DK2178500T3 - Tørpulver-medikament - Google Patents
Tørpulver-medikament Download PDFInfo
- Publication number
- DK2178500T3 DK2178500T3 DK08775998.1T DK08775998T DK2178500T3 DK 2178500 T3 DK2178500 T3 DK 2178500T3 DK 08775998 T DK08775998 T DK 08775998T DK 2178500 T3 DK2178500 T3 DK 2178500T3
- Authority
- DK
- Denmark
- Prior art keywords
- particulate
- active ingredient
- particle size
- carrier
- dry powder
- Prior art date
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- 239000000843 powder Substances 0.000 title claims description 32
- 239000003814 drug Substances 0.000 claims description 63
- 239000002245 particle Substances 0.000 claims description 62
- 229940079593 drug Drugs 0.000 claims description 33
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims description 31
- GIIZNNXWQWCKIB-UHFFFAOYSA-N Serevent Chemical compound C1=C(O)C(CO)=CC(C(O)CNCCCCCCOCCCCC=2C=CC=CC=2)=C1 GIIZNNXWQWCKIB-UHFFFAOYSA-N 0.000 claims description 31
- 239000004480 active ingredient Substances 0.000 claims description 31
- 239000008101 lactose Substances 0.000 claims description 31
- WMWTYOKRWGGJOA-CENSZEJFSA-N fluticasone propionate Chemical compound 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 claims description 30
- 229960000289 fluticasone propionate Drugs 0.000 claims description 28
- 238000000034 method Methods 0.000 claims description 28
- 229960005018 salmeterol xinafoate Drugs 0.000 claims description 25
- 238000005194 fractionation Methods 0.000 claims description 7
- 239000000470 constituent Substances 0.000 claims 2
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- 239000000443 aerosol Substances 0.000 description 10
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- 239000002775 capsule Substances 0.000 description 6
- 238000009472 formulation Methods 0.000 description 6
- 230000008021 deposition Effects 0.000 description 5
- 239000010419 fine particle Substances 0.000 description 5
- 229960004017 salmeterol Drugs 0.000 description 5
- 230000000694 effects Effects 0.000 description 4
- 238000002474 experimental method Methods 0.000 description 4
- 238000002156 mixing Methods 0.000 description 4
- 238000012552 review Methods 0.000 description 4
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 description 3
- 229940124630 bronchodilator Drugs 0.000 description 3
- 238000009826 distribution Methods 0.000 description 3
- 239000011521 glass Substances 0.000 description 3
- 238000004128 high performance liquid chromatography Methods 0.000 description 3
- 230000003993 interaction Effects 0.000 description 3
- LRFVTYWOQMYALW-UHFFFAOYSA-N 9H-xanthine Chemical compound O=C1NC(=O)NC2=C1NC=N2 LRFVTYWOQMYALW-UHFFFAOYSA-N 0.000 description 2
- 208000006545 Chronic Obstructive Pulmonary Disease Diseases 0.000 description 2
- 239000000853 adhesive Substances 0.000 description 2
- 230000001070 adhesive effect Effects 0.000 description 2
- 238000004458 analytical method Methods 0.000 description 2
- 208000006673 asthma Diseases 0.000 description 2
- 239000000168 bronchodilator agent Substances 0.000 description 2
- 238000012512 characterization method Methods 0.000 description 2
- 230000007423 decrease Effects 0.000 description 2
