BR112017009521A2 - comprimido de múltiplas camadas que contém um fármaco instável à luz - Google Patents

comprimido de múltiplas camadas que contém um fármaco instável à luz

Info

Publication number
BR112017009521A2
BR112017009521A2 BR112017009521A BR112017009521A BR112017009521A2 BR 112017009521 A2 BR112017009521 A2 BR 112017009521A2 BR 112017009521 A BR112017009521 A BR 112017009521A BR 112017009521 A BR112017009521 A BR 112017009521A BR 112017009521 A2 BR112017009521 A2 BR 112017009521A2
Authority
BR
Brazil
Prior art keywords
light
tablet containing
multilayer tablet
unstable drug
stable
Prior art date
Application number
BR112017009521A
Other languages
English (en)
Inventor
Hayashi Kentaro
Toyoda Toshitada
Muguruma Yoshitsugu
Original Assignee
Shionogi & Co
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=55954364&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=BR112017009521(A2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Shionogi & Co filed Critical Shionogi & Co
Publication of BR112017009521A2 publication Critical patent/BR112017009521A2/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
    • A61K9/2072—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
    • 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
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2009—Inorganic compounds
    • 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
    • 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
    • A61K9/2813—Inorganic compounds
    • 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
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Inorganic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Zoology (AREA)
  • Cardiology (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Urology & Nephrology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

a presente invenção refere-se a um comprimido que se desintegra oralmente que contém a rosuvastatina ou um sal da mesma e é estável à luz. um comprimido que se desintegra oralmente estável à luz, à temperatura e à umidade pode ser provido mediante a preparação de um comprimido de múltiplas camadas que contém a rosuvastatina ou um sal farmaceuticamente aceitável da mesma como um ingrediente ativo, um estabilizante de luz, e um sal inorgânico ou um óxido básico.
BR112017009521A 2014-11-11 2015-11-10 comprimido de múltiplas camadas que contém um fármaco instável à luz BR112017009521A2 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2014228516 2014-11-11
PCT/JP2015/081526 WO2016076280A1 (ja) 2014-11-11 2015-11-10 光に対して不安定な薬物を含有する多層錠剤

Publications (1)

Publication Number Publication Date
BR112017009521A2 true BR112017009521A2 (pt) 2017-12-19

Family

ID=55954364

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112017009521A BR112017009521A2 (pt) 2014-11-11 2015-11-10 comprimido de múltiplas camadas que contém um fármaco instável à luz

Country Status (9)

Country Link
US (1) US10398694B2 (pt)
EP (1) EP3219318A4 (pt)
JP (1) JP6075818B2 (pt)
KR (1) KR20170083071A (pt)
CN (1) CN107072997A (pt)
BR (1) BR112017009521A2 (pt)
CL (1) CL2017001186A1 (pt)
CO (1) CO2017005544A2 (pt)
WO (1) WO2016076280A1 (pt)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20190290631A1 (en) * 2016-05-27 2019-09-26 Nippon Kayaku Kabushiki Kaisha Pharmaceutical composition comprising rapamycin or derivative thereof
CN109528665A (zh) * 2017-09-21 2019-03-29 浙江京新药业股份有限公司 一种治疗迟发型运动障碍的药物的口崩片及其制备方法
CN108245516B (zh) * 2017-11-09 2019-04-12 浙江京新药业股份有限公司 一种含瑞舒伐他汀钙的药物组合物及其制备方法
CN111135149B (zh) * 2018-11-04 2021-05-11 张家港市中医医院 一种瑞舒伐他汀钙片及其制备方法
JP2021120357A (ja) * 2020-01-30 2021-08-19 サンノーバ株式会社 錠剤
GB2622822A (en) * 2022-09-28 2024-04-03 Novumgen Ltd A rapidly disintegrating tablet of rosuvastatin and its process of preparation

