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
  • A61K9/14—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
  • A61K9/1629—Organic macromolecular compounds
  • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
• • A—HUMAN NECESSITIES
  • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
  • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
  • A23L29/00—Foods or foodstuffs containing additives; Preparation or treatment thereof
  • A23L29/20—Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents
  • A23L29/206—Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents of vegetable origin
  • A23L29/238—Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents of vegetable origin from seeds, e.g. locust bean gum or guar gum
• • A—HUMAN NECESSITIES
  • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
  • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
  • A23L29/00—Foods or foodstuffs containing additives; Preparation or treatment thereof
  • A23L29/20—Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents
  • A23L29/206—Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents of vegetable origin
  • A23L29/244—Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents of vegetable origin from corms, tubers or roots, e.g. glucomannan
• • A—HUMAN NECESSITIES
  • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
  • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
  • A23L29/00—Foods or foodstuffs containing additives; Preparation or treatment thereof
  • A23L29/20—Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents
  • A23L29/206—Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents of vegetable origin
  • A23L29/25—Exudates, e.g. gum arabic, gum acacia, gum karaya or tragacanth
• • A—HUMAN NECESSITIES
  • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
  • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
  • A23L29/00—Foods or foodstuffs containing additives; Preparation or treatment thereof
  • A23L29/20—Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents
  • A23L29/269—Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents of microbial origin, e.g. xanthan or dextran
  • A23L29/27—Xanthan not combined with other microbial gums
• • A—HUMAN NECESSITIES
  • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
  • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
  • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
  • A23L33/20—Reducing nutritive value; Dietetic products with reduced nutritive value
  • A23L33/21—Addition of substantially indigestible substances, e.g. dietary fibres
• • A—HUMAN NECESSITIES
  • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
  • A23P—SHAPING OR WORKING OF FOODSTUFFS, NOT FULLY COVERED BY A SINGLE OTHER SUBCLASS
  • A23P10/00—Shaping or working of foodstuffs characterised by the products
  • A23P10/20—Agglomerating; Granulating; Tabletting
  • A23P10/22—Agglomeration or granulation with pulverisation of solid particles, e.g. in a free-falling curtain
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
  • A61K36/18—Magnoliophyta (angiosperms)
  • A61K36/185—Magnoliopsida (dicotyledons)
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
  • A61K36/18—Magnoliophyta (angiosperms)
  • A61K36/185—Magnoliopsida (dicotyledons)
  • A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
  • A61K36/18—Magnoliophyta (angiosperms)
  • A61K36/185—Magnoliopsida (dicotyledons)
  • A61K36/577—Malvaceae (Mallow family)
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
  • A61K36/18—Magnoliophyta (angiosperms)
  • A61K36/185—Magnoliopsida (dicotyledons)
  • A61K36/68—Plantaginaceae (Plantain Family)
• • 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

