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WO2004040992A1 - Comestibles medicinaux - Google Patents

Comestibles medicinaux Download PDF

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Publication number
WO2004040992A1
WO2004040992A1 PCT/GB2003/004823 GB0304823W WO2004040992A1 WO 2004040992 A1 WO2004040992 A1 WO 2004040992A1 GB 0304823 W GB0304823 W GB 0304823W WO 2004040992 A1 WO2004040992 A1 WO 2004040992A1
Authority
WO
WIPO (PCT)
Prior art keywords
weight
binding
constitutes
substrate
composition
Prior art date
Application number
PCT/GB2003/004823
Other languages
English (en)
Inventor
Leigh Conyers
Original Assignee
Ssl International Plc
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 Ssl International Plc filed Critical Ssl International Plc
Priority to AU2003283533A priority Critical patent/AU2003283533A1/en
Publication of WO2004040992A1 publication Critical patent/WO2004040992A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
    • A23G3/00—Sweetmeats; Confectionery; Marzipan; Coated or filled products
    • A23G3/34—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof
    • A23G3/36—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof characterised by the composition containing organic or inorganic compounds
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
    • A23G3/00—Sweetmeats; Confectionery; Marzipan; Coated or filled products
    • A23G3/34—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof
    • A23G3/36—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof characterised by the composition containing organic or inorganic compounds
    • A23G3/364—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof characterised by the composition containing organic or inorganic compounds containing microorganisms or enzymes; containing paramedical or dietetical agents, e.g. vitamins
    • A23G3/368—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof characterised by the composition containing organic or inorganic compounds containing microorganisms or enzymes; containing paramedical or dietetical agents, e.g. vitamins containing vitamins, antibiotics
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
    • A23G3/00—Sweetmeats; Confectionery; Marzipan; Coated or filled products
    • A23G3/34—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof
    • A23G3/36—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof characterised by the composition containing organic or inorganic compounds
    • A23G3/42—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof characterised by the composition containing organic or inorganic compounds characterised by the carbohydrates used, e.g. polysaccharides
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23G—COCOA; COCOA PRODUCTS, e.g. CHOCOLATE; SUBSTITUTES FOR COCOA OR COCOA PRODUCTS; CONFECTIONERY; CHEWING GUM; ICE-CREAM; PREPARATION THEREOF
    • A23G3/00—Sweetmeats; Confectionery; Marzipan; Coated or filled products
    • A23G3/34—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof
    • A23G3/36—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof characterised by the composition containing organic or inorganic compounds
    • A23G3/44—Sweetmeats, confectionery or marzipan; Processes for the preparation thereof characterised by the composition containing organic or inorganic compounds containing peptides or proteins
    • 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

