HRP20100615T1 - Farmaceutski sastavi koji sadrže imatinib i usporivač otpuštanja - Google Patents

Farmaceutski sastavi koji sadrže imatinib i usporivač otpuštanja Download PDF

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HRP20100615T1
HRP20100615T1 HR20100615T HRP20100615T HRP20100615T1 HR P20100615 T1 HRP20100615 T1 HR P20100615T1 HR 20100615 T HR20100615 T HR 20100615T HR P20100615 T HRP20100615 T HR P20100615T HR P20100615 T1 HRP20100615 T1 HR P20100615T1
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Croatia
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pharmaceutical composition
release
imatinib
composition according
retarder
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HR20100615T
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Vasanthavada Madhav
Parthiban Lakshman Jay
Tong Wei-Qin
T. M. Serajuddin Abu
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Novartis Ag
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Publication of HRP20100615T1 publication Critical patent/HRP20100615T1/hr

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    • 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
    • A61K31/506—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
    • 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
    • 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
    • A61K31/517—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with carbocyclic ring systems, e.g. quinazoline, perimidine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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    • A61P35/02—Antineoplastic agents specific for leukemia
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    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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    • B29C43/00—Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor
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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C43/00—Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor
    • B29C43/02—Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor of articles of definite length, i.e. discrete articles
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
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    • B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/03—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor characterised by the shape of the extruded material at extrusion
    • B29C48/05—Filamentary, e.g. strands
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/03—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor characterised by the shape of the extruded material at extrusion
    • B29C48/06—Rod-shaped
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/25—Component parts, details or accessories; Auxiliary operations
    • B29C48/36—Means for plasticising or homogenising the moulding material or forcing it through the nozzle or die
    • B29C48/395—Means for plasticising or homogenising the moulding material or forcing it through the nozzle or die using screws surrounded by a cooperating barrel, e.g. single screw extruders
    • B29C48/40—Means for plasticising or homogenising the moulding material or forcing it through the nozzle or die using screws surrounded by a cooperating barrel, e.g. single screw extruders using two or more parallel screws or at least two parallel non-intermeshing screws, e.g. twin screw extruders
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/25—Component parts, details or accessories; Auxiliary operations
    • B29C48/88—Thermal treatment of the stream of extruded material, e.g. cooling
    • B29C48/911—Cooling
    • 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
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2001/00—Use of cellulose, modified cellulose or cellulose derivatives, e.g. viscose, as moulding material
    • B29K2001/08—Cellulose derivatives
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2105/00—Condition, form or state of moulded material or of the material to be shaped
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    • B29K2105/0035—Medical or pharmaceutical agents
    • B—PERFORMING OPERATIONS; TRANSPORTING
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    • B29K2105/00—Condition, form or state of moulded material or of the material to be shaped
    • B29K2105/25—Solid
    • B29K2105/251—Particles, powder or granules
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    • B29K2995/00—Properties of moulding materials, reinforcements, fillers, preformed parts or moulds
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    • B29K2995/00—Properties of moulding materials, reinforcements, fillers, preformed parts or moulds
    • B29K2995/0037—Other properties
    • B29K2995/0059—Degradable
    • B29K2995/006—Bio-degradable, e.g. bioabsorbable, bioresorbable or bioerodible

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Abstract

Oralni farmaceutski sastav s odgođenim otpuštanjem, naznačen time, da sadrži rastaljene granule imatiniba ili bilo koju od njegovih soli i usporivač otpuštanja, te koji sadrži najmanje 400 mg imatinib mesilata. Patent sadrži još 22 patentna zahtjeva.

Claims (23)

