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WO1999004759A1 - Homeopathic granules and method for making same - Google Patents

Homeopathic granules and method for making same Download PDF

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Publication number
WO1999004759A1
WO1999004759A1 PCT/FR1998/001600 FR9801600W WO9904759A1 WO 1999004759 A1 WO1999004759 A1 WO 1999004759A1 FR 9801600 W FR9801600 W FR 9801600W WO 9904759 A1 WO9904759 A1 WO 9904759A1
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WO
WIPO (PCT)
Prior art keywords
granules
core
sucrose
lactose
mixture
Prior art date
Application number
PCT/FR1998/001600
Other languages
French (fr)
Inventor
Anne-Marie Binsard
Pierre Dupinay
Michel Huc
Philippe Eychenne
Original Assignee
Plantes Et Medecines
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Plantes Et Medecines filed Critical Plantes Et Medecines
Priority to AU88658/98A priority Critical patent/AU8865898A/en
Publication of WO1999004759A1 publication Critical patent/WO1999004759A1/en

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Classifications

    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5015—Organic compounds, e.g. fats, sugars
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules

Definitions

  • the present invention relates to a new form of homeopathic granules as well as their manufacturing process.
  • granules includes both granules and homeopathic globules.
  • Classic homeopathic granules are made from inert granules which are impregnated with one or more homeopathic dilutions, each containing an active principle, and of which they bear the name (s).
  • Arnica 4 CH granules are obtained by impregnating inert granules with the Arnica 4 CH homeopathic dilution. Therefore, only homeopathic dilutions of soluble products can be used for the impregnation of inert granules.
  • Calcarea Phosphorica being insoluble at a dilution of less than 3 CH.
  • the inert granules for homeopathic use have a mass of approximately 50 mg and consist of a mixture of lactose and sucrose.
  • the inert granules are made from sucrose or lactose particles or a mixture of the two, by successive additions of these constituents in a turbine, according to conventional techniques of
  • the inert granules are then impregnated in a turbine with a dilution or a mixture of several homeopathic dilutions in the proportion of 1 percent-V / m. To obtain an as homogeneous as possible impregnation, the granules are then stirred and dried at a tem perature * of less than 40 ° C.
  • the present invention provides a new form of homeopathic granules which overcomes all the disadvantages of conventional granules.
  • the granules according to the invention make it possible: to obtain, at the heart of the mass of each granule, a precise, homogeneous and reproducible dosage of the active ingredient (s), and therefore to deliver a drug claiming a precise and constant dosage, protect the active ingredient (s) from any external attack, thus guaranteeing better stabilization over time, and to remove the precautions for handling the granules and to be able to take them with your fingers.
  • the process for manufacturing the granules according to the invention is simple, rapid and in accordance with current pharmaceutical requirements.
  • the present invention relates to homeopathic granules characterized in that each granule consists of a core containing one or more active ingredients which are distributed over its entire mass, said core being covered with a neutral coating layer protecting the or said active ingredients contained in the nucleus.
  • the active ingredients are homeopathic deconcentrations prepared in the form of homeopathic dilutions and / or homeopathic triturations.
  • the granules according to the invention have a diameter of between 2 and 5 mm.
  • the granules according to the invention have a mass of between 5 and 115 mg.
  • the core constituting each granule has a diameter between 1 and 4 mm. It contains one or more active ingredients, an excipient and possibly one or more auxiliary substances.
  • the excipient is chosen from sucrose, lactose or a mixture of sucrose and lactose.
  • the auxiliary substances are preferably lubricating agents intended to facilitate the compression of the mixture and / or disintegrating agents intended to accelerate the disintegration of the granule.
  • a lubricating agent used is advantageously glycerol behenate. This non-ionic product, produced without a catalyst, has no specific reactivity and respects the stability of the active ingredients. Its taste is neutral. It does not alter the hardness of the nuclei and does not influence their disintegration time.
  • the disintegrating agents are chosen from cellulose, cellulose derivatives such as croscarmellose sodium and carmellose calcium, starches such as wheat starch, corn starch, starch rice and potato starch, modified starches such as pregelatinized starch, gums such as guar gum, agar-agar gum and pectin, alginates and crosslinked polyvidone.
  • the coating layer protecting the core advantageously consists of sucrose, lactose or a mixture of sucrose and lactose.
  • the mass of the coating layer represents 50 to 70% of the mass of the granule.
  • the disintegration time in water of the granules according to the invention is between 1 and 8 minutes approximately.
  • the present invention also relates to a method for manufacturing the granules described above.
  • the method according to the invention comprises two steps: a step of manufacturing the core from a mixture containing the active ingredient (s) and the excipient, and a step of coating the core.
  • a finely divided excipient is chosen, preferably a powder whose particle size is less than 1 mm.
  • the manufacturing step of the core can be carried out by impregnation or by trituration followed by compression.
  • the mixture containing the active ingredient (s) and the excipient is prepared according to two different methods.
  • the excipient is impregnated with a solution of active principle (s) (s) soluble (s) in said appropriate pharmaceutical vehicle, so that the granules obtained are titrated at 1 percent V / m of active principle (s).
  • the appropriate pharmaceutical vehicle is most often a hydroalcoholic mixture.
  • a trituration is prepared by deconcentration of this or these active ingredients in the excipient, the trituration being carried out according to the usual homeopathic pharmaceutical techniques.
  • the excipient is chosen from sucrose, lactose and a mixture of sucrose and lactose.
  • the core coating step is preferably carried out in a turbine, according to a conventional method, by progressive addition of a coating agent which may be sucrose, lactose or a mixture of sucrose and lactose.
  • a coating agent which may be sucrose, lactose or a mixture of sucrose and lactose.
  • the mass of the coating agent added during the coating step represents 50 to 70% of the total mass of the granules obtained.
