STABILIZED LIQUID NUTRITIONALS INCLUDING INSOLUBLE
CALCIUM SALTS
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to and any benefit of U.S. Provisional
Application No. 61/726,269, filed November 14, 2012, the entire contents of which
are incorporated by reference in its entirety.
FIELD OF THE DISCLOSURE
[0002] The present disclosure relates to a liquid nutritional composition
having improved stability without the use of carrageenan or other stabilizers. More
particularly, the liquid nutritional composition includes at least two insoluble calcium
salts having different average particles sizes in combination with an emulsifier that
desirably includes monoglycerides.
BACKGROUND OF THE DISCLOSURE
[0003] Manufactured liquid nutritional composition comprising a targeted
selection of nutrition ingredients are well known and widely available, some of which
may provide a sole source of nutrition while others may provide a supplemental
source. These nutritional liquids include powders that can be reconstituted with water
or other aqueous liquid, as well as ready to drink nutritional liquids such as milk or
protein based emulsions or non-emulsified or substantially clear liquids for use in
infant and pediatric formulas and medical and adult nutritionals.
[0004] Traditionally, some liquid nutritional compositions have been
confronted with at least two potential problems that can shorten shelf life. The first
problem is known as creaming, whereby the fat globules in the liquid nutritional
composition float to the top of the product. If these fat globules harden, a seal
effectively forms across the top of the liquid nutritional composition's container.
Additionally, these hard, fatty deposits can block or clog feeding tubes or nipples, and
can give the liquid nutritional composition an unappealing appearance and cause
nutritional insufficiencies.
[0005] The second problem potentially associated with liquid nutritional
compositions is sedimentation, whereby minerals or other components, or both,
precipitate out of solution and settle to the bottom of the liquid nutritional
composition's container. The problem of sedimentation is made more acute where
the sediment hardens into a cementous type of material known as "nondispersible
sediment". The problem with nondispersible sediment is two-fold. First, the liquid
nutritional composition may potentially be subject to nutrient insufficiency as the
nondispersible sediment often refuses to solubilize back into the solution upon
agitation of the liquid nutritional composition. The second problem with
nondispersible sediment is that, similar to hardened creaming deposits, it can plug
feeding tubes or nipples.
[0006] Stabilizers are commonly used to maintain the rheological properties
of the liquids over their shelf lives while maintaining their organoleptic properties and
appearance. Although modified stabilizer systems have been proposed to address
sedimentation problems, they have met with limited success. These systems permit
the minerals to be suspended longer, but nevertheless, they can ultimately irreversibly
fall out of solution.
[0007] Conventionally, one of the key components used in liquid nutritional
compositions for product stability is carrageenan. Carrageenan is a group of highly
sulfated, high molecular weight, linear polysaccharides. The functionality of
carrageenan can be attributed to its chemical structure, especially the ester sulfate
group content and molecular size. There are three main types of carrageenan: kappa,
lambda and iota.
[0008] While carrageenan has proven relatively effective in stabilizing liquid
nutritional compositions, there is a need in the art to find alternative methods for
improving the physical stability of liquid nutritional products, and particularly infant
nutritional products, specifically with regard to the avoidance of sedimentation of
insoluble minerals and the creaming of fats. More particularly, liquid nutritional
compositions that can be stabilized without the use of carrageenans or other stabilizers
would be especially advantageous for those matrices where stabilization with
carrageenans proves inadequate. Further, carrageenans do not enjoy universal
acceptance, and can be subject to restrictive regulation.
[0009] The present disclosure is directed to nutritional products in the form
of liquid nutritional compositions comprising at least two insoluble calcium salts and
one or more emulsifiers, including monoglycerides. The combination of insoluble
calcium salt and emulsifiers allows for a stable emulsion with good mineral
suspension.
SUMMARY OF THE DISCLOSURE
[0010] The present disclosure is directed to a stabilized liquid nutritional
composition comprising a first insoluble calcium salt, a second insoluble calcium salt,
an emulsifier, and a fat. The first insoluble calcium salt and the second insoluble
calcium salt have different average particle sizes.
[001 1] The present disclosure is further directed to a stabilized liquid infant
formula comprising a first insoluble calcium salt, a second insoluble calcium salt, an
emulsifier, and a fat. The first insoluble calcium salt and the second insoluble
calcium salts have different average particle sizes and the first insoluble calcium salt
and the second insoluble calcium salt are selected from the group consisting of
calcium carbonate, calcium citrate, calcium phosphate, dicalcium phosphate,
tricalcium phosphate and combinations thereof. In certain embodiments disclosed
herein, the emulsifier comprises monoglycerides.
[0012] The present disclosure is further directed to a process for
manufacturing a stabilized liquid nutritional composition. The process comprises
introducing a first insoluble calcium salt, a second insoluble calcium salt, and an
emulsifier with a fat to form a fat blend. The first insoluble calcium salt and the
second insoluble calcium salt have different average particle sizes. The emulsifier
comprises monoglycerides. The fat blend is mixed with a carbohydrate blend to form
the stabilized liquid.
[0013] The stabilized liquid nutritional products as described herein not only
provide sufficient nutritional benefits for individuals, but are also universally label
friendly. More particularly, it has been unexpectedly found that when at least two
insoluble calcium salts having different average particle sizes are combined with an
emulsifier, stable liquid nutritional products can be prepared without the use of added
stabilizers. The liquid nutritional products provide good mineral suspension such to
minimize mineral fallout, allowing for homogenous and precise delivery of micro and
minor nutrients to infants and pediatric individuals.
DETAILED DESCRIPTION OF THE DISCLOSURE
[0014] The liquid nutritional products of the present disclosure comprise at
least two insoluble calcium salts having different average particles sizes and an
emulsifier. These and other essential features of the nutritional products, as well as
some of the many optional variations and additions, are described in detail hereafter.
