WO2018138652A1 - Pharmaceutical composition of loratadine, phenylephrine, paracetamol and amantadine for oral administration, for the treatment of allopathies related to a common cold - Google Patents

Pharmaceutical composition of loratadine, phenylephrine, paracetamol and amantadine for oral administration, for the treatment of allopathies related to a common cold Download PDF

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Publication number
WO2018138652A1
WO2018138652A1 PCT/IB2018/050431 IB2018050431W WO2018138652A1 WO 2018138652 A1 WO2018138652 A1 WO 2018138652A1 IB 2018050431 W IB2018050431 W IB 2018050431W WO 2018138652 A1 WO2018138652 A1 WO 2018138652A1
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WIPO (PCT)
Prior art keywords
paracetamol
loratadine
phenylephrine
amantadine
pharmaceutical composition
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PCT/IB2018/050431
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Spanish (es)
French (fr)
Inventor
Oliver Daniel WALLS FLORES
Ramón RODRÍGUEZ HERNÁNDEZ
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Laboratorios Liomont, S.A. De C.V.
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Publication of WO2018138652A1 publication Critical patent/WO2018138652A1/en

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    • 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
    • A61K31/04—Nitro compounds
    • 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
    • A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • 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
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • A61K31/4523—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
    • A61K31/4545—Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a six-membered ring with nitrogen as a ring hetero atom, e.g. pipamperone, anabasine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/02—Nasal agents, e.g. decongestants