  • the granules obtained are dried in an oven at a temperature between 30 and 40 ° C for about 12 hours.
  • the water content of the granules leaving the oven is less than 2%, preferably of the order of 1%.
  • Example 1 Manufacture of the granules by crushing
  • Granules with a diameter equal to 2.8 mm having the following formulation are produced by trituration, compression and then coating: Calcarea Phosphorica core
  • sucrose 7-13 mg instead of lactose, sucrose or a mixture of sucrose and lactose can be used.
  • croscarmellose sodium, carmellose calcium or starch can be used instead of glycerol behenate.
  • trituration is prepared by deconcentration of the active ingredient in lactose, according to the methods usually used in homeopathy.
  • the trituration is then mixed with the glycerol behenate using a conventional mixer, by inversion for example.
  • the mixture thus obtained is compressed on a conventional tableting machine which is adjusted so as to obtain a theoretical weight of 7.77 mg + 10% per core.
  • the weight of the tablets obtained and their disintegration time are checked regularly every hour, or better every 30 minutes.
  • the disintegration time in water of the 2 mm cores is between 1 and 2 minutes approximately.
  • the core obtained from the compression of the crushed mixtures, according to a very strict weight standard, makes it possible to guarantee a unit dosage of particularly precise, rigorous and reproducible active ingredient.
  • the dose administered subsequently is perfectly titrated in active principle and remains constant.
  • the coating of the cores is then carried out in a turbine, using sucrose or lactose or a lactose-sucrose mixture, according to the process usually used for this operation.
  • the granules obtained are spherical, white in color, with a sweet flavor, easily soluble in water. Diameter: 2.8mm approx.
  • Granules with a diameter equal to 2.8 mm having the following formulation are produced by impregnation, compression and then coating.
  • sucrose lactose or a sucrose-lactose mixture can be used.
  • the homeopathic dilution is prepared by deconcentration of the active ingredient in alcohol at 70%, according to the methods usually used in homeopathy.
  • Sucrose powder is then impregnated with this homeopathic dilution, in a turbine or in a spray mixer.
  • the triple impregnation method can be applied or any other method which can give a homogeneous distribution of the active principle on the powder.
  • the impregnated sucrose is mixed with the glycerol behenate using a conventional mixer, by inversion for example.
  • the mixture thus obtained is compressed on a conventional tableting machine which is adjusted so as to obtain a theoretical weight of 7.77 mg + 10% per core.
  • the weight of the tablets obtained and their disintegration time are checked regularly every hour, or better every 30 minutes.
  • the disintegration time in water of the 2 mm cores is between 1 and 2 minutes approximately.
  • the core obtained from the compression of the impregnated mixtures, according to a very strict weight standard, makes it possible to guarantee a unit dosage of particularly precise, rigorous, reproducible active ingredient.
  • the dose administered subsequently is perfectly titrated in active principle and remains constant.
  • the coating of the cores is then carried out in a turbine, using sucrose or lactose or a lactose-sucrose mixture, according to the process usually used for this operation.
  • the granules obtained are spherical, white in color, with a sweet flavor, easily soluble in
  • Granules with a diameter equal to 4 mm having the following formulation are produced by crushing, compression and then coating. .
  • sucrose or a sucrose-lactose mixture can be used.
  • the trituration is prepared by deconcentration of the active principle in lactose, according to the methods usually used in homeopathy.
  • the trituration is mixed with the glycerol behenate using a conventional mixer, by inversion for example.
  • the mixture thus obtained is compressed on a conventional tableting machine which is adjusted so as to obtain a theological weight of 21 mg + 10% per core.
  • the weight of the tablets obtained and their disintegration time are checked regularly every hour, or better every 30 minutes.
  • the disintegration time in water of the 3 mm cores is between 1 and 3 minutes approximately.
  • the core obtained from the compression of the crushed mixtures, according to a very strict weight standard, makes it possible to guarantee a unit dosage of particularly precise, rigorous and reproducible active ingredient.
  • the dose administered subsequently is perfectly titrated in active principle and remains constant.
  • the coating of the cores is then carried out in a turbine, using sucrose or lactose or a lactose-sucrose mixture, according to the process usually used for this operation.
  • the granules obtained are spherical, white in color, with a sweet flavor, easily soluble in water.
  • Granules with a diameter equal to 4 mm having the following formulation are produced by impregnation, compression and then coating.
  • sucrose lactose or a sucrose-lactose mixture can be used.
  • the homeopathic dilution is prepared by deconcentration of the active ingredient in alcohol at 70%, according to the methods usually used in homeopathy.
  • Sucrose powder is then impregnated with this homeopathic dilution, in a turbine or in a spray mixer.
  • the triple impregnation method can be applied or any other method which can give a homogeneous distribution of the active principle on its support.
  • the important thing is to adapt the quantity of powder to be impregnated, to the turbine and to the mixer while optimizing the dilution volumes and their distribution method, this in order to obtain the best distribution homogeneity.
  • the impregnated sucrose is mixed with the glycerol behenate using a conventional mixer, by inversion for example.
  • the mixture thus obtained is compressed on a conventional tableting machine which is adjusted so as to obtain a theoretical weight of 21 mg + 10% per core.
  • the weight of the tablets obtained and their disintegration time are checked regularly every hour, or better every 30 minutes.
  • the disintegration time in water of the 3 mm cores is between 1 and 3 minutes approximately.
  • the core obtained from the compression of the impregnated mixtures, according to a very strict weight standard, makes it possible to guarantee a unit dosage of particularly precise, rigorous, reproducible active ingredient.
  • the dose administered subsequently is perfectly titrated in active principle and remains constant.
  • the coating of the cores is then carried out in a turbine, using sucrose or lactose or a lactose-sucrose mixture, according to the process usually used for this operation.
  • the granules obtained are spherical, white in color, with a sweet flavor, easily soluble in water.