1. Oralni farmaceutski sastav s odgođenim otpuštanjem, naznačen time, da sadrži rastaljene granule imatiniba ili bilo koju od njegovih soli i usporivač otpuštanja, te koji sadrži najmanje 400 mg imatinib mesilata.
2. Farmaceutski sastav prema Zahtjevu 1, naznačen time, da sadrži između 50 i 99 masenih % imatiniba.
3. Farmaceutski sastav prema Zahtjevu 1, naznačen time, da spomenuti sastav sadrži između 62 i 99 masenih % imatiniba.
4. Farmaceutski sastav prema Zahtjevu 1, naznačen time, da spomenuti usporivač otpuštanja je polimer.
5. Farmaceutski sastav prema Zahtjevu 4, naznačen time, da spomenuti polimer ima temperaturu prijelaznog vremena prozirnosti nižu od tališta imatinib mesilata.
6. Farmaceutski sastav prema Zahtjevu 5, naznačen time, da nadalje sadrži plastifikator.
7. Farmaceutski sastav prema Zahtjevu 1, naznačen time, da spomenuti usporivač otpuštanja je ne-polimerni usporivač otpuštanja.
8. Farmaceutski sastav prema Zahtjevu 7, naznačen time, da se spomenuti ne-polimerni usporivač otpuštanja rastaljuje na temperaturi nižoj nego što je talište imatiniba ili soli imatiniba koje su u upotrebi.
9. Farmaceutski sastav prema Zahtjevu 7, naznačen time, da spomenuti ne-polimerni usporivač otpuštanja je hidrogenirano ricinovo ulje.
10. Farmaceutski sastav prema Zahtjevu 1, naznačen time, da farmaceutski sastav sadrži barem jedan usporivač otpuštanja odabran iz skupine koja se sastoji od celuloznih polimera, akrilnih polimera, polisaharida i poliola, koji su topivi u vodi, koji nisu topivi u vodi i koji nabubre u vodi.
11. Farmaceutski sastav prema Zahtjevu 1, naznačen time, da farmaceutski sastav sadrži barem jedan usporivač otpuštanja odabran iz skupine koja se sastoji od hidroksipropilne celuloze, hidroksipropilmetilne celuloze, etilceluloze i metakrilatnih polimera.
12. Farmaceutski sastav prema bilo kojem Zahtjevu od 1 do 11, naznačen time, da nadalje obuhvaća modifikator otpuštanja.
13. Postupak izrade oralnog farmaceutskog sastava s odgođenim otpuštanjem, naznačen time, da sadrži korak rastaljivanja granuliranog imatiniba ili bilo koje njegove soli s usporivačem otpuštanja i opcijski s modifikatorom otpuštanja u ekstruderu gdje se vrši zagrijavanje na temperaturu ispod temperature taljenja imatiniba ili njegovih soli, kako bi se oblikovale rastaljene granule, pri čemu sastav sadrži najmanje 50 % imatiniba po masi sastava.
14. Postupak prema Zahtjevu 13, naznačen time, da se rastaljene granule stavljaju još jednom u ekstruder, na daljnje granuliranje sa ili bez usporivača otpuštanja ili modifikatora otpuštanja ili plastifikatora, na temperaturi nižoj od tališta imatiniba ili soli imatiniba koje su u upotrebi.
15. Postupak prema Zahtjevu 13, naznačen time, da nadalje obuhvaća hlađenje spomenutih rastaljenih granula na željenu temperaturu, koja je niža od temperature u postupku taljenja i granuliranja.
16. Postupak prema Zahtjevu 13, naznačen time, da nadalje obuhvaća zbijanje rastaljenih granula u tabletu.
17. Postupak prema Zahtjevu 16, naznačen time, da se rastaljene granule proizvode odvojeno koristeći različite usporivače otpuštanja i/ili modifikatore otpuštanja i/ili plastifikatore, za različite sastave koji se miješaju i zbijaju u tabletu.
18. Postupak prema Zahtjevu 13, naznačen time, da spomenuti ekstruder je dvostruko-navojni ekstruder.
19. Postupak prema Zahtjevu 14, naznačen time, da je usporivač otpuštanja polimer.
20. Postupak prema Zahtjevu 19, naznačen time, da spomenuti polimer je hidroksipropilna celuloza.
21. Farmaceutski sastav prema bilo kojem od Zahtjeva 1 do 12, naznačen time, da otpuštanje lijeka iz farmaceutskog sastava nije veće od 80% za 1 sat i nije manje od 80% za 10 sati, kada se testira koristeći korpasti uređaj USP I na 50rpm u 900mL od 0,1 N klorovodične kiseline na 37°C.
22. Farmaceutski sastav prema bilo kojem od Zahtjeva 1 do 12, naznačen time, da otpuštanje lijeka iz farmaceutskog sastava nije veće od 80% za 2 sata i nije manje od 80% za 8 sati, kada se testira koristeći korpasti uređaj USP I na 50rpm u 900mL od 0,1 N klorovodične kiseline na 37°C.
23. Farmaceutski sastav prema bilo kojem od Zahtjeva 1 do 12, naznačen time, da sastav opskrbljava, kod zdravih ljudi, prosječnu vrijednost koncentracije u plazmi koja ne prelazi 3,5μg Imatinib/mL, kada se dozira 2 sata nakon laganog doručka.
HR20100615T 2005-05-10 2010-11-12 Farmaceutski sastavi koji sadrže imatinib i usporivač otpuštanja HRP20100615T1 (hr)

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US67960705P 2005-05-10 2005-05-10
PCT/US2006/017558 WO2006121941A2 (en) 2005-05-10 2006-05-08 Pharmaceutical compositions comprising imatinib and a release retardant

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EP (1) EP1888040B1 (hr)
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KR (2) KR20080007249A (hr)
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