WO2007085676A1 - Method for producing a solution based on polyethylene glycol with electrolytes, product thus obtained and use of same - Google Patents

Method for producing a solution based on polyethylene glycol with electrolytes, product thus obtained and use of same Download PDF

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Publication number
WO2007085676A1
WO2007085676A1 PCT/ES2007/000043 ES2007000043W WO2007085676A1 WO 2007085676 A1 WO2007085676 A1 WO 2007085676A1 ES 2007000043 W ES2007000043 W ES 2007000043W WO 2007085676 A1 WO2007085676 A1 WO 2007085676A1
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Prior art keywords
solution
prepared
weight
incorporation
polyethylene glycol
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PCT/ES2007/000043
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Spanish (es)
French (fr)
Inventor
Daniel Tabuenca Navarro
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Laboratorios Casen-Fleet, S.L.
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Publication of WO2007085676A1 publication Critical patent/WO2007085676A1/en

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    • 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
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • 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
    • A61K31/765—Polymers containing oxygen
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/10—Laxatives

Definitions

  • the present specification refers to a process of manufacturing a solution based on polyethylene glycol with electrolytes, product obtained and use, by means of which procedure the product based on polyethylene glycol and electrolytes is obtained in a gel state presenting a better solubility facilitating its absorption, better organoleptic properties and a greater predisposibility in the organism.
  • the solutions manufactured based on polyethylene glycol and electrolytes are presented in powder for dissolution in water and administered orally, being applied as an osmotic laxative and as an intestinal evacuator for the previous preparation, for example, to colonoscopy, surgery , radiology and other colorectal and genitourinary examinations.
  • solutions based on polyethylene glycol and electrolytes are obtained by the homogeneous mixture of its components resulting in a powder product for dissolution in water and oral administration.
  • oral solutions based on polyethylene glycol as an osmotic agent and electrolytes are hypertonic solutions, so that it facilitates the outflow of water to the intestinal lumen and therefore the laxative / evacuating effect.
  • auxiliary reactor of 150 I. 0.3% by weight of the batch of solution to be prepared of orange flavor has been dissolved in 100 I. (approximately 2% of the batch to be prepared) of purified water, the mixture being incorporated into the main reactor.
  • half of the hydroxyethylcellulose is mixed in each of them, that is, approximately 0.5% by weight of the solution to be prepared and half of the anhydrous sodium sulfate, that is , approximately, 1.6% by weight of the solution to be prepared, proceeding to its incorporation into the main reactor, so that the content of one of the vessels is first introduced and once dissolved, the content of the second will be introduced container.
  • the product obtained in a gel state has a pH between 7 and 9.5 and a viscosity between 500 and
  • the product obtained is applicable as an osmotic laxative - A - for the treatment of constipation and as an intestinal evacuator for prior preparation in color and genitourinary examinations.

Abstract

The invention relates to a method for producing polyethylene glycol with electrolytes, in which the product based on polyethylene glycol and electrolytes is obtained in the gel state and with improved solubility, facilitating the absorption thereof, improved organoleptic properties and improved pre-availability in the organism.