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Abstract

The invention concerns a novel form of homeopathic granules, each granule consisting of a core containing one or several active principles distributed over the whole volume, said core being coated with a neutral coating layer protecting said active principle(s) contained in the core. The invention also concerns the method for making said granules comprising a step for making the core and a step for coating the core.

Description

Granules homéopathiques et procédé de fabrication Homeopathic granules and method of making
La présente invention concerne une nouvelle forme de granules homéopathiques ainsi que leur procédé de fabrication.The present invention relates to a new form of homeopathic granules as well as their manufacturing process.
Dans la présente demande, le terme "granules" regroupe à la fois les granules et les globules homéopathiques .In the present application, the term "granules" includes both granules and homeopathic globules.
Les granules homéopathiques classiques sont fabriqués à partir de granules inertes qui sont imprégnés avec une ou plusieurs dilutions homéopathiques, contenant chacune un principe actif, et dont ils portent la ou les dénominations .Classic homeopathic granules are made from inert granules which are impregnated with one or more homeopathic dilutions, each containing an active principle, and of which they bear the name (s).
Par exemple, les granules Arnica 4 CH sont obtenus par imprégnation de granules inertes avec la dilution homéopathique Arnica 4 CH . De ce fait, seules les dilutions homéopathiques de produits solubles peuvent être utilisées pour l'imprégnation des granules inertes.For example, Arnica 4 CH granules are obtained by impregnating inert granules with the Arnica 4 CH homeopathic dilution. Therefore, only homeopathic dilutions of soluble products can be used for the impregnation of inert granules.
Pour certains produits, il est donc impossible de fabriquer des granules au-dessous d'un certain seuil de hauteur de dilution. C'est le cas, par exemple, deFor certain products, it is therefore impossible to manufacture granules below a certain dilution height threshold. This is the case, for example,
Calcarea Phosphorica qui ne peut être délivré sous la forme de granules à une dilution inférieure à 3 CH,Calcarea Phosphorica which cannot be delivered in the form of granules at a dilution of less than 3 CH,
Calcarea Phosphorica étant insoluble à une dilution inférieure à 3 CH.Calcarea Phosphorica being insoluble at a dilution of less than 3 CH.
Les granules inertes pour usage homéopathique ont une masse de 50 mg environ et sont constitués d'un mélange de lactose et de saccharose .The inert granules for homeopathic use have a mass of approximately 50 mg and consist of a mixture of lactose and sucrose.
Les granules inertes sont fabriqués à partir de particules de saccharose ou de lactose ou d'un mélange des deux, par additions successives de ces constituants en turbine, selon les techniques classiques deThe inert granules are made from sucrose or lactose particles or a mixture of the two, by successive additions of these constituents in a turbine, according to conventional techniques of
1 ' enrobage .1 coating.
Les granules inertes sont ensuite imprégnés en turbine avec une dilution ou un mélange de plusieurs dilutions homéopathiques dans la proportion de 1 pour cent-V/m. Pour obtenir une imprégnation la plus homogène possible, les granules sont ensuite agités puis séchés à une tem *pérature inférieure à 40°C.The inert granules are then impregnated in a turbine with a dilution or a mixture of several homeopathic dilutions in the proportion of 1 percent-V / m. To obtain an as homogeneous as possible impregnation, the granules are then stirred and dried at a tem perature * of less than 40 ° C.
Compte tenu de leur taille, de la présence d'un noyau compact et de leur faible porosité, la qualité d'imprégnation de ces granules et donc leur teneur en principe (s) actif (s) est aléatoire, en raison notamment des difficultés liées à la capacité d'imprégnation, l'homogénéité d'imprégnation et la profondeur d'imprégnation de ces granules.Given their size, the presence of a compact core and their low porosity, the quality of impregnation of these granules and therefore their content of active ingredient (s) is random, due in particular to the difficulties associated to the impregnation capacity, the homogeneity of impregnation and the depth of impregnation of these granules.
La teneur en principe (s) actif (s) des granules homéopathiques ne peut donc être garantie.The content of active ingredient (s) in homeopathic granules cannot therefore be guaranteed.
Cette teneur n'est actuellement pas indiquée sur le conditionnement des granules homéopathiques. Seule la hauteur de la ou des dilutions homéopathiques utilisées pour l'imprégnation est revendiquée.This content is not currently indicated on the packaging of homeopathic granules. Only the height of the homeopathic dilution (s) used for the impregnation is claimed.
Enfin, en raison de la qualité intrinsèque du granule liée à son mode de fabrication, et de sa difficulté à absorber la dilution ou le mélange de dilutions homéopathiques, une partie du ou des principes actifs reste sur la surface externe du granule. Il en résulte que des précautions de manipulation des granules doivent être prises. Notamment, il est recommandé de ne pas prendre les granules avec les doigts. De plus, le procédé classique de fabrication des granules est long, délicat et peu en accord avec la qualité pharmaceutique actuelle.Finally, due to the intrinsic quality of the granule linked to its method of manufacture, and to its difficulty in absorbing the dilution or the mixture of homeopathic dilutions, part of the active principle (s) remains on the external surface of the granule. As a result, precautions in handling the granules must be taken. In particular, it is recommended not to take the granules with your fingers. In addition, the conventional process for manufacturing the granules is long, delicate and not in keeping with current pharmaceutical quality.
La présente invention propose une nouvelle forme de granules homéopathiques qui permet de pallier tous les inconvénients des granules classiques .The present invention provides a new form of homeopathic granules which overcomes all the disadvantages of conventional granules.