[0015] The term "insoluble calcium salt" as used herein, unless otherwise
specified, refers to calcium salts that are substantially insoluble in water at room
temperature, and specifically to calcium salts that are less than 1wt.% or less than 0.5
wt.% or less than 0.1wt.% soluble in water at room temperature.
[00 16] The terms "liquid nutritional product" "liquid nutritional
composition" and "nutritional liquid" are used interchangeably herein, and unless
otherwise specified, refer to nutritional products in ready-to-drink liquid form and
concentrated form comprising one or more of fat, protein, and carbohydrate.
[0017] The terms "fat" and "oil" as used herein, unless otherwise specified,
are used interchangeably to refer to lipid materials derived or processed from plants or
animals. These terms also include synthetic lipid materials so long as such synthetic
materials are suitable for oral administration to humans.
[00 18] The term "shelf stable" as used herein, unless otherwise specified,
refers to a liquid nutritional composition that remains commercially stable after being
packaged and then stored at 18-24°C for at least 3 months, including from about 6
months to about 24 months, and also including from about 12 months to about 18
months.
[0019] The terms "retort packaging" and "retort sterilizing" are used
interchangeably herein, and unless otherwise specified, refer to the common practice
of filling a container, most typically a metal can or other similar package, with a
liquid nutritional composition and then subjecting the liquid-filled package to the
necessary heat sterilization step, to form a sterilized, retort packaged, liquid
nutritional product.
[0020] The term "aseptic packaging" as used herein, unless otherwise
specified, refers to the manufacture of a packaged product without reliance upon the
above-described retort packaging step, wherein the liquid nutritional composition and
package are sterilized separately prior to filling, and then are combined under
sterilized or aseptic processing conditions to form a sterilized, aseptically packaged,
liquid nutritional product.
[0021] The term "infant formula" as used herein, unless otherwise specified,
refers to liquid infant formulas and pediatric formulas, wherein infant formulas are
intended for infants up to about 1 year of age and toddler formulas are intended for
children from about 1 year of age to about 10 years of age.
[0022] The term "preterm infant formula" as used herein, unless otherwise
specified, refers to liquid nutritional compositions suitable for consumption by a
preterm infant. The term "preterm infant" as used herein, refers to a person born prior
to 36 weeks of gestation.
[0023] All percentages, parts and ratios as used herein, are by weight of the
total composition, unless otherwise specified. All such weights as they pertain to
listed ingredients are based on the active level and, therefore, do not include solvents
or by-products that may be included in commercially available materials, unless
otherwise specified.
[0024] All references to singular characteristics or limitations of the present
disclosure shall include the corresponding plural characteristic or limitation, and vice
versa, unless otherwise specified or clearly implied to the contrary by the context in
which the reference is made.
[0025] All combinations of method or process steps as used herein can be
performed in any order, unless otherwise specified or clearly implied to the contrary
by the context in which the referenced combination is made.
[0026] The various embodiments of the nutritional products of the present
disclosure may also be substantially free of any optional or selected essential
ingredient or feature described herein, provided that the remaining nutritional product
still contains all of the required ingredients or features as described herein. In this
context, and unless otherwise specified, the term "substantially free" means that the
selected nutritional product contains less than a functional amount of the optional
ingredient, typically less than about 1%, including less than about 0.5%, including
less than about 0.1%, and also including zero percent, by weight of such optional or
selected essential ingredient.
[0027] The nutritional product may comprise, consist of, or consist
essentially of the essential elements of the products as described herein, as well as any
additional or optional element described herein or otherwise useful in nutritional
product applications.
Product Form
[0028] The liquid nutritional compositions of the present disclosure include
both concentrated and ready-to-feed liquid nutritional compositions. These liquid
nutritional compositions are most typically formulated as suspensions or emulsions.
Suitable product forms in the present disclosure include preterm and term infant
formulas, pediatric/toddler formulas, and follow on formulas.
[0029] The nutritional products may be formulated with sufficient kinds and
amounts of nutrients to provide a sole, primary, or supplemental source of nutrition,
or to provide a specialized nutritional product for use in individuals afflicted with
specific diseases or conditions or with a targeted nutritional benefit.
[0030] The nutritional liquids typically contain up to about 95% by weight
of water, including from about 50% to about 95%, also including from about 60% to
about 90%, and also including from about 70% to about 85%, of water by weight of
the nutritional liquid. The nutritional liquids may have a variety of product densities,
but most typically have a density greater than about 1.03 g/mL, including greater than
about 1.04 g/mL, including greater than about 1.055 g/mL, including from about 1.06
g/mL to about 1.12 g/mL, and also including from about 1.085 g/mL to about 1.1
g/mL.
[003 1] The nutritional liquids may have a caloric density tailored to the
nutritional needs of the ultimate user. In certain embodiments, the liquids comprise at
least about 640 kcal/liter (about 19 kcal/fl oz), more particularly from about 675
kcal/liter (about 20 kcal/fl oz) to about 845 kcal/liter (about 25 kcal/fl oz), more
particularly from about 675 kcal/liter (about 20 kcal/fl oz) to about 815 kcal/liter
(about 24 kcal/fl oz). Generally, the about 740 kcal/liter (about 22 kcal/fl oz) to about
815 kcal/liter (about 24 kcal/fl oz) formulas are more commonly used in preterm or
low birth weight infants, and the about 675 kcal/liter (about 20 kcal/fl oz) to about
710 kcal/liter (about 2 1 kcal/fl oz) formulas are more often used in term infants. In
certain other embodiments, the liquid may have a caloric density of from about 100
kcal/liter to about 660 kcal/liter, particularly from about 150 kcal/liter to about 500
kcal/liter.
