METHODS FOR REDUCING MICROBIAL
CONTAMINATION OF DRYBLENDED
POWDERED NUTRITIONAL COMPOSITIONS
CROSS REFERENCE TO RELATED APPLICATIONS
The present invention hereby claims the benefit of the provisional patent
application Serial No. 61/581,458, filed December 29, 201 1, the disclosure of
which is hereby incorporated by reference in its entirety.
FIELD OF THE DISCLOSURE
[000 ] The present disclosure relates to methods of inactivating microbes
in dry ingredients, dryblended powdered nutritional compositions, and spray dried
nutritional compositions. More particularly, the dry ingredients or compositions are
heat treated at a temperature and for a period of time sufficient to inactivate microbes
present therein without substantially altering the physical and functional properties of
the dry ingredients and the resulting dryblended or spraydried powdered nutritional
composition.
BACKGROUND OF THE DISCLOSURE
[0002] Adult, pediatric, and infant manufactured nutritional
compositions comprising a targeted selection of nutritional 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 compositions
include nutritional powders that can be reconstituted with water or other aqueous
liquid. These nutritional powders may be dryblended nutritional powders that
include dry ingredients blended together or spray dried nutritional powders that may
optionally include one or more dryblended components.
[0003] Powdered infant formulas are especially popular for providing
nutrition early in life and their use continues to increase around the world. These
powdered infant formulas are typically prepared by making at least two separate
slurries that are first blended together. One slurry may be an aqueous-based slurry and
one may be an oil-based slurry. After blending, the resulting mixture is generally
heat-treated, standardized, heat-treated a second time, spray dried, agglomerated and
packaged. With this manufacturing process, a substantial amount of energy is
required to spray dry the composition and the drying process significantly increases
manufacturing time. Some beneficial ingredients in the formulas are potentially heat
sensitive and may possibly partially thermally degrade under some of the conditions
of heat treatments and spray drying. Other beneficial components may potentially be
highly reactive and should be handled with care during manufacturing to ensure that
they do not react, and subsequently degrade, with other nutritional ingredients present
in the composition. Accordingly, some of these sensitive ingredients and/or reactive
ingredients have been added to base nutritional powders that have been
conventionally prepared using a spray drying process by dryblending or drymixing
the ingredient into the base powder. With dryblending or drymixing, the ingredient is
introduced into a base powder, which is generally a spray dried base powder, after the
powder exits the spray drier. The ingredient is mixed into the base powder to create a
substantially homogeneous end dryblended composition.
[0004] Although dryblending or drymixing has been used to introduce
some heat sensitive or highly reactive nutritional components into a conventionally
prepared base powder, maintaining an acceptable level of microorganisms has been a
general concern for dryblending applications as an additional ingredient, that has not
generally been subjected to the heat treatments for sterilization, and is being added to a
powder previously subjected to a heat treatment. To date, the use of dryblending has
been generally somewhat limited to certain components, such as vitamins and
minerals, which are less susceptible to microbial contamination, including
contamination by Enterobacteriaceae, including Cronobacter sakazakii, such that the
risk of contamination of the end dryblended composition is reduced. Many
components, including proteins, have traditionally simply had too high of a risk of
potential microbial contamination to allow for safe dryblending or drymixing.
[0005] Accordingly, there is a continuing need in the art for methods of
preparing dryblended powdered nutritional compositions including dry ingredients
having a reduced risk of microbial contamination and an acceptable level of
microorganisms. Additionally, it would be advantageous if microbes in the dry
ingredients could be inactivated using conditions that will not compromise the physical
quality and function of the ingredients so as not to deteriorate the final nutritional
composition. It would also be advantageous if the dryblended ingredient could be
treated for microbial contamination prior to or after introduction into the
commercial base powder.
SUMMARY OF THE DISCLOSURE
[0006] The present disclosure is directed to methods of reducing the
microbial contamination of dry ingredients for use in dryblended compositions, and
to methods of reducing the microbial contamination of dryblended compositions.
The methods described herein utilize heat treatment methods that are capable of
significantly reducing the microbial content of a single dry ingredient or dryblended
composition without substantially altering the nutritional or physical quality of the
ingredient or composition. The heat treatment methods are easy to use, safe and
provide a dry ingredient or dryblended composition with a high degree of microbial
inactivation.
