Lipid particle formulations and lipid particle-fortified beverages

Abstract

Lipid particle formulations disclosed herein may be included in beverages, for example energy drinks. Disclosed lipid particle formulations comprise one or more lipid particles comprising a payload component, an organic solvent extract of a lipid-containing food ingredient and a beverage component.

Description

LIPID PARTICLE FORMULATIONS AND LIPID PARTICLE-FORTIFIED BEVERAGESCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 617,334, filed January 3, 2024, the title of which is “Lipid Particle Formulations and Lipid Particle-Fortified Beverages” and the content of which is incorporated herein by reference in its entirety.BACKGROUND

[0002] Inclusion of various hydrophobic and / or hydrophilic compounds in beverages for human ingestion has been difficult to achieve because of their poor stability after short term and / or long-term storage. Conventional methods of preserving the stability of compounds susceptible to degradation can negatively affect characteristics (e.g., turbidity, taste, viscosity, etc.) of the beverage to which they are added. Moreover, compounds ingested by a subject may be degraded before being absorbed in the gastrointestinal tract of a human subject following ingestion. Thus, there is a need to develop formulations that improve the storage stability of compounds in beverages and / or the sustained release / bioavailability of compounds when ingested. Accordingly, the present disclosure provides lipid particle formulations, fortified beverages comprising the same, and methods of producing the same to address this unmet need.SUMMARY

[0003] The present disclosure provides formulations including one or more lipid particles, and fortified beverages incorporating said one or more formulations, wherein the one or more lipid particles incorporate a pay load component, an organic solvent extract of a lipid containing food ingredient, and a beverage component. Exemplary formulations of the present disclosure provide improved stability / recovery of a payload component, improved solubility / reduced turbidity of lipid particle particles when added to a base beverage, delayed release of a payload component when added to a base beverage, and / or delayed release of a payload component in the gastrointestinal tract of a subject that ingests the formulation.

[0004] In some embodiments, the present disclosure provides a formulation including one or more lipid particle, wherein the one of more lipid particle incorporates:0.1 wt% to 13.4 wt% of a payload component;0.2 wt% to 7.4 wt% of an organic solvent extract of a lipid-containing food ingredient;0 wt% (e.g., 0.1 wt%) to 1.8 wt% of a stabilizing component;0 wt% (e.g., 0.1 wt%) to 1.8 wt% of a surfactant component;0 wt% (e.g., 0.1 wt%) to 1.8% of an antioxidant component; and at least 70% of a beverage component.

[0005] In some embodiments, a payload component comprises lutein, vitamin D, vitamin B12, caffeine, creatine, tannic acid, gallic acid, glucose, zeaxanthin, curcurmin, quercetin, rutin, naringenin, fatty acids, ketone esters, or combination thereof.

[0006] In some embodiments, a lipid extract is an organic solvent extract of the lipid- containing food ingredient. In some embodiments, an organic solvent extract is an ethanol extract, a tetrahydro furan (THF) extract, a methanol extract, an isopropanol extract, a 1,4- dioxane extract, a methyl term-butyl ether (MTBE) extract, an acetonitrile extract, an acetone extract, a transcutol extract, or combination thereof.

[0007] In some embodiments, a lipid-containing food ingredient includes buttermilk, milk, egg yolk, beef brain, pig liver, chicken liver, herring dark muscle, soybean, de-hulled oat, rapeseed, lecithin, or combination thereof.

[0008] In some embodiments, a stabilizing component includes cholesterol, P-sitosterol, oleic acid, tetradecanol, hexadecanol, octadecanol, glycerol, or combination thereof.

[0009] In some embodiments, a surfactant component includes polysorbate 80, saponin, or combination thereof.

[0010] In some embodiments, an antioxidant component includes a-tocopherol, citric acid, abscorbic acid, butylated hydroxytoluene, or combination thereof.

[0011] In some embodiments, a beverage component includes an energy beverage, carbonated drink, sports drink, coffee, tea, juice, milk, milk alternative, or baby formula.

