BR112014025041B8 - Composição farmacêutica - Google Patents

Composição farmacêutica

Info

Publication number
BR112014025041B8
BR112014025041B8 BR112014025041A BR112014025041A BR112014025041B8 BR 112014025041 B8 BR112014025041 B8 BR 112014025041B8 BR 112014025041 A BR112014025041 A BR 112014025041A BR 112014025041 A BR112014025041 A BR 112014025041A BR 112014025041 B8 BR112014025041 B8 BR 112014025041B8
Authority
BR
Brazil
Prior art keywords
pharmaceutical composition
pharmaceutically acceptable
suvorexant
optionally
concentration
Prior art date
Application number
BR112014025041A
Other languages
English (en)
Other versions
BR112014025041B1 (pt
Inventor
A Harmon Paul
Variankaval Narayan
Original Assignee
Merck Sharp & Dohme
Merck Sharp & Dohme 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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=49674030&utm_source=***_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=BR112014025041(B8) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Merck Sharp & Dohme, Merck Sharp & Dohme Llc filed Critical Merck Sharp & Dohme
Publication of BR112014025041B1 publication Critical patent/BR112014025041B1/pt
Publication of BR112014025041B8 publication Critical patent/BR112014025041B8/pt

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
    • A61K31/551—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having two nitrogen atoms, e.g. dilazep
    • 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
    • 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
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • 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
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • 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
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • 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
    • A61P1/08—Drugs for disorders of the alimentary tract or the digestive system for nausea, cinetosis or vertigo; Antiemetics
    • 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
    • A61P1/14—Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/06—Antiasthmatics
    • 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
    • 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
    • A61P25/06—Antimigraine agents
    • 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
    • A61P25/08—Antiepileptics; Anticonvulsants
    • 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
    • A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A61P25/16—Anti-Parkinson drugs
    • 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
    • A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
    • 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
    • A61P25/20—Hypnotics; Sedatives
    • 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
    • A61P25/22—Anxiolytics
    • 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
    • A61P25/24—Antidepressants
    • 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
    • A61P3/04—Anorexiants; Antiobesity agents
    • 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
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • 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
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/02—Drugs for disorders of the endocrine system of the hypothalamic hormones, e.g. TRH, GnRH, CRH, GRH, somatostatin
    • 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
    • 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
    • A61P9/12—Antihypertensives

Abstract

COMPOSIÇÃO FARMACÊUTICA. A presente invenção refere-se a uma composição farmacêutica compreendendo o composto suvorexanto, ou um sal farmaceuticamente aceitável do mesmo, um polímero intensificador de concentração, e opcionalmente um tensoativo farmaceuticamente aceitável.
BR112014025041A 2012-05-31 2013-05-29 Composição farmacêutica BR112014025041B8 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201261653539P 2012-05-31 2012-05-31
US201361787686P 2013-03-15 2013-03-15
PCT/US2013/042959 WO2013181174A2 (en) 2012-05-31 2013-05-29 Solid dosage formulations of an orexin receptor antagonist

Publications (2)

Publication Number Publication Date
BR112014025041B1 BR112014025041B1 (pt) 2019-10-22
BR112014025041B8 true BR112014025041B8 (pt) 2023-04-18

Family

ID=49674030

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112014025041A BR112014025041B8 (pt) 2012-05-31 2013-05-29 Composição farmacêutica

Country Status (10)

Country Link
US (2) US10098892B2 (pt)
EP (1) EP2854816B1 (pt)
JP (1) JP6263169B2 (pt)
KR (1) KR102123130B1 (pt)
CN (2) CN109078015A (pt)
AU (2) AU2013267613A1 (pt)
BR (1) BR112014025041B8 (pt)
MX (1) MX368859B (pt)
RU (2) RU2699358C2 (pt)
WO (1) WO2013181174A2 (pt)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2015248736B2 (en) * 2014-04-17 2018-11-29 Sandoz Ag Solid dispersion comprising an orexin receptor antagonist
WO2015164160A1 (en) * 2014-04-21 2015-10-29 Merck Sharp & Dohme Corp. Pharmaceutical salts of an orexin receptor antagonist
CN105377840B (zh) * 2014-05-28 2017-12-22 杭州普晒医药科技有限公司 一种二氮杂环庚烷化合物的盐及其晶型与无定型物
EP3223803A1 (en) * 2014-11-24 2017-10-04 INSERM (Institut National de la Santé et de la Recherche Médicale) Use of ox1r antagonists for the treatment of inflammatory bowel diseases
CZ201587A3 (cs) 2015-02-10 2016-08-17 Zentiva, K.S. Amorfní pevná forma suvorexantu s kyselinou sírovou
WO2017001499A1 (en) 2015-06-30 2017-01-05 Hexal Ag Liquid composition comprising suvorexant
WO2017072264A1 (en) 2015-10-29 2017-05-04 Hexal Ag Solid composition comprising suvorexant
CN105886592A (zh) * 2016-03-02 2016-08-24 昆明理工大学 一种基于食欲素受体1分子探针的药物活性成分筛选方法
US20190151304A1 (en) * 2016-05-10 2019-05-23 Inserm (Institut National De La Santé Et De La Rechercjae Médicale Methods and pharmaceutical compositions for the treatment of autoimmune inflammatory
US20200078303A1 (en) * 2016-12-19 2020-03-12 Druggability Technologies Ip Holdco Ltd. Pharmaceutical formulations of suvorexant
AU2018252153A1 (en) * 2017-04-13 2019-11-07 Jean Paul Remon Xanthohumol-based compositions
US11504327B1 (en) 2019-01-21 2022-11-22 Eric Morrison Method of preparing nanoparticles by hot-melt extrusion