Definitions

• the invention relates to a drinkable dietary fibre composition for mixing in cold water.
• dietary fibre is "macromolecules of vegetable origin characterized by the fact that they are not degraded by the human digestion enzymes". Dietary fibres may be divided into two main groups - the soluble and the insoluble ones. These are very different relating to physical-chemical and nutritional properties. The insoluble dietary fibres that for instance are found in coarse bread and bran possess a certain laxative effect and probably prevent colon cancer. It is relatively easy to increase the consumption of insoluble dietary fibres for instance by changing from fine to more coarse sorts of bread in the daily diet.
• the soluble dietary fibres also have these beneficial properties but are in addition assumed to have other beneficial therapeutical and preventive properties in relation to increased serum cholesterol, diabetes and obesity.
• An increase of one's consumption of soluble dietary fibres through dietary changes is no simple matter because die contents of normal foods are relatively low. For that reason a radical change of the diet is needed - something that notoriously is difficult to many people to go through with in practice.
• a dietary supplement based on soluble dietary fibre therefore is highly justified.
• Tablets are not suitable as pharmaceutical formulations because rather large amounts of soluble dietary fibre are to be consumed to achieve d e beneficial effects (10-30 gram per day according to J.W. Anderson et al.: “Dietary fibre. Chemistry, Physiology and Health Effects. ", 1990 Plenum Press, New York, p. 339-63). "Nutritional guidelines for health education in Germany” recommends 30 gram per day (Nutr. Today, 21, 21, 1986). In addition it is difficult to achieve a sufficient release of the fibres from a tablet.
• a drinkable dietary fibre composition d erefore is the preferred dietary supplement based on soluble dietary fibre. The fluid supply is also ensured which is necessary for the soluble dietary fibre to carry out their beneficial effect.
• a dietary supplement is to be of beneficial value it is not sufficient to have a composition which is optimal with respect to the composition of the dietary fibres.
• the product also has to be organoleptically attractive, as it is to be consumed daily for many years. Soluble dietary fibre present in this case the particular problem of a tendency to form highly viscous aqueous solutions.
• highly viscous drinks are regarded as unappetizing by many consumers. It is therefore important for the sake of the organoleptic impression to try to keep the viscosity low until the drink has been consumed.
• a dispersion where the still undissolved particles after dispersion in water distribute evenly in the liquid therefore is preferred from an organoleptic point of view.
• Water soluble hydrolysed starch oligosaccharide here is defined as a starch hydrolysed by d e application of either acids or enzymes.
• the film is applied by spraying of either starch oligosaccharide, polyglycose, or polymaltose dissolved in water.
• the usual method of applying a such film will be to apply a finely sprayed solution via a nozzle while e particles are kept in a steady motion, typical in a so called fluidized bed. It appears from the patent that this is the method of application thought of. To make ⁇ ese conventional methods of application work the liquid to be applied must have a low viscosity, otherwise a sufficient spray condition will not be obtained.
• US Patent 5,118,510 relates to a water dispersable fibre containing mixture consisting of among other ingredients a gel forming dietary fibre and an edible acid. The granulates formed are coated with a gel forming component.
• the mixture contains a mineral salt releasing a physiologically acceptable gas after administration of die dispersed fibre-mixture as well as a pharmaceutically active compound.
• US Patent 4,824,672 relates to an edible composition that contains a gel forming fibre able to lower serum cholesterol. The composition also contains a mineral salt which by dissolution in the stomach releases a gas (carbon dioxide).
• US Patent 4,551,331 relates to a dietary fibre composition which is easily dispersed in water. This effect is obtained by coating the dietary fibre with 0.05-20% of an emulsifier suitable for the use in foods. These emulsifiers normally will be of a fatty substance character Thus they will, when they are distributed over a large surface, have a tendency to go rancid.
• the present invention relates to dietary fibre particles of which a granulate is produced which in addition contains 1-10% of an easily soluble acid being acceptable in foods and 2-25 % of one or more thickening agents characterized by easily dissolving in cold water.
• Preferred types of dietary fibre are psyllium husk as well as combinations of psyllium husk wim one or more of the following: guar gum, glucomannan, karaya gum, locust bean gum, and xanman gum, where psyllium husk constitutes at least 40%.
• the most preferred acids are malic acid and citric acid.
• the most preferred thickening agents are guar gum, xanthan gum, locust bean gum, and pregelatinised starch.
• pregelatinised starch is a starch which has been boiled and subsequently dried. Therefore it is a starch which has not gone through a hydrolysis widi acid or enzymes.
• the granulation takes place during spraying with liquid.
• some of die powdery ingredients preferably the thickening agents, may be powdered on to the surface of the moist granules. By this powdering a quicker release of the diickening effect is also achieved. Subsequently the granules are dried, f.inst. in a fluidized bed.
• Vitamins and minerals can be added to me product.
• the organoleptical quality may be improved by the addition of suitable flavours and colorants. Preferred are fruit flavours like orange and odier citrus fruits as well as various tropical fruits like papaya.
• the dietary fibre particles become easily dispersable in water and a reduction of the sedimentation rate without an unacceptably high viscosity within normal drinking time is achieved.
• the fibre composition will give a drink very much like fresh fruit juice with a certain content of fruit pulp, in particular when suitable flavours and colorants have been added.
• the citric acid adds a fresh taste to the drink. This makes the fibre drink more organoleptically appealing than it has been possible to obtain through any of the so far described methods.
• the citric acid have a certain preservative effect. Through a number of combinations of different dietary fibre sources a synergistic effect of thickening may be obtained.
