FR3034991A1 - BICOID PHARMACEUTICAL TABLET, METHOD OF MANUFACTURE AND USE AS A MEDICINAL PRODUCT - Google Patents

Abstract

The invention relates to a bilayer pharmaceutical tablet intended for oral administration consisting of: an orodispersible layer, the dispersion of which in the mouth takes place in a maximum of 3 minutes; a sugar-free sucking layer, the dispersion in the mouth is between 3 and 15 minutes, one of two layers comprising at least one pharmaceutical active ingredient, and the other layer having sensory properties adapted to soothe local symptoms. The subject of the invention is also a process for the manufacture of this tablet and its use as a medicament, in particular for the outpatient treatment of pathologies of the ENT sphere or gastrointestinal pathologies.

Description

The present invention relates to a particular pharmaceutical tablet consisting of two different layers having different properties, as well as its manufacturing process. BACKGROUND OF THE INVENTION The subject of the invention is also the use of this bilayer tablet as a medicament in particular for the ambulatory treatment of pathologies of the ENT sphere or of gastrointestinal pathologies. The pharmaceutical products commonly used for the outpatient treatment of diseases of the ENT sphere or gastrointestinal pathologies, are generally in the form of tablets, capsules, pills, etc. There are forms for local action, such as, for example, mouthwashes, sucking tablets or local antibacterial and / or anesthetic lozenges, antacid chewable chewable tablets, chewable chewable tablets or anti-rheumatic chewable tablets. . There are also orodispersible forms which have a systemic action, such as orodispersible anti-inflammatory, anti-diarrheal or antispasmodic tablets. In addition, there are also multilayer tablets. In these products all layers have similar characteristics, therefore similar releases and do not allow to associate substances with different modes of action. None of the existing products currently actually meet the need for diseases of the ENT field and gastrointestinal pathologies, which require both a systemic and / or local action via a pharmaceutical active ingredient and soothing sensory effects of local symptoms. More recently, multilayer tablets have been described in application EP2170275. These tablets consist of a sweet layer and a fast disintegrating layer, both layers containing an active ingredient. Nevertheless, these products have the disadvantage of having a very different disintegration time between the two layers and therefore a significant shift of actions, of having sugar, and of not having a rapid sensory effect to relieve the symptoms. of these pathologies before the active ingredient can have an action. The object of the invention is to overcome the disadvantages of the products of the prior art and to provide pharmaceutical tablets particularly adapted to the needs of patients suffering from pathologies of the ENT sphere and gastrointestinal pathologies. For this purpose, the invention is directed to a bilayer pharmaceutical tablet intended for oral administration, consisting of: an orodispersible layer, the dispersion of which in the mouth takes place in a maximum of 3 minutes, a layer to be sucked, without sugar, the dispersion in the mouth is between 3 and 15 minutes, one of the two layers comprising at least one pharmaceutical active ingredient. Advantageously, such a tablet associates a systemic and / or local action via the layer which comprises one or more active principle (s), to soothing sensory effects of the local symptoms of the pathology to be treated via the layer containing no active ingredient. It allows, by its specific sensory properties, to quickly relieve the patient on its first symptoms the time that the active ingredient can act and take over by its therapeutic action. The subject of the invention is also the use of this tablet as a medicament for the ambulatory treatment of pathologies of the ENT sphere or of gastrointestinal pathologies. The invention also relates to a method of manufacturing this tablet which comprises the following steps: - manufacture of the orodispersible layer: o spitting of the raw materials: a diluent, a disintegrant, a sweetener, an aroma, a glidant, a lubricant, possibly a dye, and at least one active ingredient if it is not contained in the layer to be sucked, o mixture of all the raw materials, - manufacture of the layer to be sucked: o mixture of the raw materials: a diluent, a binder , a sweetener, an aroma, a glidant, a lubricant, optionally a dye and / or a disintegrant, and at least one active ingredient if it is not contained in the orodispersible layer, o lubrication - compression of the layers in the following order: 5 o orodispersible layer o layer to suck. Other features and advantages will become apparent from the detailed description of the invention which follows, illustrated by results. Definitions For the purposes of the invention, the term "tablet" is intended to mean a solid preparation obtained by compressively agglomerating a constant volume of particles. The tablets are intended for the oral route. By "pharmaceutical tablet" within the meaning of the invention is meant a tablet containing a unit for taking one or more active substances. The constitutive particles of the tablet consist of one or more active substances, with or without the excipient (s) such as: diluents, binders, disintegrants, glidants, lubricants, compounds that can modify the behavior of the preparation in the digestive tract, authorized dyes for pharmaceutical applications, flavorings, sweeteners. For the purposes of the invention, the term "orodispersible layer" means a layer of the tablet whose dispersion in the mouth is rapid, in a maximum of 3 minutes, preferably in less than 2 minutes, even more preferably in the range of 30 to 90 seconds. For the purposes of the invention, the term "layer to be sucked" is intended to mean a layer of the tablet whose dispersion in the mouth is slower, in addition to 3 minutes, preferably between 3 and 15 minutes, even more preferably between 5 and 7 minutes. minutes.

