BR112012021445B8 - formulação farmacêutica ou neutracêutica, e uso de um agente promotor de biodisponibilidade - Google Patents

formulação farmacêutica ou neutracêutica, e uso de um agente promotor de biodisponibilidade

Info

Publication number
BR112012021445B8
BR112012021445B8 BR112012021445A BR112012021445A BR112012021445B8 BR 112012021445 B8 BR112012021445 B8 BR 112012021445B8 BR 112012021445 A BR112012021445 A BR 112012021445A BR 112012021445 A BR112012021445 A BR 112012021445A BR 112012021445 B8 BR112012021445 B8 BR 112012021445B8
Authority
BR
Brazil
Prior art keywords
pharmaceutical
formulation
promoting agent
bioavailability
bioavailability promoting
Prior art date
Application number
BR112012021445A
Other languages
English (en)
Other versions
BR112012021445B1 (pt
BR112012021445A2 (pt
Inventor
Lizio Rosario
Gottschalk Michael
Damm Michael
Windhab Norbert
Liefke Melanie
Schmitt Günter
Roth Erna
Alexowsky Rüdiger
Original Assignee
Evonik Roehm Gmbh
Roehm Gmbh
Evonik Degussa Gmbh
Evonik Operations 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 Evonik Roehm Gmbh, Roehm Gmbh, Evonik Degussa Gmbh, Evonik Operations Gmbh filed Critical Evonik Roehm Gmbh
Publication of BR112012021445A2 publication Critical patent/BR112012021445A2/pt
Publication of BR112012021445B1 publication Critical patent/BR112012021445B1/pt
Publication of BR112012021445B8 publication Critical patent/BR112012021445B8/pt

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/55—Protease inhibitors
    • A61K38/56—Protease inhibitors from plants
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • A61K9/1676—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
    • 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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/726—Glycosaminoglycans, i.e. mucopolysaccharides
    • A61K31/727—Heparin; Heparan
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/08—Peptides having 5 to 11 amino acids
    • A61K38/095—Oxytocins; Vasopressins; Related peptides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/12—Cyclic peptides, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/168—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from plants
    • 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
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5026—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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings with drug-free core

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Botany (AREA)
  • Dermatology (AREA)
  • Molecular Biology (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Coloring Foods And Improving Nutritive Qualities (AREA)

Abstract

FORMULAÇÃO FARMACÊUTICA OU NEUTRACÊUTICA. A invenção refere-se a um formulação farmacêutica ou nutracêutica compreendendo um núcleo, compreendendo um ingrediente ativo farmacêutico ou nutracêutico, um promotor de penetração e um agente promotor de biodisponibilidade, e um revestimento polimérico para a liberação gastrointestinal alvejada do ingrediente ativo, caracterizada pelo fato em que o agente promotor de biodisponibilidade é um inibidor farmaceuticamente aceitável de enzimas proteolíticas, que aumenta a biodisponibilidade oral do ingrediente ativo por um fator de pelo menos cinco, comparado a uma formulação correspondente sem o agen-te promotor de biodisponibilidade.
BR112012021445A 2010-02-25 2010-02-25 formulação farmacêutica ou neutracêutica, e uso de um agente promotor de biodisponibilidade BR112012021445B8 (pt)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/EP2010/052401 WO2011103920A2 (en) 2010-02-25 2010-02-25 Pharmaceutical or neutraceutical formulation

Publications (3)

Publication Number Publication Date
BR112012021445A2 BR112012021445A2 (pt) 2016-05-31
BR112012021445B1 BR112012021445B1 (pt) 2020-12-01
BR112012021445B8 true BR112012021445B8 (pt) 2022-07-05

Family

ID=44021897

Family Applications (2)

Application Number Title Priority Date Filing Date
BR112012021445A BR112012021445B8 (pt) 2010-02-25 2010-02-25 formulação farmacêutica ou neutracêutica, e uso de um agente promotor de biodisponibilidade
BR112012021455A BR112012021455A2 (pt) 2010-02-25 2010-02-25 formulação farmacêutica ou nutracêutica.

Family Applications After (1)

Application Number Title Priority Date Filing Date
BR112012021455A BR112012021455A2 (pt) 2010-02-25 2010-02-25 formulação farmacêutica ou nutracêutica.

