NZ631411B2 - Infant formulae and their preparations - Google Patents

Abstract

The invention pertains to an infant formula powder composition comprising micronized lactose or lactose microcrystals (i) smaller than 30 micrometer, and/or (ii) of which at least 80 % has a size less than 20 micrometer, and/or (iii) at least 80 % has a size less than 10 micrometer, and/or (iv) having a median particle size D50 below 10 micrometer. The invention also pertains to the use of micronized lactose or lactose microcrystals for improving flow of an infant formula powder composition. ng a median particle size D50 below 10 micrometer. The invention also pertains to the use of micronized lactose or lactose microcrystals for improving flow of an infant formula powder composition.

Description

Infant formulae and their preparations BACKGROUND Today, ed infant formula is manufactured by more than a dozen firms in 40-50 processing plants worldwide. These formulations have to comply with strict regulations which allow for the use of only a limited number of ingredients which should or may be present within narrow ranges. Any changes beyond the tory nutrient requirements have to be notified to the tory bodies which have the authority to take compliance action if needed.

Hitherto, the main challenges the infant formula manufacturers face are those concerning nutritional and microbiological properties of infant formula, in their attempts to mimic human milk. Aside, there are however also issues concerning nutrient imbalances and powder flow properties. Some of these ms are easy dosing by preventing clumping and ease dissolving of the powder in water which is related to a particle structure and size distribution. This remains to be a challenging task for the manufacturers. Both moisture and fat present in infant formula ially contribute to caking.

According to the instruction manuals provided with the cial infant formulae, the end user should prepare a milk bottle by measuring the amount of powder using a scoop or spoon, and dispersing the termined amount in water at the desired temperature. US 041861 is an example thereof. Without improved flow properties, scoops or spoons cannot be dispensed with, yet these spoons and scoops are found inconvenient by users: These lly end up in the powder and if left damp can become coated with powder. Dosing with scoops and spoons may be regarded as problematic. U82012/0000929 fails to provide a suitable solution using conventional infant formula.

In the art there is thus a need to avoid or minimize lumping and cohesion particularly when sing the formula in water.

SUMIVIARY OF THE INVENTION In a first , it is the inventors’ contribution to the field of infant formulae to improve consumer handling of infant formula powder formulations by rendering such formulations having improved flowing properties, preferably reducing caking or lumping issues. With their insights consumer handling can be greatly improved, and it is much easier for the end user to prepare a baby milk bottle without making any hand contact with the powder. Infant formula can be dispensed without the need for spoons or scoops.

If anything is clear from the above, it is that flowability of infant formula compositions cannot be amended by orating just any free-flowing agent. Care is taken to introduce new components foreign to infant a nutrients as these are defined by the CODEX STAN 73 — 1981 “StandardFor Infant Formula and Formulas For SpecialMedical Purposes Intendedfor Infants” and tory bodies. It is therefore an object of the ion to render the infant formula powder in a free- flowing format without the need for ingredients not approved by authorities as infant formula nutrients.

To that end, the inventors have found that microcrystalline lactose could advantageously be used as a flowing agent to render the powder e. e is one of those few nts that authorities allow for use in infant formulations, and is, albeit in larger forms, already part of the infant formula powder particulate material in copious amounts of about 40 wt%. The invention thus pertains to the use of micronized e or lactose microcrystals for improving flow of an infant formula powder composition. 2O The fact that fine lactose particles could advantageously be applied to render an infant formula with improved flow properties is unattended in the art: EP 2 discloses adding crystalline edible lactose together with minerals and vitamins only to a spray-dried, sterile mixture of proteins, lipids and carbohydrates, for lling the formation of advanced glycation ducts (AGE) during food processing involving heat steps (such as sterilization). The s using conventional lactose ingredients disclosed in EP 1799052 does not implicitly render any improved flow ties.

Nevertheless, its contents are herein incorporated by reference in their entirety. The present inventors have found it is key to use micronized lactose or lactose microcrystals, suff1ciently fine or small to render good flow properties.

Outside the field of infant formulae, WOl996/033619 discusses the usefulness of crystallized lactose microparticles as bulking agents, consistency-improving agents or as fat and/or sugar replacement agents. /O33619 is looking for a fat-like mouthfeel. Also, lactose microcrystals are sometimes used in small amounts in the art 2012/050330 as seeds for initiating and controlling crystallization in food ts where so desired.

