BR112016026667A8 - comprimido oralmente desintegrante para administração de avanafil, métodos associados de fabricação e uso de um inibidor de pde v - Google Patents

comprimido oralmente desintegrante para administração de avanafil, métodos associados de fabricação e uso de um inibidor de pde v

Info

Publication number
BR112016026667A8
BR112016026667A8 BR112016026667A BR112016026667A BR112016026667A8 BR 112016026667 A8 BR112016026667 A8 BR 112016026667A8 BR 112016026667 A BR112016026667 A BR 112016026667A BR 112016026667 A BR112016026667 A BR 112016026667A BR 112016026667 A8 BR112016026667 A8 BR 112016026667A8
Authority
BR
Brazil
Prior art keywords
orally disintegrating
avanafil
absorption
administration
formulations
Prior art date
Application number
BR112016026667A
Other languages
English (en)
Other versions
BR112016026667A2 (pt
Inventor
Calvin Theodore Broman
Eric Sheu
Original Assignee
Vivus 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 Vivus Inc filed Critical Vivus Inc
Publication of BR112016026667A2 publication Critical patent/BR112016026667A2/pt
Publication of BR112016026667A8 publication Critical patent/BR112016026667A8/pt

Links

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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • 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
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • 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
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/506—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • 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
    • 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
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Nutrition Science (AREA)
  • Zoology (AREA)
  • Physiology (AREA)
  • Engineering & Computer Science (AREA)
  • Inorganic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

comprimido oralmente desintegrante para a administração de avanafil, métodos associados de fabricação e uso de u inibidor de pde v. são fornecidas formulações para a administração oral de avanafil, um inibidor de fosfodiesterase tipo v ("inibidor de pde v"), e análogos do mesmo. as formulações são comprimidos oralmente de-sintegrantes (odts), que se dissolvem ou se desintegram rapidamente na cavidade oral. os comprimidos contêm uma composição de realce da absorção, que aumenta a absorção duodenal do agente ativo, após a transferência do ambiente de baixo ph do estômago para o ph mais básico do duodeno. métodos para administrar o agente ativo usando as formas de dosagem são fornecidos. a invenção também abrange um método de selecionar componentes e composições para incorporar nas formulações que facilitarão a absorção aumentada do agente ativo no duodeno e, desse modo, serve como "composições de realce da absorção" aqui. são também fornecidos métodos para a fabricação de comprimidos de desintegração oral para otimizar as propriedades físicas das formas de dosagem, particularmente, a dureza e tempo de desintegração.
BR112016026667A 2014-05-16 2015-05-15 comprimido oralmente desintegrante para administração de avanafil, métodos associados de fabricação e uso de um inibidor de pde v BR112016026667A8 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201461994349P 2014-05-16 2014-05-16
PCT/US2015/031198 WO2015176008A1 (en) 2014-05-16 2015-05-15 Orally disintegrating dosage form for administration of avanafil, and associated methods of manufacture and use

Publications (2)

Publication Number Publication Date
BR112016026667A2 BR112016026667A2 (pt) 2017-08-15
BR112016026667A8 true BR112016026667A8 (pt) 2021-07-06

Family

ID=53284563

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112016026667A BR112016026667A8 (pt) 2014-05-16 2015-05-15 comprimido oralmente desintegrante para administração de avanafil, métodos associados de fabricação e uso de um inibidor de pde v

Country Status (8)

Country Link
US (4) US10028916B2 (pt)
EP (1) EP3142640A1 (pt)
AU (1) AU2015258836B2 (pt)
BR (1) BR112016026667A8 (pt)
CA (1) CA2949094A1 (pt)
MX (1) MX2016014771A (pt)
RU (1) RU2740903C2 (pt)
WO (1) WO2015176008A1 (pt)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105663066A (zh) * 2016-04-07 2016-06-15 山东省药学科学院 一种阿伐那非片剂及其制备方法
JP7197474B2 (ja) * 2016-10-24 2022-12-27 ヤンセン・サイエンシズ・アイルランド・アンリミテッド・カンパニー 分散性組成物
WO2018191793A1 (en) * 2017-04-20 2018-10-25 Zeenar Enterprises Pty Ltd Fast disintegrating tablet
US11638698B2 (en) 2017-04-20 2023-05-02 Zeenar Enterprises Pty Ltd Liquid crystalline dosage form for administering a statin
AU2018255509A1 (en) * 2017-04-20 2019-12-05 Zeenar Enterprises Pty Ltd Process for preparing an oral disintegrating dosage form
WO2020056249A1 (en) 2018-09-14 2020-03-19 Cara Therapeutics, Inc. Oral formulations of kappa opioid receptor agonists
CN109696502A (zh) * 2019-02-22 2019-04-30 重庆安格龙翔医药科技有限公司 气相色谱检测阿伐那非中苯及异亚丙基丙酮残留的方法
US11986509B2 (en) 2020-03-18 2024-05-21 Cara Therapeutics, Inc. Oligosaccharide formulations of kappa opioid receptor agonists