Country Status (16)

Country Link
US (1) US8765152B2 (pt)
EP (1) EP2538955B1 (pt)
JP (1) JP6000128B2 (pt)
KR (1) KR101708086B1 (pt)
CN (1) CN103037884A (pt)
AU (1) AU2010346995B2 (pt)
BR (2) BR112012021445B8 (pt)
CA (1) CA2790918C (pt)
ES (1) ES2561652T3 (pt)
HU (1) HUE026713T2 (pt)
IL (1) IL221087A (pt)
MX (1) MX346316B (pt)
PL (1) PL2538955T3 (pt)
RU (1) RU2604861C2 (pt)
SI (1) SI2538955T1 (pt)
WO (1) WO2011103920A2 (pt)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016046817A1 (en) * 2014-09-24 2016-03-31 Vital Beverages Global Inc. Compositions and methods for selective gi tract delivery
RU2639414C1 (ru) * 2017-02-06 2017-12-21 Федеральное государственное бюджетное учреждение науки Ордена Трудового Красного Знамени Институт нефтехимического синтеза им. А.В. Топчиева Российской академии наук (ИНХС РАН) Антипротеиназный препарат
AU2019275409A1 (en) 2018-05-24 2020-07-16 Celanese Eva Performance Polymers Llc Implantable device for sustained release of a macromolecular drug compound
SG11202005947RA (en) 2018-05-24 2020-07-29 Celanese Eva Performance Polymers Corp Implantable device for sustained release of a macromolecular drug compound
RU2747401C1 (ru) * 2020-06-22 2021-05-04 Федеральное государственное бюджетное образовательное учреждение высшего образования "Курский государственный университет" Способ получения фармацевтических лекарственных форм на основе сополимеров метилметакрилата

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DE2135073C3 (de) 1971-07-14 1974-07-11 Roehm Gmbh Überzugsmittel für Arzneiformen
DE3106449A1 (de) 1981-02-20 1982-09-09 Röhm GmbH, 6100 Darmstadt "in magensaft loesliche oder quellbare ueberzugsmasse und ihre verwendung in einem verfahren zum ueberziehen von arzneiformen"
DE3208791A1 (de) 1982-03-11 1983-09-22 Röhm GmbH, 6100 Darmstadt Verfahren zum ueberziehen von arzneiformen mittes eines in wasser dispergierten ueberzugsmittels
EP0164669B1 (de) 1984-06-13 1991-01-23 Röhm Gmbh Verfahren zum Überziehen von Arzneiformen
JP2792862B2 (ja) 1988-07-30 1998-09-03 寛治 高田 経口腸溶製剤
US6331318B1 (en) * 1994-09-30 2001-12-18 Emisphere Technologies Inc. Carbon-substituted diketopiperazine delivery systems
WO1993013753A1 (de) 1992-01-17 1993-07-22 Alfatec-Pharma Gmbh Peptidarzneistoffe enthaltende pellets und ihre herstellung sowie deren verwendung
SE9402431D0 (sv) 1994-07-08 1994-07-08 Astra Ab New tablet formulation
DE9414065U1 (de) 1994-08-31 1994-11-03 Roehm Gmbh Thermoplastischer Kunststoff für darmsaftlösliche Arznei-Umhüllungen
DE9414066U1 (de) 1994-08-31 1994-11-03 Roehm Gmbh Überzugs- und Bindemittel für Arzneiformen sowie damit hergestellte Arzneiform
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Also Published As

Publication number Publication date
EP2538955A2 (en) 2013-01-02
JP2013520451A (ja) 2013-06-06
BR112012021455A2 (pt) 2016-05-31
MX2012009764A (es) 2012-10-05
ES2561652T3 (es) 2016-02-29
WO2011103920A3 (en) 2013-03-28
MX346316B (es) 2017-03-15
EP2538955B1 (en) 2015-12-02
CN103037884A (zh) 2013-04-10
RU2012140651A (ru) 2014-03-27
AU2010346995A1 (en) 2012-08-16
PL2538955T3 (pl) 2016-04-29
IL221087A (en) 2015-07-30
KR101708086B1 (ko) 2017-02-17
RU2604861C2 (ru) 2016-12-10
US8765152B2 (en) 2014-07-01
AU2010346995B2 (en) 2014-12-04
SI2538955T1 (sl) 2016-03-31
BR112012021445B1 (pt) 2020-12-01
US20120315334A1 (en) 2012-12-13
CA2790918A1 (en) 2011-09-01
JP6000128B2 (ja) 2016-09-28
CA2790918C (en) 2019-08-06
BR112012021445A2 (pt) 2016-05-31
KR20120123106A (ko) 2012-11-07
HUE026713T2 (en) 2016-07-28
WO2011103920A2 (en) 2011-09-01

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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]
B06T Formal requirements before examination [chapter 6.20 patent gazette]
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
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

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: 10 (DEZ) ANOS CONTADOS A PARTIR DE 01/12/2020, OBSERVADAS AS CONDICOES LEGAIS.

B16C Correction of notification of the grant [chapter 16.3 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 25/02/2010 OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF

B25D Requested change of name of applicant approved

Owner name: ROEHM GMBH (DE)

B25G Requested change of headquarter approved

Owner name: ROEHM GMBH (DE)

B25A Requested transfer of rights approved

Owner name: EVONIK DEGUSSA GMBH (DE)

B25D Requested change of name of applicant approved

Owner name: EVONIK OPERATIONS GMBH (DE)