Definitions

  • the present invention relates to chewable comestibles containing pharmaceutically active substances.
  • EP 0 075 443B describes chewable confectionary products containing inorganic antacid compounds. With these products the chalky taste and texture associated with the previously available antacid products can be effectively masked. One such product is sold under the Registered Trade Mark Remegel.
  • EP 0 075 443B Whilst the products of EP 0 075 443B can provide a satisfactory means of delivery of inorganic antacids they may not be suitable for other pharmaceutically active substances, particularly organic substances, which are temperature sensitive or which incorporate or are coated with heat sensitive materials such as wax or microencapsulated polyglycerides and which may undergo undesired chemical change during the high temperature formulation stages.
  • the manufacturing process involves changes in the crystalline structure of the sugar during boiling, and again during the cooling of the boiled sugar. Since these crystalline changes are not always predictable there can be significant variation in the properties of the chewable product obtained. Accordingly, operation and control of the process can be complicated and expensive and may not be suitable for use with pharmaceutically active ingredients where stringent control of composition parameters and dosage is important.
  • An object of the present invention is to provide a manufacturing process for a chewable medicated comestible which can be readily economically performed in a controlled manner and is suitable for use with a wide range of pharmaceutically active ingredients.
  • a method for the manufacture of a chewable medicated comestible comprising mixing together water, a substrate comprising at least one particulate substance, and at least one pharmaceutically active ingredient, wherein the substrate has confectionary and binding properties whereby the mixing together of the substrate and the water produces a malleable solid confection which can be divided into discrete dosed units in the form of chewable tablets.
  • the resulting malleable product can be made without requiring application of elevated temperatures. This facilitates ready performance of the process in a reliably consistent and carefully controlled manner and without the need to subject incorporated pharmaceutically active ingredients to destructive processing conditions.
  • the process is therefore suitable for use with a wide range of pharmaceutically active ingredients and can be performed conveniently and economically.
  • the product produced with the method of the invention is malleable i.e. it has a pliable or plasticised gum consistency when chewed in the mouth rather than being of the nature of a hard brittle tablet. This provides an acceptable medium for delivery of the active ingredient particularly for administration of active ingredients to small children and those who have difficulty swallowing.
  • Chewing the product of the present invention gives rise to the potential for administration of active ingredients via the buccal cavity of the mouth. Generally, active ingredients administered in this way enjoy slower metabolic decomposition by the body.
  • the present invention provides enhanced opportunities for administration of pharmaceutically active ingredients.
  • the product can be formulated such that it can be consumed, and therefore the active ingredient can be administered, without need to take a drink at the same time.
  • the substrate may be any suitable pharmaceutically acceptable water soluble entity which does not chemically react with the said active ingredient(s).
  • the substrate comprises at least one particulate substance which provides or contributes to both the said confectionary properties and the said binding properties.
  • This particulate substrate may be a natural sugar compound or modified starch or a synthetic sugar substitute or even a non-sugar synthetic polymer.
  • this particulate substrate is a natural sugar, most preferably sucrose and/or glucose.
  • the particulate substrate preferably has a fme particle size, particularly a mean particle size ranging from 5 microns to 150 microns and most particularly a mean particle size of 10 microns to 80 microns.
  • a particularly preferred sugar is castor sugar or confectioner's sugar which is also known as icing sugar or powdered sugar. Where icing sugar is used it may be pure sugar or it may contain additives to prevent clumping such as starch.
  • the absorption of water by the substrate is facilitated such that binding to form a malleable consistency can occur without heating.
  • This may be at room temperature or slight heating may be applied if necessary. Where heat is applied the temperature does not exceed 80°C, at least not when the active ingredient(s) is added.
  • a chewable product can be obtained with - softer, more agreeable texture than a similar product made with boiled sugar syrup, yet which has a pleasant confection taste.
  • the substrate constitutes from 30 % to 70 % by weight of the total product composition and preferably from 50 % to 60 % by weight of the total product composition.
  • the substrate may incorporate a particulate substance which provides both the confectionary and binding properties.
  • the substrate may comprise one or more separate or supplementary confectionary or binding modifier substances.
  • At least one whipping agent may be added to the substrate.
  • the binding modifier may be added to the substrate as a foam which in particular is pre-blended with water and which in addition to at least one whipping agent may further comprise at least one starch component and/or at least one gelling agent.
  • the specific components of the binding modifier are dictated by the way in which the substrate is to be modified.
  • the whipping agent may be blended with water and the starch component to provide a material having a foam consistency which is then added to the substrate.
  • a gelling agent may be blended into the binding modifier foam referred to above before it is added to the substrate.
  • a suitable whipping agent may include any of the following either alone or in combination milk protein, egg albumin or modified soya protein.
  • the whipping agent is a commercially available milk protein.
  • the milk protein constitutes from 3 % to 10 % by weight of the binding modifier composition and preferably from 6 % to 7 % by weight of the binding modifier composition.
  • a suitable starch component may include any of the following either alone or in combination corn (or maize) starch, wheat starch or potato starch.
  • the starch component is the corn starch.
  • the starch component constitutes from 5 % to 15 % by weight of the binding modifier composition and preferably from 10 % to 12 % by weight of the binding modifier composition.
  • a suitable gelling agent may include any of the following either alone or in combination gelatine, pectin, agar agar or gellan gum.
  • the gelling agent is gelatine.
  • the gelling agent constitutes from 2 % to 15 % by weight of the binding modifier composition and preferably from 4 % to 5 % by weight of the binding modifier composition. Where pre-blended with water the water constitutes from 15 % to 30 % by weight of the binding modifier composition and preferably from 25 % to 30 % by weight of the binding modifier composition.