Definitions

  • the present invention consists of a pharmaceutical composition in a combination of an antihistamine agent, with a decongestant agent, with an antipyretic / analgesic agenta and one with an antiviral agent, which results in having a medicament with stability characteristics conducive to oral administration. for the supply in mammals and especially in humans for the treatment of allopathies related to a common cold.
  • an oral administration tablet containing an antihistamine, an antipyretic / analgesic and a decongestant is described.
  • the therapeutic indication for this pharmaceutical composition is for the relief of influenza of viral origin and for the relief of some allergies, with an administration every twelve hours.
  • the International Drug Index indicates the use of; paracetamol as an analgesic / antipyretic, phenylephrine as a decongestant and loratadine as an antihistamine.
  • paracetamol as an analgesic / antipyretic
  • phenylephrine as a decongestant
  • loratadine as an antihistamine.
  • the reason for the present invention is to have a pharmaceutical composition in tablet or capsule for oral administration with a fourth component corresponding to an antiviral such as is amantadine hydrochloride, as an alternative for the treatment of allopathies related to a common cold
  • Phenylephrine, amantadine, loratadine and paracetamol as active ingredients and their salts in relation to patents are already in the public domain.
  • no patent was found to protect the combination of phenylephrine, amantadine, loratadine and paracetamol in a tablet or capsule.
  • the challenge that had to be overcome in the development of this combination of active ingredients, was to have a process that allowed its administration by oral route, which is why different tests were performed until the excipients were found and the process that allowed the compression of the assets in a tablet or its filling in a capsule to be administered orally.
  • It consists of providing a pharmaceutical composition that can be administered orally as an alternative for the treatment of allopathies related to a common cold.
  • a further object of the invention is to have a dosage alternative that includes an antiviral agent for the treatment of a common cold.
  • a further object of the invention is to specifically provide a tablet or capsule pharmaceutical form of phenylephrine, amantadine, paracetamol and loratadine or their similar salts so that it can be administered orally.
  • step 2 To the powder mixture from step 1, mix with one or more previously sifted lubricating / non-stick / gliding agents and paracetamol.
  • step 3 The powder mixture from step 3 is again mixed with one with one or more lubricants / non-stick / slip agents previously screened.
  • a tablet / encapsulator compress / fill the powder mixture from step 2 and the powder mixture from step 4, in a blcapa tablet / in a capsule.
  • step 5 In a bass drum, the tablets of step 5 are coated with the dispersion of step 6.
  • Example 1 In a mixer, mix amantadine hydrochloride, sodium starch glycolate and previously screened microcrystalline cellulose. ) To the powder mixture from step 1, mix with previously sifted sodium stearyl fumarate and paracetamol. ) In a mixer, mix loratadine or its salts, phenylephrine hydrochloride, sodium starch glycolate, copovidone and previously screened cellulosic microcrystalline. ) The powder mixture from step 3 is mixed with sodium stearyl fumarate previously screened. ) On a tablet machine, compress the powder mixture from step 2 and the powder mixture from step 4 on a bilayer tablet.
  • step 5 In a container with water, disperse the mixture of the coating polymer with a non-stick / lubricant / slider, dye, opalescent and / or plasticizer.
  • a bass drum the tablets of step 5 are coated with the dispersion of step 6.
  • Example 2) In a mixer, mix amantadlan hydrochloride, sodium starch glycolylate and microcrystalline cellulose previously sieved. ) To the powder mixture from step 1, mix with paracetamol. ) To the powder mixture from step 2, mix with previously sifted sodium stearyl fumarate.
  • a mixer mix loratadine or its salts, phenylephrine hydrochloride, sodium starch glycolate, copovidone and previously screened cellulosic microcrystalline.
  • the powder mixture from step 4 is mixed with sodium stearyl fumarate previously sieved.
  • On a tablet machine compress the powder mixture from step 3 and the powder mixture from step 5 on a bilayer tablet.
  • step 6 In a container with water, disperse the mixture of the coating polymer with a non-stick / lubricant / slider, dye, opalescent and / or plasticizer. ) In a bass drum, the tablets of step 6 are coated with the dispersion of step 7.
  • Example 3 In a mixer, mix amantadine hydrochloride, sodium starch glycolate and previously screened microcrystalline cellulose. ) To the powder mixture from step 1, mix with paracetamol. ) To the powder mixture from step 2, mix with previously sifted sodium stearyl fumarate. ) In a mixer, mix loratadine or its salts, phenylephrine hydrochloride, sodium starch glycolate, copovidone and previously screened cellulosic microcrystalline. ) The powder mixture from step 4 is mixed with previously sifted sodium stearyl fumarate. In a tablet machine, compress the powder mixture from step 3 and the powder mixture from step 5 into a bilayer tablet.
  • step 1 To the powder mixture from step 1, mix with one or more previously sifted lubricating / non-stick / gliding agents and paracetamol.
  • a mixer mix loratadine or its salts, phenylephrine or its salts, one or more disintegrants, one or more polyvinylpyrrolidone derivatives and one or more previously screened diluting agents.
  • the powder mixture from step 3 is again mixed with one with one or more lubricants / non-stick / slip agents previously screened.
  • step 6 In a bass drum, the tablets of step 6 are coated with the dispersion of step 7.
  • step 1 To the powder mixture from step 1, mix with one or more previously sifted lubricating / non-stick / gliding agents and paracetamol.
  • a mixer mix loratadlna or its salts, phenylephrine or its salts, one or more disintegrants, one or more polyvinylpyrrolidone derivatives and one or more previously screened diluting agents.
  • the powder mixture from step 3 is again mixed with one with one or more lubricants / non-stick / slip agents previously screened.
  • step 2 Mix the powder mixture from step 2 and step 4.
  • step 5 In a potting machine fill the powder mixture from step 5.

Abstract

The present invention relates to the preparation of a pharmaceutical composition with an antihistamine agent, a descongesting agent, an antipyretic/analgesic agent and an antiviral agent in an oral administration for the treatment of allopathies related to the common cold.