[0007] One embodiment of the present disclosure is directed to a method
of inactivating microbes in a dry ingredient, the method comprising subjecting the
dry ingredient to a heat treatment at a temperature of greater than 48°C to no greater
than 60°C for a period of from 2 days to about 30 days.
[0008] Another embodiment of the present disclosure is directed to a
method of preparing a dryblended powdered nutritional composition, the
dryblended powdered nutritional composition comprising at least one dry
ingredient. The method comprises subjecting the dry ingredient to a heat treatment
at a temperature of greater than 48°C to no greater than 60°C for a period of from 2
days to about 30 days; and dryblending the heat treated dry ingredient with a base
powder to form the dryblended powdered nutritional composition.
[0009] Another embodiment of the present disclosure is directed to a
method of preparing a dryblended powdered nutritional composition, the dryblended
powdered nutritional composition comprising at least one dry ingredient. The method
comprises dryblending the dry ingredient with a base powder to form the dryblended
powdered nutritional composition; and subjecting the dryblended powdered
nutritional composition to a heat treatment at a temperature of greater than 48°C to
no greater than 60°C for a period of from 2 days to about 30 days.
[0010] Another embodiment of the present disclosure is directed to a
method of preparing a powdered nutritional composition. The method comprises
subjecting the powdered nutritional composition to a heat treatment at a temperature
of greater than 48°C to no greater than 60°C for a period of from 2 days to about 30
days.
[001 ] It has been unexpectedly found that microbes present in dry
ingredients can be inactivated under relatively low temperatures when held at the
low temperatures for a relatively long time period. By treating dry ingredients under
these conditions, dryblended powdered nutritional compositions can be prepared
with reduced risk of microbial contamination without compromising the physical
and functional properties of the dry ingredient. That is, the dry ingredients can be
treated without reducing or eliminating the nutritional benefits provided from such
ingredients. This is a significant finding as conventional heat treatments have
invariably lead to at least some change in the physical and/or functional properties
of the treated ingredient.
DETAILED DESCRIPTION OF THE DISCLOSURE
[0012] The methods of the present disclosure provide for dry ingredients
and dryblended powdered nutritional compositions including the dry ingredients that
have been heat treated under conditions sufficient to inactivate microbes without
altering, or substantially altering, the physical and functional properties of the dry
ingredient and dryblended powdered composition. The methods described in the
present disclosure address and overcome the longstanding problem of microbial
contamination in dry ingredients that can be used in dryblended nutritional
compositions, as well as the resulting dryblended compositions themselves. Although
prior methods of reducing the microbial load in dry ingredients have been available,
these methods have had the tendency to potentially change the functional, physical,
and/or nutritional quality of the dry ingredient and resulting dryblended composition.
Additionally, such methods have not been particularly convenient to utilize during
the manufacturing process.
[0013] The methods described herein offer a new alternative means for
reducing the microbial load of dry ingredients and dryblended nutritional
compositions by subjecting the ingredient and/or composition to a new low
temperature heat treatment over a longer period of time than conventionally used,
such that the dry ingredient and resulting dryblended composition are not
substantially altered functionally, physically or nutritionally and have a reduced
microbial content. Conveniently, the methods of the present disclosure can easily be
utilized with dry ingredients in original packaging as received so that the dry
ingredient can be treated as received just prior to dryblending. The low temperature
heat treatment methods described herein advantageously do not require any special
handling or special processing steps prior to heat treatment for microbial load
reduction. As such, the present disclosure provides for an easy and cost effective
means of reducing the microbial loads of dry ingredients and/or dryblended
compositions that may be carried out in a number of commercial locations,
including the warehouse where the ingredients are stored prior to use or where the
dryblended compositions are stored after manufacture.
[0014] These and other optional elements or limitations of the methods
and nutritional compositions prepared by the methods of the present disclosure are
described in detail hereafter.
[0015] The term "dryblended powdered nutritional composition" as used
herein, unless otherwise specified, refers to nutritional compositions prepared by
mixing at least one dry component or ingredient to form a nutritional base powder
or, by the addition of a dry, powdered or granulated component or ingredient to a
base powder to form the powdered nutritional composition. The powdered
nutritional compositions are reconstitutable with an aqueous liquid and are suitable
for oral administration to a human. It should be understood that the nutritional base
powder may be prepared using solely dryblending processes or other conventional
wet processes known in the art that utilized heat steps and drying steps.
