ES2642106T3 - Fabricación de productos de goma de mascar mediante radiofrecuencia - Google Patents

Fabricación de productos de goma de mascar mediante radiofrecuencia Download PDF

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ES2642106T3
ES2642106T3 ES10761100.6T ES10761100T ES2642106T3 ES 2642106 T3 ES2642106 T3 ES 2642106T3 ES 10761100 T ES10761100 T ES 10761100T ES 2642106 T3 ES2642106 T3 ES 2642106T3
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chewing gum
energy
fifteen
radiofrequency
manufacture
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Gregory E. Koll
Harry S. Sowden
Joseph R. Luber
Leo B. Kriksunov
Frank J. Bunick
Jen-Chi Chen
Rolland Olsson
Christopher E. Szymczak
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Johnson and Johnson Consumer Inc
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Johnson and Johnson Consumer Inc
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/10—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of compressed tablets
    • 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
    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid 
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • A61K9/0058—Chewing gums
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2068—Compounds of unknown constitution, e.g. material from plants or 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/2853—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers, poly(lactide-co-glycolide)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/288—Compounds of unknown constitution, e.g. material from plants or animals
    • 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
    • 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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P23/00—Anaesthetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
    • A61P25/34—Tobacco-abuse
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C43/00—Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor
    • B29C43/02—Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor of articles of definite length, i.e. discrete articles
    • B29C43/04—Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor of articles of definite length, i.e. discrete articles using movable moulds
    • B29C43/06—Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor of articles of definite length, i.e. discrete articles using movable moulds continuously movable in one direction, e.g. mounted on chains, belts
    • B29C43/08—Compression moulding, i.e. applying external pressure to flow the moulding material; Apparatus therefor of articles of definite length, i.e. discrete articles using movable moulds continuously movable in one direction, e.g. mounted on chains, belts with circular movement, e.g. mounted on rolls, turntables
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B30—PRESSES
    • B30B—PRESSES IN GENERAL
    • B30B11/00—Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses
    • B30B11/02—Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses using a ram exerting pressure on the material in a moulding space
    • B30B11/022—Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses using a ram exerting pressure on the material in a moulding space whereby the material is subjected to vibrations
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B30—PRESSES
    • B30B—PRESSES IN GENERAL
    • B30B11/00—Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses
    • B30B11/02—Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses using a ram exerting pressure on the material in a moulding space
    • B30B11/027—Particular press methods or systems
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B30—PRESSES
    • B30B—PRESSES IN GENERAL
    • B30B11/00—Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses
    • B30B11/02—Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses using a ram exerting pressure on the material in a moulding space
    • B30B11/08—Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses using a ram exerting pressure on the material in a moulding space co-operating with moulds carried by a turntable
    • B30B11/10—Presses specially adapted for forming shaped articles from material in particulate or plastic state, e.g. briquetting presses, tabletting presses using a ram exerting pressure on the material in a moulding space co-operating with moulds carried by a turntable intermittently rotated
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B30—PRESSES
    • B30B—PRESSES IN GENERAL
    • B30B15/00—Details of, or accessories for, presses; Auxiliary measures in connection with pressing
    • B30B15/02—Dies; Inserts therefor; Mounting thereof; Moulds
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B30—PRESSES
    • B30B—PRESSES IN GENERAL
    • B30B15/00—Details of, or accessories for, presses; Auxiliary measures in connection with pressing
    • B30B15/34—Heating or cooling presses or parts thereof
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C35/00—Heating, cooling or curing, e.g. crosslinking or vulcanising; Apparatus therefor
    • B29C35/02—Heating or curing, e.g. crosslinking or vulcanizing during moulding, e.g. in a mould
    • B29C35/08—Heating or curing, e.g. crosslinking or vulcanizing during moulding, e.g. in a mould by wave energy or particle radiation
    • B29C35/0805—Heating or curing, e.g. crosslinking or vulcanizing during moulding, e.g. in a mould by wave energy or particle radiation using electromagnetic radiation
    • B29C2035/0861—Heating or curing, e.g. crosslinking or vulcanizing during moulding, e.g. in a mould by wave energy or particle radiation using electromagnetic radiation using radio frequency

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Description

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164 y un vástago de guía 165 proporcionan rigidez y soporte a la placa del accionador 162 y evitan que actúen sobre el accionador 163 cargas laterales destructivas creadas por la fuerza de expulsión. Se muestra un envase tipo blíster 190 por debajo de la platina 171.