- 238000013461 design Methods 0.000 description 2
- 238000011156 evaluation Methods 0.000 description 2
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- 238000011084 recovery Methods 0.000 description 2
- 208000023504 respiratory system disease Diseases 0.000 description 2
- ZFXYFBGIUFBOJW-UHFFFAOYSA-N theophylline Chemical compound O=C1N(C)C(=O)N(C)C2=C1NC=N2 ZFXYFBGIUFBOJW-UHFFFAOYSA-N 0.000 description 2
- 238000005303 weighing Methods 0.000 description 2
- JWZZKOKVBUJMES-UHFFFAOYSA-N (+-)-Isoprenaline Chemical compound CC(C)NCC(O)C1=CC=C(O)C(O)=C1 JWZZKOKVBUJMES-UHFFFAOYSA-N 0.000 description 1
- XWTYSIMOBUGWOL-UHFFFAOYSA-N (+-)-Terbutaline Chemical compound CC(C)(C)NCC(O)C1=CC(O)=CC(O)=C1 XWTYSIMOBUGWOL-UHFFFAOYSA-N 0.000 description 1
- LSLYOANBFKQKPT-DIFFPNOSSA-N 5-[(1r)-1-hydroxy-2-[[(2r)-1-(4-hydroxyphenyl)propan-2-yl]amino]ethyl]benzene-1,3-diol Chemical compound C([C@@H](C)NC[C@H](O)C=1C=C(O)C=C(O)C=1)C1=CC=C(O)C=C1 LSLYOANBFKQKPT-DIFFPNOSSA-N 0.000 description 1
- USFZMSVCRYTOJT-UHFFFAOYSA-N Ammonium acetate Chemical compound N.CC(O)=O USFZMSVCRYTOJT-UHFFFAOYSA-N 0.000 description 1
- 239000005695 Ammonium acetate Substances 0.000 description 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 description 1
- VOVIALXJUBGFJZ-KWVAZRHASA-N Budesonide Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@@H]2[C@@H]1[C@@H]1C[C@H]3OC(CCC)O[C@@]3(C(=O)CO)[C@@]1(C)C[C@@H]2O VOVIALXJUBGFJZ-KWVAZRHASA-N 0.000 description 1
- 244000132059 Carica parviflora Species 0.000 description 1
- 235000014653 Carica parviflora Nutrition 0.000 description 1
- LUKZNWIVRBCLON-GXOBDPJESA-N Ciclesonide Chemical compound C1([C@H]2O[C@@]3([C@H](O2)C[C@@H]2[C@@]3(C[C@H](O)[C@@H]3[C@@]4(C)C=CC(=O)C=C4CC[C@H]32)C)C(=O)COC(=O)C(C)C)CCCCC1 LUKZNWIVRBCLON-GXOBDPJESA-N 0.000 description 1
- 239000001828 Gelatine Substances 0.000 description 1
- ZCVMWBYGMWKGHF-UHFFFAOYSA-N Ketotifene Chemical compound C1CN(C)CCC1=C1C2=CC=CC=C2CC(=O)C2=C1C=CS2 ZCVMWBYGMWKGHF-UHFFFAOYSA-N 0.000 description 1
- 229940121948 Muscarinic receptor antagonist Drugs 0.000 description 1
- VQDBNKDJNJQRDG-UHFFFAOYSA-N Pirbuterol Chemical compound CC(C)(C)NCC(O)C1=CC=C(O)C(CO)=N1 VQDBNKDJNJQRDG-UHFFFAOYSA-N 0.000 description 1
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 1
- 239000000556 agonist Substances 0.000 description 1
- NDAUXUAQIAJITI-UHFFFAOYSA-N albuterol Chemical compound CC(C)(C)NCC(O)C1=CC=C(O)C(CO)=C1 NDAUXUAQIAJITI-UHFFFAOYSA-N 0.000 description 1
- 229960003556 aminophylline Drugs 0.000 description 1
- FQPFAHBPWDRTLU-UHFFFAOYSA-N aminophylline Chemical compound NCCN.O=C1N(C)C(=O)N(C)C2=C1NC=N2.O=C1N(C)C(=O)N(C)C2=C1NC=N2 FQPFAHBPWDRTLU-UHFFFAOYSA-N 0.000 description 1
- 229940043376 ammonium acetate Drugs 0.000 description 1
- 235000019257 ammonium acetate Nutrition 0.000 description 1
- 239000002260 anti-inflammatory agent Substances 0.000 description 1
- 229940124599 anti-inflammatory drug Drugs 0.000 description 1
- 230000003110 anti-inflammatory effect Effects 0.000 description 1
- 239000000043 antiallergic agent Substances 0.000 description 1
- 238000013459 approach Methods 0.000 description 1
- 229950000210 beclometasone dipropionate Drugs 0.000 description 1
