WO2017076711A1 - Composition solide lixiviable et son procédé de fabrication - Google Patents

Composition solide lixiviable et son procédé de fabrication Download PDF

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Publication number
WO2017076711A1
WO2017076711A1 PCT/EP2016/075756 EP2016075756W WO2017076711A1 WO 2017076711 A1 WO2017076711 A1 WO 2017076711A1 EP 2016075756 W EP2016075756 W EP 2016075756W WO 2017076711 A1 WO2017076711 A1 WO 2017076711A1
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WO
WIPO (PCT)
Prior art keywords
composition
water
μηη
nutrient
soluble polymer
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Application number
PCT/EP2016/075756
Other languages
English (en)
Inventor
Manoj Vilas Dagaonkar
Vetri Kumaran
Satyajit Samadder
Mahesh Subhash Tendulkar
Venkataraghavan Rajanarayana
Original Assignee
Unilever N.V.
Unilever Plc
Conopco, Inc., D/B/A Unilever
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Application filed by Unilever N.V., Unilever Plc, Conopco, Inc., D/B/A Unilever filed Critical Unilever N.V.
Publication of WO2017076711A1 publication Critical patent/WO2017076711A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/15—Vitamins
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L2/00—Non-alcoholic beverages; Dry compositions or concentrates therefor; Their preparation
    • A23L2/385—Concentrates of non-alcoholic beverages
    • A23L2/39—Dry compositions
    • A23L2/395—Dry compositions in a particular shape or form
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L2/00—Non-alcoholic beverages; Dry compositions or concentrates therefor; Their preparation
    • A23L2/52—Adding ingredients
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/16—Inorganic salts, minerals or trace elements
    • C—CHEMISTRY; METALLURGY
    • C02—TREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02F—TREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE
    • C02F1/00—Treatment of water, waste water, or sewage
    • C02F1/68—Treatment of water, waste water, or sewage by addition of specified substances, e.g. trace elements, for ameliorating potable water

Definitions

  • the present invention relates to a leachable solid composition and a process of manufacture thereof.
  • the invention more particularly relates to a fortification tablet that can be used in a water dispensing device to enable fortification of water.
  • RDA Recommended Dietary Allowance
  • water constitutes approximately 70 percent of the body weight and is a crucial constituent of daily diet. On an average, an adult consumes about 1 to 3 litres of water per day driven by thirst. Thus, providing vitamins and minerals through water as a vehicle for fortification is beneficial.
  • Binders are added to tablet formulations to add cohesiveness to powders and provide the necessary bonding to form a compact tablet mass.
  • Dextrose C6H1206
  • corn sugar is a common binder used in the pharmaceutical industry.
  • the micronutrient tablet can be produced in small scale in a single manual hydraulic press by weighing and compacting a fixed mass of powder mixture, but this is not practical for a commercial exploitation.
  • various technical challenges are encountered such as moisture pick-up by raw materials, segregation of ingredients due to difference in their particle size and bulk density, difficulty in maintaining uniform compaction properties for all tablets for achieving uniform life of each tablet and moisture wicking in tablet.
  • the tablets produced result in large variability with respect to micronutrient dosing, lack of mechanical integrity during usage.
  • EP2733122 relates to a dietary supplement dosing device capable of releasing predetermined amounts of dietary supplement to water, from a source of dietary supplement provided either in the solid or liquid form, to enable dosing controlled amounts of the dietary supplement of water upon being dispensed for consumption.
  • WO 2014/135332 relates to a cartridge for use in a water purification devices to release consistent amounts of benefit agent to water from a solid source of the benefit agent housed in the cartridge.
  • JP2013179905 (Asahi Food & Healthcare Ltd) discloses a vitamin mineral containing tablet which can suppress occurrence of browning and black pits of a tablet by highly containing vitamin C and iron and by being compression formed to be processed into a tablet even when vitamin C and iron are forcibly brought into contact with each other under minute environment, and discloses its manufacturing method.
