003-01-30 | Medproject Pharma Entwicklungs | Zweiphasige, tropfbare Hydrogele zur Anwendung am Auge |
| GB0501192D0 (en) * | 2005-01-20 | 2005-03-02 | Resolution Chemicals Ltd | Stable prostaglandin-containing compositions |
| US7851504B2 (en) | 2005-03-16 | 2010-12-14 | Allergan, Inc. | Enhanced bimatoprost ophthalmic solution |
| FR2918891B1 (fr) | 2007-07-20 | 2009-09-25 | Thea Sa Lab | Solution ophtalmique a base de prostaglandines sans conservateur |
| EP2127638A1 (en) | 2008-05-30 | 2009-12-02 | Santen Pharmaceutical Co., Ltd | Method and composition for treating ocular hypertension and glaucoma |
| FR2961694B1 (fr) * | 2010-06-29 | 2013-01-25 | Thea Lab | Systeme de delivrance polymerique d'une solution non visqueuse a base de prostaglandine sans conservateur |
| AU2011282679A1 (en) | 2010-07-29 | 2013-03-07 | Allergan, Inc. | Preservative free bimatoprost solutions |
| KR20140053894A (ko) * | 2011-05-27 | 2014-05-08 | 라티오팜 게엠베하 | Pgf2알파 유사체를 포함하는 안과용 약제 |
| BR112014001118A2 (pt) * | 2011-07-20 | 2017-02-14 | Allergan Inc | combinação tópica para aplicação oftálmica e uso de bimatoprost e brimonidina |
| CN104288092A (zh) * | 2013-07-16 | 2015-01-21 | 广东东阳光药业有限公司 | 拉坦前列素滴眼剂 |
| CN104622798B (zh) * | 2014-12-05 | 2017-12-22 | 广东东阳光药业有限公司 | 一种含有他氟前列素的滴眼液及其制备方法 |
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2015
- 2015-06-09 PL PL15171233T patent/PL3103439T3/pl unknown
- 2015-06-09 ES ES15171233T patent/ES2747302T3/es active Active
- 2015-06-09 EP EP15171233.8A patent/EP3103439B1/en active Active
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2016
- 2016-06-08 US US15/580,770 patent/US10314780B2/en active Active
- 2016-06-08 CA CA2985897A patent/CA2985897C/en active Active
- 2016-06-08 BR BR112017026552-4A patent/BR112017026552B1/pt active IP Right Grant
- 2016-06-08 ES ES16729525T patent/ES2703432T3/es active Active
- 2016-06-08 UA UAA201800181A patent/UA121139C2/uk unknown
- 2016-06-08 RS RS20181341A patent/RS57948B1/sr unknown
- 2016-06-08 AU AU2016277336A patent/AU2016277336B2/en active Active
- 2016-06-08 TR TR2018/15791T patent/TR201815791T4/tr unknown
- 2016-06-08 SG SG11201708642VA patent/SG11201708642VA/en unknown
- 2016-06-08 KR KR1020177033703A patent/KR101889878B1/ko active IP Right Grant
- 2016-06-08 LT LTEP16729525.2T patent/LT3307241T/lt unknown
- 2016-06-08 MX MX2017015835A patent/MX2017015835A/es active IP Right Grant
- 2016-06-08 EP EP16729525.2A patent/EP3307241B8/en active Active
- 2016-06-08 PT PT16729525T patent/PT3307241T/pt unknown
- 2016-06-08 PL PL16729525T patent/PL3307241T3/pl unknown
- 2016-06-08 WO PCT/EP2016/062990 patent/WO2016198434A1/en active Application Filing
- 2016-06-08 RU RU2017138099A patent/RU2698456C2/ru active
- 2016-06-08 DK DK16729525.2T patent/DK3307241T3/da active
- 2016-06-08 MA MA42290A patent/MA42290B1/fr unknown
- 2016-06-08 SI SI201630107T patent/SI3307241T1/sl unknown
- 2016-06-08 TN TNP/2017/000445A patent/TN2017000445A1/en unknown
- 2016-06-08 CN CN201680033806.8A patent/CN107771074B/zh active Active
- 2016-06-08 JP JP2017557200A patent/JP6342087B1/ja active Active
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2017
- 2017-12-03 IL IL256071A patent/IL256071B/en active IP Right Grant
- 2017-12-05 SA SA517390480A patent/SA517390480B1/ar unknown
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2018
- 2018-05-25 HK HK18106817.8A patent/HK1247118A1/zh unknown
- 2018-11-06 HR HRP20181840TT patent/HRP20181840T1/hr unknown
- 2018-11-20 CY CY181101224T patent/CY1120883T1/el unknown
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