ES2471340B1 - Composición farmacéutica oral para fármacos de elevada posología - Google Patents

Composición farmacéutica oral para fármacos de elevada posología Download PDF

Info

Publication number
ES2471340B1
ES2471340B1 ES201231993A ES201231993A ES2471340B1 ES 2471340 B1 ES2471340 B1 ES 2471340B1 ES 201231993 A ES201231993 A ES 201231993A ES 201231993 A ES201231993 A ES 201231993A ES 2471340 B1 ES2471340 B1 ES 2471340B1
Authority
ES
Spain
Prior art keywords
high dosage
pharmaceutical composition
oral pharmaceutical
composition
dosage drugs
Prior art date
Legal status (The legal status 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 status listed.)
Active
Application number
ES201231993A
Other languages
English (en)
Other versions
ES2471340A1 (es
Inventor
José Luis FÁBREGAS VIDAL
Núria RUIZ XIVILLÉ
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Laboratorios Rubio SA
Original Assignee
Laboratorios Rubio SA
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 Laboratorios Rubio SA filed Critical Laboratorios Rubio SA
Priority to ES201231993A priority Critical patent/ES2471340B1/es
Priority to PCT/ES2013/070845 priority patent/WO2014096485A1/es
Priority to EP13811582.9A priority patent/EP2937078B1/en
Priority to US14/651,931 priority patent/US10413568B2/en
Priority to ES13811582T priority patent/ES2728465T3/es
Publication of ES2471340A1 publication Critical patent/ES2471340A1/es
Application granted granted Critical
Publication of ES2471340B1 publication Critical patent/ES2471340B1/es
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/74Synthetic polymeric materials
    • A61K31/795Polymers containing sulfur
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/716Glucans
    • A61K31/717Celluloses
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/74Synthetic polymeric materials
    • A61K31/785Polymers containing nitrogen
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/74Synthetic polymeric materials
    • A61K31/785Polymers containing nitrogen
    • A61K31/787Polymers containing nitrogen containing heterocyclic rings having nitrogen as a ring hetero atom
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/68Plantaginaceae (Plantain Family)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/44Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056Mouth 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/06Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Biotechnology (AREA)
  • Botany (AREA)
  • Medical Informatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Molecular Biology (AREA)
  • Zoology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

La presente invención se refiere a una composición farmacéutica oral para fármacos de elevada posología, concretamente, resinas de intercambio iónico y laxantes formadores de volumen. Dicha composición comprende la combinación de un componente oleoso líquido y un agente texturizador, que confiere a la composición unas buenas propiedades organolépticas que permiten la ingestión de fármacos de elevada posología sin los problemas habituales asociados a su mala palatabilidad. La invención también se refiere a un procedimiento para preparar dicha composición y a su uso para el tratamiento de diversas patologías.

Description

imagen1
imagen2
imagen3
imagen4
imagen5
imagen6
imagen7
imagen8
imagen9
imagen10
imagen11
imagen12
imagen13
imagen14
imagen15
imagen16
imagen17
imagen18
imagen19
imagen20
imagen21
imagen22
imagen23
imagen24
imagen25
imagen26
imagen27
imagen28
imagen29
imagen30
imagen31
imagen32
imagen33
imagen34
imagen35
imagen36
imagen37
imagen38
imagen39
imagen40
imagen41
imagen42
imagen43
imagen44
imagen45
TABLA 3
Función
Componente 3.1 3.2 3.3 3.4 3.5
Cantidad (g)
Principio activo
PSS-Ca1 15 15 15 15
colestiramina
4
Texturizador
Gelucire® 44/142 2 2 1 1
aceite de soja hidrogenado
2
Comp. oleoso
aceite de oliva 4,8 12 4 11 12
Poliol
glicerina 3,2 1 2
PG3
4,10
Palatabilizante
manitol 2 2
Edulcorante
sacarina 0,02 0,02
sucralosa
0,028 0,027 0,027
neo-DHC
0,016 0,016 0,016
Aromatizante
aroma de turrón 0,01 0,01
aroma de vainilla
0,048 0,048
aroma de avellana
0,032 0,032
esencia de naranja
0,017
1 poliestireno sulfonato cálcico 2 macrogolglicéridos de lauroílo 3 propilenglicol
5 Las composiciones 3.1, 3.2 y 3.3 se prepararon calentando el aceite de oliva (juntamente con el manitol y/o los polioles, según cada caso) hasta una temperatura de aproximadamente 60º C. Sobre dicha mezcla se incorporó el Gelucire® 44/14, previamente
fundido a una temperatura de entre 50º C y 70º C. A continuación se añadió lentamente la imagen46
imagen47
imagen48