- 229960004436 budesonide Drugs 0.000 description 1
- 239000000872 buffer Substances 0.000 description 1
- 229960003821 choline theophyllinate Drugs 0.000 description 1
- 239000000812 cholinergic antagonist Substances 0.000 description 1
- 230000001684 chronic effect Effects 0.000 description 1
- 229960003728 ciclesonide Drugs 0.000 description 1
- 229940126523 co-drug Drugs 0.000 description 1
- 239000011362 coarse particle Substances 0.000 description 1
- 239000011248 coating agent Substances 0.000 description 1
- 238000000576 coating method Methods 0.000 description 1
- 239000013066 combination product Substances 0.000 description 1
- 229940127555 combination product Drugs 0.000 description 1
- 238000007796 conventional method Methods 0.000 description 1
- 229940109248 cromoglycate Drugs 0.000 description 1
- IMZMKUWMOSJXDT-UHFFFAOYSA-N cromoglycic acid Chemical compound O1C(C(O)=O)=CC(=O)C2=C1C=CC=C2OCC(O)COC1=CC=CC2=C1C(=O)C=C(C(O)=O)O2 IMZMKUWMOSJXDT-UHFFFAOYSA-N 0.000 description 1
- 230000003247 decreasing effect Effects 0.000 description 1
- 238000003795 desorption Methods 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 238000010586 diagram Methods 0.000 description 1
- 239000006185 dispersion Substances 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 229960001022 fenoterol Drugs 0.000 description 1
- 229960000676 flunisolide Drugs 0.000 description 1
- 229960002714 fluticasone Drugs 0.000 description 1
- MGNNYOODZCAHBA-GQKYHHCASA-N fluticasone Chemical compound 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)(O)[C@@]2(C)C[C@@H]1O MGNNYOODZCAHBA-GQKYHHCASA-N 0.000 description 1
- 235000013305 food Nutrition 0.000 description 1
- 229960002848 formoterol Drugs 0.000 description 1
- BPZSYCZIITTYBL-UHFFFAOYSA-N formoterol Chemical compound C1=CC(OC)=CC=C1CC(C)NCC(O)C1=CC=C(O)C(NC=O)=C1 BPZSYCZIITTYBL-UHFFFAOYSA-N 0.000 description 1
- 229920000159 gelatin Polymers 0.000 description 1
- 239000007903 gelatin capsule Substances 0.000 description 1
- 235000019322 gelatine Nutrition 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 229960001361 ipratropium bromide Drugs 0.000 description 1
- KEWHKYJURDBRMN-ZEODDXGYSA-M ipratropium bromide hydrate Chemical compound O.[Br-].O([C@H]1C[C@H]2CC[C@@H](C1)[N@@+]2(C)C(C)C)C(=O)C(CO)C1=CC=CC=C1 KEWHKYJURDBRMN-ZEODDXGYSA-M 0.000 description 1
- 229960001317 isoprenaline Drugs 0.000 description 1
- 229960004958 ketotifen Drugs 0.000 description 1
- 230000000670 limiting effect Effects 0.000 description 1
- 210000004072 lung Anatomy 0.000 description 1
- 229960002744 mometasone furoate Drugs 0.000 description 1
- WOFMFGQZHJDGCX-ZULDAHANSA-N mometasone furoate Chemical compound O([C@]1([C@@]2(C)C[C@H](O)[C@]3(Cl)[C@@]4(C)C=CC(=O)C=C4CC[C@H]3[C@@H]2C[C@H]1C)C(=O)CCl)C(=O)C1=CC=CO1 WOFMFGQZHJDGCX-ZULDAHANSA-N 0.000 description 1
- 229960004398 nedocromil Drugs 0.000 description 1
- RQTOOFIXOKYGAN-UHFFFAOYSA-N nedocromil Chemical compound CCN1C(C(O)=O)=CC(=O)C2=C1C(CCC)=C1OC(C(O)=O)=CC(=O)C1=C2 RQTOOFIXOKYGAN-UHFFFAOYSA-N 0.000 description 1
- 230000000414 obstructive effect Effects 0.000 description 1
- 229960001609 oxitropium bromide Drugs 0.000 description 1
