Abstract: Disclosed are methods of manufacturing powdered nutritional products including powdered infant formulas and powdered adult nutritional products using extrusion. The methods include utilizing ultrasonic energy in the extruder during manufacturing. The application of ultrasonic energy to the extruder allows the fat globules present in raw materials to be effectively emulsified by hydrated protein present in the feed stream such that the resulting powdered extruded product has a low free fat level is less susceptible to oxidation and rancidity and can be reconstituted without substantial fat separation.
ULTRASONICALLY-ASSISTED EXTRUSION METHODS FOR
MANUFACTURING POWDERED NUTRITIONAL PRODUCTS
FIELD OF THE DISCLOSURE
[000 ] The present disclosure relates to ultrasonically-assisted extrusion methods
for manufacturing powdered nutritional products. More particularly, the present disclosure
relates to methods of manufacturing powdered nutritional products, including both
powdered infant formulas and powdered adult nutritional products using ultrasonicallyassisted
extrusion methods.
BACKGROUND OF THE DISCLOSURE
[0002] Powdered nutritional products, including both powdered infant formulas
and powdered adult nutritional products are widely commercially available have their use
has grown steadily over the years. These products typically contain fat, carbohydrate,
protein, vitamins, and minerals, and potentially other nutritionally beneficial components.
Prior to use, the powdered formula or product is reconstituted in water at a predetermined
ratio to produce a ready-to-drink liquid.
[0003] Powdered nutritional products, including both powdered infant formulas
and powdered adult nutritional products generally contain from about 0.5% to about 35%
(by weight) fat. In order for the finished product to be package stable (i.e., not subject to
significant oxidation and rancidity) and not have significant fat separation when
reconstituted, during manufacturing the fat component is generally sheared to globules
having a size of between about 0.1 -20 microns while simultaneously emulsifying the
sheared fat globules with hydrated protein and other additional emulsifiers.
[0004] This shearing and emulsifying has traditionally been accomplished by
preparing a high solids water slurry (i.e., 30% to 60% total solids) and pumping the slurry
through a high pressure homogenizer with a homogenization pressure between 2000 and
4500 psig. The slurry is then typically evaporated to about 45% to 60% total solids and
spray dried. This generally produces stable fat that is not subject to substantial oxidation
during storage and is easily reconstituted.
[0005] Although extrusion methods are known as highly efficient methods that
significantly minimize the amount of water and energy needed and that are capable of
producing pellets that can be dried and ground into powdered material, extrusion processes
have generally not been used to date to produce powdered infant formulas and powdered
adult nutritional products because of the inability of the extrusion process to produce a
finished powder with a stable fat emulsion. Extrusion processes have generally not been
able to adequately hydrate the protein with the limited amount of water available during
extrusion to allow for the fat globules to be sufficiently emulsified by the hydrated protein.
Without proper emulsification of the fat globules prior to extrusion, the fat is subject to
oxidation and rancidity during storage, and fat separation during reconstitution.
[0006] As such, there is a need in the art for efficient extrusion methods for
producing powdered nutritional products. It would be advantageous if the powdered
nutritional products included fat that was sufficiently emulsified to resist oxidation and
rancidity during storage and resist fat separation upon reconstitution.
SUMMARY OF THE DISCLOSURE
[0007] The present disclosure is directed to a process for manufacturing an
extruded powdered infant formula having a free fat level of less than 5% by weight. The
process comprises introducing a dry mixture comprising protein and carbohydrate into a
preconditioner, introducing a liquid comprising water and fat into the prcconditioner,
contacting the dry mixture and liquid to produce a slurry, feeding the slurry into an
ultrasonically-assisted extruder to emulsify the fat with hydrated protein, extruding the
slurry to produce pellets, and drying and grinding the pellets to produce a powdered infant
formula. The powdered infant formula comprises from about 10% to about 35% fat, from
about 5% to about 35% protein, from about 30% to about 85% carbohydrates, and from
about 2% to about 3% water, all by weight of the powdered infant formula.
[0008] The present disclosure is further directed to a process for producing a
powdered adult nutritional product having a free fat level of less than 5% by weight of the
powdered adult nutritional product. The process comprises introducing a dry mixture
comprising protein and carbohydrate into a preconditioner, introducing a liquid comprising
water and fat into the preconditioner, contacting the dry mixture and liquid to produce a
slurry, feeding the slurry into an ultrasonically-assisted extruder to emulsify the fat with
hydrated protein, extruding the slurry to produce pellets, and drying and grinding the
pellets to produce a powdered adult nutritional product. The powdered adult nutritional
product comprises from about 0.5% to about 25% fat, from about 10% to about 90%
protein, from about 5% to about 60% carbohydrates, and from about 2% to about 5%
water, all by weight of the powdered adult nutritional product.