• psyllium husk Preferred are combinations of psyllium husk and one or more of the following: guar gum, glucomannan, karaya gum, locust bean gum, and xanthan gum. Most preferred are such combinations wherein psyllium husk constitutes 40-90% of the mixture.
• ti at a composition according to die invention is very suitable in the treatment of a number of diseases like diabetes, in particular NIDDM (type II), conditions of hyperlipidaemia, preferably caused by a too high serum concentration of LDL cholesterol, as well as in the treatment of overweight, in particular through regulation of the appetite of persons suffering from overweight.
• diseases like diabetes, in particular NIDDM (type II)
• conditions of hyperlipidaemia preferably caused by a too high serum concentration of LDL cholesterol
• overweight in particular through regulation of the appetite of persons suffering from overweight.
• aqueous solution of the following composition is prepared: beta-carotene 1 % (CWD, Hoffmann La Roche) 0.360 kg aspartame 0.280 kg demineralized water, 45 deg. C 4.500 litre
• the aqueous solution is sprayed onto the powder mixture in the intensive mixer in a fine mist while intensively mixing the powder mixture.
• the resulting granulate is subsequently dried in a fluidized bed of conventional type.
• the aqueous solution is sprayed onto the powder mixture in the intensive mixer in a fine mist while intensively mixing the powder mixture.
• the resulting granulate is subsequently dried in a fluidized bed of conventional type.
• beta-carotene 1 % (CWD, Hoffmann La Roche) 0.360 kg aspartame 0.280 kg demineralized water, 45 deg. C 4.500 litre
• the aqueous solution is sprayed onto the powder mixture in the intensive mixer in a fine mist while intensively mixing the powder mixture.
• the aqueous solution is sprayed onto the powder mixture in the intensive mixer in a fine mist while intensively mixing the powder mixture.
• the resulting granulate is subsequently dried in a fluidized bed of conventional type.
• beta-carotene 1 % (CWD, Hoffmann La Roche) 0.360 kg aspartame 0.280 kg demineralized water, 45 deg. C 4.500 litre
• the aqueous solution is sprayed onto die powder mixture in die intensive mixer in a fine mist while intensively mixing the powder mixture.
• the resulting granulate is subsequently dried in a fluidized bed of conventional type.
• the aqueous solution is sprayed onto the powder mixture in the intensive mixer in a fine mist while intensively mixing the powder mixture.
• composition corresponding to 4.4 gram of soluble fibre is suspended in 150 ml of tap water having a temperature of appr. 12 deg. C. Suspension is carried out for 30 seconds. Subsequently the suspension is characterised with respect to the following parameters: 1) Dispersability and wettability of the granulate.
• the viscosity is measured after stirring at 2, 5, 10 and 20 minutes.
• wetted drinkable dietary fibre product 6.2 g good easily more than 5 min. according to example 3 wetted drinkable dietary fibre product 6.2 g good, easily more than 5 min. according to example 4 wetted drinkable dietary fibre product 6.2 g good, easily more than 5 min. according to example 5 wetted drinkable dietary fibre product 6.2 g good, easily more than 5 min. according to example 6 wetted
• Table 2 Change in viscosity as a function of time for a number of concentrated sources of soluble dietary fibre, dispersed in water. It appears from table 1 and 2 that die dietary fibre compositions prepared according to die invention fulfils the demands of good dispersability, slow precipitation and sufficiently slow increase in viscosity after dispersion in water.
• Criteria of inclusion Age 20-70 years, sex: Male or Female, total cholesterol >7.0 mmol/1, serum ⁇ -iglycerides less than 5 mmol/1.
• Criteria of exclusion Possible secondary hyperlipidaemia, severe overweight, (BMI more than 32.5), alcohol consumption more man 5 drinks per day, use of drugs, interfering with serum cholesterol, suspicion of insufficient compliance, other serious diseases.
• Treatment The first 4 weeks served as a run-in period. The purpose partly was to give a more reliable determination of the initial test values and partly to compensate for the well known fact diat persons often change behaviour when entering into a clinical investigation.
• the treatment had a duration of two periods of 4 weeks each.
• Patients 30 patients were selected according to die following criteria of inclusion and exclusion and randomised into two groups of the same size. Criteria of inclusion: 18 - 75 years of age, sex: male and female, non-insulin- dependent diabetics under treatment with diet and tablets.
• Criteria of exclusion Possible secondary hyperlipidaemia, alcohol consumption exceeding 5 drinks a day, use of drugs which may Interfere with the monitored parameters, suspicion of insufficient compliance, liver-diseases, pregnancy, intolerance to aspartame, creatinine more than 0.120 mmol/1 or albuminuria, psychotic subjects or subjects suffering from dementia, rise in blood-pressure demanding medical treatment during the investigation.
• Treatment The two first weeks served as a run-in period. The purpose partly was to give a more reliable determination of the initial test values and partly to compensate for the well known fact that persons often change their behaviour when entering into a clinical investigation. After the run-in period a blood sample was taken and blood pressure and body weight were measured.
• blood samples for the analysis of serum cholesterol, blood sugar, HbAlc, serum calcium, triglycerides, total cholesterol, HDL-cholesterol and LDL-cholesterol were taken.
• Patients 30 patients were selected according to the following criteria of inclusion and exclusion and randomised into two groups of the same size. Criteria of inclusion: 18 - 75 years of age, sex: male and female, non-insulin- dependent diabetics under treatment with diet and tablets.
• Criteria of exclusion Possible secondary hyperlipidaemia, alcohol consumption exceeding 5 drinks a day, use of drugs which may interfere with the monitored parameters, suspicion of insufficient compliance, liver-diseases, pregnancy, intolerance to aspartame, creatinine more than 0.120 mmol/1 or albuminuria, psychotic subjects or subjects suffering from dementia, rise in blood-pressure demanding medical treatment during the investigation.
• Treatment The two first weeks served as a run-in period. The purpose partly was to give a more reliable determination of die initial test values and partly to compensate for the well known fact that persons often change their behaviour when entering into a clinical investigation. After the run-in period a blood sample was taken and blood pressure and body weight were measured.

