HRP20130835T1 - Farmaceutske formulacije otopine za davanje kao stlaäśeni inhalat u inhalatoru - Google Patents
Farmaceutske formulacije otopine za davanje kao stlaäśeni inhalat u inhalatoru Download PDFInfo
- Publication number
- HRP20130835T1 HRP20130835T1 HRP20130835TT HRP20130835T HRP20130835T1 HR P20130835 T1 HRP20130835 T1 HR P20130835T1 HR P20130835T T HRP20130835T T HR P20130835TT HR P20130835 T HRP20130835 T HR P20130835T HR P20130835 T1 HRP20130835 T1 HR P20130835T1
- Authority
- HR
- Croatia
- Prior art keywords
- inhaler
- metered dose
- severe
- dose inhalers
- pharmaceutical solution
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title claims 3
- 238000009472 formulation Methods 0.000 title claims 2
- 239000003186 pharmaceutical solution Substances 0.000 title 1
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims 2
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims 2
- OBRNDARFFFHCGE-PERKLWIXSA-N (S,S)-formoterol fumarate Chemical compound OC(=O)\C=C\C(O)=O.C1=CC(OC)=CC=C1C[C@H](C)NC[C@@H](O)C1=CC=C(O)C(NC=O)=C1.C1=CC(OC)=CC=C1C[C@H](C)NC[C@@H](O)C1=CC=C(O)C(NC=O)=C1 OBRNDARFFFHCGE-PERKLWIXSA-N 0.000 claims 1
- LVGUZGTVOIAKKC-UHFFFAOYSA-N 1,1,1,2-tetrafluoroethane Chemical compound FCC(F)(F)F LVGUZGTVOIAKKC-UHFFFAOYSA-N 0.000 claims 1
- KUVIULQEHSCUHY-XYWKZLDCSA-N Beclometasone Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@]2(Cl)[C@@H]1[C@@H]1C[C@H](C)[C@@](C(=O)COC(=O)CC)(OC(=O)CC)[C@@]1(C)C[C@@H]2O KUVIULQEHSCUHY-XYWKZLDCSA-N 0.000 claims 1
- 208000027775 Bronchopulmonary disease Diseases 0.000 claims 1
- 208000006545 Chronic Obstructive Pulmonary Disease Diseases 0.000 claims 1
- 239000013543 active substance Substances 0.000 claims 1
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 claims 1
- 229910052782 aluminium Inorganic materials 0.000 claims 1
- 208000006673 asthma Diseases 0.000 claims 1
- 229950000210 beclometasone dipropionate Drugs 0.000 claims 1
- 239000006184 cosolvent Substances 0.000 claims 1
- 229960000193 formoterol fumarate Drugs 0.000 claims 1
- 230000000977 initiatory effect Effects 0.000 claims 1
- 230000002085 persistent effect Effects 0.000 claims 1
- 230000002265 prevention Effects 0.000 claims 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
- A61K9/007—Pulmonary tract; Aromatherapy
- A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
- A61K9/008—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy comprising drug dissolved or suspended in liquid propellant for inhalation via a pressurized metered dose inhaler [MDI]
-
- 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
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/138—Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine
-
- 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
- A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
-
- 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
- A61K31/47—Quinolines; Isoquinolines
- A61K31/4704—2-Quinolinones, e.g. carbostyril
-
- 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
- A61K31/47—Quinolines; Isoquinolines
- A61K31/4738—Quinolines; Isoquinolines ortho- or peri-condensed with heterocyclic ring systems
- A61K31/4745—Quinolines; Isoquinolines ortho- or peri-condensed with heterocyclic ring systems condensed with ring systems having nitrogen as a ring hetero atom, e.g. phenantrolines
-
- 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
-
- 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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- 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
- A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
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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
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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
- A61K47/08—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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
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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
- A61K9/10—Dispersions; Emulsions
- A61K9/12—Aerosols; Foams
- A61K9/124—Aerosols; Foams characterised by the propellant
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- 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
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/06—Antiasthmatics
-
- 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)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Pulmonology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Otolaryngology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Dispersion Chemistry (AREA)
- Pain & Pain Management (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Claims (2)
1. Formulacija otopine koja se daje kao stlačeni inahalat u inhalatoru koja kao aktivne tvari sadrži kombinaciju fromeoterol-fumarata i beklometazon-dipropionata otopljenih u smjesi HFA134a propelanta i 12% v/v etanola kao kootapala te 0.024 % v/v klorovodične kiseline (1M), naznačena time da je za upotrebu u prevenciji i/ili liječenju ozbiljnih bronhopulmonarnih bolesti odabranih od sljedećih: ozbiljna trajna astma ili ozbiljna ili vrlo ozbiljna kornična opstuktivna bolest pluća (COPD), s tim da se pokretanjem rečenog inhalatora isporučuje 50 mL rečene otopine koja sadrži dozu od 6 mg formoterol-fumarata te 100 mg beklametozaom-dipropionata po pokretanju.