[0032] The nutritional liquids may have a pH ranging from about 3.5 to
about 8, but are most advantageously in a range of from about 4.5 to about 7.5,
including from about 5.5 to about 7.3, including from about 6.2 to about 7.2.
[0033] Although the serving size for the nutritional liquid can vary
depending upon a number of variables, a typical serving size is generally at least
about 2 mL, in particular embodiments at least about 5 mL, in other particular
embodiments at least about 10 mL, in other particular embodiments at least about 25
mL, including ranges from about 2 mL to about 300 mL, including from about 4 mL
to about 250 mL, and including from about 10 mL to about 240 mL.
Insoluble Calcium Salt
[0034] The liquid nutritional products comprise at least two, including at
least three, or more insoluble calcium salts in combination with an emulsifier, such as
monoglycerides, as discussed below. The insoluble calcium salts may be any
insoluble calcium salt known for use in oral nutritional products, and may include, for
example, calcium carbonate, calcium citrate, calcium monophosphate, calcium
diphosphate, tricalcium phosphate, and combinations thereof.
[0035] The two or more insoluble calcium salts that are included in the
liquid nutritional have different average particle sizes. It has been unexpectedly
found that utilizing at least two insoluble calcium salts having different average
particle sizes actually minimizes precipitation and sedimentation in the liquid
nutritional, thereby, providing sufficient calcium to the consumer and increasing long
term product stability.
[0036] Particle size measurements were performed using a laser diffraction
particle size analyzer (HELOS model KR with a RODOS M dry dispersing unit;
Sympatec GmbH, G a s ha Zel erf k Germany). Two lenses (R2 and R6) were
utilized on measurements of calcium salts based on their average particle size values.
As used herein, "average particle size" refers to the volume mean diameter of each
particle, determined based on the particle size distribution as measured by the laser
diffraction particle size analyzer. The average particle size of the insoluble calcium
salts falls within the range of from about 0.35 mih to about 15.25 mih, including from
about 0.5 mih to about 10 mih, including from about 0.65 mih to about 8 mih, including
from about 1.25 mih to about 5 mih, and including from about 2 mh to about 3.5 mih.
It is desirable to include at least two, or even three or more, insoluble calcium salts in
the liquid nutritional products, each salt having a different average particle size. In
certain embodiments, three insoluble calcium salts are included in the liquid
nutritional, the first insoluble calcium salt has an average particle size of from about
1.5 mih to about 2.5 mih, the second insoluble calcium salt has an average particle size
of from about 2 mh to about 3 mih, and the third insoluble calcium salt has an average
particle size of from about 2.5 mih to about 4.5 mih. In one particular embodiment,
three insoluble calcium salts are included in the liquid nutritional, the first insoluble
calcium salt, tricalcium phosphate, has an average particle size of about 2.3 mih, the
second insoluble calcium salt, calcium carbonate, has an average particle size of about
2.74 mh , and the third insoluble calcium salt, calcium citrate, has an average particle
size of about 3.92 mh .
[0037] The total amount of the two or more insoluble calcium salts in the
liquid nutritional products will depend on the other components of the liquid
nutritional product and the targeted use of the nutritional product, but will generally
fall within the range of from about 0.02 wt.% to about 1 wt.% of the liquid nutritional
product. The insoluble calcium salts are present in the liquid nutritional products in a
weight ratio of from about 20:80 to about 80:20, including from about 30:70 to about
70:30, including from about 40:60 to about 60:40, and including from about 50:50.
For example, in one embodiment, two insoluble calcium salts, tricalcium phosphate
and calcium citrate, are present in the liquid nutrition in a weight ratio of about 50:50.
In another embodiment, three insoluble calcium salts are present in the liquid
nutritional in a weight ratio of tricalcium phosphate: calcium citrate:calcium carbonate
of about 40:30:30. In yet another embodiment, the insoluble calcium salts are present
in a weight ratio of tricalcium phosphate: calcium citrate:calcium carbonate of about
60:20:20. Accordingly, in some embodiments, the insoluble calcium salts may
individually be present in the liquid nutritional products in amounts ranging from
about 0.004 wt.% to about 0.016 wt.%, including from about 0.006 wt.% to about
0.014 wt.%, including from about 0.008 wt.% to about 0.012 wt.%, and including
about 0.01 wt.%. In yet other embodiments, the insoluble calcium salts are
individually present in the liquid nutritional products in amounts ranging from about
0.2 wt.% to about 0.8 wt.%, including from about 0.3 wt.% to about 0.7 wt.%,
including from about 0.4 wt.% to about 0.6 wt.% and including about 0.5 wt.%.
Emulsifier
[0038] The liquid nutritional formulations of the present disclosure further
comprise at least one emulsifier in combination with the insoluble calcium salts. The
emulsifier is desirably monoglycerides (including distilled monoglycerides) and may
include, but is not limited to, monoglycerides, diglycerides, triglycerides, free
glycerol, free fatty acids, and combinations thereof. Other suitable emulsifiers for
use in the liquid nutritional formulations include lecithins. Other suitable emulsifiers
for use include both monoglycerides and/or diglycerides in combination with lecithin.
The emulsifier may act to suspend/trap the calcium salts and allow the calcium salts to
remain in solution for longer periods of time. Further, the emulsifier is capable of resuspending
the insoluble calcium salts should any precipitation occur.
[0039] The emulsifiers are present in the liquid nutritional formulations in
amounts of no more than 12% by weight of total fat component included in the liquid
nutritional product, including no more than 6% by weight of total fat component
included in the liquid nutritional product, including from about 0.5% to about 10% by
weight of total fat component included in the liquid nutritional product, including
from about 2% to about 8% by weight of total fat component included in the liquid
nutritional product, and also including from 4.5% to about 7% by weight of total fat
component included in the liquid nutritional product. In one exemplary embodiment,
monoglycerides and lecithin are included as emulsifiers in the liquid nutritional
product, wherein about 6% by weight of total fat component is monoglycerides and
about 1.5% by weight of total fat component is lecithin.
