BRPI0411344A - composições farmacêuticas granuladas de atorvastatina, forma de dosagem unitária, método para preparar as mesmas, uso e kit - Google Patents
composições farmacêuticas granuladas de atorvastatina, forma de dosagem unitária, método para preparar as mesmas, uso e kitInfo
- 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
Links
- XUKUURHRXDUEBC-KAYWLYCHSA-N Atorvastatin Chemical compound C=1C=CC=CC=1C1=C(C=2C=CC(F)=CC=2)N(CC[C@@H](O)C[C@@H](O)CC(O)=O)C(C(C)C)=C1C(=O)NC1=CC=CC=C1 XUKUURHRXDUEBC-KAYWLYCHSA-N 0.000 title abstract 5
- XUKUURHRXDUEBC-UHFFFAOYSA-N Atorvastatin Natural products C=1C=CC=CC=1C1=C(C=2C=CC(F)=CC=2)N(CCC(O)CC(O)CC(O)=O)C(C(C)C)=C1C(=O)NC1=CC=CC=C1 XUKUURHRXDUEBC-UHFFFAOYSA-N 0.000 title abstract 5
- 229960005370 atorvastatin Drugs 0.000 title abstract 5
- 239000008194 pharmaceutical composition Substances 0.000 title abstract 5
- 239000002552 dosage form Substances 0.000 title abstract 2
- 206010004446 Benign prostatic hyperplasia Diseases 0.000 abstract 2
- 229940079593 drug Drugs 0.000 abstract 2
- 239000003814 drug Substances 0.000 abstract 2
- 239000000203 mixture Substances 0.000 abstract 2
- 150000003839 salts Chemical class 0.000 abstract 2
- OUCSEDFVYPBLLF-KAYWLYCHSA-N 5-(4-fluorophenyl)-1-[2-[(2r,4r)-4-hydroxy-6-oxooxan-2-yl]ethyl]-n,4-diphenyl-2-propan-2-ylpyrrole-3-carboxamide Chemical compound C=1C=CC=CC=1C1=C(C=2C=CC(F)=CC=2)N(CC[C@H]2OC(=O)C[C@H](O)C2)C(C(C)C)=C1C(=O)NC1=CC=CC=C1 OUCSEDFVYPBLLF-KAYWLYCHSA-N 0.000 abstract 1
- 208000024827 Alzheimer disease Diseases 0.000 abstract 1
- 208000035150 Hypercholesterolemia Diseases 0.000 abstract 1
- 208000031226 Hyperlipidaemia Diseases 0.000 abstract 1
- 208000001132 Osteoporosis Diseases 0.000 abstract 1
- 239000000654 additive Substances 0.000 abstract 1
- 230000000996 additive effect Effects 0.000 abstract 1
- 229910052784 alkaline earth metal Inorganic materials 0.000 abstract 1
- -1 alkaline earth metal salt Chemical class 0.000 abstract 1
- 239000007884 disintegrant Substances 0.000 abstract 1
- 230000010354 integration Effects 0.000 abstract 1
- 150000002596 lactones Chemical class 0.000 abstract 1
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
- A61K9/14—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
- 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
-
- 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
-
- 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
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)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Physical Education & Sports Medicine (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Rheumatology (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Hematology (AREA)
- Urology & Nephrology (AREA)
- Diabetes (AREA)
- Psychiatry (AREA)
- Hospice & Palliative Care (AREA)
- Obesity (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.
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 (pt) | 2006-07-11 |
Family
ID=33551806
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| BRPI0411344-6A BRPI0411344A (pt) | 2003-06-12 | 2004-06-01 | composições farmacêuticas granuladas de atorvastatina, forma de dosagem unitária, método para preparar as mesmas, uso e kit |
Country Status (15)
| Country | Link |
|---|---|
| EP (1) | EP1635814A1 (pt) |
| JP (1) | JP2006527260A (pt) |
| KR (1) | KR100814218B1 (pt) |
| CN (1) | CN100434069C (pt) |
| AR (1) | AR044774A1 (pt) |
| AU (1) | AU2004246868B2 (pt) |
| BR (1) | BRPI0411344A (pt) |
| CA (1) | CA2465565A1 (pt) |
| CO (1) | CO5650230A2 (pt) |
| MX (1) | MXPA05013281A (pt) |
| NO (1) | NO20060022L (pt) |
| NZ (1) | NZ543337A (pt) |
| RU (1) | RU2332211C2 (pt) |
| TW (1) | TW200503690A (pt) |
| WO (1) | WO2004110431A1 (pt) |
Families Citing this family (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FI94339C (fi) | 1989-07-21 | 1995-08-25 | Warner Lambert Co | Menetelmä farmaseuttisesti käyttökelpoisen /R-(R*,R*)/-2-(4-fluorifenyyli)- , -dihydroksi-5-(1-metyylietyyli)-3-fenyyli-4-/(fenyyliamino)karbonyyli/-1H-pyrroli-1-heptaanihapon ja sen farmaseuttisesti hyväksyttävien suolojen valmistamiseksi |