[0009] It has been unexpectedly found that powdered infant formulas and
powdered adult nutritional products having sufficiently emulsified fat for excellent
reconstitution and oxidative stability during storage can be prepared utilizing an extrusion
process incorporating ultrasonic energy in the extruder. The ultrasonically-assisted
extruder provides the correct energy within the extrusion apparatus to sufficiently emulsify
the fat component with the adequately hydrated protein using a low moisture level that still
allows for adequate back pressure within the extruder for mixing and providing the
adequate internal heat generation to achieve the desired pasteurization of the extrudate.
[0010] The powdered nutritional products, including both powdered infant
formulas and powdered adult nutritional products, produced utilizing the ultrasonicallyassisted
extruder have excellent shelf life (i.e., stability) and resist oxidation of the fat that
leads to rancidity. Additionally, the powders are easily reconstituted in water with
unwanted fat separation. Additionally, the ultrasonically-assisted extruder is easily
controlled such that the protein component is not significantly denatured such that the
resulting powder has a grain level that does not exceed 4, on a scale of 1 to 6.
BRIEF DESCRIPTION OF THE DRAWINGS
[001 ] Figure 1 is a schematic diagram of an ultrasonically-assisted extrusion
apparatus suitable for use in the processes of the present disclosure.
DETAILED DESCRIPTION OF THE DISCLOSURE
[0012] The powdered infant formulas and powdered adult nutritional products
and corresponding manufacturing methods of the present disclosure arc directed to
powders that have been prepared utilizing an extrusion process incorporating ultrasonic
energy to sufficiently hydrate the protein component and emulsify the fat component.
These and other essential or optional elements or limitations of the powders and methods
of the present disclosure are described in detail hereinafter.
[0013] The term "powdered nutritional products" as used herein includes both
powdered infant formulas, powdered adult nutritional products, and powdered nutritional
products generally.
[0014] The term "powdered infant formula" as used herein includes both
powdered infant formulas and powdered 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 0 years of age.
[0015] The term "powdered adult nutritional product" as used herein includes
formulas for generally maintaining or improving the health of an adult, and includes those
formulas designed for adults who need to control their blood glucose.
[0016] The term "free fat level" as used herein refers to the amount of fat by
weight of the powdered infant formula or powdered adult nutritional product that is not in
emulsified form.
[0017] The term "shelf life" as used herein refers to a product's commercially
viable life-span, after which the product is unfit or undesirable for sale and/or
consumption.
[001 8] All percentages, parts and ratios as used herein, are by weight of the total
formulation, 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 byproducts
that may be included in commercially available materials, unless otherwise
specified.
[0019] Numerical ranges as used herein are intended to include every number
and subset of numbers within that range, whether specifically disclosed or not. Further,
these numerical ranges should be construed as providing support for a claim directed to
any number or subset of numbers in that range. For example, a disclosure of from 1 to 10
should be construed as supporting a range of from 2 to 8, from 3 to 7, from 5 to 6, from 1
to 9, from 3.6 to 4.6, from 3.5 to 9.9, and so forth.
[0020] 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.
[0021] 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.
[0022] The various embodiments of the powders of the present disclosure may
also be substantially free of any optional or selected essential ingredient or feature
described herein, provided that the remaining powder 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 powder contains 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.
[0023] The powdered nutritional products and corresponding manufacturing
methods of the present disclosure can comprise, consist of. or consist essentially of the
essential elements and limitations of the disclosure as described herein, as well as any
additional or optional ingredients, components, or limitations described herein or
otherwise useful in powdered nutritional applications.
Product Form
[0024] The products produced utilizing the ultrasonically-assisted extrusion
processes of the present disclosure are powdered nutritional products. These products are
generally mixed with water or another liquid and reconstituted prior to use.
[0025] The products of the present disclosure generally have a moisture content
of from about 2% to about 5% (by weight), or even from about 2% to about 4% (by
weight), or even from about 2% to about 3% (by weight), or even from about 2.5% to
about 3% (by weight).
[0026] The powdered products of the present disclosure have a free fat level of
less than about 5%, including from about 1% to about 5%. or even from about 1% to about
3%, or even from about 1% to about 2%, by weight of the powdered nutritional product.
By limiting the free fat level of the powdered product, the shelf life is extended as the
product is less susceptible to rancidity. Additionally, by limiting the free fat level of the
powdered product, the product can be easily reconstituted without significant fat
separation.
[0027] The products of the present disclosure generally have a shelf life of at
least about 3 months, or even at least about 4 months, or even at least about 5 months or
even months, or even 8 months, including from 6 to months.
[0028] The products of the present disclosure 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 nutritional formulation for use in individuals afflicted
with specific diseases or conditions.
Macronutrients
[0029] The powdered products of the present disclosure comprise at least fat,
protein, and carbohydrate. Generally, any source of fat, protein, and carbohydrate that is
known or otherwise suitable for use in powdered nutritional products may also be suitable
for use herein, provided thai such macronutrients arc also compatible with the essential
elements of the nutritional formulations as defined herein.
[0030] 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.
Carbohydrate
[003 1] The powdered nutritional products of the present disclosure may comprise
a carbohydrate source.