[0040] In accordance with the present disclosure, the liquid nutritional
products that include the at least two insoluble calcium salts having different average
particle sizes in combination with the emulsifier, desirably the distilled
monoglycerides, can be formulated such that additional stabilizers are not required to
produce a commercially suitable product. Specifically, the liquid nutritional products
can be formulated to be substantially carrageenan-free, including completely
carrageenan-free.
Protein
[0041] The liquid nutritional products may further comprise any protein or
sources thereof that are suitable for use in oral liquid nutritional products and are
compatible with the essential elements and features of such products. Total protein
concentrations in the liquid nutritional products may range from about 0.5% to about
30%, including from about 1% to about 15%, and also including from about 2% to
about 10%, by weight of the liquid nutritional product.
[0042] Non-limiting examples of suitable protein or sources thereof for use
in the nutritional products include hydrolyzed, partially hydrolyzed or non-hydrolyzed
proteins or protein sources, which may be derived from any known or otherwise
suitable source such as milk (e.g., casein, whey), animal (e.g., meat, fish), cereal (e.g.,
rice, corn), vegetable (e.g., soy) or combinations thereof. Non-limiting examples of
such proteins include milk protein isolates, milk protein concentrates as described
herein, casein protein isolates, whey protein, sodium or calcium caseinates, whole
cow's milk, partially or completely defatted milk, soy protein isolates, soy protein
concentrates, and so forth.
Carbohydrate
[0043] The liquid nutritional products may further comprise any
carbohydrates or sources thereof that are suitable for use in an oral liquid nutritional
product and are compatible with the essential elements and features of such products.
Carbohydrate concentrations in the liquid nutritional products, for example, may
range from about 5% to about 40%, including from about 7% to about 30%, and
including from about 10% to about 25%, by weight of the liquid nutritional
composition.
[0044] Non-limiting examples of suitable carbohydrates or sources thereof
for use in the nutritional products described herein may include maltodextrin, glucose
polymers, corn syrup, corn syrup solids, rice-derived carbohydrates, sucrose, glucose,
fructose, lactose, high fructose corn syrup, honey, sugar alcohols (e.g., maltitol,
erythritol, sorbitol), artificial sweeteners (e.g., sucralose, acesulfame potassium,
stevia) and combinations thereof.
Fat
[0045] In addition to the emulsifier described above, the liquid nutritional
products comprise additional fat or sources thereof, most typically as emulsified fat,
concentrations of which may range from about 1% to about 30%, including from
about 2% to about 15%, and also including from about 4% to about 10%, by weight of
the liquid nutritional composition.
[0046] Suitable sources of additional fat for use herein include any fat or fat
source that is suitable for use in an oral liquid nutritional product and is compatible
with the essential elements and features of such products.
[0047] Non-limiting examples of suitable fats or sources thereof for use in the
liquid nutritional products described herein include coconut oil, fractionated coconut
oil, soy oil, corn oil, olive oil, safflower oil, high oleic safflower oil, MCT oil
(medium chain triglycerides), sunflower oil, high oleic sunflower oil, palm and palm
kernel oils, palm olein, canola oil, marine oils, cottonseed oils, and combinations
thereof.
[0048] The amount of protein, fats, and proteins, if present, in any of the
liquid nutritional products described herein may also be characterized in addition to,
or in the alternative, as a percentage of total calories in the nutritional product as set
forth in the following table. These macronutrients for liquid nutritional products of
the present disclosure are most typically formulated within any of the caloric ranges
(embodiments A-F) described in the following table (each numerical value is
preceded by the term "about").
Nutrient & Total Cal. Embodiment A Embodiment B Embodiment C
Carbohydrate 0-98 2-96 10-75
Protein 0-98 2-96 5-70
Fat 0-98 2-96 20-85
Embodiment D Embodiment E Embodiment F
Carbohydrate 30-50 25-50 25-50
Protein 15-35 10-30 5-30
Fat 35-55 1-20 2-20
[0049] In one specific example, liquid infant formulas (both ready-to-feed
and concentrated liquids) include those embodiments in which the protein component
may comprise from about 7.5% to about 25% of the caloric content of the formula;
the carbohydrate component may comprise from about 35% to about 50% of the total
caloric content of the infant formula; and the fat component (inclusive of the
emulsifier) may comprise from about 30% to about 60% of the total caloric content of
the infant formula. These ranges are provided as examples only, and are not intended
to be limiting. Additional suitable ranges are noted in the following table (each
numerical value is preceded by the term "about").
Optional Ingredients
[0050] The liquid nutritional products described herein may further comprise
other optional ingredients that may modify the physical, chemical, hedonic or
processing characteristics of the products or serve as pharmaceutical or additional
nutritional components when used in the targeted population. Many such optional
ingredients are known or otherwise suitable for use in other nutritional products and
may also be used in the nutritional products described herein, provided that such
optional ingredients are safe and effective for oral administration and are compatible
with the essential and other ingredients in the selected product form.
[005 1] Non-limiting examples of such optional ingredients include
preservatives, antioxidants, emulsifying agents, buffers, pharmaceutical actives,
additional nutrients as described herein, colorants, flavors, thickeners, and so forth.
While not required, additional stabilizers may also be included without deviating from
the present disclosure.
[0052] The products may further comprise vitamins or related nutrients, nonlimiting
examples of which include vitamin A, vitamin D, vitamin E, vitamin K,
thiamine, riboflavin, pyridoxine, vitamin B12, carotenoids, niacin, folic acid,
pantothenic acid, biotin, vitamin C, choline, inositol, salts, and derivatives thereof,
and combinations thereof.