| GB0613925D0 (en) * | 2006-07-13 | 2006-08-23 | Unilever Plc | Improvements relating to nanodispersions |
| CA2691956A1 (en) * | 2007-06-25 | 2008-12-31 | Pharmathen S.A. | Improved pharmaceutical formulation containing an hmg-coa reductase inhibitor and method for the preparation thereof |
| AU2009218573A1 (en) * | 2008-02-27 | 2009-09-03 | Thommen Medical Ag | 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 (ru) * | 2009-08-11 | 2010-11-27 | Закрытое Акционерное Общество "БИОКОМ" | Твердая лекарственная форма, обладающая гиполипидемической и гипохолестеринемической активностью, и способ ее получения |
| HUP1000299A2 (hu) | 2010-06-08 | 2012-02-28 | Nanoform Cardiovascular Therapeutics Ltd | Nanostrukturált Atorvastatint, gyógyszerészetileg elfogadott sóit és kokristályait tartalmazó készítmény és eljárás elõállításukra |
| IN2014CN04119A (pt) | 2011-11-15 | 2015-07-10 | Reddys Lab Ltd Dr | |
| KR102396897B1 (ko) * | 2012-11-02 | 2022-05-13 | 버텍스 파마슈티칼스 인코포레이티드 | Ｃｆｔｒ 매개된 질환의 치료를 위한 약제학적 조성물 |
| CN104069078B (zh) * | 2014-05-22 | 2019-06-11 | 西藏九瑞健康股份有限公司 | 阿托伐他汀钙药物组合物及其制备方法 |
| SG10201900648SA (en) | 2014-07-25 | 2019-02-27 | 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 (ko) * | 2015-02-06 | 2016-09-30 | 경성대학교 산학협력단 | 고지혈증 치료에 유용한 약학 조성물 |
| EP3267977B1 (en) * | 2015-03-12 | 2021-08-11 | DuPont Nutrition USA, Inc. | Solid dispersions |
| JPWO2017170858A1 (ja) | 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 | 溶出性に優れた経口製剤 |
Family Cites Families (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ES2133158T3 (es) * | 1993-01-19 | 1999-09-01 | Warner Lambert Co | Formulacion ci-981 oral, estable y proceso de preparacion del mismo. |
| JPH06242003A (ja) * | 1993-02-12 | 1994-09-02 | Nkk Corp | 鉄鋼中のアルミナの粒度測定方法 |
| JP3014040B2 (ja) * | 1996-10-30 | 2000-02-28 | 信久 川野 | 食物繊維パン及びその製造法 |
| 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 (sl) * | 2001-03-14 | 2002-10-31 | Lek, Tovarna Farmacevtskih In Kemijskih Izdelkov, D.D. | Farmacevtska formulacija, ki vsebuje atorvastatin kalcij |
| EP1291017A3 (en) * | 2001-09-10 | 2003-07-02 | Warner-Lambert Company | Use of statins to inhibit formation of osteoclasts |
-
2004
- 2004-04-29 CA CA002465565A patent/CA2465565A1/en not_active Abandoned
- 2004-06-01 CN CNB2004800163910A patent/CN100434069C/zh not_active Expired - Fee Related
- 2004-06-01 AU AU2004246868A patent/AU2004246868B2/en not_active Ceased
- 2004-06-01 KR KR1020057023669A patent/KR100814218B1/ko not_active Expired - Fee Related
- 2004-06-01 WO PCT/IB2004/001862 patent/WO2004110431A1/en not_active Ceased
- 2004-06-01 MX MXPA05013281A patent/MXPA05013281A/es not_active Application Discontinuation
- 2004-06-01 NZ NZ543337A patent/NZ543337A/en unknown
- 2004-06-01 JP JP2006516512A patent/JP2006527260A/ja active Pending
- 2004-06-01 RU RU2005136745/15A patent/RU2332211C2/ru not_active IP Right Cessation
- 2004-06-01 BR BRPI0411344-6A patent/BRPI0411344A/pt not_active IP Right Cessation
- 2004-06-01 EP EP04735614A patent/EP1635814A1/en not_active Withdrawn
- 2004-06-10 AR ARP040102008A patent/AR044774A1/es unknown
- 2004-06-11 TW TW093116894A patent/TW200503690A/zh unknown
-
2005
- 2005-12-09 CO CO05124741A patent/CO5650230A2/es not_active Application Discontinuation
-
2006
- 2006-01-03 NO NO20060022A patent/NO20060022L/no not_active Application Discontinuation
Also Published As
| Publication number | Publication date |
|---|---|
| TW200503690A (en) | 2005-02-01 |
| KR100814218B1 (ko) | 2008-03-17 |
| CO5650230A2 (es) | 2006-06-30 |
| WO2004110431A1 (en) | 2004-12-23 |
| MXPA05013281A (es) | 2006-03-09 |
| JP2006527260A (ja) | 2006-11-30 |
| NZ543337A (en) | 2008-03-28 |
| RU2332211C2 (ru) | 2008-08-27 |
| EP1635814A1 (en) | 2006-03-22 |
| CN100434069C (zh) | 2008-11-19 |
| KR20060020666A (ko) | 2006-03-06 |
| AR044774A1 (es) | 2005-10-05 |
| AU2004246868A1 (en) | 2004-12-23 |
| CN1805741A (zh) | 2006-07-19 |
| RU2005136745A (ru) | 2006-07-27 |
| NO20060022L (no) | 2006-01-03 |
| AU2004246868B2 (en) | 2008-01-17 |
| CA2465565A1 (en) | 2004-12-12 |
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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. |