Description

PROCEDIIVHENTO DE FABRICACIÓN DE UNA SOLUCIÓN A BASE DE POLIETILENGUCOL CON ELECTROLITOS, PRODUCTO OBTENIDO Y uso. MANUFACTURING PROCEDURE OF A POLYETHYNGUCOL BASED SOLUTION WITH ELECTROLYTES, PRODUCT OBTAINED AND USE.
OBJETO DE LA INVENCIÓN. La siguiente invención, según se expresa en el enunciado deOBJECT OF THE INVENTION The following invention, as expressed in the statement of
Ia presente memoria descriptiva, se refiere a un procedimiento de fabricación de una solución a base de polietilenglicol con electrolitos, producto obtenido y uso, mediante cuyo procedimiento se obtiene el producto a base de polietilenglicol y electrolitos en estado de gel presentando una mejor solubilidad facilitando su absorción, unas mejores propiedades organolépticas y una mayor predisponibiiidad en el organismo.The present specification refers to a process of manufacturing a solution based on polyethylene glycol with electrolytes, product obtained and use, by means of which procedure the product based on polyethylene glycol and electrolytes is obtained in a gel state presenting a better solubility facilitating its absorption, better organoleptic properties and a greater predisposibility in the organism.
CAMPO DE APLICACIÓN.SCOPE.
En Ia presente memoria se describe un procedimiento de fabricación de una solución a base de polietilenglicol con electrolitos cuyo producto obtenido es de aplicación como laxante osmótico en el tratamiento del estreñimiento y como evacuante intestinal para Ia previa preparación para exámenes coloréeteles, siendo administrado por vía oral. ANTECEDENTES DE LA INVENCIÓN.In this report a process of manufacturing a solution based on polyethylene glycol with electrolytes is described, the product of which is obtained as an osmotic laxative in the treatment of constipation and as an intestinal evacuator for the previous preparation for colorectal examinations, being administered orally . BACKGROUND OF THE INVENTION
Convencionalmente, las soluciones fabricadas a base de polietilengucol y electrolitos se presentan en polvo para su disolución en agua y su administrada por vía oral, siendo de aplicación como laxante osmótico y como evacuante intestinal para Ia preparación previa, por ejemplo, a Ia colonoscopia, cirugía, radiología y otros exámenes colorectales y genitourinarios.Conventionally, the solutions manufactured based on polyethylene glycol and electrolytes are presented in powder for dissolution in water and administered orally, being applied as an osmotic laxative and as an intestinal evacuator for the previous preparation, for example, to colonoscopy, surgery , radiology and other colorectal and genitourinary examinations.
De esta forma, las soluciones a base de polietilenglicol y electrolitos se obtienen mediante Ia homogénea mezcla de sus componentes resultando un producto en polvo para su disolución en agua y administración oral.In this way, the solutions based on polyethylene glycol and electrolytes are obtained by the homogeneous mixture of its components resulting in a powder product for dissolution in water and oral administration.
Así, podemos considerar una solución en polvo a base de polietilenglicol cuya composición en peso será, aproximadamente, Ia siguiente:Thus, we can consider a powder solution based on polyethylene glycol whose composition by weight will be approximately the following:
- polietilenglicol 4000 85% - sulfato sódico anhidro 8% bicarbonato sódico 2,4% cloruro sódico 2% cloruro potásico 1% bifosfato sódico 0,7% más los correspondientes excipientes, tales como: aroma edulcorante.- polyethylene glycol 4000 85% - anhydrous sodium sulfate 8% sodium bicarbonate 2.4% sodium chloride 2% potassium chloride 1% sodium bisphosphate 0.7% plus the corresponding excipients, such as: sweetener aroma.
En definitiva, las soluciones orales a base de polietilenglicol como agente osmótico y electrolitos, son unas soluciones hipertónicas, de forma que facilita Ia salida de agua a Ia luz intestinal y por consiguiente el efecto laxante/evacuante.In short, oral solutions based on polyethylene glycol as an osmotic agent and electrolytes, are hypertonic solutions, so that it facilitates the outflow of water to the intestinal lumen and therefore the laxative / evacuating effect.
DESCRIPCIÓN DETALLADA DE LA INVENCIÓN. Con objeto de obtener de una solución a base de polietilenglicol con electrolitos, según un lote técnico de 5.500 litros, se dispondrá de un reactor principal con una capacidad de 6.000 I. provisto de un agitador de ancora o similar y un homogeneizador, así como de unos reactores auxiliares, balanzas para pesar los componentes y Ia maquinaria apropiada para su dosificación y cerrado automático de los recipientes de envasado. De esta forma, en primer lugar, se incorpora agua purificada en el reactor principal, conectando el agitador e incorporando, aproximadamente, un 0,5% en peso del lote a preparar, agitando hasta su disolución.DETAILED DESCRIPTION OF THE INVENTION. In order to obtain a solution based on polyethylene glycol with electrolytes, according to a technical batch of 5,500 liters, a main reactor with a capacity of 6,000 I will be available, equipped with an anchor stirrer or similar and a homogenizer, as well as a homogenizer. auxiliary reactors, scales for weighing the components and the appropriate machinery for dosing and automatic closing of the packaging containers. In this way, first, purified water is incorporated into the main reactor, connecting the stirrer and incorporating approximately 0.5% by weight of the batch to be prepared, stirring until dissolved.
