BRPI0411344A - atorvastatin granular pharmaceutical compositions, unit dosage form, method for preparing them, use and kit - Google Patents

atorvastatin granular pharmaceutical compositions, unit dosage form, method for preparing them, use and kit

Info

Publication number
BRPI0411344A
BRPI0411344A BRPI0411344-6A BRPI0411344A BRPI0411344A BR PI0411344 A BRPI0411344 A BR PI0411344A BR PI0411344 A BRPI0411344 A BR PI0411344A BR PI0411344 A BRPI0411344 A BR PI0411344A
Authority
BR
Brazil
Prior art keywords
atorvastatin
preparing
pharmaceutical compositions
compositions
kit
Prior art date
Application number
BRPI0411344-6A
Other languages
Portuguese (pt)
Inventor
Kenneth Craig Waterman
Michael Bruce Fergione
Barbara Alice Johnson
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 BRPI0411344A publication Critical patent/BRPI0411344A/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • A61K9/1623Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40Heterocyclic 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/08Drugs for disorders of the urinary system of the prostate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/08Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/28Drugs 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/06Antihyperlipidemics

Landscapes

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

Abstract

"COMPOSIçõES FARMACêUTICAS GRANULADAS DE ATORVASTATINA, FORMA DE DOSAGEM UNITáRIA, MéTODO PARA PREPARAR AS MESMAS, USO E KIT". A presente invenção refere-se a uma composição farmacêutica granulada úmida compreendendo atorvastatina ou um seu sal farmaceuticamente aceitável, com menos cerca de 5% em peso de um aditivo de sal de metal alcalino-terroso com um desintegrante que proporciona a atorvastatina com não mais do que cerca de 3% de lactona da atorvastatina com base na relação entre a área do pico da lactona comparado com a integração das áreas dos picos totais relacionados com a droga, bem como a referida composição farmacêutica granulada úmida, compreendendo atorvastatina ou um seu sal farmaceuticamente aceitável em combinação com pelo menos uma outra droga ativa, métodos para preparar as referidas composições, kits para conter tais composições, e um método para tratar a hipercolesterolemia e/ou hiperlipidemia, osteoporose, hiperplasia benigna da próstata (HBP), e doença de Alzheimer utilizando uma quantidade terapeuticamente eficaz das composições farmacêuticas."GRANULATED PHARMACEUTICAL COMPOSITIONS OF ATORVASTATIN, UNIT DOSAGE FORM, METHOD FOR PREPARING THE SAME, USE AND KIT". The present invention relates to a wet granular pharmaceutical composition comprising atorvastatin or a pharmaceutically acceptable salt thereof, at least about 5% by weight of an alkaline earth metal salt additive with a disintegrant providing atorvastatin with no more than that about 3% atorvastatin lactone based on the relationship between the lactone peak area compared to the integration of drug-related total peak areas as well as said wet granular pharmaceutical composition comprising atorvastatin or a pharmaceutically salt thereof acceptable in combination with at least one other active drug, methods for preparing said compositions, kits for containing such compositions, and a method for treating hypercholesterolemia and / or hyperlipidemia, osteoporosis, benign prostate hyperplasia (BPH), and Alzheimer's disease. using a therapeutically effective amount of the pharmaceutical compositions.

BRPI0411344-6A 2003-06-12 2004-06-01 atorvastatin granular pharmaceutical compositions, unit dosage form, method for preparing them, use and kit BRPI0411344A (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US47811903P 2003-06-12 2003-06-12
PCT/IB2004/001862 WO2004110431A1 (en) 2003-06-12 2004-06-01 Stable compositions of atorvastatin prepared with wet granulation

Publications (1)

Publication Number Publication Date
BRPI0411344A true BRPI0411344A (en) 2006-07-11

Family

ID=33551806

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI0411344-6A BRPI0411344A (en) 2003-06-12 2004-06-01 atorvastatin granular pharmaceutical compositions, unit dosage form, method for preparing them, use and kit

Country Status (15)