[0016] The terms "dry component" or "dry ingredient" as used herein,
unless otherwise specified, are used interchangeably to refer to an ingredient having
up to 7% by weight moisture (i.e., water), including less than 6.5% by weight
moisture, including less than 6.0% by weight moisture, including less than 5.5% by
weight moisture, including less than 5.0% by weight moisture, including less than
4.5% by weight moisture, including less than 4% by weight moisture, including less
than 3.5% by weight moisture, including less than 3% by weight moisture, including
less than 2.5% by weight moisture, including less than 2% by weight moisture,
including less than 1.5% by weight moisture, including less than 1% by weight
moisture, and including less than 0.5% by weight moisture, and including 0% by
weight moisture.
[0017] The term "infant formula" as used herein, unless otherwise
specified, refers to solid infant formulas and toddler 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.
[0018] The term "preterm infant formula" as used herein, unless
otherwise specified, refers to solid 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.
[0019] The terms "adult formula" and "adult nutritional product" as used
herein, are used interchangeably to refer to formulas for generally maintaining or
improving the health of an adult, and includes those formulas designed for adults
who have, are susceptible to, or are at risk of specific diseases and conditions.
[0020] 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.
[0021] The terms "inactivate" or "inactivating" as used herein, refer to
altering microbes such to put the microbes in a non-viable state; that is, a state in
which the microbial cells are non-culturable and are metabolically inactive. The
methods of the present disclosure inactivate at least 90% of the microbes present
in the dryblended ingredients, including at least 92% of the microbes present in
the dryblended ingredients, including at least 95% of the microbes present in the
dryblended ingredients, including at least 97% of the microbes present in the
dryblended ingredients, including at least 98% of the microbes present in the
dryblended ingredients, including at least 99% of the microbes present in the
dryblended ingredients, and also including at least 99.999% of the microbes in
the dryblended ingredients. Stated another way, the methods of the present
disclosure provide at least a 1 log, or even a 2 log, or even a 3 log, or even a 4
log, or even a 5 log or more reduction to complete inactivation.
[0022] The terms "microbe" or "microorganism" as used herein, are used
herein interchangeably to refer to organisms having a single cell, cell clusters or no
cell at all, and include, for example, bacteria, fungi, archaea, and protists, which can
cause disease.
[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 dryblended powdered nutritional
compositions prepared using the methods of the present disclosure may also be
substantially free of any optional or selected essential ingredient or feature described
herein, provided that the remaining dryblended powdered nutritional composition
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 powdered nutritional compositions contain less than a functional amount of
the optional ingredient, typically less than 0.1% by weight, and also including zero
percent by weight of such optional or selected essential ingredient.
[0027] The dryblended powdered nutritional compositions and
corresponding manufacturing methods of the present disclosure can comprise,
consist of, or consist essentially of the essential elements of the disclosure as
described herein, as well as any additional or optional element described herein or
otherwise useful in powdered nutritional composition applications.
Methods of Manufacture of Dryblended Nutritional Composition
[0028] The dryblended powdered nutritional compositions prepared in
accordance with the present disclosure include one or more dry ingredients that are
subjected to a low temperature heat treatment prior to incorporation into the
dryblended composition to inactivate microbes, thereby reducing the risk of
microbial contamination of the dryblended powdered nutritional compositions.
Alternatively, the dryblended powdered nutritional compositions can be prepared
including one or more dryblended components and the entire dryblended powdered
nutritional composition can be heat treated to inactivate microbes. As such, the
methods of the present disclosure are equally applicable to reducing the microbial
load of a single dry ingredient for use in a dryblending process and to reducing the
microbial load on an entire dryblended composition that may include one, two,
three or more dry ingredients that may or may not have been subjected to a separate
process for microbial load reduction.
