BR112018071673A2 - composição de extrusão a quente usando excipiente de compressão direta como plastificante - Google Patents

composição de extrusão a quente usando excipiente de compressão direta como plastificante

Info

Publication number
BR112018071673A2
BR112018071673A2 BR112018071673-1A BR112018071673A BR112018071673A2 BR 112018071673 A2 BR112018071673 A2 BR 112018071673A2 BR 112018071673 A BR112018071673 A BR 112018071673A BR 112018071673 A2 BR112018071673 A2 BR 112018071673A2
Authority
BR
Brazil
Prior art keywords
plasticizer
direct compression
hot extrusion
compression excipient
extrusion composition
Prior art date
Application number
BR112018071673-1A
Other languages
English (en)
Other versions
BR112018071673B1 (pt
Inventor
Lubda Dieter
Zheng Mengyao
Elia Alessandro
Di Gallo Nicole
Original Assignee
Merck Patent Gmbh
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 Merck Patent Gmbh filed Critical Merck Patent Gmbh
Publication of BR112018071673A2 publication Critical patent/BR112018071673A2/pt
Publication of BR112018071673B1 publication Critical patent/BR112018071673B1/pt

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08K—Use of inorganic or non-macromolecular organic substances as compounding ingredients
    • C08K5/00—Use of organic ingredients
    • C08K5/04—Oxygen-containing compounds
    • C08K5/05—Alcohols; Metal alcoholates
    • C08K5/053—Polyhydroxylic alcohols
    • 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
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
    • A61K31/404—Indoles, e.g. pindolol
    • A61K31/405—Indole-alkanecarboxylic acids; Derivatives thereof, e.g. tryptophan, indomethacin
    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K9/0014—Skin, i.e. galenical aspects of topical compositions
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
    • 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
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08K—Use of inorganic or non-macromolecular organic substances as compounding ingredients
    • C08K5/00—Use of organic ingredients
    • C08K5/0008—Organic ingredients according to more than one of the "one dot" groups of C08K5/01 - C08K5/59
    • C08K5/0016—Plasticisers
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L29/00—Compositions of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by an alcohol, ether, aldehydo, ketonic, acetal or ketal radical; Compositions of hydrolysed polymers of esters of unsaturated alcohols with saturated carboxylic acids; Compositions of derivatives of such polymers
    • C08L29/02—Homopolymers or copolymers of unsaturated alcohols
    • C08L29/04—Polyvinyl alcohol; Partially hydrolysed homopolymers or copolymers of esters of unsaturated alcohols with saturated carboxylic acids

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Polymers & Plastics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Dermatology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Compositions Of Macromolecular Compounds (AREA)
  • Processes Of Treating Macromolecular Substances (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Extrusion Moulding Of Plastics Or The Like (AREA)

Abstract

a presente invenção refere-se ao uso de sorbitol seco por pulverização, tal como parteck® si, como plastificante para composições contendo polímero processadas por extrusão a quente. devido às suas propriedades aprimoradas, obtidas por seu processo de fabricação especial (secagem por pulverização), esse excipiente de compressão direta apresenta mais benefícios adicionais do que a mesma substância no estado cristalino.
BR112018071673-1A 2016-05-13 2017-05-10 Uso de sorbitol seco por pulverização, composição em pó, e seu processo de produção BR112018071673B1 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP16169693 2016-05-13
EP16169693.5 2016-05-13
PCT/EP2017/061126 WO2017194576A1 (en) 2016-05-13 2017-05-10 Hot melt extrusion composition using direct compressible excipient as plasticizer

Publications (2)

Publication Number Publication Date
BR112018071673A2 true BR112018071673A2 (pt) 2019-02-19
BR112018071673B1 BR112018071673B1 (pt) 2024-02-27

Family

ID=56134085

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112018071673-1A BR112018071673B1 (pt) 2016-05-13 2017-05-10 Uso de sorbitol seco por pulverização, composição em pó, e seu processo de produção