[0032] When the ultrasonically-assisted extrusion product is a powdered infant
formula, the carbohydrate component is present in an amount of from about 30% to about
85%, including from about 45% to about 60%, including from about 50% to about 55% by
weight of the powdered infant formula. The carbohydrate source may be any known or
otherwise suitable source that is safe and effective for oral administration and is
compatible with the essential and other ingredients in the selected product form.
[0033] When the ultrasonically-assisted extrusion product is a powdered adult
nutritional product, the carbohydrate component is present in an amount of from about 5%
to about 60%, including from about 7% to about 30%, including from about 10% to about
25%, by weight of the powdered adult nutritional product. The carbohydrate source may
be any known or otherwise suitable source that is safe and effective for oral administration
and is compatible with the essential and other ingredients in the selected product form.
[0034] Suitable carbohydrates or carbohydrate sources for use in the powdered
nutritional products include glycerin, sucrose, dextrins, maltodextrin. tapioca maltodexrin,
corn syrup, tapioca syrup, isomaltulose, lactose, fructose, both unhydroyzed, partially
hydrolyzed gums, gum Arabic, also known as gum acacia, xanthan gum, gum tragacanth,
and guar gum, glycerin, vegetable fibers, glucose, maltose, cooked and uncooked waxy
and non-waxy corn starch, cooked and uncooked waxy and non-waxy tapioca starch.
cooked and uncooked waxy and non-waxy rice starch, tagatose. galacto-oligosaccharides
(GOS), fructo-oligosaccharides (FOS) including short chain, moderate length chain, and
long chain fructo-oligosaccharides, alpha-lactose, beta-lactose, polydextrose. and
combinations thereof.
[0035] Other suitable carbohydrates include any dietary fiber or fiber source,
non-limiting examples of which include insoluble dietary fiber sources such as oat hull
fiber, pea hull fiber, soy hull fiber, soy cotyledon fiber, sugar beet fiber, cellulose, corn
bran, and combinations thereof.
[0036] The carbohydrate for use in the nutritional formulation may therefore
include soluble and/or insoluble fiber, or other complex carbohydrate, preferably having a
DE (dextrose equivalent) value of less than about 40. including less than 20, and also
including from 1 to 10.
Fat
[0037] The powdered nutritional products of the present disclosure may comprise
a fat or fat source.
[0038] When the ultrasonically-assisted extrusion product is a powdered infant
formula, the fat component is present in an amount of from about 10% o about 35%.
including from about 25% to about 30%, and including from about 26% to about 28% by
weight of the powdered infant formula. The fat may be any known or otherwise suitable
source that is safe and effective for oral administration and is compatible with the essential
and other ingredients in the selected product form.
[0039] When the ultrasonically-assisted extrusion product is a powdered adult
nutritional product, the fat component is present in an amount of from about 0.5% to about
20%, including from about 1% to about 10%. and also including from about 2% to about
5% by weight of the powdered adult nutritional product. The fat may be any known or
otherwise suitable source that is safe and effective for oral administration and is
compatible with the essential and other ingredients in the selected product form.
[0040] Suitable fat or fat sources include coconut oil. soy oil. high oleic safflower
or sunflower oil, safflower oil, sunflower oil. corn oil, palm oil. palm kernel oil. canola oil.
triheptanoin, milk fat including butter, any animal fat or fraction thereof, fish or crustacean
oils containing docosahexaenoic acid (DHA) and/or eicosapentaenoic acid (EPA)
phospholipids from fish or crustacean containing docosahexaenoic acid (DHA) and/or
eicosapentaenoic acid (EPA), concentrates of DHA and/or EPA from marine, vegetable, or
fugal sources, arachidonic acid (A A) concentrate from fungal or other sources, -
linolenic acid concentrate (ALA), l ax seed oil, phospholipids and fractions thereof,
including soy lecithin and egg lecithin, both partially hydrolyzed and unhydrolyzed,
monoglycerides and/or diglycerides from both vegetable and animal sources, and plant
sterols and compounds containing plant sterols, diacetyl tartaric acid of mono and
diglycerides (DATEM) and combinations thereof.
Protein
[004 1] The powdered nutritional products of the present disclosure may comprise
a protein or protein source.
[0042] When the ultrasonically-assisted extrusion product is a powdered infant
formula, the protein component is present in an amount of from about 5% to about 35%,
including from about 8% to about 12%, and including from about 1 % to about 12% by
weight of the powdered infant formula. The protein may be any known or otherwise
suitable source that is safe and effective for oral administration and is compatible with the
essential and other ingredients in the selected product form.
[0043] When the ultrasonically-assisted extrusion product is a powdered adult
nutritional product, the protein component is present in an amount of from about 10% to
about 90%, including from about 30% to about 80%. and also including from about 40%
to about 75% by weight of the powdered adult nutritional product. The protein may be
any known or otherwise suitable source that is safe and effective for oral administration
and is compatible with the essential and other ingredients in the selected product form.