[0029] The heat treatment to reduce the microbial load on the dry
ingredient and/or dryblended composition is typically conducted at a temperature
sufficient to inactivate a wide variety of microbes yet is not sufficiently harsh to lead
to a change in the physical and/or functional and/or nutritional properties of the
treated ingredients or composition. In order to meet these requirements, the heat
treatment is conducted at a temperature of greater than 48°C, but no greater than
60°C This temperature range has been found to be sufficient to inactivate microbes
without substantially negatively impacting the dry ingredient or dryblended
composition. Other suitable temperatures for the heat treatment include from about
50°C to 60°C, from about 50°C to about 58°C, and including from about 50°C to
about 55°C, and including specifically, 49°C, 50°C, 5 1°C, 52°C, 53°C, 54°C, 55°C,
56°C, 57°C, 58°C, 59°C, and 60°C. The heat treatment is conducted for a period of
at least 2 days, including from 2 days to about 30 days, including from 2 days to
about 28 days, including from 2 days to about 25 days, including from 2 days to
about 20 days, including from 2 days to about 18 days, including from 2 days to
about 16 days, including from 2 days to about 1 days, including from 2 days to
about 1 days, including from 2 days to about 10 days, including from 2 days to
about 9 days, including from 2 days to about 8 days, including from 2 days to about
6 days, and including from 2 days to about 4 days, including 3 days.
[0030] In one embodiment, the dry ingredient is subjected to the heat
treatment prior to being dryblended into a nutritional base powder. In an alternative
embodiment, the dry ingredient is first dryblended into the base powder to form a
dryblended powdered nutritional composition, and then the composition is subjected
to the heat treatment. The dry ingredient or the composition to be heat treated, may
be packaged and the package placed in the heat treatment conditions described
herein. Alternatively, the heat treatment may occur prior to packaging. For example,
the dryblended powdered nutritional composition including the dry ingredient may
be packaged and sealed in single or multi-use containers and then stored in a storage
facility or other housing that has been heated to a temperature of from greater than
48°C to no greater than 60°C for a period of from 2 days to about 30 days to
inactivate the microbes in the dry ingredient. In one specific embodiment, an
individual ingredient for dryblending is subjected to the heat treatment in the
package in which it is shipped; that is, the ingredient need not be removed from its
packaging prior to the heat treatment to obtain the benefits described herein.
[003 1] After heat treatment, the dry ingredient and/or the dryblended
powdered nutritional compositions prepared using the methods of the present
disclosure may be stored under ambient conditions for up to about 36 months or
longer, more typically from about 1 to about 24 months. For multi-use containers,
these packages can be opened and then covered for repeated use by the ultimate user,
provided that the covered package is then stored under ambient conditions (e.g., to
avoid high temperatures) and the contents used within about one month or so.
[0032] The nutritional base powders (into which one or more of the dry
ingredients are dryblended) of the present disclosure may be prepared by any
known or otherwise effective technique suitable for making and formulating a
nutritional base powder or similar other formula, variations of which may depend
upon variables such as the ingredient combination, packaging and container
selection, and so forth, for the desired nutritional base powder. Such techniques and
variations for any given formula are easily determined and applied by one of
ordinary skill in the nutritional base powder or manufacturing arts.
[0033] The nutritional base powders of the present disclosure, including
the exemplified formulas described hereinafter, can therefore be prepared by any of
a variety of known or otherwise effective composition or manufacturing methods.
These methods most typically involve the initial formation of an aqueous slurry
containing carbohydrates, proteins, lipids, stabilizers or other formulation aids,
vitamins, minerals, or combinations thereof. The slurry is emulsified, pasteurized,
homogenized, and cooled. Various other solutions, mixtures, or other materials may
be added to the resulting emulsion before, during, or after further processing. This
emulsion can then be further diluted, heat-treated, and subsequently dried via spraydrying
or the like to produce a nutritional base powder. Other suitable methods of
producing a nutritional base powder are described, for example, in U.S. Pat. No.
6,365,218 (Borschel, et al.), U.S. Pat. No. 6,589,576 (Borschel, et al.), U.S. Pat. No.
6,306,908 (Carlson, et al), U.S. Patent Application No. 200301 18703 (Nguyen , et
al.), all of which are hereby incorporated by reference to the extent they are
consistent herewith.
[0034] Once the nutritional base powder has been produced, the dry
ingredient as described above is dryblended into the nutritional base powder to
produce the dryblended powdered nutritional composition. The dry ingredient is
introduced into the nutritional base powder and thoroughly mixed into the
nutritional base powder using suitable conventional mixing equipment to produce a
substantially homogeneous nutritional powder.