Country Link
EP (1) EP1635814A1 (en)
JP (1) JP2006527260A (en)
KR (1) KR100814218B1 (en)
CN (1) CN100434069C (en)
AR (1) AR044774A1 (en)
AU (1) AU2004246868B2 (en)
BR (1) BRPI0411344A (en)
CA (1) CA2465565A1 (en)
CO (1) CO5650230A2 (en)
MX (1) MXPA05013281A (en)
NO (1) NO20060022L (en)
NZ (1) NZ543337A (en)
RU (1) RU2332211C2 (en)
TW (1) TW200503690A (en)
WO (1) WO2004110431A1 (en)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FI94339C (en) 1989-07-21 1995-08-25 Warner Lambert Co Process for the preparation of pharmaceutically acceptable [R- (R *, R *)] - 2- (4-fluorophenyl) -, - dihydroxy-5- (1-methylethyl) -3-phenyl-4 - [(phenylamino) carbonyl] -1H- for the preparation of pyrrole-1-heptanoic acid and its pharmaceutically acceptable salts
GB0613925D0 (en) * 2006-07-13 2006-08-23 Unilever Plc Improvements relating to nanodispersions
WO2009000286A1 (en) * 2007-06-25 2008-12-31 Parmatheen S.A. Improved pharmaceutical formulation containing an hmg-coa reductase inhibitor and method for the preparation thereof
KR20100125346A (en) * 2008-02-27 2010-11-30 토멘 메디칼 아게 Implant and method for the manufacture thereof
AU2009292615B2 (en) * 2008-09-17 2015-12-03 Mylan Inc. Granulates, process for preparing them and pharmaceutical products containing them
RU2404767C1 (en) * 2009-08-11 2010-11-27 Закрытое Акционерное Общество "БИОКОМ" Solid dosage form having hypolipidemic and hypocholesteremic activity, and method of its production
HUP1000299A2 (en) 2010-06-08 2012-02-28 Nanoform Cardiovascular Therapeutics Ltd Nanostructured atorvastatin, its pharmaceutically acceptable salts and pharmaceutical compositions containing them and process for their preparation
RU2014124118A (en) 2011-11-15 2015-12-27 Др. Редди'С Лабораторис Лтд. PHARMACEUTICALS, INCLUDING ATORVASTATIN AND GLIMEPIRIDE
LT3470063T (en) * 2012-11-02 2025-02-10 Vertex Pharmaceuticals Incorporated PHARMACEUTICAL COMPOSITIONS FOR THE TREATMENT OF CFTR-RELATED DISEASES
CN104069078B (en) * 2014-05-22 2019-06-11 西藏九瑞健康股份有限公司 Atorvastatin calcium pharmaceutical composition and preparation method thereof
CA2954840A1 (en) * 2014-07-25 2016-01-28 Novartis Ag Tablet formulation of 2-fluoro-n-methyl-4-[7-(quinolin-6-ylmethyl)imidazo[1,2-b][1,2,4]triazin-2-yl]benzamide
KR101658350B1 (en) * 2015-02-06 2016-09-30 경성대학교 산학협력단 Pharmaceutical Composition For Treating Hyperlipidaemia
WO2016145132A1 (en) * 2015-03-12 2016-09-15 Fmc Corporation Solid dispersions
JPWO2017170858A1 (en) 2016-03-31 2019-02-14 インターセプト ファーマシューティカルズ, インコーポレイテッド Oral preparation with excellent dissolution

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP3254219B2 (en) * 1993-01-19 2002-02-04 ワーナー−ランバート・コンパニー Stable oral CI-981 formulation and process for its preparation
JPH06242003A (en) * 1993-02-12 1994-09-02 Nkk Corp Grain size measuring method for alumina in steel
JP3014040B2 (en) * 1996-10-30 2000-02-28 信久 川野 Dietary fiber bread and method for producing the same
CA2406574C (en) * 2000-04-10 2006-12-05 Teva Pharmaceutical Industries, Ltd. Stable pharmaceutical compositions containing 7-substituted-3,5-dihydroxyheptanoic acids or 7-substituted-3,5-dihydroxyheptenoic acids
US6242003B1 (en) * 2000-04-13 2001-06-05 Novartis Ag Organic compounds
EP1226818A1 (en) * 2001-01-26 2002-07-31 Pfizer Products Inc. Pharmaceutical dosage forms with enhanced cohesive and compressibility properties
SI20848A (en) * 2001-03-14 2002-10-31 Lek, Tovarna Farmacevtskih In Kemijskih Izdelkov, D.D. Pharmaceutical formulation containing atorvastatin calcium
EP1291017A3 (en) * 2001-09-10 2003-07-02 Warner-Lambert Company Use of statins to inhibit formation of osteoclasts

Also Published As

Publication number Publication date
CN100434069C (en) 2008-11-19
CO5650230A2 (en) 2006-06-30
AR044774A1 (en) 2005-10-05
RU2332211C2 (en) 2008-08-27
NZ543337A (en) 2008-03-28
TW200503690A (en) 2005-02-01
KR100814218B1 (en) 2008-03-17
CA2465565A1 (en) 2004-12-12
CN1805741A (en) 2006-07-19
NO20060022L (en) 2006-01-03
WO2004110431A1 (en) 2004-12-23
AU2004246868B2 (en) 2008-01-17
MXPA05013281A (en) 2006-03-09
RU2005136745A (en) 2006-07-27
JP2006527260A (en) 2006-11-30
KR20060020666A (en) 2006-03-06
AU2004246868A1 (en) 2004-12-23
EP1635814A1 (en) 2006-03-22