Landscapes

• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Chemical & Material Sciences (AREA)
• Natural Medicines & Medicinal Plants (AREA)
• Engineering & Computer Science (AREA)
• Pharmacology & Pharmacy (AREA)
• Food Science & Technology (AREA)
• Polymers & Plastics (AREA)
• Medicinal Chemistry (AREA)
• Veterinary Medicine (AREA)
• Public Health (AREA)
• Epidemiology (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Nutrition Science (AREA)
• Mycology (AREA)
• Botany (AREA)
• Microbiology (AREA)
• Medical Informatics (AREA)
• Biotechnology (AREA)
• Alternative & Traditional Medicine (AREA)
• Dispersion Chemistry (AREA)
• Bioinformatics & Cheminformatics (AREA)
• Biophysics (AREA)
• Molecular Biology (AREA)
• Coloring Foods And Improving Nutritive Qualities (AREA)
• Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
• Medicines Containing Plant Substances (AREA)

Applications Claiming Priority (3)

Publications (1)

Family

ID=8154412

Family Applications (1)

Country Status (5)

Families Citing this family (7)

Family Cites Families (2)

• 1993
  • 1993-09-02 DK DK9300398U patent/DK9300398U3/da not_active IP Right Cessation
• 1994
  • 1994-06-24 AU AU71215/94A patent/AU7121594A/en not_active Abandoned
  • 1994-06-24 EP EP94920413A patent/EP0802737A1/de not_active Withdrawn
  • 1994-06-24 WO PCT/DK1994/000258 patent/WO1995006417A1/en not_active Ceased
  • 1994-06-24 CA CA002170864A patent/CA2170864A1/en not_active Abandoned

Non-Patent Citations (1)

Also Published As

Similar Documents

Legal Events