AR078785A1 - Formulaciones de bazedoxifeno con antioxidantes - Google Patents

Formulaciones de bazedoxifeno con antioxidantes

Info

Publication number
AR078785A1
AR078785A1 ARP100103936A ARP100103936A AR078785A1 AR 078785 A1 AR078785 A1 AR 078785A1 AR P100103936 A ARP100103936 A AR P100103936A AR P100103936 A ARP100103936 A AR P100103936A AR 078785 A1 AR078785 A1 AR 078785A1
Authority
AR
Argentina
Prior art keywords
bazedoxifene
ascorbic acid
vitamin
stability
methods
Prior art date
Application number
ARP100103936A
Other languages
English (en)
Inventor
Anjali Agrawal
Srinivas Chirra
Arwinder S Nagi
Pelt Lawrence Van
Ramarao S Chatlapalli
Original Assignee
Wyeth Llc
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 Wyeth Llc filed Critical Wyeth Llc
Publication of AR078785A1 publication Critical patent/AR078785A1/es

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
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • 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
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—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
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • 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
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/12—Drugs for disorders of the urinary system of the kidneys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/02—Drugs for genital or sexual disorders; Contraceptives for disorders of the vagina
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/18—Feminine contraceptives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/10—Anti-acne agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/14—Drugs for dermatological disorders for baldness or alopecia
    • 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
    • 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
    • A61P35/00—Antineoplastic agents
    • A61P35/02—Antineoplastic agents specific for leukemia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/24—Drugs for disorders of the endocrine system of the sex hormones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Epidemiology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Endocrinology (AREA)
  • Reproductive Health (AREA)
  • Hematology (AREA)
  • Urology & Nephrology (AREA)
  • Dermatology (AREA)
  • Diabetes (AREA)
  • Gynecology & Obstetrics (AREA)
  • Rheumatology (AREA)
  • Molecular Biology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Biophysics (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Vascular Medicine (AREA)
  • Oncology (AREA)
  • Obesity (AREA)
  • Psychiatry (AREA)
  • Hospice & Palliative Care (AREA)
  • Medicinal Preparation (AREA)

Abstract

Composiciones farmacéuticas que comprenden bazedoxifeno y un antioxidante, tal como la vitamina E, la vitamina E TPGS, el galato de propilo, el ácido cítrico o el BHA/BHT, que están sustancialmente libres de ácido ascorbico. Métodos para preparar dichas composiciones. Métodos para mejorar la estabilidad de la disolucion y/o la biodisponibilidad del bazedoxifeno en una formulacion que contiene un antioxidante. Métodos para reducir las interacciones entre el bazedoxifeno o la hidroximetil celulosa y al menos el ácido ascorbico o uno o más productos de la degradacion del ácido ascorbico en dichas composiciones. Reivindicacion 19: Una composicion farmacéutica caracterizada porque comprende un nucleo que comprende estrogenos conjugados; al menos un recubrimiento que comprende bazedoxifeno o una sal farmacéuticamente aceptable de éste, un relleno, un aglutinante, un agente humectante y al menos vitamina E o vitamina E TPGS, donde el al menos un recubrimiento está sustancialmente libre de ácido ascorbico, y donde la estabilidad de la disolucion del bazedoxifeno en la composicion farmacéutica es mejor que la estabilidad de la disolucion del bazedoxifeno eh una composicion farmacéutica que comprende bazedoxifeno y ácido ascorbico.
ARP100103936A 2009-10-27 2010-10-26 Formulaciones de bazedoxifeno con antioxidantes AR078785A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US25521609P 2009-10-27 2009-10-27

Publications (1)

Publication Number Publication Date
AR078785A1 true AR078785A1 (es) 2011-11-30

Family

ID=43970656

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP100103936A AR078785A1 (es) 2009-10-27 2010-10-26 Formulaciones de bazedoxifeno con antioxidantes

Country Status (8)