En effet, les granules selon l'invention permettent : d'obtenir au coeur de la masse de chaque granule, un dosage précis, homogène et reproductible du ou des principes actifs, et donc de délivrer un médicament revendiquant un dosage précis et constant, de protéger le ou les principes actifs de toute agression extérieure garantissant ainsi une meilleure stabilicé dans le temps, et de supprimer les précautions de manipulation des granules et de pouvoir les prendre avec les doigts. En outre, le procédé de fabrication des granules selon l'invention est simple, rapide et conforme aux exigences pharmaceutiques actuelles.In fact, the granules according to the invention make it possible: to obtain, at the heart of the mass of each granule, a precise, homogeneous and reproducible dosage of the active ingredient (s), and therefore to deliver a drug claiming a precise and constant dosage, protect the active ingredient (s) from any external attack, thus guaranteeing better stabilization over time, and to remove the precautions for handling the granules and to be able to take them with your fingers. In addition, the process for manufacturing the granules according to the invention is simple, rapid and in accordance with current pharmaceutical requirements.
La présente invention concerne des granules homéopathiques caractérisés en ce que chaque granule est constitué d'un noyau contenant un ou plusieurs principes actifs qui sont répartis sur l'ensemble de sa masse, ledit noyau étant recouvert d'une couche d'enrobage neutre protégeant le ou lesdits principes actifs contenus dans le noyau .The present invention relates to homeopathic granules characterized in that each granule consists of a core containing one or more active ingredients which are distributed over its entire mass, said core being covered with a neutral coating layer protecting the or said active ingredients contained in the nucleus.
Les principes actifs sont des déconcentrations homéopathiques préparées sous la forme de dilutions homéopathiques et/ou de triturations homéopathiques.The active ingredients are homeopathic deconcentrations prepared in the form of homeopathic dilutions and / or homeopathic triturations.
Les granules selon 1 ' invention ont un diamètre compris entre 2 et 5 mm.The granules according to the invention have a diameter of between 2 and 5 mm.
Les granules selon 1 ' invention ont une masse comprise entre 5 et 115 mg. Le noyau constituant chaque granule a un diamètre compris entre 1 et 4 mm. Il contient un ou plusieurs principes actifs, un excipient et éventuellement une ou plusieurs substances auxiliaires.The granules according to the invention have a mass of between 5 and 115 mg. The core constituting each granule has a diameter between 1 and 4 mm. It contains one or more active ingredients, an excipient and possibly one or more auxiliary substances.
L'excipient est choisi parmi le saccharose, le lactose ou un mélange de saccharose et de lactose.The excipient is chosen from sucrose, lactose or a mixture of sucrose and lactose.
Les substances auxiliaires sont de préférence des agents de lubrification destinés à faciliter la compression du mélange et/ou des agents de désagrégation destinés à accélérer le délitement du granule. Un agent de lubrification utilisé est avantageusement le béhénate de glycerol . Ce produit non ionique, fabriqué sans catalyseur, n'a pas de réactivité propre et respecte la stabilité des principes actifs. Son goût est neutre. Il n'altère pas la dureté des noyaux et n'influence pas leur temps de désagrégation.The auxiliary substances are preferably lubricating agents intended to facilitate the compression of the mixture and / or disintegrating agents intended to accelerate the disintegration of the granule. A lubricating agent used is advantageously glycerol behenate. This non-ionic product, produced without a catalyst, has no specific reactivity and respects the stability of the active ingredients. Its taste is neutral. It does not alter the hardness of the nuclei and does not influence their disintegration time.
Les agents de désagrégation sont choisis parmi la cellulose, les dérivés cellulosiques comme le croscarmellose sodique et le carmellose calcique, les amidons comme l'amidon de blé, l'amidon de maïs, l'amidon de riz et l'amidon de pomme de terre, les amidons modifiés comme l'amidon prégélatinisé, les gommes comme la gomme de guar, la gomme agar-agar et la pectine, les alginates et la polyvidone réticulée. La couche d'enrobage protégeant le noyau est avantageusement constituée de saccharose, de lactose ou d'un mélange de saccharose et de lactose.The disintegrating agents are chosen from cellulose, cellulose derivatives such as croscarmellose sodium and carmellose calcium, starches such as wheat starch, corn starch, starch rice and potato starch, modified starches such as pregelatinized starch, gums such as guar gum, agar-agar gum and pectin, alginates and crosslinked polyvidone. The coating layer protecting the core advantageously consists of sucrose, lactose or a mixture of sucrose and lactose.
La masse de la couche d'enrobage représente 50 à 70 % de la masse du granule. Le temps de désagrégation dans l'eau des granules selon 1 ' invention est compris entre 1 et 8 minutes environ.The mass of the coating layer represents 50 to 70% of the mass of the granule. The disintegration time in water of the granules according to the invention is between 1 and 8 minutes approximately.
La présente invention a également pour objet un procédé de fabrication des granules décrits précédemment. Le procédé selon 1 ' invention comprend deux étapes : une étape de fabrication du noyau à partir d'un mélange contenant le ou les principes actifs et l'excipient, et une étape d'enrobage du noyau.The present invention also relates to a method for manufacturing the granules described above. The method according to the invention comprises two steps: a step of manufacturing the core from a mixture containing the active ingredient (s) and the excipient, and a step of coating the core.
Afin d'améliorer la qualité de répartition du ou des principes actifs à l'étape de fabrication du noyau, on choisit un excipient finement divisé, de préférence une poudre dont la granulométrie est inférieure à 1 mm.In order to improve the quality of distribution of the active ingredient (s) at the stage of manufacturing the core, a finely divided excipient is chosen, preferably a powder whose particle size is less than 1 mm.
L'étape de fabrication du noyau peut être réalisée par imprégnation ou par trituration suivie d'une compression.The manufacturing step of the core can be carried out by impregnation or by trituration followed by compression.
Selon que le ou les principes actifs, c'est-à-dire le ou les déconcentrations homéopathiques, sont solubles ou non dans un véhicule pharmaceutique approprié, le mélange contenant le ou les principes actifs et l'excipient est préparé selon deux méthodes différentes.Depending on whether the active ingredient (s), that is to say the homeopathic deconcentration (s), are soluble or not in an appropriate pharmaceutical vehicle, the mixture containing the active ingredient (s) and the excipient is prepared according to two different methods.