Methods of Use
[0035] The methods of the present disclosure provide for the dryblending
of nutritional dry ingredients, including, for example, carbohydrates, proteins, fats,
vitamins, minerals, and the like, into nutritional base powders to prepare dryblended
nutritional powders that have a reduced microbial contamination. Particularly, by
subjecting the dry ingredients to the heat treatment described herein (or by
subjecting an entire dryblended composition to the heat treatments described
herein), the microbes of the dry ingredient (or composition) are inactivated so as to
prevent microbial growth in the resulting dryblended powdered nutritional
composition. The heat treatment inactivates at least 90% of the microbes present in
the dryblended ingredients, including at least 98% of the microbes, including at
least 99%, and also including at least 99.999% of the microbes in the dryblended
ingredients, as further discussed in detail below.
[0036] In one particular embodiment, the present disclosure provides a
method for the inactivation of microbes in a dry ingredient for use in a dryblended
powdered nutritional composition. In this particular embodiment, the method
includes subjecting the dry ingredient, which may be in the original packaging as
received from the supplier, to a heat treatment at a temperature of greater than 48°C
to no greater than 60°C for a period of from 2 days to about 30 days to inactivate
microbes located in the dry ingredient. Thereafter, the dry ingredient may be
dryblended into a nutritional powder with a reduced risk of microbial contamination.
[0037] Further, in another particular embodiment, the present disclosure
provides a method for the preparation of a dryblended powdered nutritional
composition that has a reduced microbial load. The dryblended powdered nutritional
composition comprises at least one dry ingredient, and the method includes
subjecting the dry ingredient to a heat treatment at a temperature of greater than
48°C to no greater than 60°C for a period of from 2 days to about 30 days to
inactivate microbes located in the dry ingredient. After this inactivation, the heat
treated dry ingredient is dryblended with a base powder to form the dryblended
powdered nutritional composition. The base powder may be a spray dried base
powder, or a dryblended base powder, for example.
[0038] In one other particular embodiment, the present disclosure
provides for a method of preparing a dryblended powdered nutritional composition.
In this method, the dryblended powdered nutritional composition includes at least
one dry ingredient. This method includes dryblending the dry ingredient with a base
powder, which could be a spray dried base powder or a dryblended base powder, to
form the dryblended powdered nutritional composition that is then subjected to a
heat treatment at a temperature of greater than 48°C to no greater than 60°C for a
period of from 2 days to about 30 days. The heat treatment reduces the microbial
load of the dryblended powdered nutritional composition.
[0039] Further, the heat treatment conditions used in the methods of the
present disclosure promote microbial inactivation while not altering or substantially
altering the physical and/or functional and/or nutritional properties of the dry
ingredient or dryblended composition; that is, the heat treatment conditions utilized
will not alter or substantially alter the physical characteristics or functional or
nutritional properties of the resulting dryblended nutritional compositions. This is
significant as the methods of inactivation of the present disclosure can be utilized
without changing or substantially changing the properties of the end product. This is
unlike heat treatments conventionally used for sterilization processes as these
treatments can impart some changes to the final compositions. Thus, the dry
ingredient can be incorporated into the dryblended powdered nutritional composition
to provide similar functional benefits to the composition as conventional dry
ingredients; however, the introduction of the dry ingredient into the composition will
not increase the risk of composition contamination.
[0040] Although the embodiments of the present disclosure are discussed
primarily herein with regards to dryblended powdered nutritional compositions and
dry ingredients used therein, it should be noted that the processes for inactivating
microbes of the present disclosure are equally applicable to non-dryblended
powdered nutritional compositions (e.g., spray dried nutritional compositions) that
are in need of microbial reduction. Such bioburden reduction can be achieved in any
powdered nutritional composition when the powdered nutritional compositions are
subjected to the times and temperatures of the numerous microbial inactivation
processes of the present disclosure. As with the processes for inactivating the
microbes in the dryblended powdered compositions and dry ingredients as described
herein, the microbial load in the non-dryblended powdered nutritional can be
reduced without significantly impacting the nutritional quality of the powdered
nutritional.
Product Form
[0041] The dryblended powdered nutritional compositions prepared by
the methods of the present disclosure and described in detail herein include at least
one dry ingredient dryblended into a base powder. These powders are typically in the
form of flowable or substantially flowable particulate compositions, or at least
particulate compositions that can be easily scooped and measured with a spoon or
other similar device, wherein the compositions can easily be reconstituted by the
intended user with a suitable aqueous liquid, typically water, to form a liquid
nutritional composition for immediate oral or enteral use. In this context,
"immediate" use generally means within about 48 hours, most typically within about
24 hours, preferably right after reconstitution.