By "diluent" in the sense of the invention is meant a material used to produce a tablet with a suitable size, performance and physical properties. For the purposes of the invention, the term "disintegrant" means a material used to promote the rupture of the tablet after ingestion. By "glidant" in the sense of the invention is meant a material used to assist the flow of the powder during the compression step.

For the purposes of the invention, the term "lubricant" is intended to mean a material used to prevent friction during the compression step and to aid the ejection of the tablet from the dies in certain cases to aid the flow of the powder. By "binder" in the sense of the invention is meant a material used to promote the cohesion of the powder mixture. For the purposes of the invention, the term "active principle" or "active pharmaceutical ingredient" means a substance which produces a therapeutic effect either by a pharmacological action or by an antiseptic action. It can be a plant extract or a chemical substance. DETAILED DESCRIPTION OF THE INVENTION A first object of the invention is therefore a two-layer pharmaceutical tablet intended for oral administration, consisting of: an orodispersible layer, the dispersion of which in the mouth takes place in a maximum of 3 minutes a sucking layer, without sugar, whose dispersion in the mouth is between 3 and 15 minutes, one of the two layers comprising at least one pharmaceutical active principle. The tablet according to the invention is therefore constituted by two different layers. The orodispersible layer is a layer whose dispersion in the mouth must be in a maximum of three minutes, preferably between 30 and 90 seconds.

The orodispersible layer preferably comprises a diluent, a disintegrant, a sweetener, an aroma, a glidant and a lubricant. Possibly it also contains a dye. The orodispersible layer preferably has the following composition (excluding any active principle (s)): between 40 and 98% by weight of diluent, between 0.5 and 15% by weight of disintegrant, between 0.05 and 10% by weight of sweetener, between 0.1 and 10% by weight of flavor, between 0.1 and 10% by weight of glidant, between 0.05 and 10% by weight, lubricant weight, and - between 0 and 5% by weight of dye.

The diluent can be selected for example from polyols such as mannitol, corn starch or carbohydrates. If the diluent is a polyol or a carbohydrate, it is preferably present between 40 and 98% by weight of the orodispersible layer. If the diluent is corn starch, it is preferably present between 5 and 30% by weight of the composition of the orodispersible layer. The disintegrant may be chosen for example from crospovidone, microcrystalline cellulose, corn starch, sodium starch glycolate, croscarmellose. The sweetener may be chosen for example from polyols such as xylitol, sodium saccharin, acesulfame potassium, sucralose, sodium cyclamate. If the sweetener 10 is a polyol, it is preferably present between 0.1 and 10% by weight of the orodispersible layer. If the sweetener is sodium saccharin, acesulfame potassium, sucralose or sodium cyclamate, it is preferably present between 0.05 and 3% by weight of the composition of the orodispersible layer. The glidant may be chosen for example from silica and talc.

