HRP20110294T1 - Smjese u obliku tablete koje sadržavaju atazanavir - Google Patents

Smjese u obliku tablete koje sadržavaju atazanavir Download PDF

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Publication number
HRP20110294T1
HRP20110294T1 HR20110294T HRP20110294T HRP20110294T1 HR P20110294 T1 HRP20110294 T1 HR P20110294T1 HR 20110294 T HR20110294 T HR 20110294T HR P20110294 T HRP20110294 T HR P20110294T HR P20110294 T1 HRP20110294 T1 HR P20110294T1
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Croatia
Prior art keywords
compressed tablet
tablet according
relation
total weight
lubricant
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HR20110294T
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English (en)
Inventor
May Yue Koo Otilia
Nikfar Faranak
diaz Steven
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Bristol-Myers Squibb Company
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Publication of HRP20110294T1 publication Critical patent/HRP20110294T1/hr

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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
    • A61K9/20—Pills, tablets, discs, rods
    • 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
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4418—Non condensed pyridines; Hydrogenated derivatives thereof having a carbocyclic group directly attached to the heterocyclic ring, e.g. cyproheptadine
    • 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
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/425—Thiazoles
    • A61K31/427—Thiazoles not condensed and containing further heterocyclic rings
    • 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
    • A61K31/551—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having two nitrogen atoms, e.g. dilazep
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/14—Antivirals for RNA viruses
    • A61P31/18—Antivirals for RNA viruses for HIV
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D213/00—Heterocyclic compounds containing six-membered rings, not condensed with other rings, with one nitrogen atom as the only ring hetero atom and three or more double bonds between ring members or between ring members and non-ring members
    • C07D213/02—Heterocyclic compounds containing six-membered rings, not condensed with other rings, with one nitrogen atom as the only ring hetero atom and three or more double bonds between ring members or between ring members and non-ring members having three double bonds between ring members or between ring members and non-ring members
    • C07D213/04—Heterocyclic compounds containing six-membered rings, not condensed with other rings, with one nitrogen atom as the only ring hetero atom and three or more double bonds between ring members or between ring members and non-ring members having three double bonds between ring members or between ring members and non-ring members having no bond between the ring nitrogen atom and a non-ring member or having only hydrogen or carbon atoms directly attached to the ring nitrogen atom
    • C07D213/24—Heterocyclic compounds containing six-membered rings, not condensed with other rings, with one nitrogen atom as the only ring hetero atom and three or more double bonds between ring members or between ring members and non-ring members having three double bonds between ring members or between ring members and non-ring members having no bond between the ring nitrogen atom and a non-ring member or having only hydrogen or carbon atoms directly attached to the ring nitrogen atom with substituted hydrocarbon radicals attached to ring carbon atoms
    • C07D213/36—Radicals substituted by singly-bound nitrogen atoms
    • C07D213/42—Radicals substituted by singly-bound nitrogen atoms having hetero atoms attached to the substituent nitrogen atom
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • 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
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin

Abstract

Komprimirana tableta, naznačena time što sadržava ritonavir i granule sa sadržajem atazanavir sulfata i unutargranularnog sredstva za podmazivanje, pri čemu granule imaju unutarnji dio i vanjsku površinu gdje je barem dio sredstva za podmazivanje prisutan u unutarnjem dijelu granula. Patent sadrži još 12 patentnih zahtjeva.

Claims (13)

