CO5640071A2 - ATORVASTATIN PHARMACEUTICAL COMPOSITIONS - Google Patents

ATORVASTATIN PHARMACEUTICAL COMPOSITIONS

Info

Publication number
CO5640071A2
CO5640071A2 CO05124314A CO05124314A CO5640071A2 CO 5640071 A2 CO5640071 A2 CO 5640071A2 CO 05124314 A CO05124314 A CO 05124314A CO 05124314 A CO05124314 A CO 05124314A CO 5640071 A2 CO5640071 A2 CO 5640071A2
Authority
CO
Colombia
Prior art keywords
pharmaceutical composition
composition according
atorvastatin
pharmaceutically acceptable
unit dosage
Prior art date
Application number
CO05124314A
Other languages
Spanish (es)
Inventor
Kenneth Craig Waterman
Paul Evan Luner
Original Assignee
Warner Lambert Co
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
Application filed by Warner Lambert Co filed Critical Warner Lambert Co
Publication of CO5640071A2 publication Critical patent/CO5640071A2/en

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
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/401—Proline; Derivatives thereof, e.g. captopril
    • 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
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • 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
    • A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • A61K9/1676—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
    • 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
    • A61K9/1688—Processes resulting in pure drug agglomerate optionally containing up to 5% of excipient
    • 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
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/08—Drugs for disorders of the urinary system of the prostate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/06—Antihyperlipidemics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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
    • A61K9/1611—Inorganic compounds
    • 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
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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

Abstract

1.- Una composición farmacéutica granulada en seco que comprende atorvastatina o una sal farmacéuticamente aceptable de la misma. 2.- La composición farmacéutica de acuerdo con la reivindicación 1 en la que la composición contiene menos de aproximadamente el 5% (p:p) de un aditivo de sal de metal alcalinotérreo.3.- La composición farmacéutica de acuerdo con la reivindicación 1 en la que la composición granulada en seco, después de almacenarla a 40°C y al 75% de humedad relativa durante 4 semanas, no contiene más de aproximadamente el 2% de impurezas totales y/o productos de degradación basándose en el área porcentual de los picos de HPLC relacionados con el fármaco.4.- La composición farmacéutica de acuerdo con la reivindicación 1 en la que la composición se usa en la formación de una forma de dosificación unitaria sólida.5.- La composición farmacéutica de acuerdo con la reivindicación 4 en la que la forma de dosificación unitaria se selecciona entre el grupo compuesto por un comprimido y una cápsula.6.- La composición farmacéutica de acuerdo con la reivindicación 1 en la que la atorvastatina contiene al menos una forma de atorvastatina parcial o completamente desordenada o una sal farmacéuticamente aceptable de la misma.1. A dry granulated pharmaceutical composition comprising atorvastatin or a pharmaceutically acceptable salt thereof. 2. The pharmaceutical composition according to claim 1 wherein the composition contains less than about 5% (p: p) of an alkaline earth metal salt additive. 3. The pharmaceutical composition according to claim 1. in which the dry granulated composition, after storage at 40 ° C and 75% relative humidity for 4 weeks, does not contain more than about 2% of total impurities and / or degradation products based on the percentage area of HPLC peaks related to the drug. 4. The pharmaceutical composition according to claim 1 wherein the composition is used in the formation of a solid unit dosage form. 5. The pharmaceutical composition according to claim. 4 in which the unit dosage form is selected from the group consisting of a tablet and a capsule. 6. The pharmaceutical composition according to claim 1 wherein the ato Rvastatin contains at least one partially or completely disordered form of atorvastatin or a pharmaceutically acceptable salt thereof.

CO05124314A 2003-06-12 2005-12-07 ATORVASTATIN PHARMACEUTICAL COMPOSITIONS CO5640071A2 (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US47791703P 2003-06-12 2003-06-12

Publications (1)

Publication Number Publication Date
CO5640071A2 true CO5640071A2 (en) 2006-05-31

Family

ID=33551780

Family Applications (1)

Application Number Title Priority Date Filing Date
CO05124314A CO5640071A2 (en) 2003-06-12 2005-12-07 ATORVASTATIN PHARMACEUTICAL COMPOSITIONS

Country Status (15)

Country Link
EP (1) EP1635788A1 (en)
JP (1) JP2006527259A (en)
KR (1) KR100760112B1 (en)
CN (1) CN1805732A (en)
AR (1) AR044660A1 (en)
AU (1) AU2004246867A1 (en)
BR (1) BRPI0411354A (en)
CA (1) CA2465693A1 (en)
CO (1) CO5640071A2 (en)
MX (1) MXPA05012955A (en)
NO (1) NO20060149L (en)
RU (1) RU2325903C2 (en)
TW (1) TW200503689A (en)
WO (1) WO2004110406A1 (en)
ZA (1) ZA200508204B (en)