Description

COMPOSICION FARMACEUTICA DE LORATADINA, FENILEFRINA, PARACETAMOL Y AMANTADI NA PARA SU ADMINISTRACIÓN ORAL, PARA EL TRATAMIENTO DE ALOPATÍAS RELACIONADAS A UN  PHARMACEUTICAL COMPOSITION OF LORATADINE, PHENYLEFRINE, PARACETAMOL AND AMANTADI NA FOR ORAL ADMINISTRATION, FOR THE TREATMENT OF ALOPATHIES RELATED TO A
RESFRIADO COMÚN  COMMON COLD
CAMPO DE LA INVENCIÓN FIELD OF THE INVENTION
La presente invención consiste de una composición farmacéutica en una combinación de un agente antihistamínico, con un agente descongestionante, con un agenta antipirético/analgésico y un con un agente antiviral, que da como resultado tener un medicamento con características de estabilidad propicias para la administración oral para el suministro en mamíferos y en especial en humanos para el tratamiento de alopatías relacionadas a un resfriado común. The present invention consists of a pharmaceutical composition in a combination of an antihistamine agent, with a decongestant agent, with an antipyretic / analgesic agenta and one with an antiviral agent, which results in having a medicament with stability characteristics conducive to oral administration. for the supply in mammals and especially in humans for the treatment of allopathies related to a common cold.
ANTECEDENTES DE LA INVENCIÓN BACKGROUND OF THE INVENTION
En el Diccionario de Especialidades Farmacéuticas PLM, se describe una tableta de administración oral que contiene un antihistamínico, un antipirético/analgésico y un descongestionante. La indicación terapéutica para esta composición farmacéutica es para el alivio de la gripe de origen viral y para el alivio de algunas alergias, con una administración cada doce horas. In the Dictionary of Pharmaceutical Specialties PLM, an oral administration tablet containing an antihistamine, an antipyretic / analgesic and a decongestant is described. The therapeutic indication for this pharmaceutical composition is for the relief of influenza of viral origin and for the relief of some allergies, with an administration every twelve hours.
The International Drug Index indica el uso de; paracetamol como un analgésico/ antipirético, la fenilefrina como un descongestionante y la loratadina como un antihistamínico. En el anuario de morbilidad emitido por la Dirección General de Epidemiología índica que en el año 2015 en México la principal enfermedad consultada fue la de las enfermedades respiratorias. The International Drug Index indicates the use of; paracetamol as an analgesic / antipyretic, phenylephrine as a decongestant and loratadine as an antihistamine. In the morbidity yearbook issued by the Directorate General of Indica Epidemiology that in 2015 in Mexico the main disease consulted was that of respiratory diseases.
Con base en lo anterior y tomando como base la composición de paracetamol, clorhidrato de fenilefrina y loratadina, el motivo de la presente invención es el tener una composición farmacéutica en tableta o cápsula para su administración oral con un cuarto componente que corresponde a un antiviral como es el clorhidrato de amantadina, como una alternativa para el tratamiento de alopatías relacionadas a un resfriado común Based on the foregoing and based on the composition of paracetamol, phenylephrine hydrochloride and loratadine, the reason for the present invention is to have a pharmaceutical composition in tablet or capsule for oral administration with a fourth component corresponding to an antiviral such as is amantadine hydrochloride, as an alternative for the treatment of allopathies related to a common cold
La fenilefrina, la amantadina, la loratadina y el paracetamol como principios activos y sus sales en lo referente a patentes ya son del dominio público. En la revisión de patentes no se encontró alguna patente que protegiera la combinación de fenilefrina, amantadina, loratadina y paracetamol en una tableta o cápsula. El reto que se tuvo que vencer en el desarrollo de esta combinación de principios activos, fue el de tener un proceso que permitiera su administración por vía oral, razón por la cual se realizaron diferentes pruebas hasta encontrar los excipientes y proceso que permitiera la compresión de los activos en una tableta o su llenado en una