Claims (1)

  1. imagen1
    imagen2
    imagen3
    imagen4
    imagen5
    imagen6
    imagen7
    imagen8
    imagen9
    imagen10
    imagen11
ES201231993A 2012-12-21 2012-12-21 Composición farmacéutica oral para fármacos de elevada posología Active ES2471340B1 (es)

Priority Applications (5)

Application Number Priority Date Filing Date Title
ES201231993A ES2471340B1 (es) 2012-12-21 2012-12-21 Composición farmacéutica oral para fármacos de elevada posología
PCT/ES2013/070845 WO2014096485A1 (es) 2012-12-21 2013-12-05 Composicion farmaceutica oral para farmacos de elevada posologia
EP13811582.9A EP2937078B1 (en) 2012-12-21 2013-12-05 Oral pharmaceutical composition for drugs with a high-dosage regimen
US14/651,931 US10413568B2 (en) 2012-12-21 2013-12-05 Oral pharmaceutical composition for drugs with a high-dosage regimen
ES13811582T ES2728465T3 (es) 2012-12-21 2013-12-05 Composición farmacéutica oral para fármacos de elevada posología

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
ES201231993A ES2471340B1 (es) 2012-12-21 2012-12-21 Composición farmacéutica oral para fármacos de elevada posología

Publications (2)

Publication Number Publication Date
ES2471340A1 ES2471340A1 (es) 2014-06-25
ES2471340B1 true ES2471340B1 (es) 2015-08-17

Family

ID=49876662

Family Applications (2)

Application Number Title Priority Date Filing Date
ES201231993A Active ES2471340B1 (es) 2012-12-21 2012-12-21 Composición farmacéutica oral para fármacos de elevada posología
ES13811582T Active ES2728465T3 (es) 2012-12-21 2013-12-05 Composición farmacéutica oral para fármacos de elevada posología

Family Applications After (1)

Application Number Title Priority Date Filing Date
ES13811582T Active ES2728465T3 (es) 2012-12-21 2013-12-05 Composición farmacéutica oral para fármacos de elevada posología

Country Status (4)

Country Link
US (1) US10413568B2 (es)
EP (1) EP2937078B1 (es)
ES (2) ES2471340B1 (es)
WO (1) WO2014096485A1 (es)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9545425B2 (en) * 2014-12-23 2017-01-17 Ardelyx, Inc. Pharmaceutical compositions for treating hyperkalemia
TW201628631A (zh) 2014-12-23 2016-08-16 亞德利克斯公司 用於治療高血鉀症之組合物及方法
WO2022147183A1 (en) * 2020-12-30 2022-07-07 Jubilant Pharma Holdings Inc. Pharmaceutical extended release suspensions of riociguat

Family Cites Families (23)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3803237A (en) 1969-11-03 1974-04-09 Upjohn Co Reaction products of polyethylenepolyamines and chlorohydrins or epoxy containing compounds
US3692895A (en) 1970-09-08 1972-09-19 Norman A Nelson Method of reducing hypercholesteremia in humans employing a copolymer of polyethylenepolyamine and a bifunctional substance, such as epichlorohydria
US4221778A (en) * 1979-01-08 1980-09-09 Pennwalt Corporation Prolonged release pharmaceutical preparations
CA1236023A (en) 1984-07-18 1988-05-03 Yegnaswami Raghunathan Controlled release pharmaceutical preparations
US4882152A (en) * 1985-12-20 1989-11-21 Yang Robert K Confectionery delivery system for laxatives, vitamins and antacids
US4895723A (en) 1986-09-08 1990-01-23 Amer And Company Cholestyramine compositions and method for preparation thereof
US4950140A (en) 1987-09-14 1990-08-21 The Procter & Gamble Company Cookies containing psyllium
US4931280A (en) * 1988-06-13 1990-06-05 Basf K & F Corporation Edible, baked compositions containing cholestyramine
ES2045748T3 (es) 1989-03-16 1994-01-16 Procter & Gamble Galletas horneadas con alto contenido en fibra, que contienen psyllium.
EP0422290A1 (en) 1989-10-09 1991-04-17 Eli Lilly And Company Novel drug delivery system
AU9052791A (en) 1990-11-16 1992-06-11 Procter & Gamble Company, The Compositions containing psyllium
US5262167A (en) * 1990-12-20 1993-11-16 Basf Corporation Edible, non-baked low moisture cholestyramine composition
US5258181A (en) 1992-03-02 1993-11-02 The Procter & Gamble Company Compositions containing psyllium
DE4314583A1 (de) 1993-04-29 1994-11-03 Astra Chem Gmbh Colestyramin enthaltende Zusammensetzung und Verfahren zu deren Herstellung
US5496545A (en) 1993-08-11 1996-03-05 Geltex Pharmaceuticals, Inc. Phosphate-binding polymers for oral administration
TW474813B (en) 1994-06-10 2002-02-01 Geltex Pharma Inc Alkylated composition for removing bile salts from a patient
US6521257B1 (en) 1997-06-20 2003-02-18 Ohkura Pharmaceutical Co., Ltd. Gelled compositions
WO1999020285A1 (en) 1997-10-16 1999-04-29 Sanwa Kagaku Kenkyusho Co., Ltd. Gel preparations containing polystyrenesulfonate
JP2001086956A (ja) * 1999-09-24 2001-04-03 Morishita Jintan Kk 食物繊維を含有する顆粒、およびその製造方法
WO2002071857A1 (en) * 2001-03-12 2002-09-19 Bristol-Myers Squibb Company Confectionery compositions containing fiber
WO2004047673A2 (en) 2002-11-21 2004-06-10 Novacea, Inc. Treatment of liver disease with active vitamin d compounds
GB2404146A (en) 2003-07-24 2005-01-26 Michael John Desmond Gamlen Edible spread for administraton of medicaments
WO2011141028A1 (en) * 2010-05-08 2011-11-17 Biofiber-Damino A/S Agglomerated oil impregnated psyllium husk

