MX2015010449A - Composicion farmaceutica multiparticulada que comprende una multitud de dos clases de granulos. - Google Patents

Composicion farmaceutica multiparticulada que comprende una multitud de dos clases de granulos.

Info

Publication number
MX2015010449A
MX2015010449A MX2015010449A MX2015010449A MX2015010449A MX 2015010449 A MX2015010449 A MX 2015010449A MX 2015010449 A MX2015010449 A MX 2015010449A MX 2015010449 A MX2015010449 A MX 2015010449A MX 2015010449 A MX2015010449 A MX 2015010449A
Authority
MX
Mexico
Prior art keywords
pellets
usp
hours
test medium
active pharmaceutical
Prior art date
Application number
MX2015010449A
Other languages
English (en)
Inventor
Preeti Patil
Shraddha Sanjeev Joshi
Ashish Sharadchandra Guha
Suresh Shahuraj Doke
Ashishkumar Prafulchandra Shah
Original Assignee
Evonik Roehm 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 filed Critical Evonik Roehm Gmbh
Publication of MX2015010449A publication Critical patent/MX2015010449A/es

Links

Classifications

    • 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
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/138—Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine
    • 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
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/009—Sachets, pouches characterised by the material or function of the envelope
    • 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
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—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
    • A61K9/2072—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
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A61K9/2081—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets with microcapsules or coated microparticles according to A61K9/50
    • 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
    • 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
    • A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • 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
    • A61K9/4833—Encapsulating processes; Filling of capsules
    • 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
    • A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
    • 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
    • A61P9/06—Antiarrhythmics
    • 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
    • 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
    • A61P9/12—Antihypertensives
    • 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
    • A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose

Landscapes

  • Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Urology & Nephrology (AREA)
  • Vascular Medicine (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)

Abstract

Una composición farmacéutica multiparticulada que comprende una multitud de dos clases de gránulos A y B, comprendiendo cada una metoprolol o una sal farmacéuticamente aceptable de la misma como un ingrediente farmacéutico activo, en donde los gránulos A se revisten con una capa de revestimiento que comprende al menos 30% por peso de un compuesto polimérico que consiste de uno o más copolímeros de (met)acrilato polimerizados de 20 a 40% por peso de etil acrilato, de 60 a 80% por peso de metil metacrilato y de 0 o menos del 5% por peso de ácido metacrílico o ácido acrílico, en una cantidad suficiente para dar como resultado un perfil de liberación del ingrediente farmacéutico activo de acuerdo con USP en un medio de prueba con pH 6.8 con una tasa de liberación de menos de 20% después de 4 horas, en donde los gránulos B no se revisten o se revisten con una capa de revestimiento y muestran un perfil de liberación del ingrediente farmacéutico activo de acuerdo con USP en un medio de prueba con pH 6.8 con una tasa de liberación del ingrediente farmacéutico activo de más del 40% después de 4 horas, en donde la tasa de liberación de metoprolol de los gránulos A en un medio de prueba con un pH de 1.2 de acuerdo con USP con la adición de 40% (v/v) de etanol es • no más del 15% después de 15 minutos • más del 15 hasta 40% después de 30 minutos, en donde la tasa de liberación de metoprolol de los gránulos B en el medio de prueba con pH 1.2 de acuerdo con USP con la adición de 40% (v/v) de etanol es • más del 15% después de 15 minutos • más de 40% después de 30 minutos y en donde los gránulos A y B se encuentran presentes en la composición farmacéutica multiparticulada en una relación que da como resultado un perfil de liberación del ingrediente farmacéutico activo combinado de la composición farmacéutica multiparticulada de acuerdo con USP en el medio de prueba con pH 6.8 con las tasas de liberación de • no más del 25% después de 1 hora • de 20 hasta 40% después de 4 horas • de 40 hasta 60% después de 8 horas • no menos del 80% después de 20 horas.
MX2015010449A 2013-02-13 2013-04-25 Composicion farmaceutica multiparticulada que comprende una multitud de dos clases de granulos. MX2015010449A (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN627CH2013 2013-02-13
PCT/EP2013/058625 WO2014124700A1 (en) 2013-02-13 2013-04-25 Multiparticulate pharmaceutical composition comprising a multitude of two kinds of pellets

Publications (1)

Publication Number Publication Date
MX2015010449A true MX2015010449A (es) 2015-10-30

Family

ID=54252463

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2015010449A MX2015010449A (es) 2013-02-13 2013-04-25 Composicion farmaceutica multiparticulada que comprende una multitud de dos clases de granulos.