La figura 10 es una sección a través del mismo conjunto después de que los pasadores de expulsión 161 hayan empujado las gomas de mascar 101a terminadas a través de la platina 171. Esta colocación directa de la goma de mascar en el blíster ayuda a evitar la rotura que podría producirse durante el uso de unos medios típicos tales como alimentadores o descargando las gomas de mascar a bidones de transporte.
En una forma de realización, se añade un lubricante a la cavidad de formación antes de añadir la mezcla en polvo dispersable. Este lubricante puede ser un líquido o un sólido. Los lubricantes adecuados incluyen, pero no se limitan a, lubricantes sólidos tales como estearato de magnesio, almidón, estearato de calcio, estearato de aluminio y ácido esteárico; o lubricantes líquidos tales como, pero no limitados a, simeticona, lecitina, aceite vegetal, aceite de oliva o aceite mineral. En determinadas formas de realización, el lubricante se añade en un porcentaje en peso de la goma de mascar inferior a un 5 por ciento, por ejemplo inferior a un 2 por ciento, por ejemplo, inferior a un 0,5 por ciento. En determinadas formas de realización, la presencia de un lubricante hidrófobo puede comprometer de manera inconveniente las propiedades de disgregación o disolución de una goma de mascar. En una forma de realización, la goma de mascar carece prácticamente de lubricante hidrófobo. Los lubricantes hidrófobos incluyen estearato de magnesio, estearato de calcio y estearato de aluminio.
Calentamiento por radiofrecuencia de la forma de goma de mascar para formar una goma de mascar
“Calentamiento por radiofrecuencia” se refiere en general al calentamiento con un campo electromagnético a frecuencias de aproximadamente 1 MHz a aproximadamente 100 MHz. En una forma de realización de la presente invención, la energía de RF se encuentra dentro del intervalo de frecuencias de aproximadamente 1 MHz a aproximadamente 100 MHz (por ejemplo, de aproximadamente 5 MHz a 50 MHz, tal como de aproximadamente 10 MHz a aproximadamente 30 MHz). La energía de RF se utiliza para calentar la goma base. El grado de compactación, el tipo y cantidad de goma base, y la cantidad de energía de RF utilizada pueden determinar la dureza y/o el tipo de goma de mascar.
Los generadores de energía de RF son bien conocidos en la técnica. Los ejemplos de generadores de RF adecuados incluyen, pero no se limitan a, COSMOS modelo C10X16G4 (Cosmos Electronic Machine Corporation, Farmingdale, NY).
En una forma de realización, las herramientas conformadoras superior e inferior sirven de electrodos (por ejemplo, están asociadas operativamente a la fuente de energía de RF) a través de los cuales se suministra la energía de RF a la forma de goma de mascar. En una forma de realización, existe contacto directo entre al menos un electrodo de RF (por ejemplo, herramienta conformadora) y la forma de goma de mascar. En otra forma de realización, no hay contacto entre ninguno de los electrodos de RF (por ejemplo, herramientas conformadoras) y la forma de goma de mascar. En una forma de realización, los electrodos de RF están en contacto directo con la superficie de la forma de goma de mascar cuando se añade la energía de RF. En otra forma de realización, los electrodos de RF no están en contacto (por ejemplo, de aproximadamente 1 mm a aproximadamente 1 cm desde la superficie de la forma de goma de mascar) durante la adición de la energía de RF.
En una forma de realización, la energía de RF se suministra mientras se está formando la forma de goma de mascar. En una forma de realización, la energía de RF se suministra una vez que se ha formado la forma de goma de mascar. En una forma de realización, la energía de RF se suministra después de que la forma de goma de mascar ha sido extraída de la matriz.
En una forma de realización, la energía de RF se aplica durante un tiempo suficiente para ablandar y fundir sustancialmente toda (por ejemplo, al menos un 90%, tal como al menos un 95%, tal como toda) la goma base en el interior de la forma de goma de mascar. En una forma de realización, la energía de RF se aplica durante un tiempo suficiente para ablandar y fundir sólo una parte (por ejemplo, menos de un 75%, tal como menos de un 50%, tal como menos de un 25%) de la goma base en el interior de la forma de goma de mascar, por ejemplo, sólo en una parte de la forma de goma de mascar, tal como el exterior de la forma de goma de mascar.