The lubricant may be chosen for example from sodium stearyl fumarate, magnesium stearate, glyceryl behenate and glycerol distearate. If the lubricant is sodium stearyl fumarate or magnesium stearate, it is preferably present between 0.1 and 5% by weight of the orodispersible layer. If the lubricant is glyceryl behenate or glycerol distearate, it is preferably present between 0.5 and 10% by weight of the composition of the orodispersible layer. The layer to suck does not include sugar. It is a layer whose dispersion in the mouth is between 3 and 15 minutes, preferably between 5 and 7 minutes. According to a preferred embodiment, the layer to be sucked comprises a diluent, a binder, a sweetener, an aroma, a glidant and a lubricant. It also optionally includes a dye and / or a disintegrant. The layer to be sucked preferably has the following composition (excluding any active principle (s)): between 40 and 98% by weight of diluent, between 1 and 20% by weight of binder, 30 between 0 and 15% by weight of disintegrant, between 0.05 and 10% by weight of sweetener, between 0.1 and 10% by weight of flavor, between 0.1 and 10% by weight of glidant , between 0.05 and 10% by weight of lubricant, and between 0 and 5% by weight of dye. The diluent may be selected for example from polyols such as sorbitol, isomalt, microcrystalline cellulose and corn starch. If the diluent is a polyol or isomalt, it is preferably present between 40 and 98% by weight of the layer to be sucked. If the diluent is corn starch or microcrystalline cellulose, it is preferably present between 5 and 50% by weight of the composition of the layer to be sucked. The binder may be selected from sodium carboxymethylcellulose, microcrystalline cellulose and corn starch. The disintegrant may be chosen for example from crospovidone, microcrystalline cellulose, corn starch, sodium starch glycolate, croscarmellose. The sweetener may be chosen for example from polyols such as xylitol, sodium saccharin, acesulfame potassium, sucralose, sodium cyclamate. If the sweetener is a polyol, it is preferably present between 0.1 and 10% by weight of the layer to be sucked. If the sweetener is sodium saccharinate, acesulfame potassium, sucralose or sodium cyclamate, it is preferably present between 0.05 and 3% by weight of the composition of the layer to be sucked. The glidant may be chosen for example from silica and talc.

The lubricant may be chosen for example from sodium stearyl fumarate, magnesium stearate, glyceryl behenate and glycerol distearate. If the lubricant is sodium stearyl fumarate or magnesium stearate, it is preferably present between 0.1 and 5% by weight of the layer to be sucked. If the lubricant is glyceryl behenate or glycerol distearate, it is preferably present between 0.5 and 10% by weight of the composition of the layer to be sucked. In the tablet according to the invention, only one of the two layers comprises at least one active pharmaceutical ingredient, the other layer therefore does not contain any. The layer containing no active principle is constituted such that it has sensory properties adapted to soothe local symptoms.

Thus, either the orodispersible layer contains one or more active ingredients and the layer to be sucked contains none, or the layer to be sucked contains one or more active ingredients and the orodispersible layer does not contain one. The active principle (s) present (s) is (are) preferentially active ingredients having action in the field of pain, inflammation, gastroenterology or respiratory tract. The present active principle (s) is (are) preferentially chosen from analgesics, antipyretics, anti-inflammatories, cholagogues, hepatotropes, local anesthetics, antiseptics local, antacids of local action.

It may be, for example, Ambroxol, lidocaine, benzocaine, an artichoke extract, an anti-H2 or simethicone. According to a first variant, the active principle (s) is (are) present in the orodispersible layer of the tablet and is (are) chosen from analgesics, antipyretics, antiretreatment agents and inflammatory, cholagogues, hepatotropes.

According to a second variant, the active principle (s) is (are) present in the layer to be sucked from the tablet and is (are) chosen from local anesthetics, local antiseptics. , antacids of local action. The tablet according to the invention, when administered orally, advantageously has a systemic and / or local action via the active principle (s) active (s) pharmaceutical (s) associated with soothing sensory effects of symptoms local. Its specific sensory properties allow to quickly relieve the patient on its first symptoms, the time that the active ingredient can act and take over by its therapeutic action. It thus makes it possible to meet the needs of patients with specific pathologies, in particular pathologies of the ENT sphere and gastrointestinal pathologies. The invention therefore also relates to the pharmaceutical tablet as described above, for its use as a drug for the outpatient treatment of diseases of the ENT sphere or gastrointestinal pathologies. The tablet according to the invention is particularly suitable for the ambulatory treatment of dyspepsia, oesogastroduodenal disorders, gastroesophageal reflux, colds, headaches, fevers or feverish conditions, sore throat, mild to moderate pain, oral mucosal diseases. and / or oropharynx.