[0012] In some embodiments, one or more lipid particle has a diameter in a range from 5 nm to 150 nm, 10 nm to 125 nm, 20 nm to 100 nm, or 25 nm to 75 nm.

[0013] In some embodiments, the present disclosure additionally provides a fortified beverage including: a formulation as described herein; and a base beverage.

[0014] In some embodiments, both a beverage component and a base beverage include an energy beverage, carbonated drink, sports drink, coffee, tea, juice, milk, milk alternative, or baby formula. In some embodiments, a beverage includes 0.1 % w / v to 18.2 % w / v of the payload component.

[0015] In some embodiments, a beverage has a turbidity no greater than 600 NTU, no greater than 575 NTU, no greater than 550 NTU, no greater than 525 NTU, no greater than 500 NTU, no greater than 400 NTU, no greater than 300 NTU, no greater than 200 NTU, no greater than 100 NTU, or no greater than 50 NTU.

[0016] In some embodiments, a beverage has a turbidity in a range from about 15 NTU to about 30 NTU, or from about 18 NTU to about 27 NTU, or from about 20 NTU to about 25 NTU. In some embodiments, a beverage has a turbidity in a range from about 150 NTU to about 200 NTU, or from about 160 NTU to about 190 NTU, or from about 170 NTU to about 180 NTU. In some embodiments, a beverage has a turbidity in a range from about 15 NTU to about 200 NTU, or from about 20 NTU to about 180 NTU.

[0017] In some embodiments, a beverage includes 0.001 to 0.075 mg / ml, 0.01 to 0.075 mg / ml, 0.02 mg / ml to 0.075 mg / ml, 0.04 mg / ml to 0.075 mg / ml, or 0.06 mg / ml to 0.075 mg / ml of a formulation described herein.

[0018] In some embodiments, at least 75% of a pay load component is recoverable from a beverage after 16 weeks of storage.

[0019] In some embodiments, the present disclosure further provides a method of preparing a lipid particle, the method includes: i) vortexing and / or sonicating a lipid-containing food ingredient with an organic solvent; ii) heating the lipid-containing food ingredient and the organic solvent; iii) separating a lipid-containing phase from a solid precipitate or aqueous phase; iv) heating the lipid-containing phase;v) adding a hydrophobic payload to the lipid-containing phase or adding a hydrophilic payload to an aqueous beverage component; and vi) vortexing and / or sonicating the lipid-containing phase with the aqueous beverage component to form the lipid particle.

[0020] In some embodiments, step ii) heating the lipid-containing food ingredient and the organic solvent is to a temperature above the glass transition temperature of a lipid in the lipid- containing food ingredient. In some embodiments, step ii) heating the lipid-containing food ingredient and the organic solvent is to 55 to 85 °C, 60 to 80 °C, or 65 to 75 °C. In some embodiments, step ii) heating the lipid-containing food ingredient and the organic solvent is for 1 hour to 72 hours, 2 hours to 48 hours, or 3 hours to 24 hours.

[0021] In some embodiments, a lipid-containing food ingredient is homogenized and / or lyophilized before step i) vortexing and / or sonicating.

[0022] In some embodiments, a method described herein further includes removing an organic solvent from a lipid-containing phase before step v) vortexing and / or sonicating. In some embodiments, an organic solvent is removed using a rotary evaporator.

[0023] In some embodiments, step iv) heating the lipid-containing phase is to a temperature above the glass transition temperature of a lipid in the lipid-containing food ingredient. In some embodiments, step iv) heating the lipid-containing phase is to 55 to 85 °C, 60 to 80 °C, or 65 to 75 °C.

[0024] In some embodiments, a hydrophobic payload includes lutein, vitamin D, zeaxanthin, curcumin, quercetin, rutin, narigenin, or fatty acids. In some embodiments, the hydrophilic pay load comprises vitamin B12, caffeine, creatine, tannic acid, gallic acid, glucose, or combination thereof.

[0025] In some embodiments, an aqueous beverage component includes spring water, an energy beverage, carbonated drink, sports drink, coffee, tea, juice, milk, milk alternative, or baby formula.