[0042] The base powders for use in the dryblended nutritional powders
including the at least one dry ingredient, can be spray dried powders, agglomerated
powders, combinations thereof, or powders prepared by other suitable methods. In
some embodiments, the base powders include 100% by weight dryblended or dry
mixed ingredients.
[0043] The dryblended powdered nutritional compositions may be
formulated with sufficient kinds and amounts of nutrients so as to provide a sole,
primary, or supplemental source of nutrition, or to provide a specialized
powdered nutritional composition for use in individuals afflicted with specific
diseases or conditions.
[0044] Specific non-limiting examples of product forms prepared using
the methods as disclosed herein include, for example, dryblended powdered human
milk fortifiers, dryblended powdered preterm infant formulas, dryblended powdered
infant formulas, dryblended powdered elemental and semi-elemental formulas,
dryblended powdered pediatric formulas, dryblended powdered toddler formulas,
dryblended powdered adult formulas, and dryblended powdered medicinal formulas.
[0045] The dryblended powdered nutritional compositions may have a
caloric density tailored to the nutritional needs of the ultimate user, although in most
instances the reconstituted powders comprise from about 100 to about 900 kcal/240
mL, including from about 150 to about 350 kcal/240 mL, and also including from
about 200 to about 320 kcal/240 mL. Most common caloric densities for the infant
formula embodiments of the present disclosure are generally at least 19 kcal/fl oz
(660 kcal/liter), more typically from about 20 kcal/fl oz (675-680 kcal/liter) to about
25 kcal/fl oz (820 kcal/liter), even more typically from about 20 kcal/fl oz (675-680
kcal/liter) to about 24 kcal/fl oz (800-810 kcal/liter). Generally, the 22-24 kcal/fl oz
formulas are more commonly used in pre-term or low birth weight infants, and the
20- 2 1 kcal/fl oz (675-680 to 700 kcal/liter) formulas are more often used in term
infants. Non-infant and adult nutritional powders may have any caloric density
suitable for the targeted or intended population.
Macronutrients
[0046] The dryblended powdered nutritional compositions include at least
one of fat, protein, and carbohydrate, and in many embodiments, will include all
three. Any one or more of these macronutrients can be in the form of a dry ingredient
that can be treated for microbial contamination as described herein and then
dryblended into a base powder to form the dryblended powdered nutritional
compositions. Alternatively, the macronutrient can be dryblended into the base
powder and the resulting dryblended powder treated for microbial contamination as
described herein. In particularly suitable embodiments, the dry ingredients include
one or more carbohydrates including, for example, rice starch and/or sucrose. In
another embodiment, the dry ingredient includes one or more proteins, including, for
example, milk protein isolate.
[0047] Generally, any source of fat, carbohydrate, and/or protein that is
known or otherwise suitable for use in nutritional products may also be suitable for use
herein, provided that such macronutrients are also compatible with the essential
elements of the dryblended powdered nutritional compositions as defined herein.
[0048] Although total concentrations or amounts of the fat, protein, and
carbohydrates may vary depending upon the nutritional needs of the intended user,
such concentrations or amounts most typically fall within one of the following
embodied ranges, inclusive of any other essential fat, protein, and/or carbohydrate
ingredients as described herein.
[0049] Carbohydrate concentrations most typically range from about 5% to
about 40%, including from about 5% to about 35%, including from about 5% to about
30%, including from about 7% to about 30%, including from about 10% to about 30%,
including from about 10% to about 25%, by weight of the dryblended powdered
nutritional composition; fat concentrations most typically range from about 0.5% to
about 30% , from about 0.5%> to about 25%, including from about 0.5%o to about 20%>,
including from about 0.75% to about 20%, including from about 1% to about 15%,
including from about 1% to about 10%, and also including from about 2% to about 5%,
by weight of the dryblended powdered nutritional composition; and protein
concentrations most typically range from about 5% to about 85%o, including from about
5% to about 75%, including from about 5% to about 70%>, including from about 5% to
about 60%, including from about 7% to about 50%, and also including from about 8%
to about 32%, by weight of the dryblended powdered nutritional composition.