Country Link
US (1) US20110165241A1 (es)
EP (1) EP2493477B1 (es)
JP (1) JP5770450B2 (es)
AR (1) AR078785A1 (es)
CA (1) CA2775599A1 (es)
ES (1) ES2436841T3 (es)
TW (1) TW201127386A (es)
WO (1) WO2011056532A2 (es)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103781354A (zh) * 2011-07-28 2014-05-07 泰华制药工业有限公司 用拉喹莫德与醋酸格拉替雷的组合治疗多发性硬化症
WO2013182170A1 (en) * 2012-06-07 2013-12-12 Zentiva, K. S. Enhancement of dissolution rate from pharmaceutical composition comprising bazedoxifene acetate
CN103845336B (zh) * 2014-03-24 2016-03-09 江苏知原药业有限公司 一种性能优异的乙酸巴多昔芬组合物
CN103877581B (zh) * 2014-03-24 2016-03-02 江苏知原药业有限公司 一种性能优异的乙酸巴多昔芬缓释制剂
CN104370796B (zh) * 2014-11-21 2016-09-14 扬子江药业集团有限公司 一种醋酸巴多昔芬多晶型b的制备方法
CN106198827B (zh) * 2016-08-11 2018-03-27 齐鲁制药有限公司 高效测定醋酸巴多昔芬及其杂质的药物分析方法
WO2018182205A1 (ko) * 2017-03-30 2018-10-04 한미약품 주식회사 바제독시펜 아세테이트를 함유하는 안정화된 약제학적 조성물
CN113368075A (zh) * 2021-06-29 2021-09-10 郑州泰丰制药有限公司 一种醋酸巴多昔芬片及其制备方法

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2565115A (en) 1948-10-28 1951-08-21 Squibb & Sons Inc Method of obtaining a conjugated estrogen preparation
US2720483A (en) 1951-02-21 1955-10-11 Olin Mathieson Method of obtaining a conjugatedestrogen preparation
US5210081A (en) 1992-02-26 1993-05-11 American Home Products Corporation Alkali metal 8,9-dehydroestrone sulfate esters
US5554601A (en) 1993-11-05 1996-09-10 University Of Florida Methods for neuroprotection
US5998402A (en) 1996-04-19 1999-12-07 American Home Products Corporation 2-phenyl-1-[4-(2-aminoethoxy)-benzyl]-indoles as estrogenic agents
US6479535B1 (en) 1998-05-15 2002-11-12 Wyeth 2-phenyl-1-[4-(2-aminoethoxy)-benzyl]-indole and estrogen formulations
AR029538A1 (es) 2000-07-06 2003-07-02 Wyeth Corp Composiciones farmaceuticas de agentes estrogenicos
TW200536845A (en) 2004-04-07 2005-11-16 Wyeth Corp Crystalline polymorph of bazedoxifene acetate
RU2006132180A (ru) 2004-04-07 2008-05-20 Вайет (Us) Кристаллический полиморф базедоксифен ацетата
US20070003623A1 (en) 2005-06-29 2007-01-04 Wyeth Formulations of conjugated estrogens and bazedoxifene
EP2086550A2 (en) 2006-11-29 2009-08-12 Wyeth Estrogen/ serm and estrogen/ progestin bi-layer tablets
JP2010515758A (ja) 2007-01-12 2010-05-13 ワイス エルエルシー 錠剤中錠剤組成物
WO2009102773A1 (en) * 2008-02-11 2009-08-20 Wyeth Methods of preparing polymorphic form a of bazedoxifene acetate

Also Published As

Publication number Publication date
US20110165241A1 (en) 2011-07-07
WO2011056532A2 (en) 2011-05-12
EP2493477A2 (en) 2012-09-05
WO2011056532A3 (en) 2011-12-15
TW201127386A (en) 2011-08-16
EP2493477B1 (en) 2013-10-16
ES2436841T3 (es) 2014-01-07
JP2011093902A (ja) 2011-05-12
CA2775599A1 (en) 2011-05-12
JP5770450B2 (ja) 2015-08-26

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