[0026] In some embodiments, a method described herein further includes a step of resizing a lipid particle by gas pressure extrusion, sonication, or microfluidic mixing after step vi) vortexing and / or sonicating.

[0027] In some embodiments, a method described herein further includes a step of purifying a lipid particle by size-exclusion filtration, centrifugal filtration, or tangential flow filtration after step vi) vortexing and / or sonicating.

[0028] In some embodiments, a method described herein further includes a step of concentrating a lipid particle by tangential flow filtration, rotary evaporation, or centrifugal filtration.

[0029] In some embodiments, a method described herein further includes a step of drying a lipid particle in the presence of a structural protectant. In some embodiments, drying is via lyophilization or spray drying. In some embodiments, a structural protectant is sucrose, trehalose, or sorbitol.

[0030] In another embodiment, the present disclosure provides a method of preparing a lipid particle, the method including: i) vortexing and / or sonicating a lipid-containing food ingredient with an organic solvent; ii) heating the lipid-containing food ingredient and the organic solvent; iii) separating a lipid-containing phase from a solid precipitate or aqueous phase; iv) heating the lipid-containing phase; v) adding an entrapping agent to the lipid-containing phase or adding the entrapping agent to an aqueous beverage component; vi) vortexing and / or sonicating the lipid-containing phase with the aqueous beverage component to form a lipid particle; vii) removing the entrapping agent by tangential flow filtration to establish an entrapping agent gradient across a lipid membrane of the lipid particle; viii) establishing a payload component gradient across the lipid membrane of the lipid particle to permeate the lipid particle with the payload component and form the lipid particle.

[0031] In some embodiments, an entrapping agent is tannic acid.

[0032] In some embodiments, establishing a payload component gradient includes placing a lipid particle in an aqueous beverage component, the aqueous beverage component comprising a concentration of the payload component that is higher than the concentration of the payload component in the lipid particle.BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Drawings are presented herein for illustration purposes, not for limitation. The foregoing and other objects, aspects, features, and advantages of the disclosure will become more apparent and may be better understood by referring to the following description taken in conjunction with the accompanying drawings, in which:

[0034] FIG. 1 is an illustration showing a graphical representation of an exemplary lipid particle of the present disclosure.

[0035] FIG. 2 is a flow chart showing an exemplary manufacturing method for producing lipid particles, formulations, and fortified beverages of the present disclosure.

[0036] FIG. 3A is a bar graph showing the average particle diameters (nm) of an exemplary lutein payload liposomal formulation of the present disclosure (“GK115”) compared to water and a non-liposomal Omniactive Lutein Lutemax 2020™ (“omniactive”) control.

[0037] FIG. 3B is a bar graph showing the turbidity (nephelometric turbidity unit, “NTU”) of exemplary fortified beverages (e.g., water or Red Bull™) including a lutein pay load liposomal formulation of the present disclosure (“GK115”) compared to water and a non- liposomal Omniactive Lutein Lutemax 2020™ (“omniactive”) control.

[0038] FIG. 4A is a line graph showing the average particle diameters (nm) of an exemplary lutein payload liposomal formulation of the present disclosure (“GK115”) following 30 days of storage in water as compared to water (without liposomal formulation) and a non- liposomal Omniactive Lutein Lutemax 2020™ (“omniactive”) control in water.

[0039] FIG. 4B is a line graph showing the turbidity (nephelometric turbidity unit, “NTU”) of water samples including a lutein payload liposomal formulation of the present disclosure (“GK115”) compared to water (without liposomal formulation) and a non-liposomal Omniactive Lutein Lutemax 2020™ (“omniactive”) control in water.

[0040] FIG. 4C is a photograph of the exemplary lutein payload liposomal formulation described in FIGs. 4A and 4B in water on Day 0 as compared to water (without liposomal formulation) and a non-liposomal Omniactive Lutein Lutemax 2020™ (“omniactive”) control in water.

[0041] FIG. 4D is a photograph of the exemplary lutein payload liposomal formulation described in FIGs. 4A and 4B in water on Day 30 as compared to water (without liposomal formulation) and a non-liposomal Omniactive Lutein Lutemax 2020™ (“omniactive”) control in water.

