DK2269577T3 - Injicerbare suspensioner med forbedrede injiceringsegenskaber. - Google Patents
Injicerbare suspensioner med forbedrede injiceringsegenskaber. Download PDFInfo
- Publication number
- DK2269577T3 DK2269577T3 DK10174743.4T DK10174743T DK2269577T3 DK 2269577 T3 DK2269577 T3 DK 2269577T3 DK 10174743 T DK10174743 T DK 10174743T DK 2269577 T3 DK2269577 T3 DK 2269577T3
- Authority
- DK
- Denmark
- Prior art keywords
- viscosity
- microparticles
- suspension
- injection
- poly
- Prior art date
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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
- A61K9/10—Dispersions; Emulsions
-
- 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
-
- 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
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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
- A61K47/26—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
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
-
- 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
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- 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
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
-
- 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
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
- A61K9/1647—Polyesters, e.g. poly(lactide-co-glycolide)
-
- 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
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1658—Proteins, e.g. albumin, gelatin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Inorganic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Dermatology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Neurology (AREA)
- Psychiatry (AREA)
- Biomedical Technology (AREA)
- Organic Chemistry (AREA)
- Neurosurgery (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Dispersion Chemistry (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Claims (10)
1. Sammensætning, som er egnet til injektion gennem en nål og ind i en vært, omfattende: Mikropartikler med en middelværdi af massediameteren i intervallet mellem i det mindste 10 pm og 250pm og omfattende en polymer binder og et aktivt stof, hvorved det aktive stof vælges fra gruppen, som består af risperidon, 9-hydroxyrisperidon og farmaceutisk acceptable salte deraf, og den polymere binder vælges fra gruppen, der består af po-ly(glykolsyre), poly-d-mælkesyre, poly-l-mælkesyre, copolymerer af de foregående, poly(alifatiske carboxylsyrer), copolyaxalater, polycaprolac-ton, polydioxanon, poly(ortho carbonater), poly (acetater), po-ly(mælkesyre-caprolacton), polyorthoestere, poly(glykolsyre- caprolacton), polyanhydrider, polyphosfaziner, albumin, og casein; og Et vandigt injektionsmedium, der omfatter et viskositets-forøgende middel, et vædningsmiddel og et middel til indstilling af tonicitet, hvorved mikropartiklerne er opslæmmet i injektionsmediet med en koncentration, som er større end 30 mg/ml, så der dannes en opslæmning, hvorved det vandige injektionsmedium har en viskositet, som er større end 20 mPa * s (20 cp) og mindre end 60 mPa * s (60 cp) ved 20 °C, som bestemt ved hjælp af et Brookfield Model LVT viscosimeter, der er udrustet med en UL-adapter.
2. Sammensætning ifølge krav 1, hvorved den polymere binder er poly(d,I-lactid-co-glycolid) med et molært forhold mellem lactid og glycolid, som ligger i intervallet mellem 85:15 og 50:50.
3. Sammensætning ifølge krav 1 eller 2, hvorved viskositeten for den flydende fase af opslæmningen er 40 cp ved 20 °C.
4. Sammensætning ifølge krav 1, 2 eller 3, hvorved viskositeten for den flydende fase af opslæmningen er større end 50 mPa * s og mindre end 60 mPa * s (60 cp) ved 20 °C.
5. Sammensætning ifølge et hvilket som helst af de foregående krav, hvorved middelværdien af mikropartiklernes massediameter ligger i intervallet mellem 20 pm og 150 pm.
6. Sammensætning ifølge et hvilket som helst af de foregående krav, hvorved mikropartiklerne er opslæmmet i injektionsmediet med en koncentration i intervallet mellem 100 mg/ml og 400 mg/ml.
7. Sammensætning ifølge et hvilket som helst af de foregående krav, hvorved det viskositetsforøgende middel vælges blandt natriumcarboxymethylcellu-lose, polyvinylpyrrolidon og hydroxypropylmethylcellulose.
8. Sammensætning ifølge et hvilket som helst af de foregående krav, hvorved det viskositetsforøgende middel er natriumcarboxymethylcellulose.
9. Sammensætning ifølge et hvilket som helst af de foregående krav, hvorved vædningsmidlet udvælges blandt polysorbat 20, polysorbat 40 og polysor-bat 80.
10. Sammensætning ifølge et hvilket som helst af de foregående krav, hvorved midlet til indstilling af toniciteten omfatter natriumchlorid.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US09/577,875 US6495164B1 (en) | 2000-05-25 | 2000-05-25 | Preparation of injectable suspensions having improved injectability |
EP06010734.9A EP1754469B1 (en) | 2000-05-25 | 2001-04-19 | Injectable suspensions having improved injectability properties |
Publications (1)
Publication Number | Publication Date |
---|---|
DK2269577T3 true DK2269577T3 (da) | 2016-06-27 |
Family
ID=24310496
Family Applications (3)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DK10174743.4T DK2269577T3 (da) | 2000-05-25 | 2001-04-19 | Injicerbare suspensioner med forbedrede injiceringsegenskaber. |
DK01928628T DK1283699T3 (da) | 2000-05-25 | 2001-04-19 | Fremstilling af injicerbare suspensioner med forbedrede indspröjtningsegenskaber |
DK06010734.9T DK1754469T3 (da) | 2000-05-25 | 2001-04-19 | Injicérbare opslemninger med forbedrede injektionsegenskaber |
Family Applications After (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DK01928628T DK1283699T3 (da) | 2000-05-25 | 2001-04-19 | Fremstilling af injicerbare suspensioner med forbedrede indspröjtningsegenskaber |
DK06010734.9T DK1754469T3 (da) | 2000-05-25 | 2001-04-19 | Injicérbare opslemninger med forbedrede injektionsegenskaber |
Country Status (27)
Country | Link |
---|---|
US (7) | US6495164B1 (da) |
EP (4) | EP3095442B1 (da) |
JP (1) | JP4502355B2 (da) |
KR (1) | KR100810480B1 (da) |
CN (1) | CN100453067C (da) |
AT (1) | ATE363891T1 (da) |
AU (2) | AU5546301A (da) |
BG (1) | BG66023B1 (da) |
BR (1) | BRPI0111060B8 (da) |
CA (1) | CA2406536C (da) |
CY (3) | CY1107441T1 (da) |
CZ (1) | CZ301359B6 (da) |
DE (1) | DE60128798T2 (da) |
DK (3) | DK2269577T3 (da) |
ES (3) | ES2286118T3 (da) |
HK (4) | HK1103346A1 (da) |
HU (1) | HU228587B1 (da) |
IL (1) | IL152767A (da) |
IS (1) | IS2471B (da) |
MX (1) | MXPA02011543A (da) |
NO (1) | NO334660B1 (da) |
NZ (1) | NZ522335A (da) |
PL (1) | PL204298B1 (da) |
PT (2) | PT1283699E (da) |
RU (1) | RU2002135641A (da) |
SI (2) | SI1754469T1 (da) |
WO (1) | WO2001091720A2 (da) |
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2010
- 2010-08-13 US US12/856,198 patent/US20100303900A1/en not_active Abandoned
-
2011
- 2011-07-05 HK HK11106882.5A patent/HK1152660A1/zh not_active IP Right Cessation
-
2013
- 2013-11-20 US US14/085,051 patent/US20140193507A1/en not_active Abandoned
-
2016
- 2016-06-10 CY CY20161100509T patent/CY1117734T1/el unknown
- 2016-06-16 CY CY20161100537T patent/CY1117652T1/el unknown
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