For example: a tablet according to the invention comprising an antiseptic active ingredient in the layer to be sucked is particularly suitable for the treatment of sore throat or conditions of the oral mucosa and / or the oropharynx, one tablet according to the invention comprising a local anesthetic active ingredient in the layer to be sucked is particularly suitable for the treatment of sore throats, a tablet according to the invention comprising an analgesic active ingredient in the orodispersible layer is particularly suitable for the treatment of headaches or In the case of mild to moderate pain, a tablet according to the invention comprising a nonsteroidal anti-inflammatory active ingredient in the orodispersible layer is particularly suitable for the treatment of fever or febrile states, colds, headaches, pain of mild to moderate intensity, a tablet according to the invention comprising an active ingredient anti-sp Asmodic in the layer to be sucked is particularly suitable for the treatment of gastroesophageal reflux, a tablet according to the invention comprising an anti-spasmodic active ingredient in the orodispersible layer is particularly suitable for the treatment of pain in peptic diseases, a tablet according to the invention comprising an antidiarrheal active ingredient in the orodispersible layer is particularly suitable for the treatment of acute diarrhea during peptic diseases. The tablet according to the invention may be manufactured by a process comprising the following steps: - manufacture of the orodispersible layer: o spraying of the raw materials: a diluent, a disintegrant, a sweetener, an aroma, a glidant, a lubricant, optionally a dye, and at least one active ingredient if it is not contained in the layer to be sucked, o mixture of all the raw materials, 30 - manufacture of the layer to be sucked: o mixture of the raw materials: a diluent, a binding agent, a sweetener, a flavor, a glidant, a lubricant, optionally a dye and / or a disintegrant, and the at least one active ingredient if it is not contained in the orodispersible layer, o lubrication-compression of layers in the following order: 5 o orodispersible layer o layer to suck. Preferably, for the manufacture of the orodispersible layer, the lubricant, the glidant and the optional dye are co-sieved with another material, and are spun on a grid less than 500u.m.

The pre-compression forces used for the layer compression step are preferably between 1 and 5 kN, more preferably between 2 and 3 kN. The compression forces used for the layer compression step are preferably between 15 and 20 kN, more preferably between 16 and 18 kN.

For their storage, the tablets according to the invention may be packaged in blisters or tubes in particular. The invention is now illustrated by examples of compositions and test results demonstrating its characteristics. Examples of tablets according to the invention and characteristics 1. Example 1 The tablet of Example 1 consists of: - an orodispersible layer consisting of: o 52.6% of a mixture Mannitol + maize starch o 38, 1% Mannitol 25% 5% Crospovidone o 0.15% Sodium saccharinate o 2% Menthol flavor o 1.5% Sodium stearyl fumarate o 0.5% mg colloidal silica 30 o 0.15% The percentages are given by weight relative to the total mass of the constituents of the layer.

Preferably, the total mass of the orodispersible layer is 1 g. - A layer to suck constituted by: o 2.2% of ambroxol hydrochloride (active principle) o 56.6% of sorbitol 5 o 37.7% of isomalt o 0.75% of carboxymethylcellulose o 0.60 % pink dye o 0.15% sodium saccharin o 0.5% strawberry flavor 10 o 1.5% vegetable magnesium stearate The percentages are given in mass relative to the total mass of the constituents of the layer . Preferably, the total mass of the layer to be sucked is 1 g. This tablet is obtained by carrying out the following steps: - Sintering of the raw materials used in the composition of the orodispersible layer, - Mixing of the raw materials used in the composition of the orodispersible layer, - Sintering of the raw materials entering the composition of the layer to be sucked, 20 - Mixture of raw materials used in the composition of the layer to be sucked with the exception of vegetable magnesium stearate (lubricant), - Lubrication of the mixture of raw materials used in the composition of the layer to be sucked suck with vegetable magnesium stearate, - Compression bilayer with compression of the orodispersible layer first and 25 of the layer to be sucked in second. The pre-compression force is between 8.8 and 9.1 kN. The compression force is between 17.4 and 18.1kN. The tablets obtained are round, smooth, with a green face and a pink face. They have an average hardness of 107N measured according to Monograph No. 20908 of the European Pharmacopoeia using an automated tester for checks of weight, thickness, diameter or length and hardness.