- LCELQERNWLBPSY-KHSTUMNDSA-M oxitropium bromide Chemical compound [Br-].C1([C@@H](CO)C(=O)O[C@H]2C[C@@H]3[N+]([C@H](C2)[C@@H]2[C@H]3O2)(C)CC)=CC=CC=C1 LCELQERNWLBPSY-KHSTUMNDSA-M 0.000 description 1
- RLANKEDHRWMNRO-UHFFFAOYSA-M oxtriphylline Chemical compound C[N+](C)(C)CCO.O=C1N(C)C(=O)N(C)C2=C1[N-]C=N2 RLANKEDHRWMNRO-UHFFFAOYSA-M 0.000 description 1
- 238000003921 particle size analysis Methods 0.000 description 1
- 239000008194 pharmaceutical composition Substances 0.000 description 1
- 239000000546 pharmaceutical excipient Substances 0.000 description 1
- 230000000704 physical effect Effects 0.000 description 1
- 229960005414 pirbuterol Drugs 0.000 description 1
- 239000000047 product Substances 0.000 description 1
- 230000002685 pulmonary effect Effects 0.000 description 1
- MIXMJCQRHVAJIO-TZHJZOAOSA-N qk4dys664x Chemical compound O.C1([C@@H](F)C2)=CC(=O)C=C[C@]1(C)[C@@H]1[C@@H]2[C@@H]2C[C@H]3OC(C)(C)O[C@@]3(C(=O)CO)[C@@]2(C)C[C@@H]1O.C1([C@@H](F)C2)=CC(=O)C=C[C@]1(C)[C@@H]1[C@@H]2[C@@H]2C[C@H]3OC(C)(C)O[C@@]3(C(=O)CO)[C@@]2(C)C[C@@H]1O MIXMJCQRHVAJIO-TZHJZOAOSA-N 0.000 description 1
- 238000000163 radioactive labelling Methods 0.000 description 1
- 230000002829 reductive effect Effects 0.000 description 1
- 229960002720 reproterol Drugs 0.000 description 1
- WVLAAKXASPCBGT-UHFFFAOYSA-N reproterol Chemical compound C1=2C(=O)N(C)C(=O)N(C)C=2N=CN1CCCNCC(O)C1=CC(O)=CC(O)=C1 WVLAAKXASPCBGT-UHFFFAOYSA-N 0.000 description 1
- QEVHRUUCFGRFIF-MDEJGZGSSA-N reserpine Chemical compound O([C@H]1[C@@H]([C@H]([C@H]2C[C@@H]3C4=C(C5=CC=C(OC)C=C5N4)CCN3C[C@H]2C1)C(=O)OC)OC)C(=O)C1=CC(OC)=C(OC)C(OC)=C1 QEVHRUUCFGRFIF-MDEJGZGSSA-N 0.000 description 1
- 210000002345 respiratory system Anatomy 0.000 description 1
- 230000002441 reversible effect Effects 0.000 description 1
- 229960002052 salbutamol Drugs 0.000 description 1
- 229940021597 salmeterol and fluticasone Drugs 0.000 description 1
- 239000000741 silica gel Substances 0.000 description 1
- 229910002027 silica gel Inorganic materials 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 238000001228 spectrum Methods 0.000 description 1
- 238000010561 standard procedure Methods 0.000 description 1
- 230000003068 static effect Effects 0.000 description 1
- 230000003637 steroidlike Effects 0.000 description 1
- 150000003431 steroids Chemical class 0.000 description 1
- 239000000021 stimulant Substances 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 230000003746 surface roughness Effects 0.000 description 1
- 229960000195 terbutaline Drugs 0.000 description 1
- 229960000278 theophylline Drugs 0.000 description 1
- LERNTVKEWCAPOY-DZZGSBJMSA-N tiotropium Chemical compound O([C@H]1C[C@@H]2[N+]([C@H](C1)[C@@H]1[C@H]2O1)(C)C)C(=O)C(O)(C=1SC=CC=1)C1=CC=CS1 LERNTVKEWCAPOY-DZZGSBJMSA-N 0.000 description 1
- 229940110309 tiotropium Drugs 0.000 description 1
- 229960002117 triamcinolone acetonide Drugs 0.000 description 1
- YNDXUCZADRHECN-JNQJZLCISA-N triamcinolone acetonide Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@]2(F)[C@@H]1[C@@H]1C[C@H]3OC(C)(C)O[C@@]3(C(=O)CO)[C@@]1(C)C[C@@H]2O YNDXUCZADRHECN-JNQJZLCISA-N 0.000 description 1
- 238000010200 validation analysis Methods 0.000 description 1
- 238000000207 volumetry Methods 0.000 description 1