capsula para poder ser administrado por vía oral. Phenylephrine, amantadine, loratadine and paracetamol as active ingredients and their salts in relation to patents are already in the public domain. In the patent review, no patent was found to protect the combination of phenylephrine, amantadine, loratadine and paracetamol in a tablet or capsule. The challenge that had to be overcome in the development of this combination of active ingredients, was to have a process that allowed its administration by oral route, which is why different tests were performed until the excipients were found and the process that allowed the compression of the assets in a tablet or its filling in a capsule to be administered orally.
OBJETO DE LA INVENCIÓN OBJECT OF THE INVENTION
Consiste en proporcionar una composición farmacéutica que pueda ser administrada por vía oral como una alternativa para el tratamiento de alopatías referentes a un resfriado común. It consists of providing a pharmaceutical composition that can be administered orally as an alternative for the treatment of allopathies related to a common cold.
Otro objeto más de la invención consiste tener una alternativa de dosificación que incluya un agente antiviral para el tratamiento de un resfriado común. A further object of the invention is to have a dosage alternative that includes an antiviral agent for the treatment of a common cold.
Otro objeto más de la invención consiste en proporcionar en específico una forma farmacéutica tableta o cápsula de fenilefrina, amantadina, paracetamol y loratadina o sus sales similares para que puede ser administrada por vía oral. A further object of the invention is to specifically provide a tablet or capsule pharmaceutical form of phenylephrine, amantadine, paracetamol and loratadine or their similar salts so that it can be administered orally.
DESCRIPCION DETALLADA DE LA INVENCION DETAILED DESCRIPTION OF THE INVENTION
Por tal motivo se desarrolló un proceso novedoso de una composición farmacéutica que pueda ser administrad por vía oral, la cual consiste en: For this reason, a novel process of a pharmaceutical composition was developed that can be administered orally, which consists of:
1) En un mezclador, mezclar amantadina o sus sales, uno o más agentes desintegrantes y uno o más agentes diluentes de compresión directa previamente tamizados. 1) In a mixer, mix amantadine or its salts, one or more disintegrating agents and one or more direct compression diluting agents previously screened.
2) A la mezcla de polvos del paso 1, mezclar con uno o más agentes lubricante/antiadherente/deslizante previamente tamizados y paracetamol. 2) To the powder mixture from step 1, mix with one or more previously sifted lubricating / non-stick / gliding agents and paracetamol.
3) En un mezclador, mezclar loratadina o sus sales, fenilefrina o sus sales, uno o más desintegrantes, uno o más derivados de polivinilpirrolidona y uno o más agentes diluentes previamente tamizados. 3) In a mixer, mix loratadine or its salts, phenylephrine or its salts, one or more disintegrants, one or more polyvinylpyrrolidone derivatives and one or more previously screened diluting agents.
4) A la mezcla de polvo del paso 3 se mezcla nuevamente con una con uno o más agentes lubricantes/antiadherentes/deslizantes previamente tamizado. En una tableteadora/encapsuladora comprimir/llenar la mezcla de polvos del paso 2 y la mezcla de polvos del paso 4, en una tableta blcapa/en una cápsula. 4) The powder mixture from step 3 is again mixed with one with one or more lubricants / non-stick / slip agents previously screened. In a tablet / encapsulator compress / fill the powder mixture from step 2 and the powder mixture from step 4, in a blcapa tablet / in a capsule.
En un contenedor con agua dispersar la mezcla del polímero de recubrimiento con un antiadherente/lubricante/deslizante, colorante, opalescente y/o un plastificante. In a container with water, disperse the mixture of the coating polymer with a non-stick / lubricant / slider, dye, opalescent and / or plasticizer.
En un bombo se recubren las tabletas del paso 5 con la dispersión del paso 6. In a bass drum, the tablets of step 5 are coated with the dispersion of step 6.