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000020033A1 (fr) * 1998-10-05 2000-04-13 Eisai Co., Ltd. Comprimes se delitant immediatement dans la cavite buccale
GB0204771D0 (en) * 2002-02-28 2002-04-17 Phoqus Ltd Fast disintegrating tablets
US7390503B1 (en) * 2003-08-22 2008-06-24 Barr Laboratories, Inc. Ondansetron orally disintegrating tablets
DE102005009241A1 (de) 2005-03-01 2006-09-07 Bayer Healthcare Ag Arzneiformen mit kontrollierter Bioverfügbarkeit
WO2009117410A2 (en) * 2008-03-17 2009-09-24 Board Of Regents, The University Of Texas System Formation of nanostructured particles of poorly water soluble drugs and recovery by mechanical techniques
CN102988318A (zh) * 2008-11-25 2013-03-27 田边三菱制药株式会社 口腔速崩片及其制备方法
WO2013019056A1 (en) 2011-08-01 2013-02-07 Sam-A Pharm. Co., Ltd. Novel granule formulation containing sildenafil or pharmaceutically acceptable salts thereof as an active ingredient
US20150216798A1 (en) * 2012-08-17 2015-08-06 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi Novel orally administered pharmaceutical formulations

Also Published As

Publication number Publication date
BR112016026667A2 (pt) 2017-08-15
EP3142640A1 (en) 2017-03-22
WO2015176008A1 (en) 2015-11-19
US20190133955A1 (en) 2019-05-09
AU2015258836A1 (en) 2016-12-01
US20200030239A1 (en) 2020-01-30
US10028916B2 (en) 2018-07-24
RU2016149464A (ru) 2018-06-19
RU2740903C2 (ru) 2021-01-21
AU2015258836B2 (en) 2020-07-16
US20210378964A1 (en) 2021-12-09
RU2016149464A3 (pt) 2018-08-22
CA2949094A1 (en) 2015-11-19
US20160331687A1 (en) 2016-11-17
MX2016014771A (es) 2017-02-28

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Legal Events

Date Code Title Description
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]

Free format text: DE ACORDO COM O ARTIGO 229-C DA LEI NO 10196/2001, QUE MODIFICOU A LEI NO 9279/96, A CONCESSAO DA PATENTE ESTA CONDICIONADA A ANUENCIA PREVIA DA ANVISA. CONSIDERANDO A APROVACAO DOS TERMOS DO PARECER NO 337/PGF/EA/2010, BEM COMO A PORTARIA INTERMINISTERIAL NO 1065 DE 24/05/2012, ENCAMINHA-SE O PRESENTE PEDIDO PARA AS PROVIDENCIAS CABIVEIS.

B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]
B06U Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]
B350 Update of information on the portal [chapter 15.35 patent gazette]
B08F Application dismissed because of non-payment of annual fees [chapter 8.6 patent gazette]

Free format text: REFERENTE A 7A ANUIDADE.

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: EM VIRTUDE DO ARQUIVAMENTO PUBLICADO NA RPI 2670 DE 08-03-2022 E CONSIDERANDO AUSENCIA DE MANIFESTACAO DENTRO DOS PRAZOS LEGAIS, INFORMO QUE CABE SER MANTIDO O ARQUIVAMENTO DO PEDIDO DE PATENTE, CONFORME O DISPOSTO NO ARTIGO 12, DA RESOLUCAO 113/2013.