Similar Documents

Publication Publication Date Title
BRPI0411344A (en) atorvastatin granular pharmaceutical compositions, unit dosage form, method for preparing them, use and kit
ES2124372T3 (en) COMPOSITIONS OF PROLONGED RELEASE BASED ON MORPHINE.
ATE407928T1 (en) AMINO-PHTALAZINONE DERIVATIVES, USE AS KINASE INHIBITORS, PRODUCTION AND PHARMACEUTICAL COMPOSITION
BR0113358A (en) Quinazoline derivative or a pharmaceutically acceptable salt thereof, process for its preparation, pharmaceutical composition, and use of the derivative or pharmaceutically acceptable salt thereof
BRPI0418270A (en) methods of treatment and control, treatment or prevention, control of a central nervous system disorder, and to reduce or prevent an adverse effect, and, pharmaceutical composition
BR0109966A (en) Combination of Organic Compounds
BR0108930A (en) Method of delivering an active agent to a cell type of interest, pharmaceutical composition, caspase-activated prodrug, kit, method of treating mammals, using a caspase conjugate and using a pro-agent
BRPI0411354A (en) Atorvastatin pharmaceutical compositions, unit dosage form, methods for preparing a granular pharmaceutical composition and for preparing a unit dosage form, use of the pharmaceutical composition and kit thereof
IS2114B (en) Quinazoline derivatives to treat tumors
ATE308327T1 (en) USE OF 2-HYDROXY-5-PHENYLAZOBENZOIC ACID DERIVATIVES AS ACTIVE INGREDIENTS FOR CHEMOPREVENTION AND CHEMOTHERAPY OF COLON CANCER
BRPI0411017A (en) 3-substituted indoles and derivatives thereof as therapeutic agents
AR044775A1 (en) ATORVASTATIN PHARMACEUTICAL COMPOSITIONS
DOP2004000949A (en) PIRROLO DERIVATIVES [3,4-C] PIRAZOL ASSETS AS KINASE INHIBITORS, PROCESS FOR PREPARATION AND PHARMACEUTICAL COMPOSITIONS THAT INCLUDE THE SAME
EA200300183A1 (en) NEW COMBINATION OF THE AGONIST (5-TH2) AND THE ANTAGONIST (5-HT6) SEROTONIN AS A PHARMACEUTICAL COMPOSITION
IS6558A (en) Mixed disease treatment with vasoconstrictor
FR2878158B1 (en) ORAL PHARMACEUTICAL FORM, SOLID MICROPARTICULAR DESIGNED TO PREVENT MEASUREMENT
EA200100799A1 (en) ANTAGONISTS OF THE TUMOR NECROSE FACTOR AND THEIR APPLICATION IN ENDOMETRIOSIS
AR018162A1 (en) SUBSTITUTED PIRROLS, PHARMACEUTICAL COMPOSITION AND THE USE OF THEM FOR THE PREPARATION OF SUCH PHARMACEUTICAL COMPOSITION
BRPI0409818A (en) compounds, pharmaceutical compositions, method for the treatment or prophylaxis of diseases, and uses of compounds and one or more compounds in combination with other pharmacologically active compounds
BRPI0409878A (en) compounds, pharmaceutical compositions, method for the treatment or prophylaxis of diseases, and uses of compounds and one or more compounds in combination with other pharmacologically active compounds
BRPI0409881A (en) compounds, pharmaceutical compositions, method for the treatment or prophylaxis of diseases, and uses of compounds and one or more compounds in combination with other pharmacologically active compounds
ATE400256T1 (en) PHARMACEUTICAL COMPOSITION CONTAINING A CATIONIC EXCIPIENT
BR0008054A (en) Crystalline form of eplerenone
UY26498A1 (en) SUBSTITUTED PYRROLES
WO2002085368A3 (en) Use of radical scavenging compounds for treatment and prevention of no-dependent microcirculation disorders

Legal Events

Date Code Title Description
B08F Application fees: application dismissed [chapter 8.6 patent gazette]

Free format text: REFERENTE A 6A E 7A ANUIDADES.

B08K Patent lapsed as no evidence of payment of the annual fee has been furnished to inpi [chapter 8.11 patent gazette]

Free format text: REFERENTE AO DESPACHO 8.6 PUBLICADO NA RPI 2125 DE 27/09/2011.