Additional ranges for carbohydrates, fats, and proteins, based on % calories of the
dryblended powdered nutritional composition, are set forth in the following table
[0050] Non-limiting examples of suitable fats or sources thereof for use
in the dryblended powdered nutritional compositions 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, DHA oil, ARA oil, palm and palm kernel oils, palm olein, canola
oil, marine oils, cottonseed oils, and combinations thereof. Particularly suitable fats
include high oleic safflower oil, soy oil, and coconut oil, all of which can be used
individually or in any combination.
[0051] Non-limiting examples of suitable carbohydrates or sources
thereof for use in the dryblended powdered nutritional compositions described
herein may include maltodextrin, hydrolyzed or modified starch or cornstarch,
glucose polymers, corn syrup, corn syrup solids, rice-derived carbohydrates,
glucose, fructose, lactose, high fructose corn syrup, honey, sugar alcohols (e.g.,
maltitol, erythritol, sorbitol), and combinations thereof. Particularly suitable
carbohydrates for use as the dry ingredient to be dryblended into a nutritional base
powder include starches, lactose, and combinations thereof. One particularly suitable
carbohydrate for use as the dry ingredient includes rice starch.
[0052] Non-limiting examples of suitable proteins or sources thereof for
use in the dryblended powdered nutritional compositions include partially hydrolyzed
(degree of hydrolysis less than 25%) or non-hydrolyzed proteins (i.e., intact) 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), or
combinations thereof. Non-limiting examples of such proteins include milk protein
isolates, milk protein concentrates as described herein, such as whey protein
concentrates, casein protein isolates, whey protein, caseinates, whole cow's milk,
partially or completely defatted milk, soy protein isolates, soy protein concentrates,
and so forth. A particularly suitable protein source, that can optionally be dryblended
into the dryblended composition, includes milk protein isolate.
Optional Ingredients
[0053] The dryblended powdered nutritional compositions 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 dryblended powdered
nutritional compositions 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 dryblended powdered nutritional compositions.
[0054] Non-limiting examples of such optional ingredients include
preservatives, cocoa powder, lecithin, guar gum, xanthan gum, carrageenan, gellan
gum, antioxidants, emulsifying agents, buffers, pharmaceutical actives, additional
nutrients as described herein, colorants, flavors, thickening agents and stabilizers,
and so forth.
[0055] The dryblended powdered nutritional compositions may further
comprise vitamins or related nutrients, non-limiting examples of which include
vitamin A, 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.
[0056] The dryblended powdered nutritional compositions may further
comprise minerals, non-limiting examples of which include phosphorus, magnesium,
iron, zinc, manganese, copper, sodium, potassium, molybdenum, chromium,
selenium, chloride, and combinations thereof.
[0057] The dryblended powdered nutritional compositions may also
include one or more masking agents to reduce or otherwise obscure bitter flavors and
after taste in the reconstituted powders. Suitable masking agents include natural and
artificial sweeteners, sodium sources such as sodium chloride, hydrocolloids and
combinations thereof. The amount of masking agent in the dryblended powdered
nutritional composition may vary depending upon the particular masking agent
selected, other ingredients in the composition, and other composition or product
target variables. Such amounts, however, most typically range from at least 0.1%,
including from about 0.15% to about 3.0%, and also including from about 0.18% to
about 2.5%, by weight of the dryblended powdered nutritional composition.
EXAMPLES
[0058] The following examples illustrate specific embodiments and/or
features of the dryblended powdered nutritional compositions prepared using the
methods 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.
[0059] The exemplified compositions are dryblended powdered
nutritional compositions that may be prepared in accordance with the
manufacturing methods described herein, such that each exemplified powdered
nutritional composition has a reduced risk of microbial contamination.
Examples 1-5
[0060] Examples 1-5 illustrate dryblended powdered infant formulas of
the present disclosure, the ingredients of which are listed in the table below. All
ingredient amounts are listed as kg per 1000 kg batch, unless otherwise specified.
[0061] To prepare the dryblended powdered infant formulas, the rice starch
component was first subjected to a heat treatment at a temperature from about 50°C to less
than 60°C for a period of from 2 days to about 10 days. Once treated, the rice starch was
dryblended with the remaining ingredients that had been utilized to prepare a conventional
base powder.