[0053] The products may further comprise minerals (in addition to the
insoluble calcium salts), non-limiting examples of which include phosphorus,
magnesium, iron, zinc, manganese, copper, sodium, potassium, molybdenum,
chromium, selenium, chloride, and combinations thereof.
[0054] The products may also include one or more flavoring or masking
agents. Suitable flavoring or masking agents include natural and artificial sweeteners,
sodium sources such as sodium chloride, and hydrocolloids, and combinations
thereof.
Methods of Manufacture
[0055] The liquid nutritional products for use herein may be manufactured
by any known or otherwise suitable method for making the nutritional product form
selected. Nutritional liquids may be prepared, for example, by any of the well known
methods of formulating nutritional liquids by way of retort, aseptic packaging, or hot
fill processing methods. Such methods are well known in the nutrition formulation
and manufacturing arts.
[0056] In one suitable manufacturing process, for example, at least three
separate slurries are prepared, including a protein-in-fat (PIF) slurry, a carbohydratemineral
(CHO-MIN) slurry, a protein-in-water (PIW) slurry. The PIF slurry is formed
by heating and mixing an oil blend (e.g., canola oil, corn oil, etc) and then adding an
emulsifier, fat soluble vitamins, and a portion of the total protein (e.g., milk protein
concentrate, etc) with continued heat and agitation. The CHO-MIN slurry is formed
by adding with heated agitation to water: minerals (e.g., potassium citrate,
dipotassium phosphate, sodium citrate, etc) and trace and ultra trace minerals
(TM/UTM premix). The resulting CHO-MIN slurry is held for 10 minutes with
continued heat and agitation before adding additional minerals (e.g., potassium
chloride, magnesium carbonate, potassium iodide, etc) or carbohydrates (e.g., HMOs,
fructooligosaccharide, sucrose, corn syrup, etc), or both. The PIW slurry is then
formed by mixing with heat and agitation the remaining protein, if any.
[0057] The resulting slurries are then blended together with heated agitation
and the pH adjusted to 6.5 - 7.6, after which the composition is subjected to hightemperature
short-time (HTST) processing during which the composition is heat
treated, emulsified and homogenized, and then allowed to cool. Water soluble
vitamins and ascorbic acid are added, the pH is adjusted to the desired range if
necessary, favors are added, and water is added to achieve the desired total solid level.
The composition is then aseptically packaged to form an aseptically packaged
nutritional emulsion. This emulsion can then be further diluted, heat-treated, and
packaged to form a ready-to-feed or concentrated liquid.
[0058] To form the stabilized liquid nutritional composition of the present
disclosure, the insoluble calcium salts in combination with the emulsifier are desirably
introduced into the PIF (also commonly referred to in the art as an "oil blend") slurry
prior to blending the slurries (PIF and CHO/MIN) to form the liquid nutritional
composition. It has been found that by adding the insoluble calcium salts and
emulsifier with the oil blend of the PIF slurry, calcium remains in suspension for a
longer period of time. Further, any calcium salts that may fall out of suspension are
more easily re-suspended when the calcium salt is added to the oil blend during
manufacturing.
Methods of Use
[0059] The liquid nutritional compositions as described herein comprise
insoluble calcium salt and emulsifiers that not only provide sufficient nutritional
benefits for individuals, but also allow for an improved stabilized liquid nutritional
product having universal acceptance. More particularly, the stabilized liquid
nutritional product may provide for homogenous and precise delivery of calcium, as
well as other micro and minor nutrients, to infants and toddlers.
[0060] Further, the stabilized liquid nutritional products remain in a single
homogenous phase; that is, without physical separation for longer periods of time,
allowing for a more aesthetic pleasing product. Surprisingly, the stabilized liquid
nutritional products, having no sedimentation or phase separation, can be maintained
for at least 12 hours, including at least 18 hours, including at least 24 hours, and also
including at least 48 hours.
[0061] The physically stable nutritional product of the present disclosure is
prepared without the use of carrageenan or other added stabilizer. More particularly,
the liquid nutritional products of the present disclosure are substantially free of
carrageenan; that is, the nutritional products include carrageenan in an amount of less
than 1% by weight, including less than 0.5%, including less than 0.1%, including less
than 0.01%, and also including zero percent by weight of the nutritional product.
EXAMPLES
[0062] The following examples illustrate specific embodiments and or
features of the nutritional products of the present disclosure. The examples are given
solely for the purpose of illustration and are not to be construed as limitations of the
present disclosure, as many variations thereof are possible without departing from the
spirit and scope of the disclosure. All exemplified amounts are weight percentages
based upon the total weight of the composition, unless otherwise specified.
[0063] The exemplified compositions are nutritional products prepared in
accordance with manufacturing methods well known in the nutrition industry for
preparing nutritional emulsions, and nutritional non-emulsions (e.g., substantially
clear nutritional liquids).
Example 1
[0064] In this Example, the stability after six months of infant formulas
prepared with tricalcium phosphate, calcium citrate, and calcium carbonate as
stabilizers was analyzed and compared to the stability after six months of infant
formulas prepared with carrageenan.
[0065] Liquid infant formulas were prepared using the methods described
herein. Two control formulas were prepared including carrageenan as the stabilizer.
Two additional test formulas were prepared replacing the carrageenan with three
insoluble calcium salts, tricalcium phosphate, calcium citrate and calcium carbonate,
present in a weight ratio of tricalcium phosphate:calcium citrate:calcium carbonate of
about 40:30:30.
[0066] Immediately after preparation, the amounts of calcium and phosphate
in solution were determined in the formulas. After 6 months, the formulas were
shaken, three cycles/second for four seconds, and the amounts of calcium and
phosphate in solution were again determined in the formulas. The results are shown
in the table below.