A continuación se procederá a añadir todos los principios activos, a excepción del sulfato sódico, de uno en uno y agitando antes de adicionar el siguiente, de forma que estos principios activos son: un 35% en peso de Ia solución a preparar de polietilenglicol;Next, all active ingredients will be added, with the exception of sodium sulfate, one at a time and stirring before adding the following, so that these active ingredients are: 35% by weight of the solution to be prepared of polyethylene glycol;
- un 1% en peso de Ia solución a preparar de bicarbonato sódico; un 0,85% en peso de Ia solución a preparar de cloruro sódico; un 0,45% en peso de Ia solución a preparar de cloruro potásico, y; - un 0,3% en peso de Ia solución a preparar de bifosfato sódico; siendo, lógicamente, estos porcentajes cantidades aproximadas.- 1% by weight of the solution to be prepared of sodium bicarbonate; 0.85% by weight of the solution to be prepared of sodium chloride; 0.45% by weight of the solution to be prepared of potassium chloride, and; - 0.3% by weight of the solution to be prepared from bisphosphate sodium; logically, these percentages are approximate amounts.
Una vez homegeneizada Ia mezcla se procede a incorporar un 0,45% en peso del lote de Ia solución a preparar de los edulcorantes agitando hasta su disolución.Once the mixture is homegeneized, 0.45% by weight of the batch of the solution to be prepared of the sweeteners is stirred while stirring until dissolved.
Por otra parte, en un reactor auxiliar de 150 I. se ha disuelto un 0,3% en peso del lote de solución a preparar de aroma de naranja en 100 I. (aproximadamente el 2% del lote a preparar) de agua purificada, siendo incorporada Ia mezcla al reactor principal. Asimismo, en dos recipientes o reactores auxiliares se mezcla, en cada uno de ellos, Ia mitad de Ia hidroxietilcelulosa, esto es, aproximadamente, un 0,5% en peso de Ia solución a preparar y Ia mitad del sulfato sódico anhidro, esto es, aproximadamente, un 1,6% en peso de Ia solución a preparar, procediendo a su incorporación al reactor principal, de forma que primero se introduce el contenido de uno de los recipientes y una vez disuelto se procederá a Ia introducción del contenido del segundo recipiente.On the other hand, in an auxiliary reactor of 150 I. 0.3% by weight of the batch of solution to be prepared of orange flavor has been dissolved in 100 I. (approximately 2% of the batch to be prepared) of purified water, the mixture being incorporated into the main reactor. Likewise, in two containers or auxiliary reactors, half of the hydroxyethylcellulose is mixed in each of them, that is, approximately 0.5% by weight of the solution to be prepared and half of the anhydrous sodium sulfate, that is , approximately, 1.6% by weight of the solution to be prepared, proceeding to its incorporation into the main reactor, so that the content of one of the vessels is first introduced and once dissolved, the content of the second will be introduced container.
Así, Ia incorporación de Ia hidroxietilcelulosa y el sulfato sódico anhidro, hace que Ia solución obtenida (producto) adquiera una consistencia de gel.Thus, the incorporation of hydroxyethyl cellulose and anhydrous sodium sulfate, makes the solution obtained (product) acquire a gel consistency.
Finalmente, se procederá a Ia lenta incorporación, aproximadamente, de un 1% en peso de Ia solución a preparar de sílice coloidal y se incorporará agua purificada hasta el total de Ia cantidad o lote predeterminado, esto es, los 5.500 I. de solución a preparar. Una vez obtenido el lote de 5.500 I. de Ia solución a base de polietilenglicol con electrolitos, en estado de gel, se procederá, de forma convencional, a su dosificación en frascos o sobres monodosis de diferentes volúmenes.Finally, approximately 1% by weight of the solution to be prepared of colloidal silica will be slowly incorporated and purified water will be incorporated up to the total of the predetermined quantity or lot, that is, 5,500 I. of solution to prepare. Once the batch of 5,500 I. of the solution based on polyethylene glycol with electrolytes has been obtained, in a gel state, it will proceed, in a conventional manner, to its dosage in bottles or single dose envelopes of different volumes.
El producto obtenido en estado de gel presenta un pH comprendido entre 7 y 9,5 y una viscosidad comprendida entre 500 yThe product obtained in a gel state has a pH between 7 and 9.5 and a viscosity between 500 and
2000 cps., y será administrado por vía oral, de forma que su estado de gel facilita su solubilidad para ser absorbido mejor por el organismo, presenta una mayor predisponibilidad en el organismo y tiene mejores propiedades organolépticas. El producto obtenido es de aplicación como laxante osmótico - A - para el tratamiento del estreñimiento y como evacuador intestinal para Ia preparación previa en exámenes coloréeteles y genitourinarios. 2000 cps., And will be administered orally, so that its gel state facilitates its solubility to be better absorbed by the body, has a greater predisposibility in the body and has better organoleptic properties. The product obtained is applicable as an osmotic laxative - A - for the treatment of constipation and as an intestinal evacuator for prior preparation in color and genitourinary examinations.