[0042] FIG. 5A is a photograph of an exemplary spray-dried lutein payload liposomal formulation of the present disclosure (in weight boat), rehydrated lutein payload liposomal formulation of the present disclosure in water (in glass vial), and a ruler for scale.

[0043] FIG. 5B is a brightfield micrograph of the exemplary spray dried lutein payload liposomal formulation described in FIG. 5A.

[0044] FIG. 5C is a graph showing the particle diameter distributions (%) of the exemplary spray-dried lutein payload liposomal formulation as described in FIG. 5A.

[0045] FIG. 5D is a graph showing the particle diameter distributions (%) of the exemplary rehydrated spray-dried lutein payload liposomal formulation in water as described in FIG. 5A.

[0046] FIG. 6A is line graph showing the turbidity (nephelometric turbidity unit, “NTU”) of Red Bull™ samples including a lutein payload liposomal formulation of the present disclosure (“GK115”) compared to Red Bull™ (without liposomal formulation) and a non- liposomal Omniactive Lutein Lutemax 2020™ (“Omniactive”) control in Red Bull™.

[0047] FIG. 6B is a photograph of the exemplary lutein payload liposomal formulation described in FIG 6A in Red Bull™ on Day 0 as compared to Red Bull™ (without liposomal formulation) and a non-liposomal Omniactive Lutein Lutemax 2020™ (“omniactive”) control in Red Bull™.

[0048] FIG. 6C is a photograph of the exemplary lutein payload liposomal formulation described in FIG. 6A in Red Bull™ on Day 30 as compared to Red Bull™ (without liposomal formulation) and a non-liposomal Omniactive Lutein Lutemax 2020™ (“omniactive”) control in Red Bull™.

[0049] FIG. 7A is a bar graph showing the percent recovery of lutein payload following 1 week, 2 weeks, 4 weeks, 8 weeks, 12 weeks, or 16 weeks of storage in Red Bull™ of an exemplary lutein payload liposomal formulation of the present disclosure (“GK115”) ascompared to a high concentration (30 mg I 250 ml) of a non-liposomal Omniactive Lutein Lutemax 2020™ (“omniactivc”) control in Red Bull™ or a low concentration (3 mg / 250 ml) ) of a non-liposomal Omniactive Lutein Lutemax 2020™ (“Omniactive”) control in Red Bull™.

[0050] FIG. 7B is a photograph of the exemplary lutein payload liposomal formulation described in FIG 7A following 16 weeks of storage in Red Bull™ as compared to Red Bull™ (without liposomal formulation) and a non-liposomal Omniactive Lutein Lutemax 2020™ (“Omniactive”) control in Red Bull™.

[0051] FIG. 8A is a bar graph showing the percent recovery of lutein payload following 1 week, and 2 weeks of storage of an exemplary lipid particle formulation of the present disclosure (GK115; “Liposome”) in water as compared to a control (free lutein in water;“Control”) and a non-liposomal Omniactive Lutein Lutemax 2020™ (“Omniactive”) control in water.

[0052] FIG. 8B is a bar graph showing the percent recovery of lutein payload following 1 week, 2 weeks, 4 weeks, and 8 weeks of storage of an exemplary lipid particle formulation of the present disclosure (GK115; “Liposome”) in Oatmilk at 4°C as compared to a control (free lutein in Oatmilk at 4°C; “Control”) and a non-liposomal Omniactive Lutein Lutemax 2020™ (“Omniactive”) control in Oatmilk at 4°C.

[0053] FIG. 8C is a bar graph showing the percent recovery of lutein payload following 1 week, 2 weeks, 4 weeks, and 8 weeks of storage of an exemplary lipid particle formulation of the present disclosure (GK115; “Liposome”) in Oatly™ at 4°C as compared to a control (free lutein in Oatly™ at 4°C; “Control”) and a non-liposomal Omniactive Lutein Lutemax 2020™ (“Omniactive”) control in Oatly™ at 4°C.

