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WO2014182003A1 - Formulation composite comprenant une couche de revêtement de film contenant de la rosuvastatine ou un sel pharmaceutiquement acceptable de celle-ci - Google Patents

Formulation composite comprenant une couche de revêtement de film contenant de la rosuvastatine ou un sel pharmaceutiquement acceptable de celle-ci Download PDF

Info

Publication number
WO2014182003A1
WO2014182003A1 PCT/KR2014/003859 KR2014003859W WO2014182003A1 WO 2014182003 A1 WO2014182003 A1 WO 2014182003A1 KR 2014003859 W KR2014003859 W KR 2014003859W WO 2014182003 A1 WO2014182003 A1 WO 2014182003A1
Authority
WO
WIPO (PCT)
Prior art keywords
composite formulation
pharmaceutically acceptable
acceptable salt
polyvinyl alcohol
rosuvastatin
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/KR2014/003859
Other languages
English (en)
Inventor
Yong Il Kim
Hayoung Jeong
Kyeong Soo Kim
Jae Hyun Park
Jong Soo Woo
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Hanmi Pharmaceutical Co Ltd
Hanmi Pharmaceutical Industries Co Ltd
Original Assignee
Hanmi Pharmaceutical Co Ltd
Hanmi Pharmaceutical Industries 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
Priority claimed from KR1020140031675A external-priority patent/KR102240429B1/ko
Application filed by Hanmi Pharmaceutical Co Ltd, Hanmi Pharmaceutical Industries Co Ltd filed Critical Hanmi Pharmaceutical Co Ltd
Priority to CN201480025369.6A priority Critical patent/CN105209022A/zh
Priority to HK16106321.9A priority patent/HK1218260A1/zh
Priority to JP2016512824A priority patent/JP2016522191A/ja
Priority to US14/778,678 priority patent/US20160045444A1/en
Publication of WO2014182003A1 publication Critical patent/WO2014182003A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • 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
    • A61K31/155—Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/20—Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids
    • A61K31/202—Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids having three or more double bonds, e.g. linolenic
    • 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
    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/216—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acids having aromatic rings, e.g. benactizyne, clofibrate
    • 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
    • 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

Definitions

  • Fig. 9 shows a normal formulation and defective formulations after a defect test.
  • the polyvinyl alcohol-polyethylene glycol graft copolymer and polyvinyl alcohol of the film coating layer may be used at a weight ratio of 7 : 3 to 5 : 5, and preferably, e.g., 6 : 4. Further, the coating material including the polyvinyl alcohol-polyethylene glycol graft copolymer and polyvinyl alcohol may be used in an amount of 0.6 to 6 parts by weight, based on 1 part by weight of rosuvastatin or its pharmaceutically acceptable salt, and preferably, e.g., 1 to 4 parts by weight.
  • the stabilizer may further increase stability of rosuvastatin or its pharmaceutically acceptable salt.
  • the stabilizer may be an alkaline stabilizer, which may include magnesium carbonate, sodium bicarbonate, sodium carbonate, calcium carbonate, and the like, and, for example, sodium bicarbonate may be used.
  • the alkaline stabilizer may be used in an amount of 0.025 to 5 parts by weight, based on 1 part by weight of rosuvastatin or its pharmaceutically acceptable salt.
  • Test Example 4 Defect test of formulation comprising polyvinyl alcohol-polyethylene glycol graft copolymer and polyvinyl alcohol

Landscapes

  • Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Emergency Medicine (AREA)
  • Medicinal Preparation (AREA)

Abstract

L'invention concerne une formulation composite comprenant : (i) un cœur comprenant un premier composant pharmacologique ; et (ii) une couche de revêtement de film formée sur une surface du cœur, qui contient de la rosuvastatine ou un sel pharmaceutiquement acceptable de celle-ci comme second composant pharmacologique, et un copolymère greffé alcool polyvinylique-polyéthylène glycol et de l'alcool polyvinylique comme matière de revêtement. Dans la formulation composite de la présente invention, la tension et la fluidité de la couche de revêtement de films sont excellentes, et ainsi une rupture et un taux de défectuosité sont faibles. Par conséquent, un agent composite contenant de la rosuvastatine efficace pour soulager et traiter un symptôme d'hyperlipidémie, ou son sel pharmaceutiquement acceptable, peut être doté d'une haute efficacité et est présent sous une forme de formulation composite, et ainsi une conformité d'un patient peut être améliorée.
PCT/KR2014/003859 2013-05-06 2014-04-30 Formulation composite comprenant une couche de revêtement de film contenant de la rosuvastatine ou un sel pharmaceutiquement acceptable de celle-ci Ceased WO2014182003A1 (fr)

Priority Applications (4)