Lorsque le ou les principes actifs sont solubles dans un véhicule pharmaceutique approprié, c'est-à-dire lorsqu'on peut utiliser une dilution ou un mélange de dilutions homéopathiques, l'excipient est imprégné d'une solution de principe (s) actif (s) soluble(s) dans ledit véhicule pharmaceutique approprié, de manière à ce que les granules obtenus soient titrés à 1 pour cent V/m de principe (s) actif (s). Le véhicule pharmaceutique approprié est le plus souvent un mélange hydroalcoolique.When the active principle (s) are soluble in a suitable pharmaceutical vehicle, that is to say when a dilution or a mixture of homeopathic dilutions can be used, the excipient is impregnated with a solution of active principle (s) (s) soluble (s) in said appropriate pharmaceutical vehicle, so that the granules obtained are titrated at 1 percent V / m of active principle (s). The appropriate pharmaceutical vehicle is most often a hydroalcoholic mixture.
Lorsque le ou les principes actifs ne sont solubles dans aucun véhicule pharmaceutique approprié, on prépare une trituration par déconcentration de ce ou ces principes actifs dans l'excipient, la trituration étant réalisée selon les techniques habituelles pharmaceutiques homéopathiques .When the active ingredient (s) are not soluble in any suitable pharmaceutical vehicle, a trituration is prepared by deconcentration of this or these active ingredients in the excipient, the trituration being carried out according to the usual homeopathic pharmaceutical techniques.
L'excipient est choisi parmi le saccharose, le lactose et un mélange de saccharose et de lactose.The excipient is chosen from sucrose, lactose and a mixture of sucrose and lactose.
L'étape d'enrobage du noyau est réalisée de préférence en turbine, selon un procédé classique, par ajout progressif d'un agent d'enrobage qui peut être du saccharose, du lactose ou un mélange de saccharose et de lactose.The core coating step is preferably carried out in a turbine, according to a conventional method, by progressive addition of a coating agent which may be sucrose, lactose or a mixture of sucrose and lactose.
La masse de l'agent d'enrobage ajoutée au cours de l'étape d'enrobage représente 50 à 70 % de la masse totale des granules obtenus.The mass of the coating agent added during the coating step represents 50 to 70% of the total mass of the granules obtained.
Lorsque l'étape d'enrobage est terminée, les granules obtenus sont séchés dans une étuve à une température comprise entre 30 et 40 °C pendant environ 12 heures .When the coating step is complete, the granules obtained are dried in an oven at a temperature between 30 and 40 ° C for about 12 hours.
La teneur en eau des granules à la sortie de 1 ' étuve est inférieure à 2 %, de préférence de l'ordre de 1 % . D'autres avantages de la présente invention apparaîtront à la lecture des exemples suivants donnés à titre illustratif mais non limitatif.The water content of the granules leaving the oven is less than 2%, preferably of the order of 1%. Other advantages of the present invention will appear on reading the following examples given by way of illustration but not limitation.
Exemple 1 : Fabrication des granules par triturationExample 1: Manufacture of the granules by crushing
On réalise par trituration, compression puis enrobage des granules d'un diamètre égal à 2,8 mm ayant la formulation suivante : Noyau Calcarea PhosphoricaGranules with a diameter equal to 2.8 mm having the following formulation are produced by trituration, compression and then coating: Calcarea Phosphorica core
Trituration dans le lactose 3 DH 7 , 4 mgTrituration in lactose 3 DH 7, 4 mg
Béhénate de glycerol 0,37 mgGlycerol behenate 0.37 mg
EnrobageCoating
Saccharose 7-13 mg A la place du lactose, on peut employer du saccharose ou un mélange de saccharose et de lactose.Sucrose 7-13 mg Instead of lactose, sucrose or a mixture of sucrose and lactose can be used.
A «la place du béhénate de glycerol, on peut utiliser du croscarmellose sodique, du carmellose calcique ou de l'amidon.Instead of glycerol behenate, croscarmellose sodium, carmellose calcium or starch can be used.
Préparation du noyau :Core preparation:
Dans un premier temps, on prépare la trituration par déconcentration du principe actif dans du lactose, selon les méthodes habituellement utilisées en homéopathie.First, trituration is prepared by deconcentration of the active ingredient in lactose, according to the methods usually used in homeopathy.
On mélange ensuite la trituration avec le béhénate de glycerol à l'aide d'un mélangeur classique, par retournement par exemple.The trituration is then mixed with the glycerol behenate using a conventional mixer, by inversion for example.
Le mélange ainsi obtenu est comprimé sur une machine à comprimer classique que l'on règle de manière à obtenir un poids théorique de 7 , 77 mg + 10 % par noyau.The mixture thus obtained is compressed on a conventional tableting machine which is adjusted so as to obtain a theoretical weight of 7.77 mg + 10% per core.
Au cours de la compression, on contrôle régulièrement toutes les heures, ou mieux toutes les 30 minutes, le poids des comprimés obtenus ainsi que leur temps de désagrégation.During compression, the weight of the tablets obtained and their disintegration time are checked regularly every hour, or better every 30 minutes.
Le temps de désagrégation dans l'eau des noyaux de 2 mm est compris entre 1 et 2 minutes environ.The disintegration time in water of the 2 mm cores is between 1 and 2 minutes approximately.
Le noyau, obtenu à partir de la compression des mélanges triturés, selon une norme de poids très stricte, permet de garantir un dosage unitaire en principe actif particulièrement précis, rigoureux, reproductible.The core, obtained from the compression of the crushed mixtures, according to a very strict weight standard, makes it possible to guarantee a unit dosage of particularly precise, rigorous and reproducible active ingredient.
Il en résulte que la dose administrée par la suite est parfaitement titrée en principe actif et reste constante .As a result, the dose administered subsequently is perfectly titrated in active principle and remains constant.
Enrobage :Coating:
L'enrobage des noyaux est ensuite réalisé en turbine, à l'aide de saccharose ou de lactose ou d'un mélange lactose-saccharose, selon le procédé habituellement utilisé pour cette opération.The coating of the cores is then carried out in a turbine, using sucrose or lactose or a lactose-sucrose mixture, according to the process usually used for this operation.
