RU2005136743A - PHARMACEUTICAL COMPOSITIONS OF ATOREASTATIN - Google Patents

PHARMACEUTICAL COMPOSITIONS OF ATOREASTATIN Download PDF

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RU2005136743A
RU2005136743A RU2005136743/15A RU2005136743A RU2005136743A RU 2005136743 A RU2005136743 A RU 2005136743A RU 2005136743/15 A RU2005136743/15 A RU 2005136743/15A RU 2005136743 A RU2005136743 A RU 2005136743A RU 2005136743 A RU2005136743 A RU 2005136743A
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Prior art keywords
atorvastatin
pharmaceutical composition
dosage form
composition according
pharmaceutically acceptable
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RU2005136743/15A
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Russian (ru)
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RU2325903C2 (en
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Кеннет Крейг УОТЕРМАН (US)
Кеннет Крейг УОТЕРМАН
Пол Эван ЛУНЕР (US)
Пол Эван ЛУНЕР
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Уорнер-Ламберт Компани Эл-Эл-Си (US)
УОРНЕР-ЛАМБЕРТ КОМПАНИ Эл-Эл-Си
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    • 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

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  • Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Rheumatology (AREA)
  • Biomedical Technology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Hematology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Psychiatry (AREA)
  • Urology & Nephrology (AREA)
  • Hospice & Palliative Care (AREA)
  • Obesity (AREA)
  • Diabetes (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Pyrrole Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Claims (13)

1. Гранулированная сухим методом фармацевтическая композиция, содержащая аторвастатин или его фармацевтически приемлемую соль и разбавитель, где разбавитель содержит более чем приблизительно 50 мас.% микрокристаллической целлюлозы, лактозы, сахарозы, ксилита или двухосновного фосфата кальция.1. A dry granulated pharmaceutical composition comprising atorvastatin or a pharmaceutically acceptable salt and diluent thereof, wherein the diluent contains more than about 50 wt.% Microcrystalline cellulose, lactose, sucrose, xylitol or dibasic calcium phosphate. 2. Фармацевтическая композиция по п.1, содержащая менее чем приблизительно 5% (масс.) добавки, представляющей собой соль щелочноземельного металла.2. The pharmaceutical composition according to claim 1, containing less than about 5% (mass.) Additives, representing a salt of an alkaline earth metal. 3. Фармацевтическая композиция по п.1, гранулированная сухим методом, которая после хранения в течение 4 недель при 40°С и относительной влажности 75% содержит суммарно не более чем приблизительно 2% примесей и/или продуктов разложения, в расчете на выраженную в процентах площадь ВЭЖХ-пиков, относящихся к лекарственному средству.3. The pharmaceutical composition according to claim 1, granular by a dry method, which after storage for 4 weeks at 40 ° C and a relative humidity of 75% contains a total of not more than approximately 2% of impurities and / or decomposition products, calculated on a percentage basis area of the HPLC peaks related to the drug. 4. Фармацевтическая композиция по п.1, используемая в получении твердой стандартной лекарственной формы.4. The pharmaceutical composition according to claim 1, used in the preparation of a solid unit dosage form. 5. Фармацевтическая композиция по п.4, где стандартная лекарственная форма выбрана из группы, состоящей из таблетки и капсулы.5. The pharmaceutical composition according to claim 4, where the standard dosage form is selected from the group consisting of tablets and capsules. 6. Фармацевтическая композиция по п.1, где аторвастатин содержит по меньшей мере частично неупорядоченную или полностью неупорядоченную форму аторвастатина или его фармацевтически приемлемой соли.6. The pharmaceutical composition according to claim 1, where atorvastatin contains at least partially disordered or completely disordered form of atorvastatin or its pharmaceutically acceptable salt. 7. Фармацевтическая композиция по п.4, где стандартная лекарственная форма после хранения в течение 4 недель при 40°С и относительной влажности 75% содержит суммарно не более чем приблизительно 1% примесей и/или продуктов разложения, в расчете на выраженную в процентах площадь ВЭЖХ-пиков, относящихся к лекарственному средству.7. The pharmaceutical composition according to claim 4, where the standard dosage form after storage for 4 weeks at 40 ° C and a relative humidity of 75% contains a total of not more than approximately 1% of impurities and / or decomposition products, based on the percentage area HPLC peaks related to the drug. 8. Стандартная лекарственная форма по п.4, которая в дополнение к аторвастатину содержит также по меньшей мере одно активное лекарственное средство.8. The unit dosage form according to claim 4, which in addition to atorvastatin also contains at least one active drug. 9. Стандартная лекарственная форма по п.8, где содержащееся в дополнение к аторвастатину указанное активное лекарственное средство включает торцетрапиб или амлодипин и их фармацевтически приемлемые соли.9. The unit dosage form of claim 8, wherein said active drug contained in addition to atorvastatin comprises torcetrapib or amlodipine and their pharmaceutically acceptable salts. 10. Способ получения гранулированной сухим методом фармацевтической композиции аторвастатина, включающий10. A method of obtaining a granular dry method of the pharmaceutical composition of atorvastatin, including а) объединение аторвастатина или его фармацевтически приемлемой соли и одного или более эксципиентов, пригодных для использования на стадии сухого гранулирования;a) combining atorvastatin or a pharmaceutically acceptable salt thereof and one or more excipients suitable for use in the dry granulation step; б) перемешивание смеси в смесителе;b) mixing the mixture in a mixer; в) прессование смеси;c) pressing the mixture; г) размалывание, измельчение или просеивание прессованного материала;d) grinding, grinding or sieving the pressed material; д) возможное добавление дополнительных эксципиентов и смешивание комбинации с получением композиции.d) the possible addition of additional excipients and mixing the combination to obtain a composition. 11. Способ получения стандартной лекарственной формы, содержащей аторвастатин и по меньшей мере одно другое активное лекарственное средство, при котором композицию, полученную в соответствии со способом по п.10, объединяют по меньшей мере с одним другим активным лекарственным средством и, возможно, дополнительными эксципиентами.11. A method of obtaining a standard dosage form containing atorvastatin and at least one other active drug, in which the composition obtained in accordance with the method of claim 10, is combined with at least one other active drug and, possibly, additional excipients . 12. Применение фармацевтической композиции по п.1 для изготовления лекарства для лечения гиперхолестеринемии и/или гиперлипидемии, остеопороза, доброкачественной гиперплазии простаты и болезни Альцгеймера.12. The use of the pharmaceutical composition according to claim 1 for the manufacture of a medicament for the treatment of hypercholesterolemia and / or hyperlipidemia, osteoporosis, benign prostatic hyperplasia and Alzheimer's disease. 13. Набор для достижения терапевтического эффекта у млекопитающего, включающий терапевтически эффективное количество гранулированного сухим методом аторвастатина или его фармацевтически приемлемой соли в составе стандартной лекарственной формы, и контейнер, вмещающий указанную лекарственную форму.13. A kit for achieving a therapeutic effect in a mammal, comprising a therapeutically effective amount of a dry granulated atorvastatin or a pharmaceutically acceptable salt thereof in a unit dosage form, and a container containing said dosage form.
RU2005136743/15A 2003-06-12 2004-06-01 Pharmaceutical formulation of atorvastatin RU2325903C2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US47791703P 2003-06-12 2003-06-12
US60/477,917 2003-06-12

