ES2720954T3 - Formulaciones estabilizadas de estatina - Google Patents

Formulaciones estabilizadas de estatina Download PDF

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Publication number
ES2720954T3
ES2720954T3 ES11769321T ES11769321T ES2720954T3 ES 2720954 T3 ES2720954 T3 ES 2720954T3 ES 11769321 T ES11769321 T ES 11769321T ES 11769321 T ES11769321 T ES 11769321T ES 2720954 T3 ES2720954 T3 ES 2720954T3
Authority
ES
Spain
Prior art keywords
atorvastatin
statin
buffer
pharmaceutically acceptable
aqueous solution
Prior art date
Legal status (The legal status 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 status listed.)
Active
Application number
ES11769321T
Other languages
English (en)
Inventor
Leo Pavliv
Andrew Vila
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Cumberland Pharmaceuticals Inc
Original Assignee
Cumberland Pharmaceuticals Inc
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 Cumberland Pharmaceuticals Inc filed Critical Cumberland Pharmaceuticals Inc
Application granted granted Critical
Publication of ES2720954T3 publication Critical patent/ES2720954T3/es
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • A61K9/08—Solutions
    • 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
    • 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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/40—Cyclodextrins; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/69—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
    • A61K47/6949—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes
    • A61K47/6951—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes using cyclodextrin
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • 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)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Dermatology (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Inorganic Chemistry (AREA)
  • Rheumatology (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Pain & Pain Management (AREA)
  • Emergency Medicine (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

Una formulacion farmaceutica liquida que es una solucion acuosa que comprende una cantidad eficaz de atorvastatina o una sal farmaceuticamente aceptable de la misma, complejada con una cantidad eficaz de un agente complejante farmaceuticamente aceptable, que es hidroxil-propil-ß-ciclodextrina, para hacer que la atorvastatina sea soluble en agua, un agente de ajuste del pH seleccionado entre el grupo que consiste en un agente alcalinizante, un tampon, y una combinacion de un agente alcalinizante y un tampon, y un antioxidante opcional en una solucion acuosa que tiene un pH de 7 a 9 para proporcionar una concentracion de atorvastatina solubilizada de al menos 3,32 mg/ml.
ES11769321T 2010-04-16 2011-04-06 Formulaciones estabilizadas de estatina Active ES2720954T3 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US12/762,025 US8372877B2 (en) 2010-04-16 2010-04-16 Stabilized statin formulations
PCT/US2011/031388 WO2011130079A1 (en) 2010-04-16 2011-04-06 Stabilized statin formulations

Publications (1)

Publication Number Publication Date
ES2720954T3 true ES2720954T3 (es) 2019-07-25

Family

ID=44788660

Family Applications (1)

Application Number Title Priority Date Filing Date
ES11769321T Active ES2720954T3 (es) 2010-04-16 2011-04-06 Formulaciones estabilizadas de estatina

Country Status (10)

Country Link
US (8) US8372877B2 (es)
EP (2) EP3524053A1 (es)
JP (2) JP5938394B2 (es)
KR (1) KR101462326B1 (es)
CN (1) CN102892287B (es)
AU (1) AU2011240925B2 (es)
BR (1) BR112012026465A2 (es)
CA (1) CA2799550C (es)
ES (1) ES2720954T3 (es)
WO (1) WO2011130079A1 (es)

Families Citing this family (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8372877B2 (en) * 2010-04-16 2013-02-12 Cumberland Pharmaceuticals Stabilized statin formulations
WO2012054321A2 (en) 2010-10-19 2012-04-26 University Of Miami Assays, methods and kits for predicting renal disease and personalized treatment strategies
US9592296B2 (en) * 2011-09-08 2017-03-14 Hexal Ag Pharmaceutical composition for oral administration with a statin
WO2013155485A2 (en) * 2012-04-13 2013-10-17 Alessia Fornoni Method of using cyclodextrin
JP6053945B2 (ja) * 2012-11-23 2016-12-27 ペキン ユニバーシティ サード ホスピタルＰｅｋｉｎｇ Ｕｎｉｖｅｒｓｉｔｙ Ｔｈｉｒｄ Ｈｏｓｐｉｔａｌ 肥満症、糖尿病、高血圧症及び高脂血症を治療するための局所薬としてのスタチン化合物の使用
US9974767B2 (en) 2014-07-14 2018-05-22 University Of Washington Statins in the treatment of muscular dystrophies and myopathies
KR101686881B1 (ko) * 2014-07-25 2016-12-20 연세대학교 산학협력단 스타틴을 포함하는 갑상선 안병증의 예방 또는 치료용 약제학적 조성물
JP6355688B2 (ja) * 2016-09-01 2018-07-11 ペキン ユニバーシティ サード ホスピタルＰｅｋｉｎｇ Ｕｎｉｖｅｒｓｉｔｙ Ｔｈｉｒｄ Ｈｏｓｐｉｔａｌ 虚血性疾患の治療におけるスタチンの使用
KR102099627B1 (ko) 2018-04-13 2020-04-10 (주)바이오리치 냉이 추출물 및 신이 추출물을 유효성분으로 포함하는 지질 대사 개선용 조성물
CN110237055B (zh) * 2019-07-15 2021-09-07 江苏中兴药业有限公司 一种水飞蓟宾与辛伐他汀的药物组合物及其制备方法与应用
EP4294403A4 (en) * 2021-02-18 2024-12-11 Beren Therapeutics P.B.C. METHODS OF TREATMENT OF HETEROZYGOUS AND HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA WITH CYCLODEXTRINS
GB2624171A (en) 2022-11-08 2024-05-15 Novumgen Ltd An orally disintegrating tablet containing atorvastatin and process of preparing the same
WO2025221463A1 (en) * 2024-04-19 2025-10-23 Prevep, Inc. Pharmaceutical compositions comprising atorvastatin, or a salt thereof, and a liquid carrier

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Also Published As

Publication number Publication date
EP2557919A1 (en) 2013-02-20
WO2011130079A1 (en) 2011-10-20
CN102892287A (zh) 2013-01-23
HK1180541A1 (en) 2013-10-25
US20110257240A1 (en) 2011-10-20
JP6178444B2 (ja) 2017-08-09
AU2011240925A1 (en) 2012-11-15
US20150065553A1 (en) 2015-03-05
US20130137745A1 (en) 2013-05-30
JP5938394B2 (ja) 2016-06-22
US8933115B2 (en) 2015-01-13
US9820966B2 (en) 2017-11-21
JP2013525301A (ja) 2013-06-20
CN102892287B (zh) 2014-11-05
BR112012026465A2 (pt) 2017-07-11
KR101462326B1 (ko) 2014-11-14
JP2016166179A (ja) 2016-09-15
CA2799550A1 (en) 2011-10-20
US20180344693A1 (en) 2018-12-06
CA2799550C (en) 2015-03-17
EP2557919A4 (en) 2013-12-25
AU2011240925B2 (en) 2015-01-15
US20210106561A1 (en) 2021-04-15
US8372877B2 (en) 2013-02-12
US20180036282A1 (en) 2018-02-08
US20160128977A9 (en) 2016-05-12
US20200316022A1 (en) 2020-10-08
KR20130020788A (ko) 2013-02-28
EP3524053A1 (en) 2019-08-14
EP2557919B1 (en) 2019-01-30
US20190117621A1 (en) 2019-04-25

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