- 229940075420 xanthine 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
- A61K9/0012—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
- 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
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
- A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline
-
- 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
- A61K31/38—Heterocyclic compounds having sulfur as a ring hetero atom
-
- 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
-
- 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
-
- 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
- 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
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/08—Antiallergic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pulmonology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Otolaryngology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Biochemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Molecular Biology (AREA)
- Pain & Pain Management (AREA)
- Immunology (AREA)
- Rheumatology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Claims (8)
1. Fremgangsmåde til fremstilling af et inhalerbart tørpulver-medikament omfattende trinnene at: (i) fraktionere en partikelformig aktiv bestanddel baseret på aerodynamisk partikelstørrelse, (ii) genvinde mindst en fraktion af den partikelformige aktive bestanddel og (iii) kombinere den genvundne fraktion med en bærer for at tilvejebringe det inhalerbare tørpulver-medikament; yderligere omfattende trinnene at fraktionere én eller flere yderligere partikelformige bestanddele baseret på aerodynamisk partikelstørrelse, genvinde mindst én fraktion af den ene eller flere yderligere partikelformige bestanddele og kombinere de genvundne fraktion(er) med det inhalerbare tørpulver-medikament; hvor den ene eller flere yderligere partikelformige bestanddele omfatter yderligere partikelformige aktive bestanddele og en partikelformig findelt bærer; hvor den partikelformige findelte bærer er findelt lactose; og hvor den partikelformige aktive bestanddel og yderligere partikelformige aktive bestanddel omfatter fluticasonpropionat og salmeterolxinafoat.
2. Fremgangsmåde ifølge krav 1, hvor fraktioneringen udføres under anvendelse af en NGI.
3. Fremgangsmåde ifølge krav 2, hvor den genvundne fraktion er fra et stadie eller stadier med en øvre afskæringsgrænse på 7,0-9,0 pm og en nedre afskæringsgrænse på 2,5-3,0 pm bestemt ved en flowhastighed på 60±5 L/min.
4. Inhalerbart tørpulver-medikament omfattende en partikelformig aktiv bestanddel og en bærer, hvor den partikelformige aktive bestanddel er præfraktioneret baseret på aerodynamisk partikelstørrelse; yderligere omfattende en eller flere yderligere partikelformige bestanddele der er præfraktionerede baseret på aerodynamisk partikelstørrelse; hvor den ene eller flere yderligere partikelformige bestanddele omfatter en yderligere partikelformig aktiv bestanddel og en partikelformig findelt bærer; hvor den partikelformige findelte bærer er findelt lactose; og hvor den partikelformige aktive bestanddel og yderligere partikelformige aktive bestanddele omfatter fluticasonpropionat og salmeterolxinafoat.
