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HRP20141134T1 - Kruta farmaceutska formulacija - Google Patents

Kruta farmaceutska formulacija Download PDF

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Publication number
HRP20141134T1
HRP20141134T1 HRP20141134AT HRP20141134T HRP20141134T1 HR P20141134 T1 HRP20141134 T1 HR P20141134T1 HR P20141134A T HRP20141134A T HR P20141134AT HR P20141134 T HRP20141134 T HR P20141134T HR P20141134 T1 HRP20141134 T1 HR P20141134T1
Authority
HR
Croatia
Prior art keywords
solid pharmaceutical
pharmaceutical formulation
formulation according
starch
gelatinized
Prior art date
Application number
HRP20141134AT
Other languages
English (en)
Inventor
Tadashi Mukai
Original Assignee
Otsuka Pharmaceutical Co., Ltd.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=40847022&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HRP20141134(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Otsuka Pharmaceutical Co., Ltd. filed Critical Otsuka Pharmaceutical Co., Ltd.
Publication of HRP20141134T1 publication Critical patent/HRP20141134T1/hr

Links

Classifications

    • 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
    • A61K31/4709—Non-condensed quinolines 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
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1635—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
    • A61K9/14—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
    • 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
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/06—Antiasthmatics
    • 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
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/12—Antihypertensives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/14—Vasoprotectives; Antihaemorrhoidals; Drugs for varicose therapy; Capillary stabilisers

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Vascular Medicine (AREA)
  • Pulmonology (AREA)
  • Pain & Pain Management (AREA)
  • Hematology (AREA)
  • Rheumatology (AREA)
  • Diabetes (AREA)
  • Urology & Nephrology (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Claims (17)

1. Kruta farmaceutska formulacija naznačena time da sadrži (a) cilostazol, (b) pre-želatinizirani škrob u količini od 10 do 90 % težinski na temelju težine cijele formulacije, (c) jednu ili više vrsta enteričkih sastojaka i (d) organsku kiselinu.
2. Kruta farmaceutska formulacija prema zahtjevu 1 naznačena time da je organska kiselina sadržana u količini 0.5 do 5 % težinski.
3. Kruta farmaceutska formulacija prema zahtjevu 1 ili 2 naznačena time da organska kiselina je limunska kiselina.
4. Kruta farmaceutska formulacija prema bilo kojem zahtjevu od 1 do 3 naznačena time da jedna ili više vrsta enteričkih sastojaka sadrži hidroksipropil metilceluloza acetat sukcinat, hidroksipropil metilceluloza ftalat, karboksimetiletilcelulozu, kopolimer L metakrilne kiseline i/ili kopolimer S metakrilne kiseline.
5. Kruta farmaceutska formulacija prema zahtjevu 3 naznačena time da enterički sastojci sadrže kopolimer S metakrilne kiseline.
6. Kruta farmaceutska formulacija prema bilo kojem zahtjevu od 1 do 5 naznačena time da pre-želatinizirani škrob je pre-želatinizirani kukuruzni škrob.
7. Kruta farmaceutska formulacija prema bilo kojem zahtjevu od 1 do 6 naznačena time da se pripravlja sljedećim koracima (i) i (ii): (i) miješanje cilostazola, škroba, jedne ili više vrsta enteričkih sastojaka i organske kiseline za pripremu polaznog pripravka, i (ii) podvrgavanje polaznog pripravka postupku pre-želatinizacije škroba.
8. Kruta farmaceutska formulacija prema zahtjevu 7 naznačena time da škrob u koraku (i) je jedan ili smjesa koja sadrži škrob, djelomično pre-želatinizirani škrob i/ili pre-želatiniziran škrob, pod uvjetom da škrob u koraku (i) nije samo pre-želatinizirani škrob.
9. Kruta farmaceutska formulacija prema bilo kojem zahtjevu od 1 do 8 naznačena time da je u obliku čestice.
10. Kruta farmaceutska formulacija prema bilo kojem zahtjevu od 1 do 8 naznačena time da je u obliku granule ili praška.
11. Kruta farmaceutska formulacija prema zahtjevu 10 naznačena time da se pripravlja pomoću tehnike ekstruzijske granulacije.
12. Formulacija kapsule naznačena time da sadrži krutu farmaceutsku formulaciju prema zahtjevima 9, 10 i/ili 11.
13. Formulacija tablete naznačena time da sadrži krutu farmaceutsku formulaciju prema zahtjevima 9, 10 i/ili 11.
14. Postupak za pripravu krute farmaceutske formulacije prema bilo kojem zahtjevu od 1 do 11, naznačen time da je škrob pre-želatiniziran pomoću zagrijavanja tijekom postupka priprave.
15. Postupak prema zahtjevu 14 naznačen time da je grijanje popraćeno ovlaživanjem.
16. Kruta farmaceutska formulacija prema bilo kojem zahtjevu od 1 do 11 naznačena time da se priprema postupkom prema zahtjevu 14 ili 15.
17. Formulacija kapsule naznačena time da je ispunjena s granulama ili praškom s brzim oslobađanjem koje sadržavaju cilostazol, te granulama ili praškom prema bilo kojem ili više zahtjeva od 9 do 11.
HRP20141134AT 2008-05-15 2009-05-14 Kruta farmaceutska formulacija HRP20141134T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JP2008128259 2008-05-15
PCT/JP2009/059300 WO2009139504A2 (en) 2008-05-15 2009-05-14 A solid pharmaceutical formulation
EP09746710.4A EP2273981B1 (en) 2008-05-15 2009-05-14 A solid pharmaceutical formulation