[0044] Suitable protein or protein sources include either intact, partially
hydrolyzed, or fully hydrolyzed, or a combination thereof, of lactase treated nonfat dry
milk, milk protein isolate, milk protein concentrate, whey protein concentrate,
glycomacropeptides, whey protein isolate, milk caseinates such as sodium caseinate,
calcium caseinate, or any combination of caseinate salts of any mineral, soy protein
concentrate, soy protein isolate, soy protein flour, pea protein isolate, pea protein
concentrate, any monocot or dicot protein isolate or protein concentrate, animal collagen,
gelatin, all amino acids, taurine, milk protein peptides, whey protein peptides, bovine
colostrum, human colostrum, other mammalian colostrum, genetic communication
proteins found in colostrum and in mammalian milk such as, but not limited to. interlcukin
proteins, hydrolyzed animal collagen, hydrolyzed yeast, and combinations thereof.
Macronutricnt Profile
[0045] The total amount or concentration of fat. carbohydrate, and protein, in the
powdered infant formulas or powdered adult nutritional products of the present disclosure
can vary considerably depending upon the selected formulation and dietary or medical
needs of the intended user. Additional suitable examples of macronutrient concentrations
are set forth below. n this context, the total amount or concentration refers to all fat,
carbohydrate, and protein sources in the powdered product. For powdered infant formulas,
such total amounts or concentrations are most typically and preferably formulated within
any of the embodied ranges described in the following table (all numbers have "about" in
front of them).
[0046] For powdered adult nutritional products, such total amounts or
concentrations are most typically and preferably formulated within any of the embodied
ranges described in the following table (all numbers have "about" in front of them).
Optional Ingredients
[0047] The powdered nutritional products of the present disclosure may further
comprise other optional components that may modify the physical, chemical, aesthetic 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 medical food or other nutritional
products or pharmaceutical dosage forms and may also be used in the formulations 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.
[0048] Non-limiting examples of such optional ingredients include preservatives,
anti-oxidants, emulsifying agents, buffers, pharmaceutical actives, additional nutrients as
described herein, vitamins, minerals, sweeteners including artificial sweeteners (e.g.,
saccharine, aspartame, acesulfame , Stevia extract, and sucralosc) colorants, flavorants in
addition to those described herein, thickening agents and stabilizers, emulsifying agents,
lubricants, probiotics (such as acidophilous and/or bifidus bacteria both alive and
inactive), prebiotics, beta-hydroxy beta-methylbutyrate ( MB) arginine, glutamine, and
so forth.
[0049] Non-limiting examples of suitable minerals for use herein include
phosphorus, sodium, chloride, magnesium, manganese, iron, copper, zinc, iodine, calcium,
potassium, chromium, molybdenum, selenium, and combinations thereof.
[0050] Non-limiting examples of suitable vitamins for use herein include
carotenoids (e.g., beta-carotene, zeaxanthtn, lutein, lycopene), biotin. choline, inositol,
folic acid, pantothenic acid, choline, vitamin A. thiamine (vitamin B|). riboflavin (vitamin
B ), niacin (vitamin B3), pyridoxine (vitamin Bo), cyanocobalamine (vitamin B| ), ascorbic
acid (vitamin C), vitamin D. vitamin E, vitamin , and various salts, esters or other
derivatives thereof, and combinations thereof.
Manufacture
[0051] The powdered nutritional products of the present disclosure may be
prepared by any known or otherwise effective extrusion process so long as the extruder
utilized to form the extrudate is subjected to ultrasonic energy during the manufacturing
process as described herein.
[0052] The methods of the present disclosure incorporating the ultrasonic energy
in the extruder provide for improved emulsification of the fat component and improved
hydration of the protein component in the raw materials introduced into the extruder. By
increasing the hydration of the protein component, the protein is able to sufficiently
emulsify the fat component such that the resulting product is significantly less susceptible
to oxidation and can provide for excellent reconstitution without fat separation.
[0053] Any suitable extruder including ultrasonic energy as described herein may
be suitable for use in the present disclosure including, for example, single screw, multi
screw, ring screw, planetary gear extruders and the like. Generally, the extrusion will be
carried out at a temperature of at least about 70 C and including from about 70°C to about
120°C.
[0054] Referring now to Figure 1 there is shown an extrusion apparatus 1
suitable for use in the processes of the present disclosure. The extrusion apparatus 1
includes feeder 3 (which may optionally include one or more stirrers within, not shown)
for dry ingredients, feeding screw 4, and liquid additive opening 5 for liquid ingredients.
Feeder 3 and liquid additive opening 5 both feed into preconditioner 7, which includes
mixing arms 9, 1 , 13, and 15. Preconditioner 7 provides a mixture of dry and liquid
ingredients for extrusion into extruder 17 including screw 19 (multiple screws may also be
used, not shown) and through shaping die 2 1. Connected to the extruder 7 is horn 23,
which provides the ultrasonic energy to the extruder 17. Horn 23 is connected to booster
25, which is connected to converter 27 for originating the ultrasonic energy. Ultrasonic
power supply 29 and wattmeter 31 are also shown.