5. Fremgangsmåde ifølge et hvilket som helst af de foregående krav, hvor bæreren er lactose med grove partikler.
6. Fremgangsmåde ifølge et hvilket som helst af de foregående krav, hvor partiklerne i den genvundne fraktion af den partikelformige aktive bestanddel har en aerodynamisk partikelstørrelse på 1,0 til 5,0 pm, fortrinsvis 1,5 til 4,5 pm, fortrinsvis 2,0 til 3,5 pm.
7. Fremgangsmåde ifølge et hvilket som helst af kravene 1 til 3 eller 5 til 6 eller et medikament ifølge krav 4, hvor partiklerne af én eller flere yderligere partikelformige bestanddele har en aerodynamisk partikelstørrelse på 1,0 til 5,0 pm, fortrinsvis 1,5 til 4,5 pm, fortrinsvis 2,0 til 3,5 pm.
8. Inhalerbart tørpulver-medikament opnåeligt ved fremgangsmåden ifølge et hvilket som helst af kravene 1 til 3 eller 5 til 7.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GBGB0714134.4A GB0714134D0 (en) | 2007-07-19 | 2007-07-19 | Dry-powder medicament |
| PCT/GB2008/002473 WO2009010770A2 (en) | 2007-07-19 | 2008-07-18 | Dry-powder medicament |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK2178500T3 true DK2178500T3 (da) | 2016-08-01 |
Family
ID=38476653
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK08775998.1T DK2178500T3 (da) | 2007-07-19 | 2008-07-18 | Tørpulver-medikament |
Country Status (15)
| Country | Link |
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| US (1) | US20100236550A1 (da) |
| EP (2) | EP3040066A1 (da) |
| JP (1) | JP5404618B2 (da) |
| KR (2) | KR101794467B1 (da) |
| CN (1) | CN101754746B (da) |
| BR (1) | BRPI0814079A2 (da) |
| CA (1) | CA2693577C (da) |
| DK (1) | DK2178500T3 (da) |
| EA (1) | EA025887B1 (da) |
| ES (1) | ES2581358T3 (da) |
| GB (1) | GB0714134D0 (da) |
| HU (1) | HUE029685T2 (da) |
| IL (2) | IL203379A (da) |
| PL (1) | PL2178500T3 (da) |
| WO (1) | WO2009010770A2 (da) |
Families Citing this family (24)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US9925282B2 (en) | 2009-01-29 | 2018-03-27 | The General Hospital Corporation | Cromolyn derivatives and related methods of imaging and treatment |
| EP2221048A1 (en) * | 2009-02-18 | 2010-08-25 | Siegfried Generics International AG | Pharmaceutical composition for inhalation |
| JP2012524817A (ja) * | 2009-04-24 | 2012-10-18 | シェーリング コーポレイション | 標的粒子サイズを有する、活性医薬を含む凝集体配合物 |
| GB0910537D0 (en) | 2009-06-18 | 2009-07-29 | Ivax Pharmaceuticals Ireland | Inhaler |
| TR200909791A2 (tr) * | 2009-12-25 | 2011-07-21 | B�Lg�� Mahmut | Salmeterol ve flutikazon içeren farmasötik bileşim@ |
| KR101886987B1 (ko) * | 2010-09-30 | 2018-08-08 | 키에시 파르마슈티시 엣스. 피. 에이. | 흡입용 건조 분말 제제 내 마그네슘 스테아레이트의 용도 |
| JP2015155379A (ja) * | 2012-05-23 | 2015-08-27 | 杏林製薬株式会社 | 吸入粉末剤及びその製造方法 |
| JP5087182B1 (ja) | 2012-06-13 | 2012-11-28 | クリニプロ株式会社 | 吸入用パウダーの製造方法 |