Claims

R E I V I N D 1 C A C 1 O N E S.R E I V I N D 1 C A C 1 O N E S.
1a.- PROCEDIMIENTO DE FABRICACIÓN DE1 a .- MANUFACTURING PROCEDURE OF
POLIETILENGLICOL CON ELECTROLITOS, siendo de utilidad para el tratamiento del estreñimiento y como evacuante intestinal previo a exámenes colorectales, caracterizado porque el procedimiento comprende:POLYETHYLENE GLYCOL WITH ELECTROLYTES, being useful for the treatment of constipation and as a bowel movement prior to colorectal examinations, characterized in that the procedure comprises:
- Ia incorporación en un reactor principal con agua purificada y provisto de un agitador, de un 0,5% de benzoato sódico en peso de Ia solución a preparar, agitando hasta su disolución;- the incorporation in a main reactor with purified water and provided with an agitator, of 0.5% of sodium benzoate by weight of the solution to be prepared, stirring until dissolved;
- Ia incorporación, uno a uno, agitando tras cada disolución: de un 35% en peso de Ia solución a preparar de polietilenglicol; - de un 1% en peso de Ia solución a preparar de bicarbonato sódico; - de un 0,85% en peso de Ia solución a preparar de cloruro sódico; de un 0,45% en peso de Ia solución a preparar de cloruro potásico, y; de un 0,3% en peso de Ia solución a preparar de bifosfato sódico;- the incorporation, one by one, stirring after each dissolution: of 35% by weight of the solution to be prepared of polyethylene glycol; - of 1% by weight of the solution to be prepared of sodium bicarbonate; - of 0.85% by weight of the solution to be prepared of sodium chloride; of 0.45% by weight of the solution to be prepared of potassium chloride, and; of 0.3% by weight of the solution to be prepared of sodium bisphosphate;
Ia incorporación de un 0,45% en peso de Ia solución a preparar de edulcorantes agitando hasta su disolución; - Ia incorporación, mediante una bomba, de un 2% en peso de Ia disolución a preparar, de agua purificada en Ia que, previamente, se ha dϊsuelto un 0,3% en peso de Ia disolución a preparar de aroma;The incorporation of 0.45% by weight of the solution to be prepared as sweeteners while stirring until dissolved; - the incorporation, by means of a pump, of 2% by weight of the solution to be prepared, of purified water in which, previously, 0.3% by weight of the solution to be prepared of aroma has been dissolved;
- Ia incorporación de un 0,5% en peso de Ia solución a preparar de hidroxietilcelulosa y un 1,6% en peso de Ia solución a preparar de sulfato sódico anhidro, mezclados previamente;- The incorporation of 0.5% by weight of the solution to be prepared of hydroxyethyl cellulose and 1.6% by weight of the solution to be prepared of anhydrous sodium sulfate, previously mixed;
Ia incorporación de un 0,5% en peso de Ia solución a preparar de hidroxietilcelulosa y un 1,6% en peso de Ia solución a preparar de sulfato sódico anhidro, mezclados previamente;The incorporation of 0.5% by weight of the solution to be prepared of hydroxyethyl cellulose and 1.6% by weight of the solution to be prepared of anhydrous sodium sulfate, mixed previously;
Ia incorporación de un 1% en peso de Ia solución a preparar de sílice coloidal, y;The incorporation of 1% by weight of the solution to be prepared of colloidal silica, and;
- Ia incorporación de agua purificada hasta el total de Ia cantidad o lote predeterminado de solución a preparar.- The incorporation of purified water up to the total of the predetermined quantity or batch of solution to be prepared.
2a.- PRODUCTO OBTENIDO, según Ia reivindicación 1a, caracterizado porque Ia solución obtenida se encuentra en estado de gel.2 .- RESULTING PRODUCT, according to claim 1, characterized in that the solution obtained is in gel state.
3a.- PRODUCTO OBTENIDO, según Ia reivindicación 2a, caracterizado porque presenta un pH comprendido entre 7 y 9,5.3 .- RESULTING PRODUCT, according to claim 2, characterized in that it has a pH between 7 and 9.5.
4a.- PRODUCTO OBTENIDO, según Ia ' reivindicación 2a, caracterizado porque presenta una viscosidad comprendida entre 500 y 2000 cps.4 .- product obtained according to the 'claim 2, characterized in that it has a viscosity comprised between 500 and 2000 cps.
5a.- PRODUCTO OBTENIDO, según Ia reivindicación 1a, caracterizado porque es administrado por vía oral.5 .- RESULTING PRODUCT, according to claim 1, characterized in that it is administered orally.
6a.- USO, del producto obtenido según reivindicaciones anteriores como laxante osmótico y evacuador intestinal. 6 .- USE of the product obtained according to previous claims as osmotic laxative and bowel evacuator.
PCT/ES2007/000043 2006-01-30 2007-01-29 Method for producing a solution based on polyethylene glycol with electrolytes, product thus obtained and use of same WO2007085676A1 (en)