[0055] In one embodiment of the present disclosure, a powdered nutritional
product is prepared by first blending together the "dry" ingredients and introducing the dry
ingredient blend into feeder 3. The "dry" ingredients may include, for example, the
protein, the carbohydrates, the minerals, the vitamins, processing aids, optional dry
components, etc. The dry blended feed may be prepared with a batch dry blender such that
the dry ingredient blend is introduced into the feeder 3 batchwisc. or the dry ingredient
blend may be continuously made with a continuous mixer and continuously fed into the
feeder 3. Into the liquid additive opening 5 is introduced the fat and water mixture (water
is typically present in an amount of from about 10% to about 25%, or from about 10% to
about 20%, or from about 10% to about 1 % by weight of all of the raw materials), which
may optionally include other liquid ingredients desired to be incorporated into the ultimate
extruded powdered material. The dry ingredient blend from the feeder 3 and the fat/water
liquid blend from the liquid additive opening 5 are brought together, contacted and mixed
in the preconditioner 7, which feeds the mixed dry ingredient blend and liquid blend
(generally referred to as a slurry) into the extruder 9, which is ultrasonically-assisted by
horn 23 through booster 25 and converter 27.
[0056] The formed pellets (not shown) are extruded through the shaping die 2 1.
The pellets can be in pieces, chunks, layers, or any other form of cxtrudate. Subsequent to
extrusion through die 21, the pellets may be dried and optionally ground to the desired size
using conventional drying and grinding means.
[0057] As will be recognized by one skilled in the art based on the disclosure
herein, the feeder 3 with feeding screw 4 and the liquid additive opening 5 are set to
provide a continuous flow of raw materials (i.e., dry ingredient blend and liquid water/fat
blend) into the preconditioner 7 at the desired amounts to produce the desired powdered
product. Although generally discussed herein as having a feeder 3 and a liquid additive
opening 5, it is within the scope of the present invention to have a feeder 3 for the "dry"
ingredients and have the water/fat mixture added to the preconditioner 7 at one or multiple
ports (not shown) over the length of the preconditioner 7. or at the beginning of the
extruder 17. Regardless of how the water/fat mixture is introduced into the preconditioner
7 or extruder 17, it is desirable to establish a constant flow rate of all of the raw materials
(i.e. the slurry) into the extruder to produce a substantially homogeneous extruded pellet.
In some preferred embodiments, the flow rate of the water/ at mixture and/or the dry
ingredients is controlled with flow meters (not shown).
[0058] In some embodiments of the present disclosure, the extrusion apparatus
including ultrasonic energy may include two or more preconditioncrs and/or two or more
ultrasonic extruders, depending upon the exact setup of the apparatus. In some
embodiments, the product may be a multiply extruded product: that is. the ultimate product
produced by the extrusion apparatus may have been extruded with ultrasonic energy two,
three, four or more times, with additional components being added prior to each successive
extrusion.
[0059] In one specific example of multiple extrusions, the total carbohydrate
component may be added in various amounts to multiple slurries prior to extrusion; that is,
a portion of the carbohydrate component may be added to a slurry that is extruded and then
additional carbohydrate component may be added to the extruded material and
subsequently extruded a second time to produce the final extrudate. In some
embodiments, the carbohydrate component as described herein is utilized to control the
viscosity of the slurry being extruded such that it is not too viscous to be moved through
the extruded and yet not too thin or watery such that proper extrusion cannot occur. In a
specific embodiment including two ultrasonic extrusion steps, the first slurry subjected to
ultrasonic extrusion may include from about 0% to about 80%. including from about 5% to
about 70%, including from about 10% to about 50% carbohydrate by weight total
carbohydrate component and the slurry subjected to the second ultrasonic extrusion may
include from about 20% to about 100%, including from about 30% to about 95%,
including from about 50% to about 90% carbohydrate by weight total carbohydrate
component.
[0060] In some embodiments of the present disclosure, one or more components
of the powdered nutritional product that are heat sensitive (that is, subject to degradation,
oxidation, and/or destruction at elevated temperatures) may be admixed into the extruded
pellets post-extrusion using a continuous mixer, or equivalent mixing device. For
example, heat sensitive components such as certain vitamins, probiotics and/or oils that in
some embodiments could be degraded or destroyed at the elevated temperatures of the
extruder, may be admixed into the pellets post-extrusion via continuous mixing or similar
device.
[0061] The frequency of the ultrasonic energy used in the extrusion processes
described herein may be less than about 30 kHz, or less than about 20 kHz, or even less
than about 0 kHz and, in some embodiments, may be from about 16 kHz to about 24 kHz.
The energy density is between about 0.0001 W/cubic centimeters to about 30 W/cubic
centimeters. The amplitude of the ultrasonic energy may be from about 0.1 microns to
about 150 microns. Suitable ultrasonic energy setups for extrusion are shown, for
example, in WO 2010/012032 and U.S. 2007/0172559, both of which are incorporated by
reference herein.