Hitherto, there is however no use of lactose microcrystals in an infant formula, particularly not for controlling its flowing properties.

LIST OF EMBODIMENTS In a first embodiment, the invention relates to an infant formula powder composition sing micronized lactose or lactose microcrystals (i) smaller than 30 micrometer, and/or (ii) of which at least 80 % has a size less than 20 micrometer, and/or (iii) at least 80 % has a size less than 10 micrometer, and/or (iv) having a median particle size D50 below 10 micrometer.

In a preferred embodiment, said micronized lactose or lactose microcrystals in the infant formula powder ition as defined above are characterized by at least (iii) and/or (iv), preferably at least (iii).

In a preferred embodiment, said micronized lactose or e microcrystals are I5 present in an amount of 0.5 — 20 wt%, preferably 0.5 — 15 wt%, more preferably 0.5 — wt%, based on total weight of the composition.

In a preferred embodiment, at least 90 % of said micronized lactose or lactose microcrystals have a size less than 10 micrometer.

In a preferred ment, the infant formula powder composition is free- .

In a red embodiment, the infant formula powder composition has a FlodeX flowability indeX of at least 50, preferably at least 80, preferably at least 100, more preferably at least 125, more ably at least 170, even more preferably at least 200, most preferably at least 250.

In a preferred embodiment, the infant formula powder composition comprises - 55 en% fat, based on total energy content.

In a preferred embodiment, the infant formula powder composition has a density of 0.45 — 0.52 g/ml.

In a preferred embodiment, the infant formula powder composition has a a moisture content of 2 — 3 wt%, based on total composition.

In a preferred ment, the infant formula powder composition comprises infant formula powder particles, said particles other than the micronized lactose or WO 69097 lactose rystals, said infant formula powder particles having a particle size of less than 400 micrometer, preferably less than 300 eter.

In a further aspect, the invention ns to a method for manufacturing an infant formula powder composition, comprising (a) providing a spray-dried powder comprising proteins, lipids and carbohydrates, vitamins and micronutrients, (b) blending said powder with micronized lactose or lactose microcrystals (i) smaller than eter, and/or (ii) of which at least 80 % has a size less than 20 micrometer, and/or (iii) at least 80 % has a size less than 10 micrometer, and/or (iv) having a median particle size D50 below 10 micrometer.

In a red embodiment, the said micronized lactose or lactose microcrystals used in the method are characterized by at least (iii) and/or (iv), preferably at least (iii).

In a further , the invention pertains to the use of the infant formula powder composition according to one or more of the above ments for providing nutrition to an infant.

In a further aspect, the invention pertains to a method for providing nutrition to an infant, comprising providing said infant with the infant formula powder composition according to one or more of the above embodiments reconstituted in water.

LIST OF FIGURES Figure 1 depicts flowability of infant formula powder compositions as a function of the micronized lactose content, Figure 2 schematically represents a FlodeX tus suitable for determining the flowability of the infant formula powder, Figure 3 shows the le size distribution of micronized lactose according to specifications provided by the manufacturer.

DETAILED DESCRIPTION OF THE INVENTION In a first , the invention pertains to an infant formula powder composition comprising lactose microcrystals or micronized lactose. In a preferred aspect, the invention thus pertains to an infant formula powder composition comprising lactose microcrystals or micronized lactose with at least 80 % of said particles having a size of less than 20 um, preferably at least 90 % of said particles having a size of less than 10 um. Alternatively or additionally, the invention pertains to an infant formula powder composition comprising lactose microcrystals or micronized lactose smaller than 30 um, preferably 0.1 — 25 um of size.

As detailed here above, ‘infant a’ is well-defined and controlled internationally and consistently by regulatory bodies. In particular, the CODEX mentioned above is widely accepted. This recommends for nutritional value and formula composition, which e the prepared milk to contain per 100 ml not less than 60 kcal (250 kJ) and no more than 70 kcal (295 kJ) of energy. FDA and other regulatory bodies have set nutrient requirements in accordance therewith. In one embodiment, the infant formula is defined according to FDA 21 CFR 107.100. The content is herein incorporated by reference. The terminology ‘infant formula powder’ and ‘powdered infant formula’ are used interchangeably.