Family Cites Families (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3222359A (en) 1965-12-07 Process for preparing benzodiazepine compounds
JP2003518485A (ja) 1999-12-23 2003-06-10 ファイザー・プロダクツ・インク 向上された薬物濃度を与える医薬組成物
CA2448864C (en) * 2001-06-22 2008-04-22 Pfizer Products Inc. Pharmaceutical compositions containing a solid dispersion of a poorly-soluble drug in a matrix and a solubility-enhancing polymer
KR100758045B1 (ko) * 2002-02-01 2007-09-11 화이자 프로덕츠 인크. 압력 노즐을 이용하여 균질한 분무 건조된 비결정질 고체약물 분산제를 제조하는 방법
CN101299993A (zh) * 2005-11-04 2008-11-05 伊士曼化工公司 用于给药难溶的药学活性剂的羧烷基纤维素酯
JP5773560B2 (ja) * 2006-02-09 2015-09-02 メルク・シャープ・アンド・ドーム・コーポレーションＭｅｒｃｋ Ｓｈａｒｐ ＆ Ｄｏｈｍｅ Ｃｏｒｐ． Ｃｅｔｐ阻害剤のポリマー製剤
CA2647678A1 (en) 2006-03-29 2007-11-08 Merck & Co., Inc. Diazepan orexin receptor antagonists
PE20081229A1 (es) * 2006-12-01 2008-08-28 Merck & Co Inc Antagonistas de receptor de orexina de diazepam sustituido
CN101702878B (zh) 2007-05-11 2012-11-28 弗·哈夫曼-拉罗切有限公司 可溶性差的药物的药物组合物
EP2249808A2 (en) * 2008-01-11 2010-11-17 Cipla Limited Solid pharmaceutical dosage form
US7902376B2 (en) 2008-01-23 2011-03-08 Merck Sharp & Dohme Corp. Process for preparing chiral dipeptidyl peptidase-IV inhibitor intermediates
WO2012148553A1 (en) 2011-03-03 2012-11-01 Merck Sharp & Dohme Corp. Process for the preparation of an orexin receptor antagonist
US20160272627A1 (en) 2012-11-12 2016-09-22 Dr. Reddy's Laboratories Limited Polymorphic forms of suvoroxant
US20160168138A1 (en) 2013-07-15 2016-06-16 Dr. Reddy's Laboratories Limted Process for the preparation of suvorexant and intermediates useful in the synthesis of suvorexant
EP3102188A4 (en) 2014-02-05 2017-07-12 Merck Sharp & Dohme Corp. Novel disintegration systems for pharmaceutical dosage forms
CN103923068B (zh) 2014-02-13 2016-09-07 武汉珈瑜科技有限公司 用于制备suvorexant的化合物及其制备方法
AU2015248736B2 (en) 2014-04-17 2018-11-29 Sandoz Ag Solid dispersion comprising an orexin receptor antagonist
WO2015164160A1 (en) 2014-04-21 2015-10-29 Merck Sharp & Dohme Corp. Pharmaceutical salts of an orexin receptor antagonist
CN105377840B (zh) 2014-05-28 2017-12-22 杭州普晒医药科技有限公司 一种二氮杂环庚烷化合物的盐及其晶型与无定型物

Also Published As

Publication number Publication date
US11160811B2 (en) 2021-11-02
MX368859B (es) 2019-10-18
AU2018201279A1 (en) 2018-03-15
CN104321059A (zh) 2015-01-28
RU2699358C2 (ru) 2019-09-05
JP6263169B2 (ja) 2018-01-17
EP2854816A2 (en) 2015-04-08
US20150190402A1 (en) 2015-07-09
US20220062295A1 (en) 2022-03-03
US20190038635A1 (en) 2019-02-07
WO2013181174A3 (en) 2014-01-30
RU2759837C2 (ru) 2021-11-18
RU2014152031A (ru) 2016-07-20
US10098892B2 (en) 2018-10-16
RU2019126797A (ru) 2019-10-07
MX2014014644A (es) 2015-02-12
BR112014025041B1 (pt) 2019-10-22
AU2018201279B2 (en) 2019-11-21
KR20150014940A (ko) 2015-02-09
EP2854816B1 (en) 2020-07-08
WO2013181174A2 (en) 2013-12-05
KR102123130B1 (ko) 2020-06-15
EP2854816A4 (en) 2015-10-28
AU2013267613A1 (en) 2014-10-02
CN109078015A (zh) 2018-12-25
RU2019126797A3 (pt) 2020-02-25
JP2015518867A (ja) 2015-07-06

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Legal Events

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B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B06I Publication of requirement cancelled [chapter 6.9 patent gazette]

Free format text: ANULADA A PUBLICACAO CODIGO 6.6.1 NA RPI NO 2462 DE 13/03/2018 POR TER SIDO INDEVIDA.

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B07B Technical examination (opinion): publication cancelled [chapter 7.2 patent gazette]

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B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]

Free format text: NOTIFICACAO DE ANUENCIA RELACIONADA COM O ART 229 DA LPI

B07A Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
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Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 29/05/2013, OBSERVADAS AS CONDICOES LEGAIS.

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Owner name: MERCK SHARP AND DOHME LLC (US)