1. Komprimirana tableta, naznačena time što sadržava ritonavir i granule sa sadržajem atazanavir sulfata i unutargranularnog sredstva za podmazivanje, pri čemu granule imaju unutarnji dio i vanjsku površinu gdje je barem dio sredstva za podmazivanje prisutan u unutarnjem dijelu granula.
2. Komprimirana tableta prema zahtjevu 1, naznačena time što u odnosu na ukupnu masu komprimirane tablete sadržava od 0.1 do 10% unutargranularnog sredstva za podmazivanje.
3. Komprimirana tableta prema zahtjevu 1, naznačena time što u odnosu na ukupnu masu komprimirane tablete sadržava od 0.5 do 8% unutargranularnog sredstva za podmazivanje.
4. Komprimirana tableta prema bilo kojem od prethodnih zahtjeva, naznačena time što se unutargranularno sredstvo za podmazivanje izabire iz grupe koja obuhvaća magnezijev stearat, cinkov stearat, kalcijev stearat, stearinsku kiselinu, palmitinsku kiselinu, natrijev stearil fumarat, natrijev benzoat, natrijev lauril sulfat, gliceril monostearat, gliceril palmitostearat, hidrogenirano ricinusovo ulje, hidrogenirano biljno ulje, mineralno ulje, karnauba vosak, polietilen glikol i njihove smjese.
5. Komprimirana tableta prema bilo kojem od prethodnih zahtjeva, naznačena time što u odnosu na ukupnu masu komprimirane tablete dalje sadržava od 1 do 20% sredstva za raspadanje.
6. Komprimirana tableta prema bilo kojem od prethodnih zahtjeva, naznačena time što u odnosu na ukupnu masu komprimirane tablete dalje sadržava od 0.1 do 10% vezivnog sredstva.
7. Komprimirana tableta prema bilo kojem od prethodnih zahtjeva, naznačena time što u odnosu na ukupnu masu komprimirane tablete dalje sadržava od 5 do 90% punila.
8. Komprimirana tableta prema bilo kojem od prethodnih zahtjeva, naznačena time što u odnosu na ukupnu masu komprimirane tablete dalje sadržava od 0.1 do 3% vangranularnog sredstva za podmazivanje.
9. Komprimirana tableta prema bilo kojem od prethodnih zahtjeva, naznačena time što dolazi u obliku višeslojne tablete gdje je atazanavir sulfat jedan sloj, a ritonavir je drugi sloj.
10. Komprimirana tableta prema bilo kojem od zahtjeva 1 do 8, naznačena time što je u obliku jedinstvene cjeline gdje su atazanavir sulfat i ritonavir u istom sloju.
11. Komprimirana tableta prema bilo kojem od prethodnih zahtjeva, naznačena time što se takva tableta priprema vlažnom granulacijom pri čemu se ritonavir, atazanavir sulfat i unutargranularno sredstvo za podmazivanje miješaju unutargranularno.
12. Komprimirana tableta prema bilo kojem od zahtjeva 1 do 10, naznačena time što takva tableta priprema vlažnom granulacijom pri čemu atazanavir sulfat i unutargranularno sredstvo za podmazivanje miješaju unutargranularno, a ritonavir se dodaje izvan granula.
13. Komprimirana tableta prema bilo kojem od prethodnih zahtjeva, naznačena time što se koristi u postupku liječenja HIV infekcije.
HR20110294T 2007-06-22 2011-04-21 Smjese u obliku tablete koje sadržavaju atazanavir HRP20110294T1 (hr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US94569407P 2007-06-22 2007-06-22
PCT/US2008/067633 WO2009002829A2 (en) 2007-06-22 2008-06-20 Tableted compositions containing atazanavir

Publications (1)

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HRP20110294T1 true HRP20110294T1 (hr) 2011-05-31

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US (2) US20100183716A1 (hr)
EP (1) EP2178513B1 (hr)
JP (1) JP2010530892A (hr)
KR (1) KR20100033377A (hr)
CN (1) CN101795674A (hr)
AT (1) ATE503467T1 (hr)
AU (1) AU2008268537B2 (hr)
CY (1) CY1111957T1 (hr)
DE (1) DE602008005896D1 (hr)
DK (1) DK2178513T3 (hr)
ES (1) ES2361796T3 (hr)
HR (1) HRP20110294T1 (hr)
MX (1) MX2009013461A (hr)
PL (1) PL2178513T3 (hr)
PT (1) PT2178513E (hr)
SI (1) SI2178513T1 (hr)
WO (1) WO2009002829A2 (hr)

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ES2361796T3 (es) 2011-06-22
WO2009002829A3 (en) 2009-11-05
EP2178513A2 (en) 2010-04-28
AU2008268537B2 (en) 2012-11-01
MX2009013461A (es) 2010-01-15
DK2178513T3 (da) 2011-07-11
PL2178513T3 (pl) 2011-09-30
AU2008268537A1 (en) 2008-12-31
CY1111957T1 (el) 2015-11-04
DE602008005896D1 (de) 2011-05-12
EP2178513B1 (en) 2011-03-30
JP2010530892A (ja) 2010-09-16
ATE503467T1 (de) 2011-04-15
US20100183716A1 (en) 2010-07-22
KR20100033377A (ko) 2010-03-29
US20150320731A1 (en) 2015-11-12
SI2178513T1 (sl) 2011-05-31
PT2178513E (pt) 2011-05-31
CN101795674A (zh) 2010-08-04

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