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 PDFInfo
- 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
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
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 |
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 |
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 |
HK16106321.9A HK1218260A1 (zh) | 2013-05-06 | 2016-06-03 | 包含含有瑞舒伐他汀或其可藥用鹽的膜包衣層的複合製劑 |
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 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)
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)
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 |
-
2014
- 2014-04-30 WO PCT/KR2014/003859 patent/WO2014182003A1/fr active Application Filing
Patent Citations (6)
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)
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 |
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 |
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 |
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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