Les granules obtenus sont sphériques, de couleur blanche, de saveur sucrée, facilement solubles dans 1 ' eau . Diamètre : 2 , 8 mm environThe granules obtained are spherical, white in color, with a sweet flavor, easily soluble in water. Diameter: 2.8mm approx.
Masse : 14,77 mg à 20,77 mg Temps de désagrégation dans l'eau : 1 à 3 minutes environ.Mass: 14.77 mg to 20.77 mg Time for disintegration in water: 1 to 3 minutes approximately.
Exemple 2 : Fabrication des granules par imprégnationEXAMPLE 2 Manufacture of the Granules by Impregnation
On réalise par imprégnation, compression puis enrobage des granules d'un diamètre égal à 2,8 mm ayant la formulation suivante :Granules with a diameter equal to 2.8 mm having the following formulation are produced by impregnation, compression and then coating.
. Noyau. Core
Chininum 3 DH 0,000185 mlChininum 3 DH 0.000185 ml
Saccharose 7,4 mgSucrose 7.4 mg
Béhénate de glycerol 0,37 mgGlycerol behenate 0.37 mg
. Enrobage. Coating
Saccharose 7 à 13 mgSucrose 7 to 13 mg
A la place du saccharose on peut employer du lactose ou un mélange saccharose-lactose.Instead of sucrose, lactose or a sucrose-lactose mixture can be used.
Préparation du noyau :Core preparation:
Dans un premier temps, on prépare la dilution homéopathique par déconcentration du principe actif dans l'alcool à 70 %, selon les méthodes habituellement utilisées en homéopathie.First, the homeopathic dilution is prepared by deconcentration of the active ingredient in alcohol at 70%, according to the methods usually used in homeopathy.
On imprègne ensuite de la poudre de saccharose avec cette dilution homéopathique, en turbine ou en mélangeur par pulvérisation. La méthode par triple imprégnation peut être appliquée ou toute autre méthode pouvant donner une répartition homogène du principe actif sur la poudre.Sucrose powder is then impregnated with this homeopathic dilution, in a turbine or in a spray mixer. The triple impregnation method can be applied or any other method which can give a homogeneous distribution of the active principle on the powder.
L'important étant d'adapter la quantité de poudre à imprégner, à la turbine et au mélangeur tout en optimisant les volumes de dilution et leur mode de répartition ceci dans le but d'obtenir la meilleure homogénéité de répartition. Dans un deuxième temps, on mélange le saccharose imprégné avec le béhénate de glycerol à l'aide d'un mélangeur classique, par retournement par exemple.The important thing is to adapt the quantity of powder to be impregnated, to the turbine and to the mixer while optimizing the dilution volumes and their distribution method this in order to obtain the best distribution homogeneity. In a second step, the impregnated sucrose is mixed with the glycerol behenate using a conventional mixer, by inversion for example.
Le mélange ainsi obtenu est comprimé sur une machine à comprimer classique que l'on règle de manière à obtenir un poids théorique de 7,77 mg + 10 % par noyau.The mixture thus obtained is compressed on a conventional tableting machine which is adjusted so as to obtain a theoretical weight of 7.77 mg + 10% per core.
Au cours de la compression, on contrôle régulièrement toutes les heures, ou mieux toutes les 30 minutes, le poids des comprimés obtenus ainsi que leur temps de désagrégation.During compression, the weight of the tablets obtained and their disintegration time are checked regularly every hour, or better every 30 minutes.
Le temps de désagrégation dans l'eau des noyaux de 2 mm est compris ente 1 et 2 minutes environ.The disintegration time in water of the 2 mm cores is between 1 and 2 minutes approximately.
Le noyau, obtenu à partir de la compression des mélanges imprégnés, selon une norme de poids très stricte, permet de garantir un dosage unitaire en principe actif particulièrement précis, rigoureux, reproductible .The core, obtained from the compression of the impregnated mixtures, according to a very strict weight standard, makes it possible to guarantee a unit dosage of particularly precise, rigorous, reproducible active ingredient.
Il en résulte que la dose administrée par la suite est parfaitement titrée en principe actif et reste constante.As a result, the dose administered subsequently is perfectly titrated in active principle and remains constant.
Enrobage :Coating:
L'enrobage des noyaux est ensuite réalisé en turbine, à l'aide de saccharose ou de lactose ou d'un mélange lactose-saccharose, selon le procédé habituellement utilisé pour cette opération.The coating of the cores is then carried out in a turbine, using sucrose or lactose or a lactose-sucrose mixture, according to the process usually used for this operation.
Les granules obtenus sont sphériques, de couleur blanche, de saveur sucrée, facilement solubles dansThe granules obtained are spherical, white in color, with a sweet flavor, easily soluble in
1 ' eau. Diamètre : 2,8 mm environ1 water. Diameter: about 2.8mm
Masse : 14 , 77 mg à 20,77 mgMass: 14.77 mg to 20.77 mg
Temps de désagrégation dans l'eau : 1 à 3 minutes environ.Time of disintegration in water: 1 to 3 minutes approximately.
Exemple 3 : Fabrication des granules par triturationEXAMPLE 3 Manufacture of the Granules by Trituration
On réalise par trituration, compression puis enrobage des granules d'un diamètre égal à 4 mm ayant la formulation suivante : . NoyauGranules with a diameter equal to 4 mm having the following formulation are produced by crushing, compression and then coating. . Core
Calcarea Phosphorica trituration dans le lactose 3 DH 20 mg Béhénate de glycerol 1 mgCalcarea Phosphorica trituration in lactose 3 DH 20 mg Glycerol behenate 1 mg
. Enrobage. Coating
Saccharose 20 à 30 mg.Sucrose 20 to 30 mg.
A la place du lactose on peut employer du saccharose ou un mélange saccharose-lactose.Instead of lactose, sucrose or a sucrose-lactose mixture can be used.
Préparation du noyau :Core preparation:
Dans un premier temps on prépare la trituration par déconcentration du principe actif dans du lactose, selon les méthodes habituellement utilisées en homéopathie.Firstly, the trituration is prepared by deconcentration of the active principle in lactose, according to the methods usually used in homeopathy.
On mélange la trituration avec le béhénate de glycerol à l'aide d'un mélangeur classique, par retournement par exemple.The trituration is mixed with the glycerol behenate using a conventional mixer, by inversion for example.
Le mélange ainsi obtenu est comprimé sur une machine à comprimer classique que l'on règle de manière à obtenir un poids théolique de 21 mg + 10 % par noyau.The mixture thus obtained is compressed on a conventional tableting machine which is adjusted so as to obtain a theological weight of 21 mg + 10% per core.