  • the binding modifier may comprise additional ingredients such as a sweetener in order to provide a pleasant confection taste.
  • Suitable sweeteners which may be used alone or in combination may include any of the following sorbitol, fme sugar, Aspartame, Acesulfame K or Saccharin.
  • the sweetener is sorbitol.
  • the sweetener constitutes from 0 to 60 % by weight of the binding modifier composition and preferably from 45 % to 55 % by weight of the binding modifier composition.
  • the binding modifier constitutes from 5 % to 20 % by weight of the total product composition and preferably from 8 % to 12 % by weight of the total product composition.
  • the at least one active ingredient may be any medicament or pharmaceutical compound. Suitable active ingredients which may be used alone or in combination, together with their utility, include; paracetamol (pain relief), antacids (indigestion), ibuprofen (pain relief, anti-inflammatory properties), diphenhydramine (antihistamine), meclozine (travel sickness), pseudoephedrine (decongestant), dexfromethorphan (cold relief), benzocaine (sore throat medication), lidocaine (anaesthetic), attapulgite (anti- diarrhoeal), loperamide (anti-diarrhoeal), mebendozole (parasite treatment), caffeine
  • the said active ingredient(s) constitute from ⁇ 1 % to 40 % by weight of the total product composition dependent on the required therapeutic dosage.
  • the said active ingredient(s) may be incorporated into the composition as solid particles, a dispersion, a liquid or any other suitable physical form.
  • the active ingredient(s) is incorporated into the composition as solid particles which may be coated with a taste masking agent such as wax or microencapsulated polyglycerides in order to minimise the unpalatable flavour of the said active ingredient(s).
  • a taste masking agent such as wax or microencapsulated polyglycerides
  • the manufacturing process described herein enables the incorporation of the said coated actives as elevated temperatures need not be employed by the process described herein.
  • the product of the present invention may also contain a supplementary binding agent to assist the binder in holding the components of the product together. Suitable agents, which may be used alone or in combination, include; polyvinylpyrrolidone, alginate, gum acacia, carrageenan.
  • the polymer may constitute from 0 % to 10 % of the total product composition.
  • the product may contain an edible fat.
  • the fat may be of vegetable or animal origin or may even be a synthetic fat substitute.
  • a suitable commercially available vegetable fat is Paramount C.
  • the fat constitutes from 0 % to 6 % of the total product composition.
  • the product of the present invention may further contain additional ingredients such as colourings, flavourings, suspending agent, and bulking agents.
  • Suitable bulking agents include calcium carbonate, lactose, talcum powder, microcrystalline cellulose, maltodextrim and other modified starches and are included in the composition up to 50 % by weight of the total product composition.
  • the process of the present invention comprises the preparation of the chewable comestible product described herein may comprise a series of stages.
  • the first stage of the process is the dry blending of an aliquot of the powdered substrate together with the said stabiliser.
  • the blending occurs as the said substrate and stabiliser are passed through a sieve before entering a Z-blade mixer, such a mixer is well known to those skilled in the art.
  • Sufficient water is then slowly added, with mixing, to this dry blend to form a granular mixture. It has been found that mixing the substrate mixture with water for about 5 minutes is sufficient time to furnish the desired granular mixture.
  • the remainder of the powdered sugar is then added to the said granular mixture wherein the ensuing mixture is mixed for about a further 5 minutes. It is preferable to incorporate the powdered substrate in more than one aliquot due to its bulk density.
  • the components of the binding modifier i.e. a milk protein, water, a gelling agent, a starch component and a sweetener are mixed together separately before being added to the substrate mixture at room temperature i.e. 20-25°C.
  • the resulting mixture is stirred at room temperature for about 5 minutes until a creamy mass ensues.
  • the colouring agents are added to the creamy mass and stirred for about 5 minutes or until a homogenous composition is observed.
  • the mouth feel agent is then added to the mixture.
  • the mouth feel agent i.e. fat or oil, it may be necessary to melt the said agent to liquefy the said agent in order that when the said agent is added to the product mixture homogeneity is achieved.
  • the bulking agent calcium carbonate is then stirred into the product mixture. Ensuring the product mixture is at a temperature below 40°C and preferably below 30°C, the at least one active ingredient is stirred into the mixture.
  • flavouring and any additional ingredients are added to the mixture and the resulting mixture is stirred for about a further 5 minutes.
  • the addition of water takes place after the addition of the binding modifier composition rather than in the middle of the powdered sugar mixing steps. That is, the binding modifier composition can be added to the dry blend of substrates and the mix stirred at room temperature for about 5 minutes. Sufficient water is then slowly added to this, with mixing, to form a smooth mixture. The remainder of the process is as described above.
  • the process of the present invention is a one pot process. Furthermore the lower process temperature gives rise to a cost saving since steam and heat generation are not required.
  • the product mixture is emptied into shallow trays and left until the desired firmness is achieved.
  • the firmness of the product can be determined using suitable testing equipment such as a penetrometer. Generally, conditioning occurs at between 10 and
  • the firmed product is removed from the trays and formed into discrete dosable units.
  • chewable tablets can be cut from the conditioned product or the firmed product can be extruded and discrete tablets can be punched from the extruded material.
  • Omeprazole is a substituted benzimidazole which is a gastric secretion inhibitor. Although it melts with decomposition at 155°C, it degrades rapidly in acidic media (sugars are mildly acidic).
  • Promethazine hydrochloride is phenothiazine derivative which is used as an antiemetic and an antihistamine. It is subject to oxidation on prolonged exposure to air.
  • Vitamin C is highly susceptible to oxidation at elevated temperatures.
  • Vitamin C This formulation results in chewable tablets.
  • the tablets were analysed following BP analytical methods for the determination of Vitamin C (BP 2002). This demonstrated that there had been no decomposition or loss of Vitamin C. However, when a solution of 2.5% Vitamin C in water containing 60% dextrose monohydrate was heated at 80°C for one hour, analysis for Vitamin C showed substantial degradation.