[0062] As will be recognized by one skilled in the art based on the disclosure
herein, the volume (i.e., the flow rate) of the slurry being fed into the extruder for
extrusion into pellets and the time of exposure of the slurry to the ultrasonic energy at a
desired energy density may be considered in order to make the process suitable for
scalability and reproducibility. As noted above, it is generally desirable to maintain a
constant flow rate of the slurry into the extruder. Suitable flow rates of the slurry into the
extruder may be, for example, from about 0.1 kg/min to about 0 kg/min, including from
about 1 kg/min to about 7 kg/min, including from about 2 kg/min to about 5 kg/min. A
constant flow rate and a consistent application of ultrasonic energy allow for the intensity
of the processing of a given amount of slurry to remain consistent such that reproducible
samples can be produced and scaled as desired.
[0063] In some embodiments of the present disclosure, the ultrasonic energy
level introduced into the extruder is set at a level such that the protein present in the
material to be extruded is not substantially denatured; that is, the ultrasonic energy level is
set at a level such that the protein in the material to be extruded remains substantially nondenatured.
Generally, the ultrasonic energy is set at a level such that when the finished
powder is reconstituted, the grain level does not exceed 4 on a scale of from 1 to 6. The
grain scale is a visual representation of undissolved powder either due to having poor
solubility or containing denatured protein. A scale of 1 has little or no undissolved powder
when a clean glass slide is dipped in the properly mixed power-water solution in a beaker.
As the scale increases, more and more undissolved powder is observed when a clean slide
is dipped in a beaker with the properly mixed powder-water solution. Grain values of 5 or
6 are considered unacceptable and contain significant amounts of undissolved powder
when a clean slide is dipped into a beaker containing the properly mixed powder-water
solution.
[0064] The powdered nutritional products of the present disclosure may, of
course, be manufactured by other known or otherwise suitable extrusion techniques and
ultrasonic setups not specifically described or shown herein without departing from the
spirit and scope of the present disclosure so long as the extruder is subjected to ultrasonic
energy as described herein. The present embodiments are, therefore, to be considered in all
respects as illustrative and not restrictive and that all changes and equivalents also come
within the description of the present disclosure. The following non-limiting examples will
further illustrate the formulations and methods of the present invention.
EXAMPLES
[0065] The following examples illustrate specific embodiments and/or features of
the powdered 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 formulation, unless otherwise specified.
Examples 1-5
[0066] Examples 1-5 illustrate powdered infant formulas that could be produced
from an extrusion process including ultrasonic energy as described in the present
disclosure. The starting ingredients of Examples 1-5 are listed in the following Table.
[0067] The powdered infant formula may be prepared by first mixing together all
of the dry ingredients to produce a dry ingredient mixture and then mixing together all of
the liquid ingredients to produce a liquid ingredient mixture. The dry ingredient mixture is
fed into the feeder of an ultrasonically-assisted extruder apparatus similar to that of Figure
1 and the liquid ingredient mixture is fed into the liquid additive opening and the dry
ingredient mixture and liquid ingredient mixture are brought together in the
preconditioner, where they are mixed together and metered into the extruder and extruded
through the ultrasonically-assisted extruder and through the exit die. The frequency of the
ultrasonic energy may be about 20 kHz, the energy density may be about 10 W/cubic
centimeters, and the amplitude of the ultrasonic energy may be about 100 microns. The
temperature of the extruder may be about 100°C and the slurry flow rate may be about 4.6
kg/min. The extruded pellets are dried and ground by conventional drying and grinding
means to produce the powdered infant formula.
WHAT IS CLAIMED IS:
. A process for manufacturing an extruded powdered nutritional product,
the process comprising:
providing a dry mixture comprising protein and carbohydrate and a liquid
comprising water and fat;
contacting the dry mixture and liquid to produce a slurry;
feeding the slurry into an ultrasonically-assisted extruder to emulsify the fat
with hydrated protein;
extruding the slurry to produce pellets; and
drying and grinding the pellets to produce a powdered nutritional product,
wherein the powdered nutritional product comprises a free fat level of less than 5% by
weight of the powdered nutritional product.
2. The process of claim 1 wherein the ultrasonically-assisted extruder is
subjected to ultrasonic energy having a frequency selected from the group consisting
of less than about 30 Kilohertz, less than about 20 Kilohertz, and less than about 1
Kilohertz.
3. The process of claim 1 wherein one or more additional components are
mixed into the extruded pellets prior to drying and grinding.
4. The process of claim 3 wherein the one or more components are
selected from probiotics, prebiotics, vitamins, and combinations thereof.
5. The process of claim 1 wherein the dry mixture additionally includes
minerals.
6. A process for manufacturing an extruded powdered infant formula
having a free fat level of less than 5% by weight of the powdered infant formula, the
process comprising:
introducing a dry mixture comprising protein and carbohydrate into a
preconditioner;
introducing a liquid comprising water and fat into the preconditioner;
contacting the dry mixture and liquid to produce a slurry;
feeding the slurry into an ultrasonically-assisted extruder to emulsify the fat
with hydrated protein;
extruding the slurry to produce pellets; and
drying and grinding the pellets to produce a powdered infant formula, wherein
the powdered infant formula comprises from about 10% to about 35% fat, from about
5% to about 35% protein, from about 30% to about 85% carbohydrates, and from
about 2% to about 5% water, all by weight of the powdered infant formula.