The present composition is preferably enterally administered, more preferably orally, upon reconstitution with water. The present composition excludes human milk.

The t composition can be advantageously applied as a complete nutrition for infants. The t ition therefore preferably ses a lipid component, protein component and carbohydrate component. The present infant formula is preferably provided as a ed powder, and it may be accompanied with ctions as to mix said dry food mixture with a le liquid (e. g. water).

In a preferred embodiment, the terms ‘lactose microcrystals’, ‘microf1ne lactose crystals, ‘micronized lactose’ and ‘microcrystalline lactose’ in the context of the present invention are all used interchangeably, and ably refer to e particles: (i) smaller than 30 um, preferably smaller than 25 um, and/or (ii) of which at least 80 % has a size less than 20 um, preferably at least 90 % has a size less than 20 um, and/or (iii) at least 80 % has a size less than 10 um, more preferably at least 90 % has a size less than 10 um, and/or (iv) having a median particle size D50 below 10 um, ably below 8 um, more preferably below 7 um, most preferably below 6 um. The percentages in this paragraph are in terms of weight The lactose particles are preferably characterized by (iii) and/or (iv), preferably at least (iii) here above. The microparticles may be distinguished from the infant formula powder particulate materials by size, the latter being much larger. In one embodiment, the lactose microcrystals according to the invention have an average particle size ranging between 0.1 and 20 um, more preferably between 0.5 and 15 um, more preferably between 1 and 10 um, most preferably between 2 and 10 um.

The inventors found that good results are obtained when the micronized lactose content in the powder ition ranges between 0.5 and 20 wt%, more preferably between 0.5 and 15 wt%, even more preferably between 0.5 and 10 wt%, most preferably between 1 and 10 wt%, particularly between 1 and 8 wt%, based on total weight ofthe ition. Weight optimization is depicted in Figure 1. Despite that no use is made of any nutrients foreign to infant formula, it is still preferred to maintain low levels of lactose microparticles. It is the ors’ belief that the optimum flow properties may be the interplay between the microcrystalline lactose particle size and the relative amount of les present in the composition; with the dge ed by the inventors, it is considered within the ambit of the skilled person’s knowledge to find the optimum amount and size distribution of micronized lactose particles in order to achieve the desired flow.

In one embodiment, the lactose microcrystals are alpha-lactose monohydrate les which are milled or sieved to the d particle size distribution. Good results are obtained with Lactochem®microf1ne, commercially available from DFE Pharma.

The infant a powder ing to the invention may be characterized in terms of its improved flowing properties. The improvement provided by the flowing agent of the invention may be characterized as ‘easy flowing’ or ‘controlled flow’. Various manners of determining and defining flowability are ble in the art. For the purpose of the present invention, this is determined in that the powdered infant formula composition preferably has an absolute value for the cohesion index of less than 14, preferably less than 12, for instance as measured using a TA. HD Plus Powder Flow Analyzer (Stable Micro Systems, Surrey, UK).

The infant formula according to the invention ts flow behavior which may readily be tested by the skilled person using routine experimentation available in the laboratory, for instance by flowability index ement. Such a test according to the FlodexTM protocol (Pharma Alliance Group) is described in the Example below. This test is especially marketed for ining the Flodex flowability index measurements.

The infant formula powder composition according to the present invention ably flows freely by gravity through a circular opening having a width of 20 mm or less, preferably 16 mm or less, more preferably 12 mm or less, most preferably 8 mm or less. Worded differently, in the context of the invention, ‘free-flowing’, ‘easy flowing’ or ‘flowing’ preferably means that the infant formula powder in the above test continuously or interruptedly flows through the above-def1ned openings inuous flow’ meaning that the infant formula poured through the opening is rrupted to the eye].

In a preferred embodiment, the flowing properties of the infant formula are still regarded acceptable for the e of the invention when showing flow through a circular opening having a width in the range of 4 - 20 mm, particularly 5 — 20 mm, more preferably 5 — 16 mm, more preferably 5 — 8 mm. For reference sake, commercially available infant formulae (lacking any free-flowing agents) are found to flow through an opening with a diameter of 24 mm only, at smaller-sized openings blocking occurs. More than other flow parameters existing in the art, this test is regarded indicative of the situation experienced by the end user when reconstituting the infant formula in water. Flowability index measurements (in terms of the minimum opening or ‘ring size’ through which flow was observed) are d as a function of the amount of microcrystalline lactose added in Figure 1 ed. The results are in accordance with the above preferences.