Publications (1)

Publication Number Publication Date
HRP20141134T1 true HRP20141134T1 (hr) 2015-01-30

Family

ID=40847022

Family Applications (1)

Application Number Title Priority Date Filing Date
HRP20141134AT HRP20141134T1 (hr) 2008-05-15 2009-05-14 Kruta farmaceutska formulacija

Country Status (31)

Country Link
US (1) US20110091535A1 (hr)
EP (1) EP2273981B1 (hr)
JP (1) JP5552434B2 (hr)
KR (1) KR101585280B1 (hr)
CN (2) CN104971037A (hr)
AR (1) AR071706A1 (hr)
AU (1) AU2009247156B2 (hr)
BR (1) BRPI0912656A2 (hr)
CA (1) CA2722244C (hr)
CL (1) CL2009001183A1 (hr)
CO (1) CO6321223A2 (hr)
CY (1) CY1115955T1 (hr)
DK (1) DK2273981T3 (hr)
EA (1) EA022712B1 (hr)
EC (1) ECSP10010683A (hr)
ES (1) ES2524261T3 (hr)
HR (1) HRP20141134T1 (hr)
IL (1) IL208788A (hr)
MX (1) MX2010012432A (hr)
MY (1) MY153109A (hr)
NZ (1) NZ588794A (hr)
PE (2) PE20091900A1 (hr)
PL (1) PL2273981T3 (hr)
PT (1) PT2273981E (hr)
RS (1) RS53775B1 (hr)
SG (1) SG190643A1 (hr)
SI (1) SI2273981T1 (hr)
TW (1) TWI501789B (hr)
UA (1) UA102547C2 (hr)
WO (1) WO2009139504A2 (hr)
ZA (1) ZA201008115B (hr)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR101282847B1 (ko) * 2011-07-27 2013-07-05 조선대학교산학협력단 실로스타졸을 함유하는 고체분산체 및 이를 포함하는 약학 조성물
TWI615157B (zh) * 2013-02-06 2018-02-21 大塚製藥股份有限公司 包括不定形西洛他唑的固體分散劑
CN103920156B (zh) * 2014-04-04 2016-06-01 成都科特包衣技术有限公司 一种口服给药肠道定位释药薄膜包衣预混辅料及其制备方法
CN106511313B (zh) * 2016-10-21 2019-06-07 浙江为康制药有限公司 西洛他唑缓释胶囊组合物及其制备方法
EP3409294A1 (en) 2017-06-01 2018-12-05 Przedsiebiorstwo Farmaceutyczne Lek-Am Sp Z O. O. Tablets containing cilostazol of specific particle size distribution
WO2020218517A1 (ja) * 2019-04-25 2020-10-29 富士製薬工業株式会社 医薬製剤およびその製造方法
WO2025133928A2 (en) * 2023-12-19 2025-06-26 Angelini Pharma S.P.A. Pharmaceutical matrices for prolonged drug release