Table: Calcium (mg/100 g) and Phosphorous (mg/100 g) Recovery at 6 months
[0067] As shown in the table, the amount of calcium in solution was the
same or even higher as compared to the amount at initial preparation upon shaking the
formulas after 6 months using the insoluble salts or carrageenan as stabilizers.
Similarly, the amount of phosphate in solution was the same or even higher as
compared to the amount at initial preparation upon shaking the formulas after 6
months using the insoluble salts or carrageenan as stabilizers. Further, it was shown
that the insoluble salts behaved as well or better than the carrageenan as stabilizers in
the infant formulas.
Examples 2-6
[0068] Examples 2-6 illustrate nutritional emulsions of the present
disclosure including insoluble calcium salts and monoglycerides, the ingredients of
which are listed in the table below. All ingredient amounts are listed as kilogram per
approximately 1000 kg batch of product, unless otherwise specified.
[0069] The nutritional emulsions were prepared by making at least two
separate slurries that were later blended together, heat treated, standardized, and
terminally sterilized. Initially, a carbohydrate-mineral slurry was prepared by
dissolving the selected carbohydrates (e.g. lactose, galactooligosaccharides) in water
at 74-79°C, followed by the addition of citric acid, magnesium chloride, potassium
chloride, potassium citrate, choline chloride, and sodium chloride. The resulting
slurry was held under moderate agitation at 49-60°C until it was later blended with the
other prepared slurries.
[0070] A protein-in-fat slurry was prepared by combining the high oleic
safflower oil, coconut oil, monoglycerides and soy lecithin under agitation and
heating to 66-79°C. Following a 10-15 minute hold time, soybean oil, mixed
carotenoid premix, vitamin A, calcium carbonate, tricalcium phosphate, ARA oil,
DHA oil, and whey protein concentrate were then added to the slurry. The resulting
oil slurry was held under moderate agitation at 49-60°C until it was later blended with
the other prepared slurries.
[007 1] Water was heated to 49-60°C and then combined with the
carbohydrate-mineral slurry, nonfat milk, and the protein-in-fat slurry under adequate
agitation. The pH of the resulting blend was adjusted with potassium hydroxide. This
blend was held under moderate agitation at 49-60°C.
[0072] The resulting blend was heated to 74-79°C, emulsified through a
single stage homogenizer to 900-1 100 psig, and then heated to 144-147°C, for about 5
seconds. The heated blend was passed through a flash cooler to reduce the
temperature to 88-93°C and then through a plate cooler to further reduce the
temperature to 74-85°C. The cooled blend was then homogenized at 2900-3 100/400-
600 psig, held at 74-85°C for 16 seconds, and then cooled to 2-7°C. Samples were
taken for analytical testing. The mixture was held under agitation at 2-7°C.
[0073] A water-soluble vitamin (WSV) solution and an ascorbic acid
solution were prepared separately and added to the processed blended slurry. The
vitamin solution was prepared by adding the following ingredients to water with
agitation: potassium citrate, ferrous sulfate, WSV premix, L-carnitine, potassium
phosphate, riboflavin, inositol, and the nucleotide-choline premix. The ascorbic acid
solution was prepared by adding potassium hydroxide and ascorbic acid to a sufficient
amount of water to dissolve the ingredients. The ascorbic acid solution pH was then
adjusted to 5-9 with potassium hydroxide.
[0074] The blend pH was adjusted to a specified pH range of 6.5-7.6 with
potassium hydroxide (varied by product) to achieve optimal product stability. The
completed product was then filled into suitable containers and thermally sterilized.
particle size 2.30 mhi )
Magnesium chloride 118 g 118 g 118 g 8 g 118 g
Mixed carotenoid premix 72.9 g 72.9 g 72.9 g 72.9 g 72.9 g
Vitamin A, D3, E and K 48.2 g 48.2 g 48.2 g 48.2 g 48.2 g
premix pediatric products
Choline Chloride 45 g 45 g 45 g 45 g 45 g
Ferrous sulfate 29 g 29 g 29 g 29 g 29 g
Zinc sulfate .9 g 17.9 g 17.9 g 17.9 g 17.9 g
L-Carnitine 5.5 g 5.5 g 5.5 g 5.5 g 5.5 g
Cupric sulfate 1.9 g 1.9 g 1.9 g 1.9 g 1.9 g
Manganese sulfate 09 mg 109 mg 109 mg 109 mg 109 mg
Examples 7-11
[0075] Examples 7-11 illustrate nutritional emulsions of the present
disclosure including insoluble calcium salts and monoglycerides, the ingredients of
which are listed in the table below. All ingredient amounts are listed as kilogram per
approximately 1000 kg batch of product, unless otherwise specified.
[0076] The nutritional emulsions were prepared by making at least two
separate slurries that were later blended together, heat treated, standardized, and
terminally sterilized as described in Examples 2-6.
Potassium Chloride 186 g 186 g 186 g 186 g 186 g
Nucleotide-Choline Premix 100.6 g 100.6 g 100.6 g 100.6 g 100.6 g
Ferrous Sulfate 76.1 g 76.1 g 76.1 g 76.1 g 76.1 g
Vitamin DEK premix 59.2 g 59.2 g 59.2 g 59.2 g 59.2 g
Choline Chloride 48.1 g 48.1 g 48.1 g 48.1 g 48.1 g
Vitamin A (55%) 9.69 g 9.69 g 9.69 g 9.69 g 9.69 g
Potassium Citrate - Non GMO 6.84 g 6.84 g 6.84 g 6.84 g 6.84 g
Copper Sulfate 3.53 g 3.53 g 3.53 g 3.53 g 3.53 g
Riboflavin Non-GMO 292 mg 292 mg 292 mg 292 mg 292 mg
Manganese Sulfate 109 mg 109 mg 109 mg 109 mg 109 mg
Sodium Chloride As needed As needed As needed As needed As needed
Examples 12-16
[0077] Examples 12-16 illustrate nutritional emulsions of the present
disclosure including insoluble calcium salts and monoglycerides, the ingredients of
which are listed in the table below. All ingredient amounts are listed as kilogram per
approximately 1000 kg batch of product, unless otherwise specified.