Associated therewith, the powder of the invention may be characterized in terms of its FlodexTM flowability (index) according to the FlodexTM protocol (Pharma Alliance Group) as defined in the Example below, and which FlodexTM flowability index is defined as 1000 d by the diameter in millimeters of the smallest hole through which the sample will pass three consecutive (Flodex) tests. The infant powder preferably exhibits a Flodex flowability index of at least 50, preferably at least 80, preferably at least 100, more preferably at least 125, more ably at least 170, even more preferably at least 200, most preferably at least 250. For most practical purposes, Flodex flowability indexes greater than 500 would not be required since an opening of 2 mm er would unlikely allow sufficient flow for normal dosing purposes. In one ment, the Flodex flowability index is 200 - 250. The Flodex flowability index of commercial infant formulae is about 40. It is noted that the Flodex flowability index is a ted tool to characterize flowability for ce demonstrated outside the field in US 5,236,920, its entire contents and particularly the part ‘FLODEX METHOD FOR FLOWABILITY DETERMINATION” herein incorporated by nce.

In one embodiment, the powder may be characterized in terms of its bulk density. “Bulk density” used herein is typically determined by measuring the volume that a given weight of the powder es when poured through a funnel into a stationary ted cylinder. The powder preferably has a tapped bulk density of between 100 and 800 g/L, preferably between 150 and 700 g/L, more preferably between 180 and 600 g/L, particularly less than 500 g/L, most preferably less than 450 g/L, even more ably less than 400 g/L. For the poured bulk density the above limits are preferably 50 g/l lower and can be straightforwardly calculated from the above ranges and numbers.

The infant formula according to the t invention preferably contains 35 — 55 energy % (preferably 35 — 50 en%) fat, more preferably 5 to 12.5 energy % (preferably 7.5 — 12.5 en%) protein, 40 to 55 energy % carbohydrates, and 35 to 50 energy % fat.

The term energy %, also abbreviated as en%, represents the relative amount each constituent contributes to the total caloric value of the formula. With the universally applied conversion factors these energy contributions could be recalculated in terms of relative weight amounts.

In one ment, the infant milk powder average particle size — excluding the above-def1ned microparticles - ranges between 100 and 400 um, preferably 130 - 300 um, the average particle size is more preferably less than 250 um.

The infant formula powder composition preferably has a density of 0.45 — 0.52 g/ml. In one embodiment, the infant formula powder composition has a moisture content of 2 — 3 wt%, based on total ition. These water levels are preferred to safeguard fat stability and minimize fat oxidation during shelf life.

The present composition preferably comprises at least one lipid selected from the group consisting of animal lipid (excluding human ) and vegetable lipids. ably the t composition comprises a combination of vegetable lipids and at least one oil selected from the group consisting of fish oil, animal oil, algae oil, fungal oil, and bacterial oil. Preferably the present composition comprises at least 0.50 wt%, preferably at least 0.60 wt%, more preferably at least 0.70 wt% As with 20 and 22 carbon atoms of the total fat content It is preferred that at least 80 wt%, more 2012/050330 preferably at least 85 wt%, most preferably 85 — 100 wt% of the LCPUFAs with 20 and 22 carbon atoms is provided by the combination of EPA and DHA.

The present infant formula preferably comprise protein selected from the group consisting of non-human animal proteins (such as milk ns, meat proteins and egg proteins), vegetable ns (such as soy protein, wheat protein, rice protein, and pea protein) and amino acids and mixtures thereof. Preferably the infant formula comprise cow milk derived nitrogen source, particularly cow milk proteins such as casein and whey proteins. In one embodiment the infant formula comprises hydrolyzed milk protein, for e hydrolyzed casein and/or hydrolyzed whey protein. The preferred infant a in the context of the ion is dairy-based, i.e. ‘infant milk formula’.