En formas de realización alternativas de la invención, las herramientas conformadoras pueden hacerse para conseguir efectos caloríficos localizados y también pueden configurarse para dar forma al campo eléctrico que se desarrolla en las herramientas. La figura 11A muestra una configuración de ese tipo. Hay un generador de RF 200 conectado a unas placas de electrodo de RF 201 y 202. Unas herramientas conformadoras 205 y 204 están hechas de un material electroconductor y tienen unos accesorios 207 y 208 que están hechos de material aislante de la energía eléctrica y de RF tal como cerámica, Teflon®, polietileno o polietileno de alta densidad. La platina 203 también está hecha de material aislante de la energía eléctrica y de RF. Esta configuración crea una mayor distancia entre las herramientas conformadoras conductoras para debilitar el campo eléctrico, lo que resulta beneficioso para la producción de gomas de mascar delgadas sin riesgo de formación de un arco eléctrico que dañaría el producto y el herramental. La figura 11B representa una configuración similar, pero con unas herramientas conformadoras 210 y
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Se carga una porción de 3,0 kg de las partículas preparadas en la Parte I en el aparato de recubrimiento de lecho fluildizado con rotor (Glatt modelo GPCG 5/9). Las partículas estratificadas con el fármaco se fluidifican a 36°C y se pulveriza sobre ellas la solución de polímero a una velocidad de 40 g/minuto hasta que las partículas de fármaco contengan aproximadamente un 20% en peso del recubrimiento de polímero.
5 Ejemplo 2b: Preparación de un producto de goma de mascar que contiene dextrometorfano recubierto
La mezcla en polvo de la Tabla 2 se prepara de la siguiente manera. El colorante, el saporífero, el acesulfamo-K y la sucralosa se hacen pasar manualmente por una criba de malla 50. La mezcla anterior y los materiales restantes, incluido el dextrometorfano recubierto, se añaden a un frasco de plástico, se mezclan mediante movimientos de volteo durante aproximadamente tres minutos, y, a continuación, se vierten. A continuación, la mezcla en polvo se coloca en la cavidad de formación, se compacta ligeramente, y se activa con energía de RF como se describe en el Ejemplo 1 para formar la goma de mascar y, posteriormente, se saca de la platina.
15 Tabla 2
Material
g/lote mg/goma % en peso
Goma base HiG PWD-03
87,96 879,65 87,96
Dextrometorfano recubierto (32%)
9,04 90,40 9,04
Colorante Blue Lake
0,02 0,20 0,02
Sabor de vainilla-menta
1,00 10,00 1,00
Sabor de menta
0,50 5,00 0,50
Bicarbonato sódico anhidro
0,50 5,00 0,50
Acesulfamo-K
0,20 2,00 0,20
Polvo de sucralosa
0,40 4,00 0,40
Sílice amorfa
0,38 3,75 0,38
TOTAL
100,0 1.000,00 100,0
Ejemplo 3: Preparación de un producto de goma de mascar que contiene bitartrato de nicotina dihidratado
La mezcla en polvo de la Tabla 3 se prepara de la siguiente manera. El colorante, el saporífero, el acesulfamo-K y la sucralosa se hacen pasar manualmente por una criba de malla 50. La mezcla anterior y los
35 materiales restantes, incluido el bitartrato de nicotina dihidratado y la L-arginina se añaden a un frasco de plástico, se mezclan mediante movimientos de volteo durante aproximadamente tres minutos, y, a continuación, se vierten. A continuación, la mezcla en polvo se coloca en la cavidad de formación, se compacta ligeramente, y se activa con energía de RF como se describe en el Ejemplo 1 para formar la goma de mascar y, posteriormente, se saca de la platina.