[0078] The nutritional emulsions were prepared by making at least two
separate slurries that were later blended together, heat treated, standardized, and
terminally sterilized as described in Examples 2-6.
Sodium Citrate 250 g 250 g 250 g 250 g 250 g
DHA Algal Oil 230 g 230 g 230 g 230 g 230 g
Potassium Chloride 138 g 138 g 138 g 138 g 138 g
Calcium Carbonate (avg. particle
size 2.74 mi ) 145g 160 g 152 g 138 g 130 g
Vitamin ADE premix 82.60 g 82.60 g 82.60 g 82.60 g 82.60 g
Ferrous Sulfate 48.93 g 48.93 g 48.93 g 48.93 g 48.93 g
Choline Chloride 35.00 g 35.00 g 35.00 g 35.00 g 35.00 g
L-Carnitine 30.70 g 30.70 g 30.70 g 30.70 g 30.70 g
Beta-carotene 1.61 g 1.61 g 1.61 g 1.61 g 1.61 g
Vitamin A 1.610 g 1.610 g 1.610 g 1.610 g 1.610 g
Vitamin A Palmitate 880 mg 880 mg 880 mg 880 mg 880 mg
Sodium Chloride as needed as needed as needed as needed as needed
Potassium Phosphate as needed as needed as needed as needed as needed
Examples 17-21
[0079] Examples 1 - 1 illustrate nutritional emulsions of the present
disclosure including insoluble calcium salts and monoglycerides, the ingredients of
which are listed in the table below. All ingredient amounts are listed as kilogram per
approximately 1000 kg batch of product, unless otherwise specified.
[0080] The nutritional emulsions were prepared by making at least two
separate slurries that were later blended together, heat treated, standardized, and
terminally sterilized as described in Examples 2-6.
Calcium Carbonate(avg. particle size
2.74 mp ) 1.82 2.0 1.91 1.73 1.64
Nucleotide-Choline Premix 293.3 g 293.3 g 293.3 g 293.3 g 293.3 g
Potassium Citrate 288.7 g 288.7 g 288.7 g 288.7 g 288.7 g
DHA Algal Oil 272.0 g 272.0 g 272.0 g 272.0 g 272.0 g
Potassium Chloride 233.0 g 233.0 g 233.0 g 233.0 g 233.0 g
Vitamin ADE Premix 98.9 g 98.9 g 98.9 g 98.9 g 98.9 g
Ferrous Sulfate 58.30 g 58.30 g 58.30 g 58.30 g 58.30 g
Choline Chloride 48. 10 g 48. 10 g 48. 10 g 48. 10 g 48. 10 g
L-Carnitine 36.60 g 36.60 g 36.60 g 36.60 g 36.60 g
Beta- Carotene 1.68 g 1.68 g 1.68 g 1.68 g 1.68 g
Vitamin A 870 mg 870 mg 870 mg 870 mg 870 mg
Vitamin A Palmitate 478 mg 478 mg 478 mg 478 mg 478 mg
Sodium Chloride As needed As needed As needed As needed As needed
Potassium Phosphate As needed As needed As needed As needed As needed
Examples 22-26
[0081] Examples 22-26 illustrate nutritional emulsions of the present
disclosure including insoluble calcium salts and monoglycerides, the ingredients of
which are listed in the table below. All ingredient amounts are listed as kilogram per
approximately 1000 kg batch of product, unless otherwise specified.
[0082] The nutritional emulsions were prepared by making at least two
separate slurries that were later blended together, heat treated, standardized, and
terminally sterilized as described in Examples 2-6.
Magnesium Chloride 554 g 554 g 554 g 554 g 554 g
AA Fungal Oil 541 g 541 g 541 g 541 g 541 g
Sodium Citrate 438.5 g 438.5 g 438.5 g 438.5 g 438.5 g
Nucleotide-Choline Premix 366.5 g 366.5 g 366.5 g 366.5 g 366.5 g
DHA Algal Oil 339.0 g 339.0 g 339.0 g 339.0 g 339.0 g
Vitamin A, D3,E,K1 Premix 123.60 g 123.60 g 123.60 g 123.60 g 123.60 g
Ferrous Sulfate 72.97 g 72.97 g 72.97 g 72.97 g 72.97 g
Choline Chloride 60.07 g 60.07 g 60.07 g 60.07 g 60.07 g
L-Carnitine 40.34 g 40.34 g 40.34 g 40.34 g 40.34 g
Potassium Citrate (2) 4.60 g 4.60 g 4.60 g 4.60 g 4.60 g
Thiamine HCL 4.34g 4.34g 4.34g 4.34g 4.34g
Riboflavin 1.76g 1.76g 1.76g 1.76g 1.76g
Vitamin A 463 mg 463 mg 463 mg 463 mg 463 mg
Vitamin A Palmitate 254 mg 254 mg 254 mg 254 mg 254 mg
Beta-carotene 210 mg 210 mg 210 mg 210 mg 210 mg
Potassium Citrate (1) as needed as needed as needed as needed as needed
Potassium Chloride as needed as needed as needed as needed as needed
Potassium Phosphate as needed as needed as needed as needed as needed
Examples 27-31
[0083] Examples 27-3 1 illustrate nutritional emulsions of the present
disclosure including insoluble calcium salts and monoglycerides, the ingredients of
which are listed in the table below. All ingredient amounts are listed as kilogram per
approximately 1000 kg batch of product, unless otherwise specified.
[0084] The nutritional emulsions were prepared by making at least two
separate slurries that were later blended together, heat treated, standardized, and
terminally sterilized as described in Examples 2-6.