  • SOLUTION In a vitamin mineral containing tablet contains at least vitamin C and iron. In the vitamin mineral containing tablet, the content of the iron is 1 mass percent or more per one tablet. A difference between color of a tablet surface before storage at 60 degrees centigrade and relative humidity of 0 percent for three days and color after storage for three days at 60 degrees centigrade and relative humidity of 0 percent is 12.0 or less.
  • micronutrient fortification tablet that gives uniform delivery of micronutrients per litre of water in a controlled and sustained manner when in contact with a flowing stream of water.
  • micronutrient fortification tablet which is stable and has a good shelf life for performing in a water dispensing device.
  • a leachable solid composition comprising a nutrient active from 5% to 80% by weight of the composition and having particle size from of 80 ⁇ to 600 ⁇ ; a binder comprising a water soluble polymer from 30% to 85 % wt and a hydrophobic dispersible compound from 10% to 50 %wt based on weight of the composition; wherein the nutrient active is substantially free of particles having a size of less than 80 ⁇ .
  • a process for making a composition of the first aspect of the invention comprising steps of providing a nutrient premix having size from 80-600 ⁇ ; mixing nutrient premix and a water soluble polymer to form a mix, and compacting the mix to form tablets; wherein, the process is carried out at relative humidity up to 50% and temperature between 20-27°C.
  • a composition of the first aspect of the invention for fortification of water.
  • a process of delivering a nutrient active in drinking water comprising steps of: placing the leachable solid composition of the first aspect of the invention at a designated place in a water dispensing device and allowing water to dispense through the device to collect water with the nutrient active.
  • the present invention provides a leachable solid composition comprising a nutrient active and a binder comprising a water soluble polymer from and a hydrophobic dispersible compound.
  • the invention also provides a process of manufacture of the leachable solid composition by optimizing the size of the nutrient active between 80 to 600 ⁇ and maintaining the parameters of relative humidity up to 50% and temperature from 20-27°C.
  • the present inventors have surprisingly identified water soluble polymers as potential binders which are also permitted food additives for use in drinking water and used the same as a micronutrient carrier in the formulation.
  • Another surprising result was ability to replace dextrose (a common micronutrient mix carrier) with water soluble polymer which resulted in reduced moisture pick up and also elimination of lubricant.
  • the inventors unexpectedly found that by identifying the right particle size of the micronutrient premix in the range of 80-600 ⁇ and selecting right processing environment conditions by maintaining the humidity up to 50% and temperature from 20- 27°C they are able to obtain fortification tablets that were able to deliver micronutrients in the range of 10-20% RDA per litre of water in a controlled and sustained manner when in contact with a flowing stream of water and the life of each solid composition, weighing 1 g, made under the conditions listed above was found to be approximately enough to fortify 80-100 Litres of dispensed water.
  • compositions of the present invention are preferred for use in water dispensing device, and more particularly preferred for use in fortification of water.
  • the leachable solid composition is provided in the solid form and is preferably in the form of a tablet.
  • the tablet is preferably circular, square, rectangular, hexagon or oval in shape.
  • Nutrient active The word nutrient active is used throughout the text to basically refer to vitamin, mineral, electrolyte, or any other nutrient. Nutrient active includes anything which is capable of providing nourishment to the intended consumer.
  • the nutrient active of the present invention nutrient active varies from 5% to 80% by weight of the composition, preferably it varies from 10% to 60% and more preferably varies from 10% to 30%.
  • the particle size of the nutrient active of the present invention varies from of 80 ⁇ to 600 ⁇ , preferably it varies from 100 to 500 ⁇ and more preferably varies from 200 to 500 m. It is highly preferable that the nutrient active is substantially free of particles having size less than 80 ⁇ , more preferably less than 75 ⁇ and most preferably less than 70 ⁇ .
  • the nutrient active is substantially free of particles having a size less than 80 ⁇ and more preferably 'essentially free' of particles having size less than 75 ⁇ , and most preferably 'completely free' of particles having size less than 70 ⁇ .