Country Status (12)

Country Link
US (1) US11510986B2 (pt)
EP (1) EP3454836A1 (pt)
JP (1) JP6955517B2 (pt)
KR (1) KR102358069B1 (pt)
CN (1) CN109152739B (pt)
BR (1) BR112018071673B1 (pt)
CA (1) CA3023800A1 (pt)
IL (1) IL262908B (pt)
MX (1) MX2018012999A (pt)
PH (1) PH12018502055A1 (pt)
SG (1) SG11201809973YA (pt)
WO (1) WO2017194576A1 (pt)

Family Cites Families (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2542346B2 (ja) 1987-05-30 1996-10-09 日本合成化学工業株式会社 高重合度ポリビニルアルコ−ルの製造法
JP2577698B2 (ja) * 1993-08-05 1997-02-05 信道 中野 流動性の高いソルビトール粉末の製造方法
DE19617487A1 (de) * 1996-05-02 1997-11-06 Merck Patent Gmbh Geschmacksverbesserung von Arzneimittelwirkstoffen
JP4783278B2 (ja) * 2003-02-03 2011-09-28 ノバルティス アーゲー 医薬製剤
US20080311240A1 (en) * 2004-06-17 2008-12-18 Cargill Incorporated Steam Agglomeration of Polyols
BRPI0714963A2 (pt) * 2006-08-16 2013-07-30 Novartis Ag processo de fabricaÇço de dispersÕes sàlidas de compostos terapÊuticos altamente cristalinos
ES2720626T3 (es) * 2008-06-20 2019-07-23 Merck Patent Gmbh Combinación de poliol compresible directamente
GB0909680D0 (en) 2009-06-05 2009-07-22 Euro Celtique Sa Dosage form
ES2655719T3 (es) * 2009-07-10 2018-02-21 Merck Patent Gmbh Sustancia auxiliar con bajo contenido de agua para formación de comprimidos y procedimiento para su fabricación
US8551529B2 (en) * 2009-07-10 2013-10-08 Merck Patent Gmbh Composition for the production of tablets, and method for the production of said composition
GB201020895D0 (en) * 2010-12-09 2011-01-26 Euro Celtique Sa Dosage form
CN102204868B (zh) * 2011-05-18 2014-01-22 北京化工大学 采用多元辅料制备吲哚美辛速释制剂的热熔挤出工艺
RU2013155713A (ru) * 2011-07-06 2015-08-20 Профибрикс Бв Составы для лечения ран
US20130071476A1 (en) * 2011-08-19 2013-03-21 Subraman Rao Cherukuri Rapid Melt Controlled Release Taste-Masked Compositions
CN105012242A (zh) * 2015-07-21 2015-11-04 南京中医药大学 一种厚朴酚或和厚朴酚或两者混合物固体分散体及其热熔挤出制备方法

Also Published As

Publication number Publication date
PH12018502055A1 (en) 2019-06-24
WO2017194576A1 (en) 2017-11-16
IL262908A (en) 2018-12-31
US11510986B2 (en) 2022-11-29
CN109152739B (zh) 2022-09-30
IL262908B (en) 2022-04-01
US20200254098A1 (en) 2020-08-13
SG11201809973YA (en) 2018-12-28
KR20190008556A (ko) 2019-01-24
BR112018071673B1 (pt) 2024-02-27
KR102358069B1 (ko) 2022-02-03
JP2019515006A (ja) 2019-06-06
EP3454836A1 (en) 2019-03-20
CN109152739A (zh) 2019-01-04
JP6955517B2 (ja) 2021-10-27
MX2018012999A (es) 2019-01-28
CA3023800A1 (en) 2017-11-16

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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]

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]
B06W Patent application suspended after preliminary examination (for patents with searches from other patent authorities) chapter 6.23 patent gazette]
B350 Update of information on the portal [chapter 15.35 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 10/05/2017, OBSERVADAS AS CONDICOES LEGAIS