Because lactose is an important digestible carbohydrate source for infants, the present infant formula ably comprises at least 35 wt.% lactose based on weight of total digestible carbohydrate, more preferably at least 50 wt.%, most preferably at least 75 wt.%. In one embodiment, the sum of all lactose including the micronized lactose in the infant formula powder composition amounts to 30 — 50 wt%, preferably 35 — 45 % of the composition. Preferably, upon reconstitution, the composition comprises at least 3 g lactose/100 ml, more preferably at least 4 g/100ml, even more preferably at least 5 g per 100 ml. The amounts of micronized e are herein incorporated. The present composition preferably comprises 4 g to 18 g, more ably 5 to 14 g digestible carbohydrates per 100 ml composition.

The composition preferably comprises between 1.5 and 2.5 gram indigestible accharides per 100 kcal, preferably comprising: i) 1.4-2 gram galactooligosaccharides with a degree of polymerization of 2 — 7, and ii) 0.1 - 0.5 gram fructopolysaccharides with degree of polymerization of 2 -150. The term “fructopolysaccharides” comprises fructans and inulin, and hydrolyzates thereof. The preferred galactooligosaccharides are transgalactooligosaccharides. It is preferred that at least 95 wt%, preferably 95 — 100 wt% of the indigestible oligosaccharides is provided by galactooligosaccharides and fructopolysaccharides.

The infant formula preferably have a c density between 0.1 and 2.5 kcal/ml, even more preferably a caloric density of between 0.5 and 1.5 kcal/ml, most preferably n 0.6 and 0.8 kcal/ml. The infant formula of the present invention preferably have an osmolality n 50 and 500 mOsm/kg, more ably between 100 and 400 mOsm/kg.

When in liquid form, the infant formula preferably has a viscosity between 1 and 100 mPas, preferably n 1 and 60 mPas, more preferably between 1 and 20 mPa.s, most preferably between 1 and 10 mPa.s. The viscosity of the liquid can be suitably determined using a Physica Rheometer MCR 300 (Physica Messtechnik GmbH, Ostfllden, Germany) at shear rate of 95 s'1 at 20 0C. This viscosity closely resembles the viscosity of human milk. Furthermore, a low viscosity results in a normal gastric emptying and a better energy intake, which is essential for infants who need the energy for optimal growth and development.

In one aspect, the invention ns to a method for manufacturing an infant formula powder ition as defined above, said method comprising (i) providing a spray- dried powder comprising proteins, lipids and carbohydrates, ns and micronutrients, and (ii) blending said powder with lactose microcrystals smaller than um. Step (ii) is preferably a dry-miXing step.

In one aspect, the invention pertains to the use of the improved infant a powder composition for ing nutrition to an infant. Infant formulae are particularly intended for providing nutrition to infants with an age between 0 and 3 years, and more preferably infants under 1 year of age. The invention also relates to a method for ing nutrition to an infant, comprising providing said infant with the infant formula powder composition reconstituted in water, in accordance with the reconstitution instructions provided in the instruction manual accompanying the infant formula powder composition. In the context of the present ion, the method for providing ion to an infant is considered a non-therapeutic method.

EXAMPLES Infant milk formula powder composition A commercially available infant formula powder composition (Nutrilon rd ZTM [Nutricia]) was blended with X wt% of hem®microf1ne from DFE Pharma, X being 0, l, 2, 3, 3.5, 4, 5, 10 and 14, respectively, X being calculated on the total weight ofthe blended powder composition. The infant formula powder specifications are in line with those ranges regarded ed by the regulatory bodies and as defined herein above. Figure 3 shows the particle size and particle size distribution specifications of Lactochem®microf1ne as provided by the manufacturer.

Flowability indeX measurements The FlodeX apparatus 1 as shown in Figure 2, ts of a cylinder 2 with interchangeable disks 4 with holes 6 of s diameters located at the bottom of the cylinder 2. The determination of flowability is based upon the ability of the powder to fall freely through the hole 6 in the disk 4. The smaller the hole through which the powder falls freely, the better is the flowability. A funnel 8 is provided with its outlet at within 2cm above the er 2. The hole 6 in the disk 4 at the base of the cylinder is initially kept closed by a closure plate 10, which is hinged downwardly from a retort stand 12 from which the fiinnel 8 and cylinder 2 are also ted. The closure plate can be released by action of a release lever 14. A receptacle 16 is located below the cylinder2.Diskswithholesof:4,5,6,7,8,9,10,12,l4,l6,l8,20,22,24, 26 , 28 , 30 , 32 and 34 mm are provided.