Vit/Min/Taur Premix 642 g 642 g 642 g 642 g 642 g
Calcium Carbonate (avg. particle
size 2.48 mi ) 500 g 475 g 450 g 525 g 550 g
Soy Lecithin 433 g 433 g 433 g 433 g 433 g
Monoglycerides 1.5 1.5 1.5 1.5 1.5
AA Fungal Oil 433 g 433 g 433 g 433 g 433 g
Magnesium Chloride 424 g 424 g 424 g 424 g 424 g
Nucleotide-Choline Premix 293 g 293 g 293 g 293 g 293 g
DHA Algal Oil 272 g 272 g 272 g 272 g 272 g
Potassium Citrate 261 g 261 g 261 g 261 g 261 g
Sodium Citrate 203 g 203 g 203 g 203 g 203 g
Potassium Chloride 196 g 196 g 196 g 196 g 196 g
Mixed Carotenoids Suspension 110.23 g 110.23 g 110.23 g 110.23 g 110.23 g
Vitamin ADE Premix 98.9 g 98.9 g 98.9 g 98.9 g 98.9 g
Ferrous Sulfate 58.4 g 58.4 g 58.4 g 58.4 g 58.4 g
Choline Chloride 48. 1 g 48. 1 g 48. 1 g 48. 1 g 48. 1 g
L-Carnitine 36.6 g 36.6 g 36.6 g 36.6 g 36.6 g
Riboflavin 2.1 1 g 2.11 g 2.11 g 2.1 1 g 2.1 1 g
Vitamin A 1.25 g 1.25 g 1.25 g 1.25 g 1.25 g
Vitamin A Palmitate 685 mg 685 mg 685 mg 685 mg 685 mg
Sodium Chloride as needed as needed as needed as needed as needed
Potassium Phosphate as needed as needed as needed as needed as needed

WHAT IS CLAIMED IS:
1. A stabilized liquid nutritional composition comprising a first insoluble
calcium salt, a second insoluble calcium salt, an emulsifier, and a fat, wherein the first
insoluble calcium salt and the second insoluble calcium salt have different average
particle sizes.
2. The stabilized liquid nutritional composition of claim 1 further
comprising a third insoluble calcium salt having an average particle size different
from the first insoluble calcium salt and the second insoluble calcium salt.
3. The stabilized liquid nutritional composition of claim 1 wherein the
emulsifier comprises monoglycerides.
4. The stabilized liquid nutritional composition of claim 3 wherein the
emulsifier further comprises diglycerides.
5. The stabilized liquid nutritional composition of claim 1 wherein the
first insoluble calcium salt has an average particle size of from about 1.5 mih to about
2.5 mih and the second insoluble calcium salt has an average particle size of from
about 2 mh to about 3 mih.
6. The stabilized liquid nutritional composition of claim 5 wherein the
third insoluble calcium salt has an average particle size of from about 2.5 mih to about
4.5 mih.
7. The stabilized liquid nutritional composition of claim 1 wherein the
first insoluble calcium salt and the second insoluble calcium salt are present in a total
amount of from about 0.02 wt.% to about 1 wt.%.
8. The stabilized liquid nutritional composition of claim 7 wherein the
first insoluble calcium salt and the second insoluble calcium salt are present in a
weight ratio of from about 20:80 to about 80:20.
9. The stabilized liquid nutritional composition of claim 1 wherein the
first insoluble calcium salt and the second insoluble calcium salt are selected from the
group consisting of calcium carbonate, calcium citrate, calcium phosphate, dicalcium
phosphate, tricalcium phosphate, and combinations thereof.
10. The stabilized liquid nutritional composition of claim 1 wherein the
emulsifier is present in an amount of no more than 12% by weight of total fat in the
liquid nutritional composition.
11. The stabilized liquid nutritional composition of claim 10 wherein the
emulsifier comprises monoglycerides.
12. The stabilized liquid nutritional composition of claim 1 wherein the
liquid nutritional composition is substantially free of carrageenan.
13. A stabilized liquid infant formula comprising a first insoluble calcium
salt, a second insoluble calcium salt, an emulsifier, and a fat, wherein the first
insoluble calcium salt and the second insoluble calcium salts have different average
particle sizes, wherein the first insoluble calcium salt and the second insoluble
calcium salt are selected from the group consisting of calcium carbonate, calcium
citrate, calcium phosphate, dicalcium phosphate, tricalcium phosphate, and
combinations thereof, and wherein the emulsifier comprises monoglycerides.
14. The stabilized liquid infant formula of claim 13 wherein the first
insoluble calcium salt has an average particle size of from about 1.5 mih to about 2.5
mh and the second insoluble calcium salt has an average particle size of from about 2
mh to about 3 mih.
15. The stabilized liquid infant formula of claim 13 wherein the emulsifier
additionally comprises diglycerides.
16. The stabilized liquid infant formula of claim 13 wherein the liquid
nutritional composition is substantially free of carrageenan.
17. A process for manufacturing a stabilized liquid nutritional
composition, the process comprising:
introducing a first insoluble calcium salt, a second insoluble calcium salt, and
an emulsifier with a fat to form a fat blend, wherein the first insoluble calcium salt
and the second insoluble calcium salt have different average particle sizes, and
wherein the emulsifier comprises monoglycerides; and
mixing the fat blend with a carbohydrate blend to form the stabilized liquid.
18. The process of claim 17 wherein the first insoluble calcium salt has an
average particle size of from about 1.5 mih to about 2.5 mih and the second insoluble
calcium salt has an average particle size of from about 2 mh to about 3 mih.
19. The process of claim 17 wherein the fat blend additionally comprises a
third insoluble calcium salt, the third insoluble calcium salt having an average particle
size different that the first insoluble calcium salt and the second insoluble calcium
salt.