2. Otopina prema patentnom zahtjevu 1, naznačena time da je inhalator načinjen od aluminija.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US11/408,026 US20060257324A1 (en) | 2000-05-22 | 2006-04-21 | Pharmaceutical solution formulations for pressurised metered dose inhalers |
PCT/EP2007/003420 WO2007121913A2 (en) | 2006-04-21 | 2007-04-19 | Pharmaceutical solution formulations for pressurised metered dose inhalers |
Publications (1)
Publication Number | Publication Date |
---|---|
HRP20130835T1 true HRP20130835T1 (hr) | 2013-10-25 |
Family
ID=38230023
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20130835TT HRP20130835T1 (hr) | 2006-04-21 | 2013-09-09 | Farmaceutske formulacije otopine za davanje kao stlaäśeni inhalat u inhalatoru |
Country Status (21)
Country | Link |
---|---|
US (4) | US20060257324A1 (hr) |
EP (1) | EP2010190B1 (hr) |
JP (1) | JP5289306B2 (hr) |
KR (1) | KR101311662B1 (hr) |
CN (4) | CN102908308A (hr) |
AU (1) | AU2007241336C1 (hr) |
BR (1) | BRPI0709510A2 (hr) |
CA (1) | CA2649556C (hr) |
CY (1) | CY1114215T1 (hr) |
DK (1) | DK2010190T3 (hr) |
EA (1) | EA016262B1 (hr) |
ES (1) | ES2424753T3 (hr) |
HR (1) | HRP20130835T1 (hr) |
ME (1) | ME02342B (hr) |
MX (1) | MX2008013460A (hr) |
PL (1) | PL2010190T3 (hr) |
PT (1) | PT2010190E (hr) |
RS (1) | RS52940B (hr) |
SI (1) | SI2010190T1 (hr) |
WO (1) | WO2007121913A2 (hr) |
ZA (1) | ZA200808965B (hr) |
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US6315985B1 (en) * | 1999-06-18 | 2001-11-13 | 3M Innovative Properties Company | C-17/21 OH 20-ketosteroid solution aerosol products with enhanced chemical stability |
US20060257324A1 (en) * | 2000-05-22 | 2006-11-16 | Chiesi Farmaceutici S.P.A. | Pharmaceutical solution formulations for pressurised metered dose inhalers |
PL207377B1 (pl) * | 2001-03-30 | 2010-12-31 | Jagotec Ag | Medyczny preparat aerozolowy, sposób wytwarzania medycznego preparatu aerozolowego oraz zastosowanie soli kwasów karboksylowych jako środków pomocniczych w tym preparacie |
GB0323684D0 (en) | 2003-10-09 | 2003-11-12 | Jagotec Ag | Improvements in or relating to organic compounds |
AU2005245248A1 (en) * | 2004-05-13 | 2005-12-01 | Chiesi Farmaceutici S.P.A. | Medicinal aerosol formulation products with improved chemical stability |
GB0501956D0 (en) * | 2005-01-31 | 2005-03-09 | Arrow Internat | Nebulizer formulation |
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EP1894568A1 (en) * | 2006-08-31 | 2008-03-05 | Novartis AG | Pharmaceutical compositions for the treatment of inflammatory or obstructive airway diseases |
EP2429297A4 (en) * | 2009-05-15 | 2013-12-25 | Map Pharmaceuticals Inc | METHOD FOR THE ADMINISTRATION OF DOSE-SAVING QUANTITIES OF FORMOTEROL-FUMARATE BUDESONIDE COMBINATION PARTICLES BY INHALATION |
US20100291221A1 (en) * | 2009-05-15 | 2010-11-18 | Robert Owen Cook | Method of administering dose-sparing amounts of formoterol fumarate-budesonide combination particles by inhalation |
ES2774391T3 (es) * | 2009-05-29 | 2020-07-20 | Pearl Therapeutics Inc | Composiciones, métodos y sistemas para la administración respiratoria de dos o más agentes activos |
US8815258B2 (en) | 2009-05-29 | 2014-08-26 | Pearl Therapeutics, Inc. | Compositions, methods and systems for respiratory delivery of two or more active agents |
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CN102665679B (zh) * | 2009-12-23 | 2014-11-26 | 奇斯药制品公司 | 用于copd的联合治疗 |
RU2561052C2 (ru) * | 2009-12-23 | 2015-08-20 | КЬЕЗИ ФАРМАЧЕУТИЧИ С.п.А. | Комбинированное лечение хронического обструктивного заболевания легких |