Country Status (11)

Country Link
US (1) US20150366825A1 (es)
EP (1) EP2956124A1 (es)
JP (1) JP2016507576A (es)
KR (1) KR20150119069A (es)
CN (1) CN105007902A (es)
BR (1) BR112015018895A2 (es)
CA (1) CA2900781A1 (es)
IL (1) IL240087A0 (es)
MX (1) MX2015010449A (es)
RU (1) RU2015138784A (es)
WO (1) WO2014124700A1 (es)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SG11202005947RA (en) 2018-05-24 2020-07-29 Celanese Eva Performance Polymers Corp Implantable device for sustained release of a macromolecular drug compound
WO2019226519A1 (en) 2018-05-24 2019-11-28 Celanese EVA Performance Polymers Corporation Implantable device for sustained release of a macromolecular drug compound
WO2019222856A1 (en) 2018-05-24 2019-11-28 Nureva Inc. Method, apparatus and computer-readable media to manage semi-constant (persistent) sound sources in microphone pickup/focus zones
WO2020221522A1 (en) * 2019-04-30 2020-11-05 Evonik Operations Gmbh Pellet and multi-unit pellet system (mups)
CN113143877A (zh) * 2021-05-07 2021-07-23 苏州康恒研新药物技术有限公司 一种琥珀酸美托洛尔微丸缓释片的制备方法

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SE450087B (sv) 1985-10-11 1987-06-09 Haessle Ab Korn med kontrollerad frisettning av farmaceutiskt aktiva emnen som anbringats teckande pa ett kompakt olosligt kernmaterial
SE455836B (sv) 1985-10-11 1988-08-15 Haessle Ab Beredning med kontrollerad frisettning innehallande ett salt av metoprolol samt metod for framstellning av denna beredning
DE10011447A1 (de) 2000-03-10 2001-09-20 Roehm Gmbh Dispersion mit nichtionischem Emulgator
SE0100200D0 (sv) 2001-01-24 2001-01-24 Astrazeneca Ab New film coating
DE20220902U1 (de) 2001-12-19 2004-06-09 Astrazeneca Ab Neuer Filmüberzug
SE0202353D0 (sv) 2002-08-01 2002-08-01 Astrazeneca Ab New film coating
US7314640B2 (en) * 2003-07-11 2008-01-01 Mongkol Sriwongjanya Formulation and process for drug loaded cores
DE102004011349A1 (de) 2004-03-05 2005-09-22 Basf Ag Wässrige Polymerdispersion auf Basis von Alkyl(meth)-acrylaten
CA2657202A1 (en) 2006-07-28 2008-01-31 Farmaprojects, S.A. Extended release pharmaceutical formulation of metoprolol and process for its preparation
CA2699224C (en) * 2007-09-21 2014-12-16 Evonik Roehm Gmbh Ph-dependent controlled release pharmaceutical composition for non-opioids with resistance against the influence of ethanol
CA2755808C (en) 2009-03-18 2016-01-19 Evonik Roehm Gmbh Controlled release pharmaceutical composition with resistance against the influence of ethanol employing a coating comprising neutral vinyl polymers and excipients

Also Published As

Publication number Publication date
IL240087A0 (en) 2015-09-24
JP2016507576A (ja) 2016-03-10
CN105007902A (zh) 2015-10-28
CA2900781A1 (en) 2014-08-21
BR112015018895A2 (pt) 2017-07-18
RU2015138784A (ru) 2017-03-17
EP2956124A1 (en) 2015-12-23
WO2014124700A1 (en) 2014-08-21
KR20150119069A (ko) 2015-10-23
US20150366825A1 (en) 2015-12-24

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