DK2311434T3 - Tørpulverformuleringer til inhalator, der omfatter overflademodificerende partikler med antiklæbende additiver - Google Patents
Tørpulverformuleringer til inhalator, der omfatter overflademodificerende partikler med antiklæbende additiver Download PDFInfo
- Publication number
- DK2311434T3 DK2311434T3 DK10179073.1T DK10179073T DK2311434T3 DK 2311434 T3 DK2311434 T3 DK 2311434T3 DK 10179073 T DK10179073 T DK 10179073T DK 2311434 T3 DK2311434 T3 DK 2311434T3
- Authority
- DK
- Denmark
- Prior art keywords
- particles
- powder
- magnesium stearate
- lactose
- active
- Prior art date
Links
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
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
-
- 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
- A61K31/473—Quinolines; Isoquinolines ortho- or peri-condensed with carbocyclic ring systems, e.g. acridines, phenanthridines
-
- 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
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
- A61K31/52—Purines, e.g. adenine
- A61K31/522—Purines, e.g. adenine having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
-
- 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
- A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
-
- 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
-
- 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
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- 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
- 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
- A61K9/145—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 compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M15/00—Inhalators
- A61M15/0028—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2202/00—Special media to be introduced, removed or treated
- A61M2202/06—Solids
- A61M2202/064—Powder
Claims (9)
1. Fremgangsmåde til fremstilling af en passiv pulverformulering til anordning, hvor glycopyrrolatpartikler samformales med magnesiumstearat, lactosepartikler samformales separat med magnesiumstearat, og de sam-formalede glycopyrrolat- og lactosepartikler herefter kombineres.
2. Fremgangsmåde ifølge krav 1, hvor samformalingen sker ved mekanofusion, anvendelse af cyclomixer eller slagformaling, såsåom kugleformaling, stråleformaling eller formaling ved anvendelse af en højtrykshomogenisator eller kombinationer deraf.
3. Fremgangsmåde ifølge krav 1 eller krav 2, hvor glycopyrrolatpartiklerne og lactosepartiklerne samformales ved anvendelse af forskellige formalingsprocesser.
4. Fremgangsmåde ifølge et hvilket som helst af ovennævnte krav, hvor glycopyrrolatpartiklerne har en diameter på mindre end 10 ym.
5. Fremgangsmåde ifølge et hvilket som helst af ovennævnte krav, hvor pulverformuleringen inkorporerer magnesiumstearat på overfladen af både glycopyrrolatpartiklerne og lactosepartiklerne.
6. Passiv pulverformulering til anordning, der omfatter glycopyrrolat, magnesiumstearat og lactose, hvor pulverformuleringen inkorporerer magnesiumstearat på overfladen af både glycopyrrolatpartiklerne og lactosepartiklerne, og hvor mængden, der anvendes, når magnesiumstearat tilsættes til glycopyrrolat, er 3 til 8 vægt- o "o ♦
7. Pulverformulering ifølge krav 6, hvilken formulering kan opnås ved samformaling af glycopyrrolatpartikler med magnesiumstearat, separat samformaling af lactosepartikler med magnesiumstearat og kombinering af de samformalede glycopyrrolat- og samformalede lactosepartikler.
8. Pulverformulering ifølge krav 6 eller 7, hvor magnesiumstearat danner en diskontinuert belægning på overfladerne af glycopyrrolat- og lactosepartiklerne.
9. Fremgangsmåde eller formulering ifølge et hvilket som helst af ovennævnte krav, hvor pulverformuleringen har en aftappet densitet på mindst 0,1 g/ml.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GBGB0425758.0A GB0425758D0 (en) | 2004-11-23 | 2004-11-23 | Preparation of pharmaceutical compositions |
EP10151576.5A EP2174653B1 (en) | 2004-11-23 | 2005-11-23 | Dry powder inhaler formulations comprising surface-modified particles with anti-adherent additives |
Publications (1)
Publication Number | Publication Date |
---|---|
DK2311434T3 true DK2311434T3 (da) | 2015-10-05 |
Family
ID=33548732
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DK10179073.1T DK2311434T3 (da) | 2004-11-23 | 2005-11-23 | Tørpulverformuleringer til inhalator, der omfatter overflademodificerende partikler med antiklæbende additiver |
DK10151576.5T DK2174653T3 (da) | 2004-11-23 | 2005-11-23 | Tørpulverinhalatorformuleringer, der omfatter overflademodificerede partikler med klæbehindrende additiver |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DK10151576.5T DK2174653T3 (da) | 2004-11-23 | 2005-11-23 | Tørpulverinhalatorformuleringer, der omfatter overflademodificerede partikler med klæbehindrende additiver |
Country Status (16)
Country | Link |
---|---|
US (4) | US20080127972A1 (da) |
EP (4) | EP2311434B1 (da) |
JP (2) | JP5339401B2 (da) |
CN (2) | CN104146960A (da) |
AT (1) | ATE456363T1 (da) |
CA (1) | CA2589514C (da) |
DE (1) | DE602005019192D1 (da) |
DK (2) | DK2311434T3 (da) |
ES (3) | ES2548884T3 (da) |
GB (1) | GB0425758D0 (da) |
HU (1) | HUE027465T2 (da) |
IN (1) | IN2014CN04336A (da) |
PL (3) | PL2311434T3 (da) |
PT (3) | PT2311434E (da) |
SI (2) | SI2311434T1 (da) |
WO (1) | WO2006056812A1 (da) |
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2004
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2005
- 2005-11-23 AT AT05808842T patent/ATE456363T1/de active
- 2005-11-23 DE DE602005019192T patent/DE602005019192D1/de active Active
- 2005-11-23 US US11/791,385 patent/US20080127972A1/en not_active Abandoned
- 2005-11-23 EP EP10179073.1A patent/EP2311434B1/en not_active Revoked
- 2005-11-23 SI SI200532009T patent/SI2311434T1/sl unknown
- 2005-11-23 CN CN201410314552.XA patent/CN104146960A/zh active Pending
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- 2005-11-23 EP EP05808842A patent/EP1814521B1/en active Active
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- 2005-11-23 ES ES10179073.1T patent/ES2548884T3/es active Active
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- 2005-11-23 DK DK10179073.1T patent/DK2311434T3/da active
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- 2005-11-23 WO PCT/GB2005/050211 patent/WO2006056812A1/en active Application Filing
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