Family Cites Families (23)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
HU9203780D0 (en) 1991-12-12 1993-03-29 Sandoz Ag Stabilized pharmaceutical products of hmg-coa reductase inhibitor and method for producing them
GB0001621D0 (en) 2000-01-26 2000-03-15 Astrazeneca Ab Pharmaceutical compositions
JP3815301B2 (ja) 2001-11-09 2006-08-30 田辺製薬株式会社 成型製剤及びその製法
ITFI20010230A1 (it) 2001-11-29 2003-05-29 Menarini Int Operations Lu Sa Composizioni farmaceutiche per il trattamento del diabete mellito di tipo ii
JP2005255617A (ja) * 2004-03-11 2005-09-22 Asahi Kasei Chemicals Corp 微粒子状活性成分および多孔質セルロース凝集体含有固形製剤組成物
MX2007009281A (es) * 2005-02-10 2007-09-25 Lufecycle Pharma As Composicion farmaceutica estable que comprende una combinacion de dosis fija de fenofibrato y un inhibidor de 3-hidroxi 3-metilglutaril-coenzima a reductasa.
WO2007018192A1 (ja) 2005-08-10 2007-02-15 Shionogi & Co., Ltd. 口腔内崩壊錠剤
US20070202159A1 (en) * 2006-02-02 2007-08-30 Mathur Rajeev S Pharmaceutical composition comprising stabilized statin particles
ATE462416T1 (de) 2006-08-04 2010-04-15 Ethypharm Sa Mehrschichtige im mund zerfallende tablette
HU227610B1 (en) * 2006-09-18 2011-09-28 Richter Gedeon Nyrt Pharmaceutical compositions containing rosuvastatin potassium
BRPI0822782A2 (pt) 2008-06-27 2015-09-29 Abdi Ibrahim Ilac Sanayi Ve Ticaret Anonim Sirketi composição farmacêutica que compreende rosuvastatina
PL386051A1 (pl) 2008-09-09 2010-03-15 Zakłady Farmaceutyczne POLPHARMA Spółka Akcyjna Stabilna doustna kompozycja farmaceutyczna zawierająca farmaceutycznie dopuszczalną sól kwsu [(E)-7-[4-(4-fluorofenylo)-6-izopropylo-2-[metylo(metylosulfonylo)amino]pirymidyn-5-ylo] (3R,5S)-3,5-dihydroksyhept-6-enowego
CN106344533A (zh) * 2009-01-29 2017-01-25 大日本住友制药株式会社 具有内核的口腔崩解片剂
EP2433652B1 (en) 2009-05-20 2016-11-09 Sumitomo Dainippon Pharma Co., Ltd. Dry-coated orally-disintegrating tablet
JP2012001460A (ja) * 2010-06-15 2012-01-05 Ohara Yakuhin Kogyo Kk 光過敏性薬物の安定化法
JP2012144564A (ja) 2010-10-25 2012-08-02 Kowa Co 医薬組成物
WO2012056509A1 (ja) * 2010-10-25 2012-05-03 興和株式会社 医薬組成物
CA2819460C (en) 2010-12-03 2017-08-01 Takeda Pharmaceutical Company Limited Orally disintegrating tablet
KR20200003219A (ko) * 2011-05-20 2020-01-08 아스트라제네카 유케이 리미티드 로수바스타틴 칼슘의 약학 조성물
JP5844573B2 (ja) * 2011-08-10 2016-01-20 共和薬品工業株式会社 ピタバスタチンを含有する錠剤
JP2013133291A (ja) 2011-12-26 2013-07-08 Novartis Ag 錠剤
PT2830618T (pt) * 2012-03-30 2016-11-04 Dae Woong Pharma Composição farmacêutica compreendendo olmesartan medoxomilo e rosuvastatina ou o seu sal
JP2013216701A (ja) 2013-07-29 2013-10-24 Ssp Co Ltd 経口投与用製剤

Also Published As

Publication number Publication date
JPWO2016076280A1 (ja) 2017-04-27
WO2016076280A1 (ja) 2016-05-19
CL2017001186A1 (es) 2018-01-05
EP3219318A1 (en) 2017-09-20
CO2017005544A2 (es) 2017-08-10
EP3219318A4 (en) 2018-07-11
US20170231989A1 (en) 2017-08-17
US10398694B2 (en) 2019-09-03
CN107072997A (zh) 2017-08-18
KR20170083071A (ko) 2017-07-17
JP6075818B2 (ja) 2017-02-08

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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 Notice 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]
B11B Dismissal acc. art. 36, par 1 of ipl - no reply within 90 days to fullfil the necessary requirements