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SI2536412T1 (sl) * | 2010-02-16 | 2015-05-29 | Teva Branded Pharmaceutical Products R & D, Inc. | Inhalabilen farmacevtski sestavek |
WO2011136752A1 (en) * | 2010-04-26 | 2011-11-03 | Mahmut Bilgic | Combined pharmaceutical composition comprising carmoterol and ciclesonide for the treatment of respiratory diseases |
WO2011136754A1 (en) * | 2010-04-26 | 2011-11-03 | Mahmut Bilgic | A medicament developed for the treatment of respiratory diseases |
CN102266560A (zh) * | 2010-06-04 | 2011-12-07 | 北京阜康仁生物制药科技有限公司 | 一种用于治疗气喘的药物组合物 |
US20130274232A1 (en) * | 2010-07-16 | 2013-10-17 | Cipla Limited | Pharmaceutical Compositions |
GB201200525D0 (en) * | 2011-12-19 | 2012-02-29 | Teva Branded Pharmaceutical Prod R & D Inc | An inhalable medicament |
RU2696582C2 (ru) | 2013-03-15 | 2019-08-05 | Перл Терапьютикс, Инк. | Способы и системы кондиционирования дисперсных кристаллических материалов |
SG11201605311UA (en) | 2013-12-30 | 2016-07-28 | Chiesi Farma Spa | Stable pressurised aerosol solution composition of glycopyrronium bromide and formoterol combination |
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GB201515310D0 (en) * | 2015-08-27 | 2015-10-14 | Jagotec Ag | Pharmaceutical composition |
BR112018011266B1 (pt) | 2015-12-04 | 2023-11-21 | Mexichem Fluor S.A. De C.V. | Composição farmacêutica, recipiente vedado, e, métodos para tratar um paciente que sofre ou é propenso a sofrer de um distúrbio respiratório e para estabilizar uma composição farmacêutica |
EP3515432B1 (en) | 2016-09-19 | 2021-08-25 | Mexichem Fluor S.A. de C.V. | Pharmaceutical composition comprising glycopyrrolate |
US10792256B2 (en) | 2016-09-19 | 2020-10-06 | Mexichem Fluor S.A. De C.V. | Pharmaceutical composition |
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CA3037080C (en) | 2016-09-19 | 2021-05-18 | Mexichem Fluor S.A. De C.V. | Stable pharmaceutical compositions comprising indacaterol and 1,1-difluoroethane (hfa-152a) suitable for use in metered dose inhalers (mdis) |
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2006
- 2006-04-21 US US11/408,026 patent/US20060257324A1/en not_active Abandoned
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2007
- 2007-04-19 AU AU2007241336A patent/AU2007241336C1/en active Active
- 2007-04-19 SI SI200731304T patent/SI2010190T1/sl unknown
- 2007-04-19 EA EA200802012A patent/EA016262B1/ru not_active IP Right Cessation
- 2007-04-19 ME MEP-2016-22A patent/ME02342B/me unknown
- 2007-04-19 CN CN2012103537724A patent/CN102908308A/zh active Pending
- 2007-04-19 BR BRPI0709510-4A patent/BRPI0709510A2/pt not_active Application Discontinuation
- 2007-04-19 CA CA2649556A patent/CA2649556C/en active Active
- 2007-04-19 PT PT77243574T patent/PT2010190E/pt unknown
- 2007-04-19 WO PCT/EP2007/003420 patent/WO2007121913A2/en active Application Filing
- 2007-04-19 CN CN201610483860.4A patent/CN106074359A/zh active Pending
- 2007-04-19 CN CN201610428382.7A patent/CN105963249A/zh active Pending
- 2007-04-19 ES ES07724357T patent/ES2424753T3/es active Active
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- 2007-04-19 KR KR1020087018846A patent/KR101311662B1/ko active IP Right Grant
- 2007-04-19 DK DK07724357.4T patent/DK2010190T3/da active
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2008
- 2008-10-20 ZA ZA2008/08965A patent/ZA200808965B/en unknown
- 2008-10-21 US US12/255,075 patent/US20090130026A1/en not_active Abandoned
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2019
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