  • the term 'substantially free' means that less than 1 wt% of the nutrient active has a size less than the indicated size.
  • 'essentially free' means that less than 0.01 wt% and 'completely free' means less than 2.0x10 "6 wt% of the nutrient active have a size of less than the indicated size.
  • the amount of particles having a size less than 80 ⁇ ranges from 0 to 5 wt%, more preferably from 0.0001 to 5 wt% and most preferably from 0.01 to 3 wt% based on the weight of the composition. It is preferred that the nutrient active comprises at most 2 wt% of particles having size less than 80 ⁇ , more preferably at most 1 wt%, even more preferably at most 0.5 wt%, based on the weight of the nutrient active.
  • composition of the nutrient active premix according to the invention may be selected from one or more of a vitamin, mineral, electrolyte, or a nutrient or a mixture thereof.
  • the nutrient active may be sourced from either a chemical or natural source.
  • the leachable solid composition may have a nutrient active which is a mineral selected from the group of calcium, iron, zinc, copper, manganese, iodine, magnesium, and mixtures thereof.
  • the leachable solid composition of the present invention typically contain at least about 1 % of the mineral compound, or an amount sufficient to deliver about 5% to about 100% recommended daily allowance (RDA) of the mineral (based per serving).
  • RDA recommended daily allowance
  • the compositions contain sufficient amounts of mineral compound to deliver from about 5% to about 50% RDA, and most preferably about 5% to about 30% RDA of the added mineral (based per serving).
  • Iron compounds which may be dosed include a water-soluble iron compound, a water-dispersible particulate iron compound, or mixtures thereof.
  • the iron compound of the present invention is preferably selected from a complexed iron compound, a chelated iron compound, an encapsulated iron compound, or mixtures thereof. Highly bioavailable iron compound is preferably chosen to provide maximum health benefits.
  • Iron-fortified water usually suffers from a metallic taste / aftertaste.
  • the elimination of the metallic taste can be achieved by encapsulating the iron compound.
  • the metallic taste can also be eliminated by binding the iron into a stable compound by complexing or chelating with a suitable ligand that does not permit the iron to be freely associated in water.
  • Preferred iron compound forms also include encapsulates and complexes that preferably have a dispersed particle size in the water that is small enough to be barely visible in solution.
  • the dispersed particle size is about 100 nanometers (nm) or less, and more preferably about 80 nm or less.
  • Ferrous iron is typically better utilized by the body than ferric iron.
  • Ferrous amino acid chelates are particularly suitable as highly bioavailable forms when the ligand to metal ratio is at least 2:1.
  • Highly bioavailable food grade ferrous salts that can be used in the present invention include ferrous sulphate, ferrous fumarate, ferrous succinate, ferrous gluconate, ferrous lactate, ferrous tartarate, ferrous citrate, ferrous amino acid chelates, as well as mixtures of these ferrous salts.
  • Certain ferric salts can also provide a highly bioavailable source of iron.
  • Highly bioavailable food grade ferric salts are ferric saccharate, ferric ammonium citrate, ferric citrate, ferric sulfate, ferric chloride, as well as mixtures of these ferric salts.
  • Other bio-available sources of iron particularly suitable for fortifying water of the present invention include certain iron-sugar-carboxylate complexes. In these iron-sugar- carboxylate complexes, the carboxylate provides the counter ion for the ferrous (preferred) or ferric iron.
  • the USRDA for iron generally ranges from 10 mg for female/ male from ages 6-8 years and to 18 mg for female and 8 mg for male for ages from 19-50 years.
  • the iron fortified water prepared using the device of the present invention typically contains at least about 1 ppm of iron compound, sufficient to deliver about 10% of USRDA of iron per litre of water to account for iron that is available from other dietary sources, assuming a reasonably balanced diet is available.
  • a preferred iron compound can be selected such that it eliminates the metallic taste and aftertaste that is typical of iron-containing fortified water. The elimination of the metallic taste can be achieved by encapsulating the iron compound. The metallic taste can also be eliminated by binding the iron into a stable compound by complexing or chelating with a suitable ligand that does not permit the iron to be freely associated in the water.