Also Published As

Publication number Publication date
WO2014096485A1 (es) 2014-06-26
EP2937078B1 (en) 2019-03-27
ES2471340A1 (es) 2014-06-25
US10413568B2 (en) 2019-09-17
US20150306135A1 (en) 2015-10-29
ES2728465T3 (es) 2019-10-24
EP2937078A1 (en) 2015-10-28

Similar Documents

Publication Publication Date Title
ES2524320T3 (es) Composición para la prevención o el tratamiento de enfermedad asociada con trombo o émbolo
CL2020000747A1 (es) Formulaciones de niraparib.
CO6410279A2 (es) Composición farmacéutica que comprende derivados de glucopiranosil difenilmetano, forma farmacéutica de la misma, procedimiento para su preparación y usos de la misma para el control glucémico mejorado en un paciente.
PE20110010A1 (es) Formulaciones liquidas de fenilefrina
AR094374A1 (es) Composiciones y métodos para el tratamiento de trastornos metabólicos
IL278188B1 (en) Sublingual formulation of riluzole
CO7101246A2 (es) Compuesto de carbamato y preparación y uso de los mismos
ES2471340B1 (es) Composición farmacéutica oral para fármacos de elevada posología
CL2007001918A1 (es) Compuestos derivados heteroarilos sustituidos; metodo para la preparacion de los compuestos; composicion farmaceutica; y uso para el tratamiento del dolor, depresion, enfermedad de alzheimer e hipertension entre otras.
ECSP066715A (es)
EA201170543A1 (ru) Жидкий фармацевтический состав, содержащий парацетамол
BR112013004016A2 (pt) formulações á base de nalbufina e as respectivas utilizações
JP2013517304A5 (es)
UY37459A (es) Formulación liposomal
AR083769A1 (es) Formulaciones orales que comprenden polietilenglicol
BR112015005942A2 (pt) extratos de cynara scolymus, coffea spp. e olea europaea para tratamento de síndrome metabólica
MX2022015629A (es) Uso de vibegron para tratar vejiga sobreactiva.
EA201301266A1 (ru) Фармацевтическая композиция, содержащая налбуфина гидрохлорид, ее применение для лечения болевого синдрома средней и высокой интенсивности и способ получения фармацевтической композиции
AR094770A1 (es) Composición masticable para administración oral y proceso para preparar la misma
CO6280503A2 (es) Conjugados de neurturina novedosas para uso farmaceutico
MX2010004194A (es) Composicion oral que comprende un agente refrescante.
AR060869A1 (es) Composicion farmaceutica solida de gabapentina
BR112015018144A8 (pt) composição de emulsão água/óleo farmacêutica estável com gotículas de óleo manométricas, método para fazer a mesma e alta dose única de clopidogrel usada para tratar um paciente
EA201691034A1 (ru) Композиции в твердой форме с замедленным высвобождением для перорального введения
AR061165A1 (es) Formulaciones de liberacion pulsada de fenilefrina y composiciones farmaceuticas

Legal Events

Date Code Title Description
FG2A Definitive protection

Ref document number: 2471340

Country of ref document: ES

Kind code of ref document: B1

Effective date: 20150817