el objeto de demostrar la actividad inventiva de la presente invención, se presentan los siguientes ejemplos: In order to demonstrate the inventive activity of the present invention, the following examples are presented:
Ejemplo 1 ) En un mezclador, mezclar clorhidrato de amantadina, almidón glicolato de sodio y celulosa microcristalina previamente tamizados. ) A la mezcla de polvos del paso 1, mezclar con estaeril fumarato de sodio previamente tamizado y paracetamol. ) En un mezclador, mezclar loratadina o sus sales, clorhidrato de fenilefrina, almidón glicolato de sodio, copovidona y celulosamicrocristalina previamente tamizados. ) A la mezcla de polvo del paso 3 se mezcla con estearil fumarato de sodio previamente tamizado. ) En una tableteadora comprimir la mezcla de polvos del paso 2 y la mezcla de polvos del paso 4, en una tableta bicapa. ) En un contenedor con agua dispersar la mezcla del polímero de recubrimiento con un antiadherente/lubricante/deslizante, colorante, opalescente y/o un plastificante. ) En un bombo se recubren las tabletas del paso 5 con la dispersión del paso 6. Ejemplo 2 ) En un mezclador, mezclar clorhidrato de amantadlna, almidón gllcolato de sodio y celulosa microcristalina previamente tamizados. ) A la mezcla de polvos del paso 1 , mezclar con paracetamol. ) A la mezcla de polvos del paso 2, mezclar con estaeril fumarato de sodio previamente tamizado. ) En un mezclador, mezclar loratadina o sus sales, clorhidrato de fenilefrina, almidón glicolato de sodio, copovidona y celulosamicrocristalina previamente tamizados. ) A la mezcla de polvo del paso 4 se mezcla con estearil fumarato de sodio previamente tamizado. ) En una tableteadora comprimir la mezcla de polvos del paso 3 y la mezcla de polvos del paso 5, en una tableta bicapa.Example 1) In a mixer, mix amantadine hydrochloride, sodium starch glycolate and previously screened microcrystalline cellulose. ) To the powder mixture from step 1, mix with previously sifted sodium stearyl fumarate and paracetamol. ) In a mixer, mix loratadine or its salts, phenylephrine hydrochloride, sodium starch glycolate, copovidone and previously screened cellulosic microcrystalline. ) The powder mixture from step 3 is mixed with sodium stearyl fumarate previously screened. ) On a tablet machine, compress the powder mixture from step 2 and the powder mixture from step 4 on a bilayer tablet. ) In a container with water, disperse the mixture of the coating polymer with a non-stick / lubricant / slider, dye, opalescent and / or plasticizer. ) In a bass drum the tablets of step 5 are coated with the dispersion of step 6. Example 2) In a mixer, mix amantadlan hydrochloride, sodium starch glycolylate and microcrystalline cellulose previously sieved. ) To the powder mixture from step 1, mix with paracetamol. ) To the powder mixture from step 2, mix with previously sifted sodium stearyl fumarate. ) In a mixer, mix loratadine or its salts, phenylephrine hydrochloride, sodium starch glycolate, copovidone and previously screened cellulosic microcrystalline. ) The powder mixture from step 4 is mixed with sodium stearyl fumarate previously sieved. ) On a tablet machine, compress the powder mixture from step 3 and the powder mixture from step 5 on a bilayer tablet.
) En un contenedor con agua dispersar la mezcla del polímero de recubrimiento con un antiadherente/lubricante/deslizante, colorante, opalescente y/o un plastificante. ) En un bombo se recubren las tabletas del paso 6 con la dispersión del paso 7. ) In a container with water, disperse the mixture of the coating polymer with a non-stick / lubricant / slider, dye, opalescent and / or plasticizer. ) In a bass drum, the tablets of step 6 are coated with the dispersion of step 7.
