BR112013026356A2 - formulação sólida oral do fármaco antituberculoso composto e método de preparo do mesmo - Google Patents

formulação sólida oral do fármaco antituberculoso composto e método de preparo do mesmo

Info

Publication number
BR112013026356A2
BR112013026356A2 BR112013026356A BR112013026356A BR112013026356A2 BR 112013026356 A2 BR112013026356 A2 BR 112013026356A2 BR 112013026356 A BR112013026356 A BR 112013026356A BR 112013026356 A BR112013026356 A BR 112013026356A BR 112013026356 A2 BR112013026356 A2 BR 112013026356A2
Authority
BR
Brazil
Prior art keywords
compound
preparation
rifampicin
coated
oral solid
Prior art date
Application number
BR112013026356A
Other languages
English (en)
Inventor
Chao Xu
Guixian Chen
Lan Zheng
Lintao Jiang
Maojian Gu
Min Wang
Ning Li
Qilan Zheng
Original Assignee
Zhejiang Hisun Pharm Co Ltd
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 Zhejiang Hisun Pharm Co Ltd filed Critical Zhejiang Hisun Pharm Co Ltd
Publication of BR112013026356A2 publication Critical patent/BR112013026356A2/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
    • A61K9/28—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
    • 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
    • A61K31/13—Amines
    • A61K31/133—Amines having hydroxy groups, e.g. sphingosine
    • 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
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4409—Non condensed pyridines; Hydrogenated derivatives thereof only substituted in position 4, e.g. isoniazid, iproniazid
    • 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
    • A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
    • 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
    • A61K31/4965—Non-condensed pyrazines
    • 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
    • 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
    • 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
    • A61K9/2072—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
    • 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
    • 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
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • 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
    • 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
    • A61K9/2886—Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • A61P31/06—Antibacterial agents for tuberculosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2121/00—Preparations for use in therapy

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)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Pulmonology (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

abstract provided is an oral solid preparation of a compound anti-tubercular drug, wherein the active ingredients are rifampicin, isoniazid, pyrazinamide and ethambutol hydrochloride. the compound oral solid preparation is a coated tablet with coated core or a coated three-layer tablet, wherein the two active ingredients rifampicin and isoniazid do not contact directly. the compound oral solid preparation not only improves the stability of the compound preparation, but also improves the bioavailability of rifampicin. fig.1 a coated tablet with coated core ----------------------------------------------------------------------------------------------------------- tradução do resumo resumo patente de invenção: "formulação sólida oral do fármaco antituberculoso composto e método de preparo do mesmo". é fornecida uma preparação sólida oral de um fármaco antituberculoso composto, em que os ingredientes ativos são rifampicina, isoniazida, pirazinamida e cloridrato de etambutol. a preparação sólida oral composta é uma drágea revestida com núcleo revestido ou uma drágea de três camadas revestida, em que os dois ingredientes ativos rifampicina e isoniazida não entram em contato direto. a preparação sólida oral composta não apenas melhora a estabilidade da preparação de composto, como também melhora a biodisponibilidade de rifampicina.
BR112013026356A 2011-04-12 2012-04-10 formulação sólida oral do fármaco antituberculoso composto e método de preparo do mesmo BR112013026356A2 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN2011100915967A CN102727496A (zh) 2011-04-12 2011-04-12 一种复方抗结核药口服固体制剂及其制备方法
PCT/CN2012/073689 WO2012139485A1 (zh) 2011-04-12 2012-04-10 一种复方抗结核药口服固体制剂及其制备方法

Publications (1)

Publication Number Publication Date
BR112013026356A2 true BR112013026356A2 (pt) 2016-12-27

Family

ID=46984266

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112013026356A BR112013026356A2 (pt) 2011-04-12 2012-04-10 formulação sólida oral do fármaco antituberculoso composto e método de preparo do mesmo

Country Status (7)

Country Link
US (1) US9555003B2 (pt)
EP (1) EP2698150B1 (pt)
CN (1) CN102727496A (pt)
BR (1) BR112013026356A2 (pt)
LT (1) LT2698150T (pt)
RU (1) RU2605388C2 (pt)
WO (1) WO2012139485A1 (pt)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104274456A (zh) * 2013-07-02 2015-01-14 安徽贝克生物制药有限公司 一种抗结核药物的四联复方制剂及其制备方法
TW201717919A (zh) * 2015-07-02 2017-06-01 國際藥品股份公司 雷諾多重壓縮錠劑
CN110898022A (zh) * 2019-12-31 2020-03-24 湖南嘉恒制药有限公司 一种异烟肼组合物及其制备方法
CN114354804A (zh) * 2021-12-31 2022-04-15 深圳市第三人民医院(深圳市肝病研究所) 试剂盒和样本中抗结核药物及其代谢物的检测方法

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4681765A (en) * 1984-09-13 1987-07-21 American Home Products Corporation Rapid releasing triamterene containing gelatin capsule dosage forms for once daily antihypertensive use
IT1289883B1 (it) * 1996-10-09 1998-10-19 Lupin Lab Ltd Composizione farmaceutica antitubercolare e procedimento per la sua produzione
FR2772615B1 (fr) * 1997-12-23 2002-06-14 Lipha Comprime multicouche pour la liberation instantanee puis prolongee de substances actives
YU26102A (sh) 2000-08-09 2004-12-31 Panacea Biotec Limited Nove farmaceutske smese antituberkuloznih lekova i postupak za njihovo dobijanje
WO2002087547A1 (en) * 2001-04-27 2002-11-07 Lupin Limited An improved process for preparation of four-drug anti-tubercular fixed dose combination
CN1279913C (zh) * 2002-09-10 2006-10-18 信谊药厂 一种含有利福平异烟肼的复方制剂及其制备方法
CN1602872A (zh) * 2003-09-29 2005-04-06 浙江可立思安制药有限公司 一种抗结核药物组合物
RU2247561C1 (ru) * 2003-12-29 2005-03-10 Открытое акционерное общество "Химико-фармацевтический комбинат "АКРИХИН" (ОАО "АКРИХИН") Комбинированная фармацевтическая композиция с противотуберкулёзным действием
CN101524355B (zh) * 2008-03-04 2011-04-20 沈阳红旗制药有限公司 抗结核药物的复方制剂及其制备方法

Also Published As

Publication number Publication date
CN102727496A (zh) 2012-10-17
US20140127294A1 (en) 2014-05-08
RU2605388C2 (ru) 2016-12-20
LT2698150T (lt) 2018-01-25
WO2012139485A8 (zh) 2013-10-10
EP2698150B1 (en) 2017-09-20
EP2698150A1 (en) 2014-02-19
WO2012139485A1 (zh) 2012-10-18
US9555003B2 (en) 2017-01-31
RU2013150254A (ru) 2015-05-20
EP2698150A4 (en) 2014-09-24

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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]
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B07G Grant request does not fulfill article 229-c lpi (prior consent of anvisa) [chapter 7.7 patent gazette]

Free format text: NOTIFICACAO DE DEVOLUCAO DO PEDIDO EM FUNCAO DA REVOGACAO DO ART. 229-C DA LEI NO 9.279, DE 1996, POR FORCA DA LEI NO 14.195, DE 2021