Example 6
[0062] In this Example, methods of the present disclosure were evaluated to
determine effectiveness to inactivate bacterial cultures associated with a nutritional
ingredient.
[0063] A mixture of heat and dry-stressed cultures of Cronobacter species,
consisting of ATCC 295544 and ATCC 51329 strains, were inoculated into rice starch and
stored at temperatures ranging from room temperature to 60°C for up to 10 days. Inocula
levels of 100 colony forming units/gram (cfu/g) to 1000 cfu/g were at a minimum used. The
number of non-inactivated microbes were estimated using the Most Probable Number
(MPN) method using ISO 22964, Milk and milk products - Detection of Enterobacter
sakazakii, enrichment and post selective enrichment procedures. The results are shown in
the tables below.
Table 1: MPN test results after 10 days of storage at 48°C, 55°C, 60°C, and
room temperature.
Table 2: MPN test results and calculated log reduction of Cronobacter species
during 10-day storage at various temperatures.
Table 3 : MPN test results and calculated log reduction of Cronobacter species
during 7-day storage at various temperatures.
[0064] As shown in the tables, by storing the nutritional ingredient
including the inoculated bacteria at a temperature between 48°C and 60°C in
accordance with the present disclosure, the bacteria was substantially inactivated.
Particularly, when stored at 60°C, all bacteria were inactivated after just 4 days
of storage.
Claims:
1. A method of inactivating microbes in a dry ingredient, the method
comprising subjecting the dry ingredient to a heat treatment at a temperature of
greater than 48°C to no greater than 60°C, preferably at a temperature of from
50°C to 60°C, for a period of from 2 days to 30 days, preferably for a period of
from 2 days to 4 days, preferably wherein at least 90%, more preferably at least
99% of microbes present in the dry ingredient are inactivated.
2. A method of claim 1 wherein the dry ingredient is a carbohydrate.
3. A method according to claim 1, wherein the dry ingredient is
selected from the group consisting of starch, xanthan gum, cocoa powder, lactose,
maltodextrin, sucrose, lecithin, mineral salts, preferably calcium mineral salts, and
combinations thereof.
4. A method according to claim 1, wherein the dry ingredient is rice
starch.
5. A method according to claim 1, wherein the dry ingredient is a
protein.
6. A method of preparing a dryblended powdered nutritional
composition, the dryblended powdered nutritional composition comprising at least
one dry ingredient, the method comprising subjecting the dry ingredient to a heat
treatment at a temperature of greater than 48°C to no greater than 60°C, preferably
at a temperature of from 50°C to 55°C, for a period of from 2 days to 30 days,
preferably from 2 days to 4 days, and dryblending the heat treated dry ingredient
with a base powder to form the dryblended powdered nutritional composition,
preferably wherein at least 90%, more preferably at least 99% of microbes present in
the dryblended powdered nutritional composition are inactivated.
7. A method of claim 6, wherein the dry ingredient is a carbohydrate.
8. A method of claim 6, wherein the dry ingredient is selected from the
group consisting of starch, xanthan gum, cocoa powder, lactose, lecithin, and
combinations thereof.
9. A method of claim 6, wherein the dry ingredient is rice starch.
10. A method of claim 6, wherein the dry ingredient is protein.
11. A method of any one of claims 6-9, the method comprising the step
of dryblending the dry ingredient with a base powder to form the dryblended
powdered nutritional composition; and subjecting the dryblended powdered
nutritional composition to a heat treatment at a temperature of greater than 48°C
to no greater than 60°C, preferably from 50°C to 60°C, more preferably from
50°C to 55°C, for a period of from 2 days to 30 days, preferably for a period of
from 2 days to 10 days, preferably from 2 days to 4 days.
12. A method of claim 11 wherein the dry ingredient is a carbohydrate.
13. A method of either one claims 11 or 12, wherein the dry ingredient is
selected from the group consisting of starch, xanthan gum, cocoa powder, lactose,
lecithin, and combinations thereof.
14. A method of either one claims 11 or 12, wherein the dry ingredient is
rice starch.
15. A method of preparing a powdered nutritional composition
comprising the step of subjecting the powdered nutritional composition to a heat
treatment at a temperature of greater than 48°C to 60°C for a period of from 2 days to
30 days.