  • Preferred iron compound forms also include encapsulates and complexes that have a dispersed particle size in the water that is small enough to be barely visible in solution.
  • the dispersed particle size is in the range of 100 nanometers (nm) to 500 nanometers, and more preferably about 200 to 400 nm.
  • Particularly preferred iron sources are inert and/or stabilized, micron-sized iron complexed with (a) pyrophosphate/orthophosphate as in SunActive iron (Taiyo Company, Japan) and (b) EDTA as in Na Fe(lll)EDTA .
  • a preferred Zinc compound includes Zinc Gluconate, Zinc Sulfate, Zinc Citrate, Zinc Lactate and any encapsulated form of Zinc such as Zinc bis-glycinate.
  • Other Minerals include Zinc Gluconate, Zinc Sulfate, Zinc Citrate, Zinc Lactate and any encapsulated form of Zinc such as Zinc bis-glycinate.
  • a nutrient active may be selected from nutritionally supplemental amounts of other minerals for incorporation into the water composition include, but are not limited to, water soluble mineral salts such as calcium, magnesium, manganese, iodine and copper. Vitamin nutrient active
  • the water compositions of the present invention preferably may also contain nutrients, for example vitamin C, vitamin E, vitamin A, niacin, vitamin B6, vitamin B2, vitamin D2, vitamin B12, folate, zinc, electrolytes such as salts of sodium, potassium or magnesium and mixtures thereof.
  • nutrients for example vitamin C, vitamin E, vitamin A, niacin, vitamin B6, vitamin B2, vitamin D2, vitamin B12, folate, zinc, electrolytes such as salts of sodium, potassium or magnesium and mixtures thereof.
  • the typical values for most healthy adults are generally: vitamin C (60 mg), vitamin A (2000 lU/day) vitamin B2 (1.7 mg), niacin (20 mg), vitamin B6 (2.0 mg), folic acid (0.2 mg/day), vitamin D2 (400 lU/day), vitamin B12 (0.001 mg/day) magnesium (300 mg), zinc (1 1 mg/day) and vitamin E (30 international units).
  • the adequate intake value of sodium is generally 1.5 g and for potassium is generally 4.7 g.
  • Nutritionally supplemental amounts of other vitamins for incorporation into the water include, but are not limited to, vitamins B6 and B12, folate, niacin and vitamins D2 (ergocalciferol) and E.
  • Preferred salt for vitamin B12 is 5,6 DNB cyanocobalamide and for folate is folic acid.
  • Vitamin C According to a highly preferred aspect of the present invention, a natural source of vitamin and mineral is Phyllanthus emblica (Amla) extract.
  • Amla primarily includes tannins, bioflavonoids, carotenoids, alkaloids, and phenolic compounds, amino acids and carbohydrates which have extraordinary longevity and rejuvenating properties.
  • Synthetic vitamin C does not provide vital nutrients such as rutin and bioflavonoids.
  • Amla is valued for its unique tannins and flavonoids, which exhibit very powerful antioxidant properties. Amla is considered as a more potent antioxidant than Vitamin C.
  • Vitamin C in Amla accounts for -45-70 percent of the antioxidant activity. There are no RDA levels for Amla.
  • commercially available sources of vitamin C may be used herein. Encapsulated ascorbic acid and edible salts of ascorbic acid may also be used.
  • Commercially available vitamin A sources may also be incorporated into the water composition.
  • Vitamin A can be provided, for example, as vitamin A palmitate (retinol palmitate), vitamin A acetate and/or as beta-carotene. It can be as an oil, as a beadlet or may be encapsulated. As used herein, “vitamin A” includes vitamin A, ⁇ -carotene, retinol palmitate and retinol acetate. Commercially available sources of vitamin B2 (riboflavin) can be used herein.