| US10058530B2 (en) | 2012-10-25 | 2018-08-28 | The General Hospital Corporation | Combination therapies for the treatment of Alzheimer's disease and related disorders |
| US9855276B2 (en) | 2012-10-25 | 2018-01-02 | The General Hospital Corporation | Combination therapies for the treatment of Alzheimer's disease and related disorders |
| CN103110584A (zh) * | 2013-01-29 | 2013-05-22 | 青岛大学 | 一种噻托溴铵粉雾剂及其制备方法 |
| US10525005B2 (en) | 2013-05-23 | 2020-01-07 | The General Hospital Corporation | Cromolyn compositions and methods thereof |
| CN105377037A (zh) * | 2013-05-23 | 2016-03-02 | Az治疗公司 | 用于递送色甘酸的方法 |
| US20160129207A1 (en) * | 2013-06-17 | 2016-05-12 | Arven Ilac Sanayi Ve Ticaret A.S. | Inhalation composition filling method |
| AU2014340182B2 (en) | 2013-10-22 | 2019-05-23 | The General Hospital Corporation | Cromolyn derivatives and related methods of imaging and treatment |
| UA118861C2 (uk) * | 2013-12-06 | 2019-03-25 | Оріон Корпорейшн | Спосіб отримання сухих порошкових композицій для інгаляцій |
| GB201321717D0 (en) * | 2013-12-09 | 2014-01-22 | Pharmachemie Bv | Inhalable Medicaments |
| CN109922800B (zh) | 2016-08-31 | 2023-06-13 | 通用医疗公司 | 与神经退行性疾病相关的神经炎症中的巨噬细胞/小胶质细胞 |
| CN110603034A (zh) * | 2017-05-04 | 2019-12-20 | 纳诺洛吉卡股份公司 | 一种适于肺、鼻、舌下和/或咽递送的，负载有至少一种生物活性化合物的多孔二氧化硅粒子的制造方法 |
| MX2020000577A (es) | 2017-07-20 | 2020-09-10 | Aztherapies Inc | Formulaciones en polvo de cromolina sodica e ibuprofeno. |
| JP2021529771A (ja) | 2018-07-02 | 2021-11-04 | ザ ジェネラル ホスピタル コーポレイション | クロモリンナトリウムおよびα−ラクトースの粉末製剤 |
| SG11202106117SA (en) | 2018-12-10 | 2021-07-29 | Massachusetts Gen Hospital | Cromolyn esters and uses thereof |
| CA3125779A1 (en) * | 2019-01-07 | 2020-07-16 | Fritz Schmitt | Process for producing a gaseous active ingredient or a gaseous active ingredient mixture, kit for use therein and gaseous composition |
| WO2021207060A1 (en) | 2020-04-06 | 2021-10-14 | The General Hospital Corporation | Methods of treatment of coronavirus-induced inflammation conditions |
Family Cites Families (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| SE9700135D0 (sv) * | 1997-01-20 | 1997-01-20 | Astra Ab | New formulation |
| IT1309592B1 (it) * | 1999-03-05 | 2002-01-24 | Chiesi Farma Spa | Particelle veicolo modificate da utilizzarsi nella preparazione diformulazioni farmaceutiche sotto forma di polimeri per inalazione e |
| JP2004500424A (ja) * | 2000-04-17 | 2004-01-08 | ヴェクトゥラ リミテッド | 吸入器で使用するための製剤 |
| GB0030074D0 (en) | 2000-12-08 | 2001-01-24 | Univ London Pharmacy | Particulate inhalation carrier |
| DE122011100043I1 (de) * | 2000-12-27 | 2011-12-15 | Gilead Sciences Inc | Inhalierbares aztreonam zur behandlung und vorbeugung von bakteriellen lungeninfektionen. |