Application Number Priority Date Filing Date Title
CN201480025369.6A CN105209022A (zh) 2013-05-06 2014-04-30 包含含有瑞舒伐他汀或其可药用盐的膜包衣层的复合制剂
HK16106321.9A HK1218260A1 (zh) 2013-05-06 2014-04-30 包含含有瑞舒伐他汀或其可药用盐的膜包衣层的复合制剂
JP2016512824A JP2016522191A (ja) 2013-05-06 2014-04-30 ロスバスタチンまたはその薬学的に許容可能な塩を含有する膜コーティング層を含む複合製剤
US14/778,678 US20160045444A1 (en) 2013-05-06 2014-04-30 Composite formulation comprising a film coating layer containing rosuvastatin or a pharmaceutically acceptable salt thereof

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
KR20130050949 2013-05-06
KR10-2013-0050949 2013-05-06
KR10-2014-0031675 2014-03-18
KR1020140031675A KR102240429B1 (ko) 2013-05-06 2014-03-18 로수바스타틴 또는 이의 약학적으로 허용되는 염이 함유된 필름 코팅층을 포함하는 복합 제형

Publications (1)

Publication Number Publication Date
WO2014182003A1 true WO2014182003A1 (fr) 2014-11-13

Family

ID=51867440

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/KR2014/003859 Ceased WO2014182003A1 (fr) 2013-05-06 2014-04-30 Formulation composite comprenant une couche de revêtement de film contenant de la rosuvastatine ou un sel pharmaceutiquement acceptable de celle-ci

Country Status (1)

Country Link
WO (1) WO2014182003A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106659692A (zh) * 2014-06-30 2017-05-10 韩美药品株式会社 包括含有活性成分的膜包衣层的复合制剂

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090196920A1 (en) * 2004-10-19 2009-08-06 Paolo Carminati Pharmaceutical composition comprising microcapsules of statins suspended in alkyl esters of polyunsaturated fatty acids (pufa)
US20100330150A1 (en) * 2009-05-01 2010-12-30 Gopi Venkatesh Orally Disintegrating Tablet Compositions Comprising Combinations of High and Low-Dose Drugs
US20110142888A1 (en) * 2009-12-16 2011-06-16 Basf Se Film coating compositions based on polyvinyl alcohol-polyether graft copolymer/polyvinyl alcohol combinations with an improved moisture barrier effect
WO2011081493A2 (fr) * 2009-12-30 2011-07-07 Bcworld Pharm. Co., Ltd. Composition pharmaceutique comprenant de la metformine et de la rosuvastatine
US20120009227A1 (en) * 2009-01-14 2012-01-12 Lek Pharmaceuticals Active coating of pharmaceutical dosage forms
WO2012128587A2 (fr) * 2011-03-23 2012-09-27 Hanmi Pharm. Co., Ltd. Composition complexe administrable par voie orale contenant des esters d'acides gras oméga-3 et un inhibiteur de la hmg-coa réductase

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090196920A1 (en) * 2004-10-19 2009-08-06 Paolo Carminati Pharmaceutical composition comprising microcapsules of statins suspended in alkyl esters of polyunsaturated fatty acids (pufa)
US20120009227A1 (en) * 2009-01-14 2012-01-12 Lek Pharmaceuticals Active coating of pharmaceutical dosage forms
US20100330150A1 (en) * 2009-05-01 2010-12-30 Gopi Venkatesh Orally Disintegrating Tablet Compositions Comprising Combinations of High and Low-Dose Drugs
US20110142888A1 (en) * 2009-12-16 2011-06-16 Basf Se Film coating compositions based on polyvinyl alcohol-polyether graft copolymer/polyvinyl alcohol combinations with an improved moisture barrier effect
WO2011081493A2 (fr) * 2009-12-30 2011-07-07 Bcworld Pharm. Co., Ltd. Composition pharmaceutique comprenant de la metformine et de la rosuvastatine
WO2012128587A2 (fr) * 2011-03-23 2012-09-27 Hanmi Pharm. Co., Ltd. Composition complexe administrable par voie orale contenant des esters d'acides gras oméga-3 et un inhibiteur de la hmg-coa réductase

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106659692A (zh) * 2014-06-30 2017-05-10 韩美药品株式会社 包括含有活性成分的膜包衣层的复合制剂
EP3162363A4 (fr) * 2014-06-30 2018-01-03 Hanmi Pharm. Co., Ltd. Préparation composite comprenant une couche de revêtement par film contenant un principe actif
EP3150201A4 (fr) * 2014-06-30 2018-01-03 Hanmi Pharm. Co., Ltd. Preparation composite comprenant une couche de revêtement pelliculaire contenant un inhibiteur de la 5-alpha-réductase, et procédé pour produire la préparation composite
CN106659692B (zh) * 2014-06-30 2020-08-18 韩美药品株式会社 包括含有活性成分的膜包衣层的复合制剂

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