  • the present inventors have determined that it is beneficial to dose it in a range between 2 to 50 ppm and preferably between 5 and 10 ppm since at concentrations more than 10 ppm, the fortified water is likely to get slightly colored. It is preferred that we dose the vitamins and minerals at 10-20% of the recommended daily allowance (RDA) per liter of water.
  • RDA recommended daily allowance
  • the dosage of these fortifcants is selected such that it does not impart any negative organoleptic property to the water.
  • vitamins, minerals and electrolytes can also be incorporated into the water depending on the nutritional needs of the consumers to which the water product is directed.
  • Electrolytes Sodium salts can be selected from sodium chloride, sodium ascorbate, sodium citrate, sodium ferric pyrophosphate, sodium gluconate, sodium phosphate, sodium pyrophosphate or mixtures thereof.
  • Potassium salts can be selected from potassium chloride, potassium gluconate, potassium glycerophosphate, potassium iodide or mixtures thereof.
  • Magnesium salts can be selected from magnesium gluconate, magnesium phosphate, magnesium sulfate or mixtures thereof.
  • Zinc salts can be selected from zinc oxide, zinc gluconate, zinc sulfate or mixtures thereof.
  • the water prepared using the device of the invention contains 10-20% of the USRDA litre or adequate intake value for these vitamins, minerals or electrolytes.
  • composition of the present invention may optionally include a sweetener.
  • a sweetener Such sweetening agents are added to the water to mask a metallic taste or after-taste caused by the minerals or vitamins.
  • Suitable particulate sugars can be granulated or powdered, and can include sucrose, fructose, dextrose, maltose, corn maltodextrin, lactose and mixtures thereof. Most preferred is sucrose.
  • Artificial sweeteners may also be used. Often gums, pectins and other thickeners are used with artificial sweeteners. Mixtures of sugars and artificial sweeteners may also be used.
  • the nutrient active can optionally include a flavouring agent.
  • the flavouring agent may be of any natural or synthetically prepared fruit or botanical flavours or with mixtures of botanical flavours and fruit juice blends.
  • Suitable natural or artificial fruit flavours include lemon, orange, grapefruit, strawberry, banana, pear, kiwi, grape, apple, mango, pineapple, passion fruit, raspberry and mixtures thereof.
  • Suitable botanical flavours include Jamaica, marigold, chrysanthemum, tea, chamomile, ginger, valerian, yohimbe, hops, eriodictyon, ginseng, bilberry, rice, red wine, mango, peony, lemon lavender, walnut, gentiam, cinnamon, aloe, peppermint and mixtures thereof.
  • flavouring agent When present the flavouring agent is present from about 0.01 % to about 10%, preferably from about 0.02 % to 8 %.
  • the actual amount of flavouring agent will depend on the type of flavouring agent used and the amount of flavour desired in the fortified water. Most preferred flavouring agent is peppermint flavour.
  • Binder is peppermint flavour.
  • the food concentrate of the invention comprises a binder, for example to maintain the desired texture and/or shape of the composition.
  • the binder comprises a water soluble polymer and a hydrophobic dispersible compound.
  • the binder preferably comprises a water soluble polymer from 30% to 85 %wt and a hydrophobic dispersible compound from 10% to 50 %wt.
  • the binder comprises one selected from the group consisting of fat, polysaccharide, sugar, and mixtures thereof.
  • Polysaccharide preferably comprises starch, gums or mixtures thereof.
  • the composition is substantially free of monosaccharide binders.
  • the composition is substantially free of dextrose used as a binding agent. Absence of dextrose is a benefit for achieving advantages such as 'less soggy' tablet and functioning at high relative humidity which translates into a better life of the solid composition. It was a surprising finding of the present invention that by making the composition free of dextrose and replacing it with a water soluble polymer resolved the issues related to moisture pick up, non-uniformity of tablet compaction, moisture wicking in tablet and also resulted in elimination of a lubricant.
  • the composition of the present invention comprises a water soluble polymer.
  • the water soluble polymer preferably ranges from 10% to 85%wt, more preferably from 30% to 70%wt and most preferably from 35 to 55% wt based on the weight of the composition.