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RU2005136743A true RU2005136743A (en) 2006-07-27
RU2325903C2 RU2325903C2 (en) 2008-06-10

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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)

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CA2547216A1 (en) * 2005-09-21 2007-03-21 Renuka D. Reddy Process for annealing amorphous atorvastatin
KR101381076B1 (en) 2006-03-29 2014-04-02 코와 가부시키가이샤 Triglyceride-lowering agent and hyperinsulinism-ameliorating agent
CN101973922B (en) * 2009-05-27 2013-01-23 天津和美生物技术有限公司 Atorvastatin semi-strontium salt polymorphs as well as preparation and application thereof as HMG-CoA enzyme inhibitor
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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
JP6306690B2 (en) * 2014-09-26 2018-04-04 株式会社フジクラ Optical fiber
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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
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WO2004056358A1 (en) * 2002-12-20 2004-07-08 Pfizer Products Inc. Dosage forms comprising a cetp inhibitor and an hmg-coa reductase inhibitor

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CO5640071A2 (en) 2006-05-31
JP2006527259A (en) 2006-11-30
CA2465693A1 (en) 2004-12-12
AR044660A1 (en) 2005-09-21
MXPA05012955A (en) 2006-02-13
AU2004246867A1 (en) 2004-12-23
NO20060149L (en) 2006-03-06
KR100760112B1 (en) 2007-09-18
WO2004110406A1 (en) 2004-12-23
EP1635788A1 (en) 2006-03-22
TW200503689A (en) 2005-02-01
KR20060025167A (en) 2006-03-20
RU2325903C2 (en) 2008-06-10
CN1805732A (en) 2006-07-19
ZA200508204B (en) 2007-03-28
BRPI0411354A (en) 2006-07-11

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