Test Protocol With the closure plate 10 in the closed position, around 160 mL of material as prepared above is loaded carefully into the cylinder 2 through the funnel, to fill it to within approximately 1 cm of the top. The material is allowed to settle for 60 seconds without tapping or otherwise disturbing the apparatus. The release lever 14 is actuated causing the closure plate 10 to pivot away from the disk 4. The test is deemed positive if the material flows out of the cylinder 2 such that an opening is visible through the disk.

The test is carried out successively with smaller disks until flow hampers. From the smallest ring g acceptable flow, the FlodeX flowability can be calculated, which is defined as 1000 d by the diameter in millimeters of the st hole through which the sample will pass three consecutive tests.

Results The flowability results in terms of minimum disk opening still showing flow of infant formula itions have been plotted in Figure 1, using the ve amount of micronized lactose derived as Lactochem®microf1ne from DFE Pharma as a parameter.

It is noted that the figure also incorporates the relatively poor flow properties for commercially ble infant formulae without any microparticles additions (Nutrilon standard ZTM [Nutricia]).

Claims (20)

1. An infant formula powder composition comprising micronized lactose or lactose rystals (i) smaller than 30 eter, and/or (ii) of which at 5 least 80 % has a size less than 20 micrometer, and/or (iii) at least 80 % has a size less than 10 micrometer, and/or (iV) having a median particle size D50 below 10 micrometer.

2. The infant formula powder composition according to claim 1, wherein said 10 micronized lactose or lactose microcrystals are characterized by at least (iii) and/or (iV), preferably at least (iii).

3. The infant formula powder composition according to claim 1 or 2, wherein said micronized lactose or lactose rystals are present in an amount of 0.5 — 2O 15 wt%, preferably 0.5 — 15 wt%, more preferably 0.5 — 10 wt%, based on total weight of the composition.

4. The infant formula powder ition ing to any one of the preceding claims, wherein at least 90 % of said micronized lactose or lactose microcrystals 20 have a size less than 10 micrometer.

5. The infant formula powder ition according to any one of the preceding claims, said composition being owing. 25

6. The infant formula powder composition according to any one of the preceding claims, haVing a FlodeX flowability index of at least 50, preferably at least 80, preferably at least 100, more preferably at least 125, more preferably at least 170, even more preferably at least 200, most preferably at least 250. 30

7. The infant formula powder composition according to any one of the preceding claims, comprising 35 - 55 en% fat, based on total energy content.

8. The infant formula powder composition according to any one of the preceding claims, having a density of 0.45 — 0.52 g/ml.

9. The infant formula powder composition according to any one of the preceding 5 claims, having a moisture content of 2 — 3 wt%, based on total composition.

10. The infant formula powder composition according to any one of the preceding claims, comprising infant formula powder particles, said particles other than the micronized lactose or lactose microcrystals, said infant formula powder 10 particles having a particle size of less than 400 micrometer, preferably less than 300 micrometer.

11. A method for manufacturing an infant formula powder composition, comprising (a) providing a spray-dried powder comprising proteins, lipids and 15 carbohydrates, vitamins and micronutrients, (b) blending said powder with micronized e or lactose rystals (i) r than 30 micrometer, and/or (ii) of which at least 80 % has a size less than 20 micrometer, and/or (iii) at least 80 % has a size less than 10 micrometer, and/or (iv) having a median particle size D50 below 10 micrometer.

12. The method according to claim 11, n said micronized lactose or e microcrystals are characterized by at least (iii) and/or (iv), preferably at least (iii). 25

13. Use of the infant formula powder composition according to any one of claims 1 — 10 for providing ion to an infant.

14. A method for providing ion to an infant, comprising providing said infant with the infant formula powder composition according to any one of claims 1 - 3 0 10 reconstituted in water.

15. Use of micronized lactose or lactose rystals for improving flow of an infant formula powder composition.

16. An infant formula powder composition according to claim 1 substantially as herein described or ified.

17. A method ing to claim 11 substantially as herein described or exemplified.

18. A use according to claim 13 substantially as herein described or exemplified.

19. A method according to claim 14 substantially as herein described or exemplified.

20. A use according to claim 15 substantially as herein described or exemplified.