  • the wherein the water soluble polymer of the composition could be a natural or a synthetic polymer.
  • the water soluble polymer when it is a natural polymer, it could be selected from the group of Gum Arabic, Carrageenan, Guar gum, Xanthan gum, the likes and combinations thereof.
  • the water soluble polymer when it is a synthetic polymer, it could be selected from the group of Polyvinyl pyrrolidine, Polyvinyl acetate, Carboxymethyl cellulose, hydroxypropyl methyl cellulose, the likes and combinations thereof.
  • the %weight ratio of the nutrient active to the water soluble polymer is from 1 :0.125 to 1 :17, more preferably from 1 :0.5 to 1 :10 and most preferably from 1 :1 to 1 :5.
  • the composition of the present invention comprises a hydrophobic dispersible compound.
  • the hydrophobic dispersible compound preferably ranges from 10% to 50%, more preferably from 15% to 40% and most preferably from 20% to 30% based on the weight of the composition.
  • the hydrophobic dispersible compound is an encapsulated metal salt or an encapsulated insoluble inorganic salt.
  • the metal salt is selected from the group of micronized ferric pyrophosphate coated with enzymatically hydrolyzed lecithin, micronized zinc oxide coated with enzymatically hydrolyzed lecithin, hydrolyzed lecithin, food-grade phospholipids, cyclodextrins, the likes and combinations thereof.
  • the insoluble inorganic salt is selected from the group of calcium carbonate, calcium phosphate, calcium sulphate, magnesium carbonate, the likes and combinations thereof.
  • the %weight ratio of the water soluble polymer to the hydrophobic dispersible compound is from 1 :1 to 8:1 , more preferably from 3:2 to 4:1 and most preferably from 2:1 to 3:1 .
  • the present invention provides a process for making a leachable solid composition comprising steps of: (a) providing a nutrient premix having size from 80-600 ⁇ ; (b) mixing nutrient premix and a water soluble polymer to form a mix; and (c) compacting the mix to form tablets.
  • step (b) is Spheronised to obtain pellets. It is also preferred that the pellets are dried before step (c).
  • Particle size is defined as the diameter of the individual granules in the mix assuming spherical particles. It's measured by passing the mix through sieves of known mesh number.
  • the hydrophobic dispersible compound is added at step (b) along with the nutrient active and water soluble polymer to form a mix.
  • Method of selecting particles between 80 ⁇ to 600 ⁇ - A sieve shaker with the standard 200 mm diameter sieve plates was used for this operation. The top most sieve was of mesh no. 30 (i.e. 30 openings per sq. inch) which corresponds to sieve openings of 595 ⁇ . Below that a sieve plate of mesh no. 200 (i.e. 200 openings per sq. inch) was attached corresponding to sieve openings of 80 ⁇ , below that a pan was attached to collect the fines. The set of two sieve plates and a pan was fixed on the sieve shaker.
  • the nutrient mix was added on the top most sieve plate and closed with a lid.
  • the sieve shaker was switched on and operated for a duration of 10 min.
  • granules of particle size more than 600 ⁇ were retained above mesh no. 30.
  • Granules of size between 600 ⁇ and 80 ⁇ were retained above mesh no. 200.
  • Finer granules of size below 80 microns were collected in the pan placed below the sieve plates. The particles retained on the 200 mesh were then used for tablet making (ASTM C136).
  • Control of relative humidity is required during the manufacture of the said leachable solid composition as moisture in the manufacturing area will interact with the soluble components in the composition and decrease the activity/potency of the components. Additionally, temperature will aggravate the interaction of moisture with the ingredients. Moisture pick-up by the powder mix will jam the tableting machine, create noise and excessive vibrations. It is preferred that the process is carried out at relative humidity which is at most 50%, more preferably at most 45% and most preferably at most 40%.
  • the process is carried out at temperature from 20-27°C, more preferably at 20-26°C from and most preferably at 23-25°C.