Applications Claiming Priority (2)

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ESP200600198 2006-01-30
ES200600198A ES2278537B1 (en) 2006-01-30 2006-01-30 PROCEDURE FOR MANUFACTURING A SOLUTION BASED ON POLYETHYLENE GLYCOL WITH ELECTROLYTES, PRODUCT OBTAINED AND USE.

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9468686B2 (en) 2009-07-30 2016-10-18 Norgine Bv Solutions comprising polyethylene glycol and electrolytes

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1987000754A1 (en) * 1985-08-01 1987-02-12 Braintree Laboratories, Inc. Low-sodium laxative and lavage formulation
WO2003092589A2 (en) * 2002-04-30 2003-11-13 Braintree Laboratories, Inc. Salt solution for colon cleansing
WO2004037292A1 (en) * 2002-10-25 2004-05-06 Norgine Europe Bv Colon cleansing compositions
WO2005049049A1 (en) * 2003-11-17 2005-06-02 Braintree Laboratories, Inc. Therapeutic peg solution concentrate
WO2005102364A1 (en) * 2004-04-23 2005-11-03 Norgine Europe Bv Compressed pharmaceutical compositions comprising peg and electrolytes

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1987000754A1 (en) * 1985-08-01 1987-02-12 Braintree Laboratories, Inc. Low-sodium laxative and lavage formulation
WO2003092589A2 (en) * 2002-04-30 2003-11-13 Braintree Laboratories, Inc. Salt solution for colon cleansing
WO2004037292A1 (en) * 2002-10-25 2004-05-06 Norgine Europe Bv Colon cleansing compositions
WO2005049049A1 (en) * 2003-11-17 2005-06-02 Braintree Laboratories, Inc. Therapeutic peg solution concentrate
WO2005102364A1 (en) * 2004-04-23 2005-11-03 Norgine Europe Bv Compressed pharmaceutical compositions comprising peg and electrolytes

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9468686B2 (en) 2009-07-30 2016-10-18 Norgine Bv Solutions comprising polyethylene glycol and electrolytes

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SA07280014B1 (en) 2009-12-22
ES2278537B1 (en) 2008-09-16
ES2278537A1 (en) 2007-08-01

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