3034991 11 They have an average thickness of 7.95mm measured using an automated tester for weight, thickness, diameter or length and hardness checks. The diameter of the tablets is between 15 and 20mm. The disintegration rate of the layers was measured according to Monograph No. 20901 of the European Pharmacopoeia. The orodispersible layer disintegrates on average in 1min45s. The layer to be sucked disintegrates on average in 7min36s. 2. Example 2 The tablet of Example 2 consists of: - an orodispersible layer consisting of: o 40% of a Mannitol + corn starch mixture o 44.2% Mannitol mg o 5% Crospovidone o 0.15% sodium saccharinate 15 o 2% aroma menthol o 2% sodium stearyl fumarate o 0.5% colloidal silica o 6% glycerin behenate o 0.15% green dye 20 Percentages are given in mass relative to the total mass of the constituents of the layer. Preferably, the total mass of the orodispersible layer is 1 g. - A layer to be sucked up consisting of: o 2.2% of ambroxol hydrochloride (active principle) 25 o 56.4% of sorbitol O 37.6% of isomalt O 0.75% of carboxymethylcellulose O 0.9 % violet dye 0.15% sodium saccharin 0 0.5% blackcurrant flavor O 1.5% vegetable magnesium stearate 3034991 12 Percentages are given by mass relative to the total mass of the constituents of layer. Preferably, the total mass of the layer to be sucked is 1 g. This tablet is obtained by carrying out the following steps: 5 - Sintering of the raw materials used in the composition of the orodispersible layer, - Mixing of the raw materials used in the composition of the orodispersible layer, - Foaming of the raw materials entering the composition of the layer to be sucked, 10 - Mixture of the raw materials used in the composition of the layer to be sucked with the exception of vegetable magnesium stearate (lubricant), - Lubrication of the mixture of raw materials used in the composition of the layer to be sucked suck with vegetable magnesium stearate, - Compression bilayer with compression of the orodispersible layer first and 15 of the layer to be sucked in second. The pre-compression force is between 2.3 and 2.5kN. The compression force is between 16.6 and 17.8kN. The tablets obtained are round, smooth, with a purple face and a green face. They have an average hardness of 12.4kN measured according to monograph No. 20908 of the European Pharmacopoeia using an automated tester for checks of weight, thickness, diameter or length and hardness. They have an average thickness of 7.93mm measured using an automated tester for checks of weight, thickness, diameter or length and hardness. The diameter of the tablets is between 15 and 20mm.

The disintegration rate of the layers was measured according to Monograph No. 20901 of the European Pharmacopoeia. The orodispersible layer disintegrates on average in 1min26s. The layer to be sucked disintegrates on average in 5min56s. 3. Example 3 The tablet of Example 3 consists of: - an orodispersible layer consisting of: o 40% of a mixture Mannitol + maize starch 3034991 13 o 44.35% mg of Mannitol o 5% of crospovidone o 0.15% sodium saccharinate o 2% menthol flavor 5 o 2% sodium stearyl fumarate o 0.5% colloidal silica o 6% glycerin behenate Percentages are given in mass relative to the total mass constituents of the layer.