Ejemplo 3 ) En un mezclador, mezclar clorhidrato de amantadina, almidón glicolato de sodio y celulosa microcristalina previamente tamizados. ) A la mezcla de polvos del paso 1 , mezclar con paracetamol. ) A la mezcla de polvos del paso 2, mezclar con estaeril fumarato de sodio previamente tamizado. ) En un mezclador, mezclar loratadina o sus sales, clorhidrato de fenilefrina, almidón glicolato de sodio, copovidona y celulosamicrocristalina previamente tamizados. ) A la mezcla de polvo del paso 4 se mezcla con estearil fumarato de sodio previamente tamizado. En una tableteadora comprimir la mezcla de polvos del paso 3 y la mezcla de polvos del paso 5, en una tableta bicapa. Example 3) In a mixer, mix amantadine hydrochloride, sodium starch glycolate and previously screened microcrystalline cellulose. ) To the powder mixture from step 1, mix with paracetamol. ) To the powder mixture from step 2, mix with previously sifted sodium stearyl fumarate. ) In a mixer, mix loratadine or its salts, phenylephrine hydrochloride, sodium starch glycolate, copovidone and previously screened cellulosic microcrystalline. ) The powder mixture from step 4 is mixed with previously sifted sodium stearyl fumarate. In a tablet machine, compress the powder mixture from step 3 and the powder mixture from step 5 into a bilayer tablet.
Ejemplo 4 Example 4
En un mezclador, mezclar amantadina o sus sales, uno o más agentes desintegrantes y uno o más agentes diluentes de compresión directa previamente tamizados. In a mixer, mix amantadine or its salts, one or more disintegrating agents and one or more direct compression diluting agents previously screened.
A la mezcla de polvos del paso 1, mezclar con uno o más agentes lubricante/antiadherente/deslizante previamente tamizados y paracetamol. To the powder mixture from step 1, mix with one or more previously sifted lubricating / non-stick / gliding agents and paracetamol.
En un mezclador, mezclar loratadina o sus sales, fenilefrina o sus sales, uno o más desintegrantes, uno o más derivados de polivinilpirrolidona y uno o más agentes diluentes previamente tamizados. In a mixer, mix loratadine or its salts, phenylephrine or its salts, one or more disintegrants, one or more polyvinylpyrrolidone derivatives and one or more previously screened diluting agents.
A la mezcla de polvo del paso 3 se mezcla nuevamente con una con uno o más agentes lubricantes/antiadherentes/deslizantes previamente tamizado. The powder mixture from step 3 is again mixed with one with one or more lubricants / non-stick / slip agents previously screened.
Mezclar la mezcla de polvos del paso 2 y paso 4. Mix the powder mixture from step 2 and step 4.
En una tableteadora comprimir la mezcla de polvos del paso 5. In a tablet press, compress the powder mixture from step 5.
En un contenedor con agua dispersar la mezcla del polímero de recubrimiento con un antiadherente/lubricante/deslizante, colorante, opalescente y/o un plastificante. In a container with water, disperse the mixture of the coating polymer with a non-stick / lubricant / slider, dye, opalescent and / or plasticizer.
En un bombo se recubren las tabletas del paso 6 con la dispersión del paso 7. In a bass drum, the tablets of step 6 are coated with the dispersion of step 7.
Ejemplo 5 Example 5
En un mezclador, mezclar amantadina o sus sales, uno o más agentes desintegrantes y uno o más agentes diluentes de compresión directa previamente tamizados. In a mixer, mix amantadine or its salts, one or more disintegrating agents and one or more direct compression diluting agents previously screened.
A la mezcla de polvos del paso 1, mezclar con uno o más agentes lubricante/antiadherente/deslizante previamente tamizados y paracetamol. En un mezclador, mezclar loratadlna o sus sales, fenilefrina o sus sales, uno o más desintegrantes, uno o más derivados de polivinilpirrolidona y uno o más agentes diluentes previamente tamizados. To the powder mixture from step 1, mix with one or more previously sifted lubricating / non-stick / gliding agents and paracetamol. In a mixer, mix loratadlna or its salts, phenylephrine or its salts, one or more disintegrants, one or more polyvinylpyrrolidone derivatives and one or more previously screened diluting agents.
A la mezcla de polvo del paso 3 se mezcla nuevamente con una con uno o más agentes lubricantes/antiadherentes/deslizantes previamente tamizado. The powder mixture from step 3 is again mixed with one with one or more lubricants / non-stick / slip agents previously screened.
Mezclar la mezcla de polvos del paso 2 y paso 4. En una encapsuladora llenar la mezcla de polvos del paso 5. Mix the powder mixture from step 2 and step 4. In a potting machine fill the powder mixture from step 5.