Tabla 3
Material
g/lote mg/goma % en peso
Goma base HiG PWD-03
92,63 926,3 92,63
Bitartrato de nicotina dihidratado (nicotina al 32,55%)
0,615 6,15* 0,615
Colorante Blue Lake
0,02 0,2 0,02
Sabor de vainilla-menta
1 10 1
Sabor de menta
0,5 5 0,5
L-arginina
4,26 42,6 4,26
Acesulfamo-K
0,2 2 0,2
Polvo de sucralosa
0,4 4 0,4
Sílice amorfa
0,375 3,75 0,375
TOTAL
100 1.000 100
*Equivalente a una dosis de 2,0 mg de nicotina
55
Ejemplo 4: Preparación de un producto de goma de mascar que contiene un complejo resinoso de nicotina
La mezcla en polvo de la Tabla 4 se prepara de la siguiente manera. El colorante, el saporífero, el acesulfamo-K y la sucralosa se hacen pasar manualmente por una criba de malla 50. La mezcla anterior y los materiales restantes, incluido el complejo resinoso de nicotina y el Trometamol se añaden a un frasco de plástico, se mezclan mediante movimientos de volteo durante aproximadamente tres minutos, y, a continuación, se vierten. A continuación, la mezcla en polvo se dosifica individualmente en una platina de Teflon electroaislante y se calienta como se expone en el Ejemplo 1. A continuación, se expulsa de la platina el producto de goma de mascar resultante
65 mediante la herramienta conformadora inferior.
16
imagen14
estearato de magnesio y se mezcla durante unos minutos. A continuación, la mezcla en polvo se dosifica individualmente en una platina de Teflon electroaislante y se calienta como se expone en el Ejemplo 1. A continuación, se expulsa de la platina el producto de goma de mascar resultante mediante la herramienta conformadora inferior.
Tabla 6
15
25
Fórmula unitaria de 0 mg (mg)
Fórmula unitaria de 0,5 mg (mg) Fórmula unitaria de 1 mg (mg) Fórmula unitaria de 2 mg (mg) Fórmula unitaria de 3 mg (mg) Fórmula unitaria de 4 mg (mg)
Complejo resinoso de nicotina al 20%
0 2,5 5 10 15 20
Base de goma de mascar
500 500 500 500 500 500
Isomalt
362 359,5 357 352 347 342
Sorbitol
50 50 50 50 50 50
Saporífero en forma de polvo
30 30 30 30 30 30
Bicarbonato sódico
20 20 15 10 5 -
Carbonato sódico
10 10 15 20 25 30
Estearato de magnesio
15 15 15 15 15 15
Óxido de magnesio
5 5 5 5 5 5
Acesulfamo-K
2 2 2 2 2 2
Sílice amorfa
5 5 5 5 5 5
Sucralosa
1 1 1 1 1 1
Ejemplo 7. Preparación de un producto de goma de mascar que contiene un complejo resinoso de nicotina con un contenido de goma base > 20%.
35 Las mezclas en polvo de la Tabla 7 se preparan de la siguiente manera. La base de goma de mascar, el carbonato sódico anhidro, el hidrogenocarbonato sódico, el acesulfamo-K, la sucralosa y el óxido de magnesio se tamizan y se cargan a una mezcladora de polvo junto con los saporíferos encapsulados y la resina de nicotina. A continuación, se mezclan las materias primas entre sí para formar una distribución homogénea de los ingredientes, por último se añade el estearato de magnesio y se mezcla durante unos minutos. A continuación, la mezcla en polvo se dosifica individualmente en una platina de Teflon electroaislante y se calienta como se expone en el Ejemplo 1. A continuación, se expulsa de la platina el producto de goma de mascar resultante mediante la herramienta conformadora inferior.
45 Tabla 7
Fórmula unitaria de 0 mg (mg)
Fórmula unitaria de 0,5 mg (mg) Fórmula unitaria de 1 mg (mg) Fórmula unitaria de 2 mg (mg) Fórmula unitaria de 3 mg (mg) Fórmula unitaria de 4 mg (mg)
Complejo resinoso de nicotina al 20%
0 2,5 5 10 15 20
Base de goma de mascar para compresión (HiG PWD-03)
905 902,5 900 895 890 885
Saporíferos encapsulados
40 40 40 40 40 40
Sorbitol
50 50 50 50 50 50
Bicarbonato sódico
20 20 15 10 5 -
Carbonato sódico
10 10 15 20 25 30
Estearato de magnesio
15 15 15 15 15 15
Óxido de magnesio
5 5 5 5 5 5
Acesulfamo-K
2 2 2 2 2 2
Sucralosa
3 3 3 3 3 3
18
imagen15
imagen16

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MX2012003549A (es) 2012-09-07
RU2545989C2 (ru) 2015-04-10
AU2010298289B2 (en) 2015-02-12
CN102762197B (zh) 2015-09-09
US8784781B2 (en) 2014-07-22
US20110071185A1 (en) 2011-03-24

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