  • the present invention provides a process of delivering a nutrient active in drinking water comprising steps of placing the leachable solid composition of any of the preceding claims at a designated place in a water dispensing device; and allowing water to dispense through the device to collect water with the nutrient active. It is preferred to use the composition of the present invention for fortification of water. It is also preferred to use the composition of the present invention for delivering the RDA levels of nutrient actives.
  • the composition of the present invention is substantially free of lubricants.
  • the lubricants include regular compounds used in pharmaceutical tableting operations such as Magnesium Stearate, Talc, etc. Lubricants prevent jamming of the tableting machines and help in easy ejection of the tablet from the die without any breakage. Lubricants also substantially reduce the mechanical load on the tablet press.
  • the present invention allows the formulation to be substantially free of the lubricants as the lubricant particles impart turbidity to water and are a drawback from consumer acceptability view-point.
  • the current solid leachable composition does not need lubricants as the smooth running of tableting machine is achieved by selection of particle size of ingredients and control of environmental conditions such as relative humidity, temperature.
  • Nutrient actives and Gum Arabic (binder) were weighed and blended in a blender according to the proportions shown in Table 1.
  • the mix (of nutrient active premix and Gum Arabic (binder)) was manually passed through a sieve to break/remove lumps, if any. These were then mixed at 20 rpm for 30 minutes in a Ribbon Blender. This mixture is fed to a Rotary Tablet Press where it gets compacted into round, flat tablets of 3-6 kg/cm 2 hardness at 16 rpm. The tablets were then packed in moisture-barrier laminates and secondary packing. The average weight of the prepared dietary supplement tablet was 1.5 g. All operations were carried out in controlled atmosphere rooms maintained at -25 deg. C and ⁇ 45% RH through HVAC systems.
  • a sieve shaker with the standard 200 mm diameter sieve plates was used for this operation.
  • the top most sieve was of mesh no. 30 (i.e. 30 openings per sq. inch) which corresponds to sieve openings of 595 ⁇ .
  • a sieve plate of mesh no. 200 i.e. 200 openings per sq. inch
  • the set of two sieve plates and a pan was fixed on the sieve shaker.
  • the nutrient mix was added on the top most sieve plate and closed with a lid.
  • the sieve shaker was switched on and operated for a duration of 10 min.
  • EXAMPLE 2 DOSING STUDIES A container of the dietary supplement cartridge was filled with five dietary supplement tablets having a composition as described in Table 1 and prepared as described in Example 1. Nine (9) litres of water was passed through a water dispensing device. Water exiting the dispensing device through the outlet port was collected in batches of 1 litre. A 10 ml sample of each of the 1 litre batch collected was analysed by measuring its conductivity. The % RDA delivered by the fortified water was calculated using a calibration curve between dietary supplement dosage and conductivity of fortified water and is given in Table 2.
  • Table 2 shows the micronutrient dosing data of tablets containing dextrose as filler and tablets made without dextrose. It shows that initially both the tablets give the required micronutrient dosage but when the tablets are exposed to water for one day, the tablet containing dextrose loses mechanical integrity, becomes soggy and deforms which resulted in a higher dosage.
  • Table 3 Effect of particle size on tableting of the composition containing nutrient active premix with dextrose and binder (gum arabic)
  • Table 3 shows that continuous tableting of the composition containing the Nutrient active premix and gum Arabic led to jamming, heavy vibrations and noise when the premix included particles with a particle size of ⁇ 80 ⁇ . This problem was solved by removing the particles of size ⁇ 80 ⁇ from the micronutrient premix.
  • Table 4 Effect of presence of dextrose on continuous tableting of the composition
  • Table 4 shows that presence of dextrose in the nutrient active premix and particle size of less than 80 ⁇ resulted in jamming of the tableting machine. Removal of dextrose from the nutrient active premix and optimizing the particle size of the nutrient active premix resolved the issue of jamming, vibrations and noise of tableting machine.