Preferably, the total mass of the orodispersible layer is 1 g. - A layer to suck constituted by: o 2.2% of ambroxol hydrochloride (active principle) o 56.6% of sorbitol o 37.7% of isomalt 15 o 0.75% of carboxymethylcellulose o 0.15% % of green dye o 0.15% of sodium saccharinate o 1% of mint flavor crisp mint permaseal o 1.45% of vegetable magnesium stearate The percentages are given in mass relative to the total mass of the constituents of the layer . Preferably, the total mass of the layer to be sucked is 1 g. This tablet is obtained by carrying out the following steps: - Sintering of the raw materials used in the composition of the orodispersible layer, - Mixing of the raw materials used in the composition of the orodispersible layer, - Foaming of the raw materials entering the Composition of the layer to be sucked - Mixture of the raw materials used in the composition of the layer to be sucked with the exception of vegetable magnesium stearate (lubricant), - Lubrication of the mixture of the raw materials used in the composition of the layer to be sucked with vegetable magnesium stearate, 3034991 14 - Compression in bilayer with compression of the orodispersible layer first and layer to be sucked in second. The pre-compression force is between 2.3 and 2.4kN. The compression force is between 16.8 and 17.3kN.

The tablets obtained are round, smooth, with a green face and a white face. They have an average hardness of 12kN measured according to Monograph No. 20908 of the European Pharmacopoeia using an automated tester for weight, thickness, diameter or length and hardness checks. They have an average thickness of 7.96mm measured using an automated tester 10 for checks of weight, thickness, diameter or length and hardness. The diameter of the tablets is between 15 and 20mm. The disintegration rate of the layers was measured according to Monograph No. 20901 of the European Pharmacopoeia. The orodispersible layer disintegrates on average in 1min27s.

The layer to be sucked disintegrates on average in 5min56s. 4. Example 4 The tablet of Example 4 consists of: - an orodispersible layer consisting of: o 54.1% of a mixture Mannitol + corn starch 20 o 38.5% Mannitol mg o 5% crospovidone o 0.4% sucralose o 1% menthol flavor o 1% sodium stearyl fumarate The percentages are given in mass relative to the total mass of the constituents of the layer. Preferably, the total mass of the orodispersible layer is 1 g. - A layer to be sucked consisting of: o 0.2% benzocaine (active principle) o 57.03% sorbitol o 38.02% isomalt o 0.75% sodium carboxymethylcellulose 3034991 15 o 0, 3% yellow dye o 0.4% sucralose powder o 1% aroma lemon juice o 0.8% citric acid anhydrous 5 o 1.5% vegetable magnesium stearate The percentages are given by weight relative to the total mass of the constituents of the layer. Preferably, the total mass of the layer to be sucked is 1 g. This tablet is obtained by carrying out the following steps: 10 - Sintering of the raw materials used in the composition of the orodispersible layer, - Mixture of the raw materials used in the composition of the orodispersible layer with the exception of sodium stearyl fumarate ( lubricant), - Lubrication of the mixture of the raw materials used in the composition of the orodispersible layer with sodium stearyl fumarate, - Emulsification of the raw materials used in the composition of the layer to be sucked, - Mixture of the raw materials used in the composition of the layer to be sucked with the exception of vegetable magnesium stearate (lubricant), - Lubrication of the mixture of raw materials used in the composition of the layer to be sucked with vegetable magnesium stearate, - Compression in bilayer with compression of the layer orodispersible first and layer to suck second. The pre-compression force is between 2.3 and 2.7 kN. The compression force is between 17.2 and 17.9 kN. The tablets obtained are round, smooth, with a white face and a yellow face. They have an average hardness of 12.2kN measured according to Monograph No. 20908 of the European Pharmacopoeia using an automated tester for checks of weight, thickness, diameter or length and hardness. They have an average thickness of 7.85 mm measured using an automated tester for weight, thickness, diameter or length and hardness checks. The diameter of the tablets is between 15 and 20mm.