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2007515430A (en) * 2004-10-18 2007-06-14 テバ ファーマシューティカル インダストリーズ リミティド Method for preparing amorphous atorvastatin hemi-calcium by dissolving a salt in an organic solvent which is a mixture of alcohol and ketone and / or ester and removing the solvent
CA2547216A1 (en) * 2005-09-21 2007-03-21 Renuka D. Reddy Process for annealing amorphous atorvastatin
WO2007111027A1 (en) * 2006-03-29 2007-10-04 Kowa Co., Ltd. Triglyceride-lowering agent and hyperinsulinism-ameliorating agent
CN102976996B (en) * 2009-05-27 2015-08-19 峡江和美药业有限公司 Atorvastatin semi strontium salt polymorphic form, its preparation and the application as HMG-CoA enzyme inhibitors
ES2453477T3 (en) 2009-12-18 2014-04-07 Frieslandcampina Nederland Holding B.V. Composition of coprocessed excipient for a tablet, its preparation and use
CA2784996A1 (en) * 2009-12-22 2011-06-30 Novartis Ag Formulation comprising 1 h-quinazoline-2,4-dione ampa receptor antagonists, in the form of immediate release tablets and preparation thereof
EP2575757A1 (en) 2010-06-03 2013-04-10 Mahmut Bilgic Water soluble formulation comprising a combination of amlodipine and a statin
EA018867B1 (en) * 2012-11-01 2013-11-29 Лаборатория Тютор С.А.С.И.Ф.И.А. Method of producing pharmaceutical composition and product therefrom
CN104825449A (en) * 2014-02-12 2015-08-12 天津药物研究院 Compound composition containing atorvastatin calcium and amlodipine and preparation method of same
WO2016047749A1 (en) * 2014-09-26 2016-03-31 株式会社フジクラ Optical fiber
RU2591079C2 (en) * 2014-12-10 2016-07-10 Александр Владимирович Диковский Pharmaceutical composition of statins with prebiotic for therapy of hypercholesteremia and hyperlipidemia
CN107690333B (en) * 2015-06-10 2021-12-17 赢创运营有限公司 Method for preparing powder containing human coagulation factor protein and lactic acid polymer
US20180303799A1 (en) * 2015-10-16 2018-10-25 Shenzhen Salubris Pharmaceuticals Co., Ltd An Oral Preparation for the Treatment of Cardiovascular Disease and Its Preparation Method
CN117835971A (en) 2021-08-25 2024-04-05 巴斯夫欧洲公司 Adjuvant composition for direct compression
CN114674944A (en) * 2022-03-04 2022-06-28 苏州东瑞制药有限公司 Method for detecting related substances of amlodipine besylate and atorvastatin calcium compound preparation

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2392096C (en) * 1999-11-17 2008-07-15 Teva Pharmaceutical Industries Ltd. Polymorphic form of atorvastatin calcium
SI20848A (en) * 2001-03-14 2002-10-31 Lek, Tovarna Farmacevtskih In Kemijskih Izdelkov, D.D. Pharmaceutical formulation containing atorvastatin calcium
BR0208504A (en) * 2001-03-27 2004-03-09 Ranbaxy Lab Ltd Pravastatin Stable Pharmaceutical Composition
JP2003055217A (en) * 2001-08-10 2003-02-26 Taiyo Yakuhin Kogyo Kk Pharmaceutical composition
GB0121436D0 (en) * 2001-09-04 2001-10-24 Pfizer Ltd Biomodulated multiparticulate formulations
CA2385529A1 (en) * 2002-05-21 2003-11-21 Bernard Charles Sherman Stable dosage forms comprising atorvastatin calcium
BR0317521A (en) * 2002-12-20 2005-11-16 Pfizer Prod Inc Dosage forms comprising a cetp inhibitor and an hmg-coa reductase inhibitor

Also Published As

Publication number Publication date
BRPI0411354A (en) 2006-07-11
MXPA05012955A (en) 2006-02-13
AU2004246867A1 (en) 2004-12-23
ZA200508204B (en) 2007-03-28
CN1805732A (en) 2006-07-19
RU2325903C2 (en) 2008-06-10
WO2004110406A1 (en) 2004-12-23
KR20060025167A (en) 2006-03-20
KR100760112B1 (en) 2007-09-18
CA2465693A1 (en) 2004-12-12
RU2005136743A (en) 2006-07-27
TW200503689A (en) 2005-02-01
AR044660A1 (en) 2005-09-21
NO20060149L (en) 2006-03-06
JP2006527259A (en) 2006-11-30
EP1635788A1 (en) 2006-03-22

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