Family Cites Families (20)

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IT8920486A0 (it) * 1989-05-12 1989-05-12 Isf Spa Composizioni farmaceutiche.
US5914132A (en) * 1993-02-26 1999-06-22 The Procter & Gamble Company Pharmaceutical dosage form with multiple enteric polymer coatings for colonic delivery
US5843479A (en) * 1993-02-26 1998-12-01 The Procter & Gamble Company Bisacodyl dosage form with multiple enteric polymer coatings for colonic delivery
EG23951A (en) * 1999-03-25 2008-01-29 Otsuka Pharma Co Ltd Cilostazol preparation
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JP4637338B2 (ja) * 2000-09-22 2011-02-23 大塚製薬株式会社 シロスタゾール有核錠
JP2002193792A (ja) * 2000-12-25 2002-07-10 Lion Corp フィルムコーティング錠剤及びエロージョン防止組成物
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WO2005023225A1 (en) * 2003-09-05 2005-03-17 Ranbaxy Laboratories Limited Cilostazol adsorbate
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JP5112619B2 (ja) * 2004-05-20 2013-01-09 大塚製薬株式会社 固形医薬製剤
TWI338583B (en) * 2004-05-20 2011-03-11 Otsuka Pharma Co Ltd Solid pharmaceutical formulation
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WO2007105229A1 (en) * 2006-03-14 2007-09-20 Panacea Biotec Ltd. Controlled release pharmaceutical composition and process thereof
KR100888131B1 (ko) * 2006-10-10 2009-03-11 한올제약주식회사 시간차 투약 원리를 이용한 심혈관계 질환 치료용 복합제제
BRPI0716302A2 (pt) * 2006-10-30 2013-08-13 Hanall Pharmaceutical Co Ltd composiÇço farmacÊutica oral de liberaÇço atrasda por tempo de intervalo e mÉtodo para preparar um composiÇço farmacÊutica oral de liberaÇço atrasada por tempo de intervalo
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Also Published As

Publication number Publication date
BRPI0912656A2 (pt) 2016-01-26
CL2009001183A1 (es) 2010-06-18
RS53775B1 (sr) 2015-06-30
WO2009139504A2 (en) 2009-11-19
SG190643A1 (en) 2013-06-28
TWI501789B (zh) 2015-10-01
AU2009247156B2 (en) 2013-10-24
EA022712B1 (ru) 2016-02-29
HK1149497A1 (en) 2011-10-07
MY153109A (en) 2014-12-31
CN104971037A (zh) 2015-10-14
KR20110007255A (ko) 2011-01-21
ES2524261T3 (es) 2014-12-04
UA102547C2 (uk) 2013-07-25
CY1115955T1 (el) 2017-01-25
CO6321223A2 (es) 2011-09-20
SI2273981T1 (sl) 2015-01-30
JP2011520774A (ja) 2011-07-21
EA201071309A1 (ru) 2011-06-30
CA2722244C (en) 2016-09-13
ECSP10010683A (es) 2011-01-31
TW201000152A (en) 2010-01-01
EP2273981A2 (en) 2011-01-19
AU2009247156A1 (en) 2009-11-19
PL2273981T3 (pl) 2015-04-30
DK2273981T3 (en) 2014-11-24
JP5552434B2 (ja) 2014-07-16
NZ588794A (en) 2012-07-27
PE20140962A1 (es) 2014-08-15
CA2722244A1 (en) 2009-11-19
MX2010012432A (es) 2010-12-06
IL208788A (en) 2016-05-31
PT2273981E (pt) 2015-01-02
US20110091535A1 (en) 2011-04-21
EP2273981B1 (en) 2014-11-05
PE20091900A1 (es) 2009-12-31
IL208788A0 (en) 2010-12-30
CN102119024A (zh) 2011-07-06
KR101585280B1 (ko) 2016-01-13
ZA201008115B (en) 2012-01-25
AR071706A1 (es) 2010-07-07
WO2009139504A3 (en) 2010-09-30

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