Claims (19)

REVENDICATIONS1. A bilayer pharmaceutical tablet intended for oral administration consisting of: - an orodispersible layer, the dispersion of which in the mouth takes place in a maximum of 3 minutes, - a layer to be sucked, without sugar, the dispersion of which in the mouth is between 3 and 15 minutes, one of the two layers comprising at least one pharmaceutical active ingredient. 2. Tablet according to claim 1, characterized in that the orodispersible layer is a layer whose dispersion in the mouth is between 30 and 90 seconds. 3. Tablet according to one of the preceding claims, characterized in that the layer to be sucked is a layer whose dispersion in the mouth is between 5 and 7 minutes. 4. Tablet according to one of the preceding claims, characterized in that the orodispersible layer comprises a diluent, a disintegrant, a sweetener, an aroma, a glidant and a lubricant. 5. Tablet according to claim 4, characterized in that the orodispersible layer also comprises a dye. 6. Tablet according to claim 4 or 5, characterized in that the orodispersible layer consists of: - between 40 and 98% by weight of diluent, - between 0.5 and 15% by weight of disintegrant, - between 0.05 and 10% by weight of sweetener, - between 0.1 and 10% by weight of flavor, - between 0.1 and 10% by weight of glidant, - between 0.05 and 10% by weight of lubricant, and between 0 and 5% by weight of dye. 7. Tablet according to one of the preceding claims, characterized in that the layer to be sucked comprises a diluent, a binder, a sweetener, an aroma, a glidant and a lubricant. 8. Tablet according to claim 6, characterized in that the layer to be sucked also comprises a dye and / or a disintegrant. 3034991 18 9. Tablet according to claim 4 or 5, characterized in that the layer to be sucked consists of: between 40 and 98% by weight of diluent, between 1 and 20% by weight of binder, between 0 and 15 % by weight of disintegrant, between 0.05 and 10% by weight of sweetener, between 0.1 and 10% by weight of flavor, between 0.1 and 10% by weight of glidant, and between 0 and 10% by weight of , 05 and 10% by weight of lubricant, and Between 0 and 5% by weight of dye. 10. Tablet according to one of the preceding claims, characterized in that at least one active ingredient present in one of the layers of the tablet is selected from analgesics, antipyretics, anti-inflammatories, cholagogues, hepatotropes, local anesthetics. , local antiseptics, antacids of local action. 15 11. Tablet according to one of the preceding claims, characterized in that at least one active ingredient is present in the orodispersible layer of the tablet and in that it is selected from analgesics, antipyretics, anti-inflammatories, cholagogues. , hepatotropes. 12. Tablet according to one of the preceding claims, characterized in that at least one active ingredient is present in the tablet sucking layer, and in that it is selected from local anesthetics, local antiseptics, antacids local action. 13. Tablet according to one of claims 1 to 12 for its use as a drug for the outpatient treatment of diseases of the ENT sphere or gastrointestinal pathologies. 25 14. Tablet for use according to claim 13, for the outpatient treatment of dyspepsia, oesogastroduodenal disorders, colds, headaches, fever or feverish conditions, sore throat, mild to moderate pain, diseases of the oral mucosa and / or of the oropharynx. 15. Tablet for use according to one of claims 13 or 14, characterized in that it has a systemic and / or local action associated with sensory effects soothing local symptoms. 3034991 19 16. A method of manufacturing a tablet according to one of the preceding claims, characterized in that it comprises the following steps: - manufacture of the orodispersible layer: o spitting of the raw materials: a diluent, a disintegrant, a sweetener , an aroma, a glidant, a lubricant, optionally a dye, and the at least one active ingredient if it is not contained in the layer to be sucked, o mixture of all the raw materials, - manufacture of the layer to be sucked 10 o mixture of the raw materials: a diluent, a binder, a sweetener, a flavor, a glidant, a lubricant, possibly a dye and / or a disintegrant, and the at least one active ingredient if it is not contained in the orodispersible layer, o lubrication 15 - compression of the layers in the following order: o orodispersible layer o layer to suck. 17. The manufacturing method according to claim 16, characterized in that for the manufacture of the orodispersible layer, the lubricant, the glidant and the optional dye are co-screened with another material, and are spun on a lower grid to 500u.m. 18. The manufacturing method according to one of claims 15 to 17, characterized in that the pre-compression forces used for the layer compression step are between 1 and 5kN. 19. Manufacturing process according to one of claims 15 to 18, characterized in that the compression forces used for the layer compression step are between 15 and 20 kN.