  • Table 5 Effect of environmental conditions on continuous tableting of composition presence of dextrose and Particle size (80 ⁇ to 600 ⁇ ).
  • Table 5 shows that the role of dextrose along with environmental conditions (Relative Humidity) in continuous tableting of the composition mix. If dextrose is present, the RH needs to be controlled at -20% for smooth operation of tableting machine, whereas, with the removal of dextrose, the tableting machine can operate smoothly even at 45% RH.
  • Example 2 The dosing study described in Example 2 was repeated through the complete dissolution of all the five tablets placed in the cartridge, while measuring the dosing of micronutrients.
  • the data in the Table 6 shows uniform and consistent dosing of micronutrient (12.4 +/- 4.9 % RDA/litre) from the five tablets through their life. This establishes the role of formulation and process conditions disclosed herein for resolving the problems of process issues and inconsistent dosing during use.

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  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Health & Medical Sciences (AREA)
  • Polymers & Plastics (AREA)
  • Food Science & Technology (AREA)
  • Nutrition Science (AREA)
  • Mycology (AREA)
  • Medicinal Chemistry (AREA)
  • Hydrology & Water Resources (AREA)
  • Environmental & Geological Engineering (AREA)
  • Water Supply & Treatment (AREA)
  • Organic Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Coloring Foods And Improving Nutritive Qualities (AREA)

Abstract

La présente invention concerne une composition solide lixiviable et son procédé de fabrication. La composition comprend un nutriment actif (5 % à 80 % en poids de la composition) et ayant une taille de particule de 80 µm à 600 µm ; et un liant comprenant un polymère soluble dans l'eau (30 % à 85 % en poids) et un composé dispersible hydrophobe (10 % à 50 % en poids, sur la base du poids de la composition) ; le nutriment actif étant sensiblement exempt de particules ayant une taille inférieure à 80 µm.
PCT/EP2016/075756 2015-11-05 2016-10-26 Composition solide lixiviable et son procédé de fabrication WO2017076711A1 (fr)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108576205A (zh) * 2018-03-22 2018-09-28 湖北省农业科学院农产品加工与核农技术研究所 一种草莓联合干燥的处理方法
CN112218545A (zh) * 2018-03-29 2021-01-12 塔塔化工有限公司 增强食用盐组合物的胶囊化微量营养素颗粒

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3293132A (en) * 1963-03-25 1966-12-20 Merck & Co Inc Spray dried vitamin compositions and method of preparation
US4495177A (en) * 1983-01-17 1985-01-22 Shaklee Corporation Gel tableting agent
JP2013179905A (ja) 2012-03-02 2013-09-12 Asahi Food & Healthcare Ltd ビタミンミネラル含有錠剤及びその製造方法
EP2733122A1 (fr) 2012-11-16 2014-05-21 Unilever N.V. Dispositif de dosage de supplément diététique
WO2014135332A1 (fr) 2013-03-05 2014-09-12 Unilever N.V. Cartouche destinée à être utilisée dans des dispositifs de purification d'eau

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3293132A (en) * 1963-03-25 1966-12-20 Merck & Co Inc Spray dried vitamin compositions and method of preparation
US4495177A (en) * 1983-01-17 1985-01-22 Shaklee Corporation Gel tableting agent
JP2013179905A (ja) 2012-03-02 2013-09-12 Asahi Food & Healthcare Ltd ビタミンミネラル含有錠剤及びその製造方法
EP2733122A1 (fr) 2012-11-16 2014-05-21 Unilever N.V. Dispositif de dosage de supplément diététique
WO2014135332A1 (fr) 2013-03-05 2014-09-12 Unilever N.V. Cartouche destinée à être utilisée dans des dispositifs de purification d'eau

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108576205A (zh) * 2018-03-22 2018-09-28 湖北省农业科学院农产品加工与核农技术研究所 一种草莓联合干燥的处理方法
CN112218545A (zh) * 2018-03-29 2021-01-12 塔塔化工有限公司 增强食用盐组合物的胶囊化微量营养素颗粒

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