7. The process of claim 6 wherein the free fat level in the powdered
infant formula is from about 1% to about 3% by weight of the powdered infant
formula.
8. The process of claim 6 wherein the powdered infant formula comprises
from about 25% to about 30% fat, from about 8% to about 12% protein, from about
45% to about 60% carbohydrates, and from about 2% to about 5% water, all by
weight of the powdered infant formula.
9. The process of claim 6 wherein the ultrasonically-assisted extruder is
subjected to ultrasonic energy having a frequency selected from the group consisting
of less than about 30 Kilohertz, less than about 20 Kilohertz, and less than about 15
Kilohertz.
10. The process of claim 6 wherein one or more additional components are
mixed into the extruded pellets after drying and grinding.
11. The process of claim 6 wherein the powdered infant formula has a
grain level of 4 or less on a grain scale of 1 to 6.
12. A process for producing a powdered adult nutritional product having a
free fat level of less than 5% by weight of the powdered adult nutritional product, the
process comprising:
introducing a dry mixture comprising protein and carbohydrate into a
preconditioner;
introducing a liquid comprising water and fat into the preconditioner;
contacting the dry mixture and liquid to produce a slurry;
feeding the slurry into an ultrasonically-assisted extruder to emulsify the fat
with hydrated protein;
extruding the slurry to produce pellets; and
drying and grinding the pellets to produce a powdered adult nutritional
product, wherein the powdered adult nutritional product comprises from about 0.5%
to about 20% fat, from about 10% to about 90% protein, from about 5% to about 40%
carbohydrates, and from about 2% to about 5% water, all by weight of the powdered
adult nutritional product.
13. The process of claim 2 wherein the free fat level in the powdered
adult nutritional product is from about 1% to about 2% by weight of the powdered
adult nutritional product.
14. The process of claim 2 wherein the powdered adult nutritional
product comprises from about 2% to about 5% fat, from about 40% to about 75%
protein, from about 10% to about 25% carbohydrates, and from about 2% to about 5%
water, all by weight of the powdered adult nutritional product.
15. The process of claim 2 wherein the powdered adult nutritional
product has a grain level of 4 or less on a grain scale of 1 to 6.
16. A process for manufacturing an extruded powdered infant formula
having a free fat level of less than 5% by weight of the powdered infant formula, the
process comprising:
introducing protein and water into a preconditioner;
introducing fat into the preconditioner;
introducing from 0 to about 80 wt.% of a carbohydrate into the preconditioner;
contacting the protein, water, fat, and carbohydrate to produce a slurry;
feeding the slurry into a first ultrasonically-assisted extruder to emulsify the
fat with hydrated protein;
introducing the remaining carbohydrate, vitamins, and minerals into a second
preconditioner feeding the discharge of the first ultrasonically-assisted extruder to
produce a second slurry;
ultrasonically extruding the second slurry to produce pellets; and
drying and grinding the pellets to produce a powdered infant formula, wherein
the powdered infant formula comprises from about 10% to about 35% fat, from about
5% to about 35% protein, from about 30% to about 85% carbohydrates, and from
about 2% to about 5% water, all by weight of the powdered infant formula.
17. The process of claim 16 wherein the powdered infant formula
comprises from about 25% to about 30% fat, from about 8% to about 12% protein,
from about 45% to about 60% carbohydrates, and from about 2% to about 5% water,
all by weight of the powdered infant formula.
18. The process of claim 16 wherein the powdered infant formula has a
grain level of 4 or less on a grain scale of 1 to 6.
1 . The process of claim 16 wherein the powdered infant formula includes
vitamins and minerals.
20. A process for manufacturing an extruded powdered nutritional product,
the process comprising:
providing a dry mixture comprising protein and carbohydrate and a liquid
comprising water and fat;
contacting the dry mixture and liquid to produce a slurry;
feeding the slurry into an ultrasonically-assisted extruder to emulsify the fat
with hydrated protein;
extruding the slurry to produce pellets; and
drying and grinding the pellets to produce a powdered infant formula, wherein
the powdered nutritional product comprises a fat free level of less than 5% by weight
of the powdered nutritional product.
2 . The process of claim 20 further comprising introducing a dry mixture
comprising protein and carbohydrate into a preconditioner and introducing a liquid
comprising water and fat into the preconditioner.
22. The process of claims 20 and 2 1 wherein the ultrasonically-assisted
extruder is subjected to ultrasonic energy having a frequency selected from the group
consisting of less than 30 Kilohertz, less than 20 Kilohertz, and less than 1 Kilohertz.
23. The process of claims 20-22 wherein one or more additional
components are mixed into the extruded pellets prior to drying and grinding.
24. The process of claim 23 wherein the one or more components are
selected from probiotics, prebiotics, vitamins, and combinations thereof.
25. The process of claims 20-24 wherein the powdered nutritional product
has a grain level of 4 or less on a grain scale of 1 to 6.