Claims

REIVINDICACIONES
Una composición farmacéutica de loratadina, fenilefrina, paracetamol y amantadina o sus sales para ser administrada oralmente. A pharmaceutical composition of loratadine, phenylephrine, paracetamol and amantadine or their salts to be administered orally.
Una composición farmacéutica de loratadina, fenilefrina, paracetamol y amantadina o sus sales para ser administrada oralmente, en conformidad con la cláusula 1 , en específico para una tableta o cápsula. A pharmaceutical composition of loratadine, phenylephrine, paracetamol and amantadine or their salts to be administered orally, in accordance with clause 1, specifically for a tablet or capsule.
Una composición farmacéutica de loratadina, fenilefrina, paracetamol y amantadina o sus sales para ser administrada oralmente, en conformidad con la cláusula 1 y 2, para el tratamiento de alopatías de resfriado común. A pharmaceutical composition of loratadine, phenylephrine, paracetamol and amantadine or their salts to be administered orally, in accordance with clause 1 and 2, for the treatment of common cold allopathies.
Una composición farmacéutica de loratadina, fenilefrina, paracetamol y amantadina o sus sales para ser administrada oralmente, en conformidad con las cláusulas 1 a 3, caracterizada porque puede o no contener al menos uno o más agentes diluentes y/o uno o más deslizantes/antiadherentes/lubricantes y/o uno o más agentes desintegrantes. A pharmaceutical composition of loratadine, phenylephrine, paracetamol and amantadine or their salts to be administered orally, in accordance with clauses 1 to 3, characterized in that it may or may not contain at least one or more diluting agents and / or one or more glidants / non-sticks / lubricants and / or one or more disintegrating agents.
Una composición farmacéutica de loratadina, fenilefrina, paracetamol y amantadina o sus sales para ser administrada oralmente, en conformidad con las cláusulas 1 a 4, caracterizada porque puede o no contener copovidona, la cual puede ser o no previamente tamizada. A pharmaceutical composition of loratadine, phenylephrine, paracetamol and amantadine or their salts to be administered orally, in accordance with clauses 1 to 4, characterized in that it may or may not contain copovidone, which may or may not be previously screened.
Una composición farmacéutica de loratadina, fenilefrina, paracetamol y amantadina o sus sales para ser administrada oralmente, en conformidad con las cláusulas 1 a 5, caracterizado porque puede o no ser recubierta la tableta. A pharmaceutical composition of loratadine, phenylephrine, paracetamol and amantadine or their salts to be administered orally, in accordance with clauses 1 to 5, characterized in that the tablet may or may not be coated.
Una composición farmacéutica de loratadina, fenilefrina, paracetamol y amantadina o sus sales para ser administrada oralmente, en conformidad con las cláusulas 1 a 6, caracterizada porque puede ser comprimida o llenada en una cápsula con un contenido de loratadina de 1 mg a 8 mg. A pharmaceutical composition of loratadine, phenylephrine, paracetamol and amantadine or their salts to be administered orally, in accordance with clauses 1 to 6, characterized in that it can be compressed or filled into a capsule with a loratadine content of 1 mg to 8 mg.
Una composición farmacéutica de loratadina, fenilefrina, paracetamol y amantadina o sus sales para ser administrada oralmente, en conformidad con las cláusulas 1 a 6, caracterizada porque puede ser comprimida o llenada en una cápsula con un contenido de clorhidrato de fenilefrina de 2 mg a 10 mg. Una composición farmacéutica de loratadina, fenilefrina, paracetamol y amantadina o sus sales para ser administrada oralmente, en conformidad con las cláusulas 1 a 6, caracterizada porque puede ser comprimida o llenada en una cápsula con un contenido de paracetamol de 300 mg a 750 mg. A pharmaceutical composition of loratadine, phenylephrine, paracetamol and amantadine or their salts to be administered orally, in accordance with clauses 1 to 6, characterized in that it can be compressed or filled in a capsule with a phenylephrine hydrochloride content of 2 mg to 10 mg A pharmaceutical composition of loratadine, phenylephrine, paracetamol and amantadine or their salts to be administered orally, in accordance with clauses 1 to 6, characterized in that it can be compressed or filled into a capsule with a paracetamol content of 300 mg to 750 mg.
Una composición farmacéutica de loratadina, fenilefrina, paracetamol y amantadina o sus sales para ser administrada oralmente, en conformidad con las cláusulas 1 a 6, caracterizada porque puede ser comprimida o llenada en una cápsula con un contenido de clorhidrato de amantadina de 50 mg a 200 mg. A pharmaceutical composition of loratadine, phenylephrine, paracetamol and amantadine or their salts to be administered orally, in accordance with clauses 1 to 6, characterized in that it can be compressed or filled in a capsule with an amantadine hydrochloride content of 50 mg to 200 mg
PCT/IB2018/050431 2017-01-26 2018-01-24 Pharmaceutical composition of loratadine, phenylephrine, paracetamol and amantadine for oral administration, for the treatment of allopathies related to a common cold WO2018138652A1 (en)

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1998052545A1 (en) * 1997-05-22 1998-11-26 The Boots Company Plc Pharmaceutical compositions of flurbiprofen and burn-masking agent for treating sore throat
WO2010094996A1 (en) * 2009-02-20 2010-08-26 Laboratorios Senosiain S.A. De C.V. Oral pharmaceutical composition for use in respiratory diseases
ES2398960T3 (en) * 2005-06-17 2013-03-22 Aft Pharmaceuticals Limited Novel pharmaceutical composition and its use in a method for the treatment of patients with mucosal cangestion of the upper respiratory tract
MX2015007749A (en) * 2015-06-17 2016-12-16 Laboratorios Liomont S A De C V Pharmaceutical composition of amanthadine hydrochloride-loratadin e-paracetamol in a capsule for treating colds amongst other allopathy.

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1998052545A1 (en) * 1997-05-22 1998-11-26 The Boots Company Plc Pharmaceutical compositions of flurbiprofen and burn-masking agent for treating sore throat
ES2398960T3 (en) * 2005-06-17 2013-03-22 Aft Pharmaceuticals Limited Novel pharmaceutical composition and its use in a method for the treatment of patients with mucosal cangestion of the upper respiratory tract
WO2010094996A1 (en) * 2009-02-20 2010-08-26 Laboratorios Senosiain S.A. De C.V. Oral pharmaceutical composition for use in respiratory diseases
MX2015007749A (en) * 2015-06-17 2016-12-16 Laboratorios Liomont S A De C V Pharmaceutical composition of amanthadine hydrochloride-loratadin e-paracetamol in a capsule for treating colds amongst other allopathy.

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