Au cours de la compression, on contrôle régulièrement toutes les heures, ou mieux toutes les 30 minutes, le poids des comprimés obtenus ainsi que leur temps de désagrégation.During compression, the weight of the tablets obtained and their disintegration time are checked regularly every hour, or better every 30 minutes.
Le temps de désagrégation dans l'eau des noyaux de 3 mm est compris entre 1 et 3 minutes environ.The disintegration time in water of the 3 mm cores is between 1 and 3 minutes approximately.
Le noyau, obtenu à partir de la compression des mélanges triturés, selon une norme de poids très stricte, permet de garantir un dosage unitaire en principe actif particulièrement précis, rigoureux, reproductible.The core, obtained from the compression of the crushed mixtures, according to a very strict weight standard, makes it possible to guarantee a unit dosage of particularly precise, rigorous and reproducible active ingredient.
Il en résulte que la dose administrée par la suite est parfaitement titrée en principe actif et reste constante .As a result, the dose administered subsequently is perfectly titrated in active principle and remains constant.
Enrobage :Coating:
L'enrobage des noyaux est ensuite réalisé en turbine, à l'aide de saccharose ou de lactose ou d'un mélange lactose-saccharose, selon le procédé habituellement utilisé pour cette opération.The coating of the cores is then carried out in a turbine, using sucrose or lactose or a lactose-sucrose mixture, according to the process usually used for this operation.
Les granules obtenus sont sphériques, de couleur blanche, de saveur sucrée, facilement solubles dans 1 'eau.The granules obtained are spherical, white in color, with a sweet flavor, easily soluble in water.
Diamètre : 4 mm environDiameter: about 4 mm
Masse : 41 mg à 51 mgMass: 41 mg to 51 mg
Temps de désagrégation dans l'eau : 1 à 6 minutes environ.Time of disintegration in water: 1 to 6 minutes approximately.
Exemple 4 : Fabrication des granules par imprégnationEXAMPLE 4 Manufacture of the Granules by Impregnation
On réalise par imprégnation, compression puis enrobage des granules d'un diamètre égal à 4 mm ayant la formulation suivante :Granules with a diameter equal to 4 mm having the following formulation are produced by impregnation, compression and then coating.
. Noyau. Core
Chininum 3 DH 0,0005 mlChininum 3 DH 0.0005 ml
Saccharose 20 mg Béhénate de glycerol 1 mgSucrose 20 mg Glycerol behenate 1 mg
. Enrobage. Coating
Saccharose 20 à 30 mgSucrose 20 to 30 mg
A la place du saccharose on peut employer du lactose ou un mélange saccharose-lactose.Instead of sucrose, lactose or a sucrose-lactose mixture can be used.
Préparation du noyau :Core preparation:
Dans un premier temps, on prépare la dilution homéopathique par déconcentration du principe actif dans l'alcool à 70 %, selon les méthodes habituellement utilisées en homéopathie.First, the homeopathic dilution is prepared by deconcentration of the active ingredient in alcohol at 70%, according to the methods usually used in homeopathy.
On imprègne ensuite de la poudre de saccharose avec cette dilution homéopathique, en turbine ou en mélangeur par pulvérisation.Sucrose powder is then impregnated with this homeopathic dilution, in a turbine or in a spray mixer.
La méthode par triple imprégnation peut être appliquée ou toute autre méthode pouvant donner une répartition homogène du principe actif sur son support. L'important étant d'adapter la quantité de poudre à imprégner, à la turbine et au mélangeur tout en optimisant les volumes de dilution et leur mode de répartition, ceci dans le but d'obtenir la meilleure homogénéité de répartition.The triple impregnation method can be applied or any other method which can give a homogeneous distribution of the active principle on its support. The important thing is to adapt the quantity of powder to be impregnated, to the turbine and to the mixer while optimizing the dilution volumes and their distribution method, this in order to obtain the best distribution homogeneity.
Dans un deuxième temps, on mélange le saccharose imprégné avec le béhénate de glycerol à l'aide d'un mélangeur classique, par retournement par exemple.In a second step, the impregnated sucrose is mixed with the glycerol behenate using a conventional mixer, by inversion for example.
Le mélange ainsi obtenu est comprimé sur une machine à comprimer classique que l'on règle de manière à obtenir un poids théorique de 21 mg + 10 % par noyau.The mixture thus obtained is compressed on a conventional tableting machine which is adjusted so as to obtain a theoretical weight of 21 mg + 10% per core.
Au cours de la compression, on contrôle régulièrement toutes les heures, ou mieux toutes les 30 minutes, le poids des comprimés obtenus ainsi que leur temps de désagrégation.During compression, the weight of the tablets obtained and their disintegration time are checked regularly every hour, or better every 30 minutes.
Le temps de désagrégation dans l'eau des noyaux de 3 mm est compris entre 1 et 3 minutes environ.The disintegration time in water of the 3 mm cores is between 1 and 3 minutes approximately.
Le noyau, obtenu à partir de la compression des mélanges imprégnés, selon une norme de poids très stricte, permet de garantir un dosage unitaire en principe actif particulièrement précis, rigoureux, reproductible .The core, obtained from the compression of the impregnated mixtures, according to a very strict weight standard, makes it possible to guarantee a unit dosage of particularly precise, rigorous, reproducible active ingredient.
Il en résulte que la dose administrée par la suite est parfaitement titrée en principe actif et reste constante .As a result, the dose administered subsequently is perfectly titrated in active principle and remains constant.
Enrobage :Coating:
L'enrobage des noyaux est ensuite réalisé en turbine, à l'aide de saccharose ou de lactose ou d'un mélange lactose-saccharose, selon le procédé habituellement utilisé pour cette opération.The coating of the cores is then carried out in a turbine, using sucrose or lactose or a lactose-sucrose mixture, according to the process usually used for this operation.
Les granules obtenus sont sphériques, de couleur blanche, de saveur sucrée, facilement solubles dans l'eau.The granules obtained are spherical, white in color, with a sweet flavor, easily soluble in water.
Diamètre : 4 mm environDiameter: about 4 mm
Masse : 41 mg à 51 mgMass: 41 mg to 51 mg
Temps de désagrégation dans l'eau : 1 à 6 minutes environ. Time of disintegration in water: 1 to 6 minutes approximately.