26. The process of claims 20-25 wherein the fat free level in the powdered
nutritional product is from about 1% to about 5% by weight of the powdered
nutritional product.
27. The process of claims 20-26 wherein the fat free level in the powdered
nutritional product is from about 1% to about 3% by weight of the powdered
nutritional product.
28. The process of claims 20-27 wherein the powdered nutritional product
comprises from about 10% to about 35% fat, from about 5% to about 35% protein,
from about 30% to about 85% carbohydrates, and from about 2% to about 5% water,
all by weight of the powdered nutritional product.
29. The process of claims 20-27 wherein the powdered nutritional product
comprises from about 25% o about 30% fat, from about 8% to about 12% protein,
from about 45% to about 60% carbohydrates, and from about 2% to about 5% water,
all by weight of the powdered nutritional product.
30. The process of claims 20-27 wherein the powdered nutritional product
comprises from about 26% to about 28% fat, from about 10% to about 12% protein,
from about 50% to about 55% carbohydrates, and from about 2% to about 5% water,
all by weight of the powdered nutritional product.
3 1. The process of claims 20-27 wherein the powdered nutritional product
comprises from about 0.5% to about 20% fat, from about 10% to about 90% protein,
from about 5% to about 40% carbohydrates, and from about 2% to about 5% water,
all by weight of the powdered nutritional product.
32. The process of claims 20-27 wherein the powdered nutritional product
comprises from about 1% to about 10% fat, from about 30% to about 80% protein,
from about 7% to about 30% carbohydrates, and from about 2% to about 5% water,
all by weight of the powdered nutritional product.
33. The process of claims 20-27 wherein the powdered nutritional product
comprises from about 2% to about 5% fat, from about 40% to about 75% protein,
from about 10% to about 25% carbohydrates, and from about 2% to about 5% water,
all by weight of the powdered nutritional product.
| # | Name | Date |
|---|---|---|
| 1 | 10908-DELNP-2012-AbandonedLetter.pdf | 2019-09-26 |
| 1 | 10908-DELNP-2012.pdf | 2012-12-21 |
| 2 | 10908-delnp-2012-Form-3-(22-04-2013).pdf | 2013-04-22 |
| 2 | 10908-DELNP-2012-FER.pdf | 2019-02-25 |
| 3 | 10908-delnp-2012-Correspondence Others-(22-12-2015).pdf | 2015-12-22 |
| 3 | 10908-delnp-2012-Correspondence Others-(22-04-2013).pdf | 2013-04-22 |
| 4 | 10908-delnp-2012-GPA.pdf | 2013-08-20 |
| 4 | 10908-delnp-2012-Form-3-(22-12-2015).pdf | 2015-12-22 |
| 5 | 10908-delnp-2012-Form-5.pdf | 2013-08-20 |
| 5 | 10908-delnp-2012-Correspondence Others-(09-01-2015).pdf | 2015-01-09 |
| 6 | 10908-delnp-2012-Form-3.pdf | 2013-08-20 |
| 6 | 10908-delnp-2012-Form-3-(09-01-2015).pdf | 2015-01-09 |
| 7 | 10908-delnp-2012-Form-2.pdf | 2013-08-20 |
| 7 | 10908-delnp-2012-Claims.pdf | 2013-08-20 |
| 8 | 10908-delnp-2012-Form-1.pdf | 2013-08-20 |
| 8 | 10908-delnp-2012-Correspondence-others.pdf | 2013-08-20 |
| 9 | 10908-delnp-2012-Form-1.pdf | 2013-08-20 |
| 9 | 10908-delnp-2012-Correspondence-others.pdf | 2013-08-20 |
| 10 | 10908-delnp-2012-Claims.pdf | 2013-08-20 |
| 10 | 10908-delnp-2012-Form-2.pdf | 2013-08-20 |
| 11 | 10908-delnp-2012-Form-3.pdf | 2013-08-20 |
| 11 | 10908-delnp-2012-Form-3-(09-01-2015).pdf | 2015-01-09 |
| 12 | 10908-delnp-2012-Form-5.pdf | 2013-08-20 |
| 12 | 10908-delnp-2012-Correspondence Others-(09-01-2015).pdf | 2015-01-09 |
| 13 | 10908-delnp-2012-GPA.pdf | 2013-08-20 |
| 13 | 10908-delnp-2012-Form-3-(22-12-2015).pdf | 2015-12-22 |
| 14 | 10908-delnp-2012-Correspondence Others-(22-12-2015).pdf | 2015-12-22 |
| 14 | 10908-delnp-2012-Correspondence Others-(22-04-2013).pdf | 2013-04-22 |
| 15 | 10908-delnp-2012-Form-3-(22-04-2013).pdf | 2013-04-22 |
| 15 | 10908-DELNP-2012-FER.pdf | 2019-02-25 |
| 16 | 10908-DELNP-2012.pdf | 2012-12-21 |
| 16 | 10908-DELNP-2012-AbandonedLetter.pdf | 2019-09-26 |
| 1 | searchstrategy_13-02-2019.pdf |