ES2471340B1 - Composición farmacéutica oral para fármacos de elevada posología - Google Patents
Composición farmacéutica oral para fármacos de elevada posología Download PDFInfo
- 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
Links
- 239000003814 drug Substances 0.000 title abstract 3
- 229940079593 drug Drugs 0.000 title abstract 3
- 239000008203 oral pharmaceutical composition Substances 0.000 title abstract 2
- 239000000203 mixture Substances 0.000 abstract description 5
- 239000003795 chemical substances by application Substances 0.000 abstract 1
- 230000037406 food intake Effects 0.000 abstract 1
- 239000003456 ion exchange resin Substances 0.000 abstract 1
- 229920003303 ion-exchange polymer Polymers 0.000 abstract 1
- 239000008141 laxative Substances 0.000 abstract 1
- 229940125722 laxative agent Drugs 0.000 abstract 1
- 239000007788 liquid Substances 0.000 abstract 1
- 238000004519 manufacturing process Methods 0.000 abstract 1
- 235000019629 palatability Nutrition 0.000 abstract 1
- 230000007170 pathology Effects 0.000 abstract 1
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 description 3
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 description 2
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 2
- 229930195725 Mannitol Natural products 0.000 description 2
- 239000000594 mannitol Substances 0.000 description 2
- 235000010355 mannitol Nutrition 0.000 description 2
- 239000004006 olive oil Substances 0.000 description 2
- 235000008390 olive oil Nutrition 0.000 description 2
- 229920005862 polyol Polymers 0.000 description 2
- 150000003077 polyols Chemical class 0.000 description 2
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 1
- 229920001268 Cholestyramine Polymers 0.000 description 1
- 240000009226 Corylus americana Species 0.000 description 1
- 235000001543 Corylus americana Nutrition 0.000 description 1
- 235000007466 Corylus avellana Nutrition 0.000 description 1
- 239000004793 Polystyrene Substances 0.000 description 1
- 239000004376 Sucralose Substances 0.000 description 1
- 235000009499 Vanilla fragrans Nutrition 0.000 description 1
- 244000263375 Vanilla tahitensis Species 0.000 description 1
- 235000012036 Vanilla tahitensis Nutrition 0.000 description 1
- JXLHNMVSKXFWAO-UHFFFAOYSA-N azane;7-fluoro-2,1,3-benzoxadiazole-4-sulfonic acid Chemical compound N.OS(=O)(=O)C1=CC=C(F)C2=NON=C12 JXLHNMVSKXFWAO-UHFFFAOYSA-N 0.000 description 1
- 229910052791 calcium Inorganic materials 0.000 description 1
- 239000011575 calcium Substances 0.000 description 1
- 235000003599 food sweetener Nutrition 0.000 description 1
- 235000011187 glycerol Nutrition 0.000 description 1
- 238000010438 heat treatment Methods 0.000 description 1
- 239000008173 hydrogenated soybean oil Substances 0.000 description 1
- 125000000400 lauroyl group Chemical group O=C([*])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])[H] 0.000 description 1
- 235000015145 nougat Nutrition 0.000 description 1
- 229920002223 polystyrene Polymers 0.000 description 1
- 235000019204 saccharin Nutrition 0.000 description 1
- CVHZOJJKTDOEJC-UHFFFAOYSA-N saccharin Chemical compound C1=CC=C2C(=O)NS(=O)(=O)C2=C1 CVHZOJJKTDOEJC-UHFFFAOYSA-N 0.000 description 1
- 229940081974 saccharin Drugs 0.000 description 1
- 239000000901 saccharin and its Na,K and Ca salt Substances 0.000 description 1
- BAQAVOSOZGMPRM-QBMZZYIRSA-N sucralose Chemical compound O[C@@H]1[C@@H](O)[C@@H](Cl)[C@@H](CO)O[C@@H]1O[C@@]1(CCl)[C@@H](O)[C@H](O)[C@@H](CCl)O1 BAQAVOSOZGMPRM-QBMZZYIRSA-N 0.000 description 1
- 235000019408 sucralose Nutrition 0.000 description 1
- 239000003765 sweetening agent Substances 0.000 description 1
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
- A61K31/74—Synthetic polymeric materials
- A61K31/795—Polymers containing sulfur
-
- 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
- A61K31/716—Glucans
- A61K31/717—Celluloses
-
- 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
- A61K31/74—Synthetic polymeric materials
- A61K31/785—Polymers containing nitrogen
-
- 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
- A61K31/74—Synthetic polymeric materials
- A61K31/785—Polymers containing nitrogen
- A61K31/787—Polymers containing nitrogen containing heterocyclic rings having nitrogen as a ring hetero atom
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/68—Plantaginaceae (Plantain Family)
-
- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
-
- 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
- A61K47/44—Oils, 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
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth 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
-
- 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
- A61K9/06—Ointments; 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
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
Claims (1)
-
imagen1 imagen2 imagen3 imagen4 imagen5 imagen6 imagen7 imagen8 imagen9 imagen10 imagen11
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)
| 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)
| 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 |
-
2012
- 2012-12-21 ES ES201231993A patent/ES2471340B1/es active Active
-
2013
- 2013-12-05 ES ES13811582T patent/ES2728465T3/es active Active
- 2013-12-05 WO PCT/ES2013/070845 patent/WO2014096485A1/es not_active Ceased
- 2013-12-05 EP EP13811582.9A patent/EP2937078B1/en active Active
- 2013-12-05 US US14/651,931 patent/US10413568B2/en active Active
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 |
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| FG2A | Definitive protection |
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