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  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Polymers & Plastics (AREA)
  • Inorganic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Food Science & Technology (AREA)
  • Nutrition Science (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Microbiology (AREA)
  • Zoology (AREA)
  • Physiology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Molecular Biology (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)
  • Medicinal Preparation (AREA)

Abstract

La présente invention a trait à un comestible médicinal à mâcher préparé par mélange d'un ingrédient pharmaceutiquement actif, de l'eau et un substrat. Le substrat présente des propriétés de confiserie et de liaison et le procédé de mélange produit une confiserie pouvant être divisée en doses unitaires sous la forme de comprimés à mâcher. Le substrat peut être un sucre spécial.
PCT/GB2003/004823 2002-11-06 2003-11-06 Comestibles medicinaux WO2004040992A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2003283533A AU2003283533A1 (en) 2002-11-06 2003-11-06 Medicated comestibles

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB0225827A GB0225827D0 (en) 2002-11-06 2002-11-06 Medicated comestibles
GB0225827.5 2002-11-06

Publications (1)

Publication Number Publication Date
WO2004040992A1 true WO2004040992A1 (fr) 2004-05-21

Family

ID=9947275

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB2003/004823 WO2004040992A1 (fr) 2002-11-06 2003-11-06 Comestibles medicinaux

Country Status (4)

Country Link
AU (1) AU2003283533A1 (fr)
GB (1) GB0225827D0 (fr)
TW (1) TW200500014A (fr)
WO (1) WO2004040992A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1946751A1 (fr) * 2007-01-22 2008-07-23 Documedica S.A. Gomme à mâcher à base de carraghénane
WO2011128625A3 (fr) * 2010-04-14 2012-05-18 Probio Asa Compositions pharmaceutiques à administration par voir orale, sécables

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2926121A (en) * 1957-03-20 1960-02-23 American Home Prod Therapeutic candy-like product and its preparation
FR2338651A1 (fr) * 1976-01-23 1977-08-19 Gen Foods France Procede de fabrication de bonbons a " pate molle "
FR2347892A2 (fr) * 1976-04-13 1977-11-10 Gen Foods France Procede de fabrication de bonbons a pate molle
US4778676A (en) * 1985-12-20 1988-10-18 Warner-Lambert Company Confectionery delivery system for actives
US5637313A (en) * 1994-12-16 1997-06-10 Watson Laboratories, Inc. Chewable dosage forms
WO1999062351A1 (fr) * 1998-06-05 1999-12-09 Fuisz Technologies Ltd. Formulation de confiserie a macher contenant des elements nutritifs
WO2000013522A1 (fr) * 1998-09-08 2000-03-16 Fuisz Technologies Ltd. Confiserie a base de nougat a macher contenant de la cafeine

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2926121A (en) * 1957-03-20 1960-02-23 American Home Prod Therapeutic candy-like product and its preparation
FR2338651A1 (fr) * 1976-01-23 1977-08-19 Gen Foods France Procede de fabrication de bonbons a " pate molle "
FR2347892A2 (fr) * 1976-04-13 1977-11-10 Gen Foods France Procede de fabrication de bonbons a pate molle
US4778676A (en) * 1985-12-20 1988-10-18 Warner-Lambert Company Confectionery delivery system for actives
US5637313A (en) * 1994-12-16 1997-06-10 Watson Laboratories, Inc. Chewable dosage forms
WO1999062351A1 (fr) * 1998-06-05 1999-12-09 Fuisz Technologies Ltd. Formulation de confiserie a macher contenant des elements nutritifs
WO2000013522A1 (fr) * 1998-09-08 2000-03-16 Fuisz Technologies Ltd. Confiserie a base de nougat a macher contenant de la cafeine

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1946751A1 (fr) * 2007-01-22 2008-07-23 Documedica S.A. Gomme à mâcher à base de carraghénane
WO2011128625A3 (fr) * 2010-04-14 2012-05-18 Probio Asa Compositions pharmaceutiques à administration par voir orale, sécables

Also Published As

Publication number Publication date
TW200500014A (en) 2005-01-01
AU2003283533A1 (en) 2004-06-07
GB0225827D0 (en) 2002-12-11

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