| AU2002333644A1 (en) * | 2001-09-17 | 2003-04-01 | Glaxo Group Limited | Dry powder medicament formulations |
| US6786105B1 (en) * | 2001-10-09 | 2004-09-07 | University Of Southern California | Personal particle monitor |
| GB0208609D0 (en) * | 2002-04-13 | 2002-05-22 | Glaxo Group Ltd | Compositions |
| AU2003269989B8 (en) * | 2002-08-21 | 2009-11-12 | Norton Healthcare Ltd. | Inhalation composition |
-
2007
- 2007-07-19 GB GBGB0714134.4A patent/GB0714134D0/en not_active Ceased
-
2008
- 2008-07-18 PL PL08775998.1T patent/PL2178500T3/pl unknown
- 2008-07-18 KR KR1020167013248A patent/KR101794467B1/ko active Active
- 2008-07-18 DK DK08775998.1T patent/DK2178500T3/da active
- 2008-07-18 EP EP16153497.9A patent/EP3040066A1/en not_active Withdrawn
- 2008-07-18 BR BRPI0814079-0A2A patent/BRPI0814079A2/pt not_active Application Discontinuation
- 2008-07-18 KR KR1020107003422A patent/KR20100049072A/ko not_active Ceased
- 2008-07-18 HU HUE08775998A patent/HUE029685T2/en unknown
- 2008-07-18 CN CN200880025012.2A patent/CN101754746B/zh active Active
- 2008-07-18 ES ES08775998.1T patent/ES2581358T3/es active Active
- 2008-07-18 EP EP08775998.1A patent/EP2178500B1/en active Active
- 2008-07-18 CA CA2693577A patent/CA2693577C/en not_active Expired - Fee Related
- 2008-07-18 WO PCT/GB2008/002473 patent/WO2009010770A2/en not_active Ceased
- 2008-07-18 JP JP2010516585A patent/JP5404618B2/ja active Active
- 2008-07-18 EA EA201070162A patent/EA025887B1/ru not_active IP Right Cessation
- 2008-07-18 US US12/669,523 patent/US20100236550A1/en not_active Abandoned
-
2010
- 2010-01-18 IL IL203379A patent/IL203379A/en active IP Right Grant
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2016
- 2016-06-13 IL IL246189A patent/IL246189B/en active IP Right Grant
Also Published As
| Publication number | Publication date |
|---|---|
| WO2009010770A2 (en) | 2009-01-22 |
| US20100236550A1 (en) | 2010-09-23 |
| JP5404618B2 (ja) | 2014-02-05 |
| KR20160060166A (ko) | 2016-05-27 |
| GB0714134D0 (en) | 2007-08-29 |
| EP2178500A2 (en) | 2010-04-28 |
| CN101754746B (zh) | 2015-08-19 |
| HK1141448A1 (zh) | 2010-11-12 |
| BRPI0814079A2 (pt) | 2015-02-03 |
| EA201070162A1 (ru) | 2010-06-30 |
| PL2178500T3 (pl) | 2016-12-30 |
| ES2581358T3 (es) | 2016-09-05 |
| EP2178500B1 (en) | 2016-05-04 |
| IL246189B (en) | 2019-08-29 |
| CA2693577C (en) | 2015-06-23 |
| KR101794467B1 (ko) | 2017-12-01 |
| KR20100049072A (ko) | 2010-05-11 |
| HUE029685T2 (en) | 2017-03-28 |
| EA025887B1 (ru) | 2017-02-28 |
| WO2009010770A3 (en) | 2010-01-07 |
| CN101754746A (zh) | 2010-06-23 |
| IL246189A0 (en) | 2016-07-31 |
| EP3040066A1 (en) | 2016-07-06 |
| IL203379A (en) | 2016-06-30 |
| CA2693577A1 (en) | 2009-01-22 |
| JP2010533697A (ja) | 2010-10-28 |
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