Claims

REVENDICATIONS
1. Granules homéopathiques caractérisés en ce que chaque granule est constitué d'un noyau contenant un ou plusieurs principes actifs qui sont répartis sur l'ensemble de sa masse, ledit noyau étant recouvert d'une couche d'enrobage neutre protégeant le ou lesdits principes actifs contenus dans le noyau.1. Homeopathic granules characterized in that each granule consists of a core containing one or more active principles which are distributed over its entire mass, said core being covered with a neutral coating layer protecting the said principle or principles active ingredients in the nucleus.
2. Granules selon la revendication 1, caractérisés en ce que leur diamètre est compris entre 2 et 5 mm.2. Granules according to claim 1, characterized in that their diameter is between 2 and 5 mm.
3. Granules selon la revendication 1 ou 2, caractérisés en ce que leur masse est comprise entre 5 et 115 mg.3. Granules according to claim 1 or 2, characterized in that their mass is between 5 and 115 mg.
4. Granules selon l'une des revendications précédentes, caractérisés en ce que le noyau a un diamètre compris entre 1 et 4 mm.4. Granules according to one of the preceding claims, characterized in that the core has a diameter between 1 and 4 mm.
5. Granules selon l'une des revendications précédentes, caractérisés en ce que le noyau contient un excipient choisi parmi le saccharose, le lactose ou un mélange de saccharose et de lactose.5. Granules according to one of the preceding claims, characterized in that the core contains an excipient chosen from sucrose, lactose or a mixture of sucrose and lactose.
6. Granules selon l'une des revendications précédentes, caractérisés en ce que le noyau contient des agents de lubrification et/ou des agents de désagrégation . 6. Granules according to one of the preceding claims, characterized in that the core contains lubricating agents and / or disintegrating agents.
7. Granules selon la revendication 6, caractérisés en ce qu'un agent de lubrification est le béhénate de glycerol .7. Granules according to claim 6, characterized in that a lubricating agent is glycerol behenate.
8. Granules selon la revendication 6 ou 7, caractérisés en ce que les agents de désagrégation sont choisis parmi la cellulose, les dérivés cellulosiques comme le croscarmellose sodique et le carmellose calcique, les amidons comme l'amidon de blé, l'amidon de maïs, l'amidon de riz et l'amidon de pomme de terre, les amidons modifiés comme l'amidon prégélatinisé, les gommes comme la gomme de guar, la gomme agar-agar et la pectine, les alginates et la polyvidone réticulée .8. Granules according to claim 6 or 7, characterized in that the disintegrating agents are chosen from cellulose, cellulose derivatives such as croscarmellose sodium and carmellose calcium, starches such as wheat starch, corn starch , rice starch and potato starch, modified starches such as pregelatinized starch, gums such as guar gum, agar-agar gum and pectin, alginates and crosslinked polyvidone.
9. Granules selon l'une des revendications précédentes, caractérisés en ce que la couche d'enrobage est constituée de saccharose, de lactose ou d'un mélange de saccharose et de lactose.9. Granules according to one of the preceding claims, characterized in that the coating layer consists of sucrose, lactose or a mixture of sucrose and lactose.
10. Granules selon l'une des revendications précédentes, caractérisés en ce que la masse de la couche d'enrobage représente 50 à 70 % de la masse du granule.10. Granules according to one of the preceding claims, characterized in that the mass of the coating layer represents 50 to 70% of the mass of the granule.
11. Granules selon l'une des revendications précédentes, caractérisés en ce que le temps de désagrégation dans l'eau des granules est compris entre 1 et 8 minutes environ. 11. Granules according to one of the preceding claims, characterized in that the disintegration time in water of the granules is between 1 and 8 minutes approximately.
12. Procédé de fabrication des granules selon l'une quelconque des revendications 1 à 11, caractérisé en ce qu'il comprend deux étapes : une étape de fabrication du noyau à partir d'un mélange contenant le ou les principes actifs et l'excipient, et une étape d'enrobage du noyau. 12. A method of manufacturing granules according to any one of claims 1 to 11, characterized in that it comprises two steps: a step of manufacturing the core from a mixture containing the active ingredient (s) and the excipient , and a step for coating the core.
13. Procédé selon la revendication 12, caractérisé en ce que 1 ' excipient est une poudre dont la granulométrie est inférieure à 1 mm.13. The method of claim 12, characterized in that the excipient is a powder whose particle size is less than 1 mm.
14. Procédé selon la revendication 12 ou 13, caractérisé en ce que l'étape de fabrication du noyau est réalisée par imprégnation ou par trituration suivie d'une compression .14. The method of claim 12 or 13, characterized in that the step of manufacturing the core is carried out by impregnation or by trituration followed by compression.
15. Procédé selon l'une quelconque des revendications 12 à 14, caractérisé en ce que l'excipient est imprégné d'une solution de principe (s) actif (s) soluble(s) dans un véhicule pharmaceutique approprié, de manière à ce que les granules obtenus soient titrés à 1 pour cent V/m de principe (s) actif (s) .15. Method according to any one of claims 12 to 14, characterized in that the excipient is impregnated with a solution of active principle (s) soluble (s) in a suitable pharmaceutical vehicle, so that that the granules obtained are titrated at 1 percent V / m of active principle (s).
16. Procédé selon la revendication 15, caractérisé en ce que le véhicule pharmaceutique approprié est un mélange hydroalcoolique.16. Method according to claim 15, characterized in that the appropriate pharmaceutical vehicle is a hydroalcoholic mixture.
17. Procédé selon l'une quelconque des revendications 12 à 14, caractérisé en ce qu'on prépare une trituration par déconcentration du ou des principe (s) actif (s) dans l'excipient. 17. Method according to any one of claims 12 to 14, characterized in that a trituration is prepared by deconcentration of the active principle (s) in the excipient.
18. Procédé selon l'une quelconque des revendications 12 à 17, caractérisé en ce que l'excipient est choisi parmi le saccharose, le lactose et un mélange de saccharose et de lactose. 18. Method according to any one of claims 12 to 17, characterized in that the excipient is chosen from sucrose, lactose and a mixture of sucrose and lactose.
19. Procédé selon l'une quelconque des revendications 12 à 18, caractérisé en ce que l'étape d'enrobage du noyau est réalisée en turbine par ajout progressif d'un agent d'enrobage. 19. Method according to any one of claims 12 to 18, characterized in that the step of coating the core is carried out in a turbine by progressive addition of a coating agent.
20. Procédé selon la revendication 19, caractérisé en ce que l'agent d'enrobage est le saccharose, le lactose ou un mélange de saccharose et de lactose.20. The method of claim 19, characterized in that the coating agent is sucrose, lactose or a mixture of sucrose and lactose.
21. Procédé selon l'une quelconque des revendications 12 à 20, caractérisé en ce que lorsque l'étape d'enrobage est terminée, les granules obtenus sont séchés dans une étuve à une température comprise entre 30 et 40 °C pendant environ 12 heures.21. Method according to any one of claims 12 to 20, characterized in that when the coating step is completed, the granules obtained are dried in an oven at a temperature between 30 and 40 ° C for about 12 hours .
22. Procédé selon la revendication 21, caractérisé en ce que la teneur en eau des granules à la sortie de 1 ' étuve est de l'ordre de 1 % . 22. Method according to claim 21, characterized in that the water content of the granules at the outlet of the oven is of the order of 1%.
PCT/FR1998/001600 1997-07-22 1998-07-21 Homeopathic granules and method for making same WO1999004759A1 (en)

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WO2003019316A1 (en) * 2001-08-22 2003-03-06 Reyes Arellano J Cristobal Homeopathic stimulant composition for seed production
US20130008807A1 (en) * 2008-02-25 2013-01-10 Essentialife Homeopathics Drinking water formulation and method and article relating to same
WO2021152009A1 (en) * 2020-01-29 2021-08-05 Alterno Labs D.O.O. Granular pharmaceutical product for oral administration from a pre-filled straw and method of manufacturing such pharmaceutical product

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WO2003019316A1 (en) * 2001-08-22 2003-03-06 Reyes Arellano J Cristobal Homeopathic stimulant composition for seed production
US20130008807A1 (en) * 2008-02-25 2013-01-10 Essentialife Homeopathics Drinking water formulation and method and article relating to same
US9307783B2 (en) * 2008-02-25 2016-04-12 Essentialife Homeopathics Drinking water formulation and method and article relating to same
US9420821B2 (en) 2008-02-25 2016-08-23 Essentialife Homeopathics Drinking water formulation and method and article relating to same
US9648899B2 (en) 2008-02-25 2017-05-16 Essentialife Homeopathics Drinking water formulation and method and article relating to same
WO2021152009A1 (en) * 2020-01-29 2021-08-05 Alterno Labs D.O.O. Granular pharmaceutical product for oral administration from a pre-filled straw and method of manufacturing such pharmaceutical product

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FR2766367B1 (en) 2000-03-31
AU8865898A (en) 1999-02-16
FR2766367A1 (en) 1999-01-29

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