[0054] FIG. 9A is a bar graph showing the percent recovery of vitamin D2 (“VD2”) payload following 1 week, and 2 weeks of storage of an exemplary lipid particle formulation of the present disclosure (Liposome A; “Liposome”) in water as compared to a control (free vitamin D in water; “Control”).

[0055] FIG. 9B is a bar graph showing the percent recovery of vitamin D2 (“VD2”) payload following 1 week, 2 weeks, and 4 weeks of storage of an exemplary lipid particleformulation of the present disclosure (Liposome A; “Liposome”) in Oatmilk at 4°C as compared to a control (free lutein in oatmilk at 4°C; “Control”).

[0056] FIG. 9C is a bar graph showing the percent recovery of vitamin D2 (“VD2”) payload following 1 week, and 2 weeks of storage of an exemplary lipid particle formulation of the present disclosure (Liposome A; “Liposome”) in Oatly™ at 4°C as compared to a control (free lutein in Oatly™ at 4°C; “Control”).

[0057] FIG. 10A is a bar graph showing the percent recovery of vitamin B 12 (“VitB12”) payload following 1 week, and 2 weeks of storage of exemplary lipid particle formulations of the present disclosure (“Liposome #1” and “Liposome #2”) in water as compared to a control vitamin B12 control in Poland Springs™ water (“B12-SD DSM Control in Poland Springs”).

[0058] FIG. 10B is a bar graph showing the percent recovery of vitamin B 12 (“VitB 12”) payload following 1 week, and 2 weeks of storage of exemplary lipid particle formulations of the present disclosure (“Liposome #1” and “Liposome #2”) in oatmilk at 4°C as compared to a control vitamin B12 control in oatmilk at 4°C (“B12-SD Control”).

[0059] FIG. 11 is a line graph showing the percentage of cumulative caffeine release from exemplary lipid particle formulations of the present disclosure (“GKLP4,” “GKLP5,” “GKLP6,” and “GKLP7”) in water, as compared to free caffeine in water (“FREE CAFFEINE CONTROL”) and a control including a blank particle (i.e., without payload) and free caffeine (“BLANK PARTICLE AND FREE CAFFEINE CONTROL”).DEFINITIONS

[0060] As described in the present disclosure, the following terms will be employed, and are defined as indicated below.

[0061] Unless defined otherwise, technical and scientific terms used herein have the same meaning as is commonly understood to which the claimed subject matter belongs. In the event that there are a plurality of definitions for terms herein, those in this section prevail.

[0062] It is to be understood that the general description and the detailed description are exemplary and explanatory only and are not restrictive of any subject matter claimed. In this application, the use of the singular includes the plural unless specifically stated otherwise. It must be noted that, as used in the specification and the appended claims, the singular- forms “a,”“an” and “the” include plural referents unless the context clearly dictates otherwise. In this application, the use of “or” means “and / or” unless stated otherwise. Furthermore, use of the term “including” as well as other forms, such as “include”, “includes,” and “included,” is not limiting.

[0063] Unless the context requires otherwise, throughout the specification and claims which follow, the word “comprise” and variations thereof, such as, “comprises” and “comprising” are to be construed in an open, inclusive sense, that is, as “including, but not limited to.” Further, headings provided herein are for convenience only and do not interpret the scope or meaning of the claimed invention.

[0064] Definition of standard chemistry terms may be found in reference works, including but not limited to, Carey and Sundberg “Advanced Organic Chemistry 4th Ed.” Vols. A (2000) and B (2001), Plenum Press, New York.

[0065] As used herein, the term “about” or “approximately” means within 10%, preferably within 10%, and more preferably within 5% of a given value or range.

[0066] Ambient: The term “ambient”, as used herein, refers to a typical indoor (e.g., climate-controlled) temperature, usually within a range of about 18° C to about 32° C, and / or typical indoor (e.g., climate-controlled) humidity, usually within a range of about 30% to 50%. In some embodiments, ambient temperature is within a range of about 20° C to about 30° C. In some embodiments, ambient temperature is 25+5° C. In some embodiments, ambient temperature is approximately 21° C. In some embodiments, ambient temperature is 18° C. In some embodiments, ambient temperature is 19° C. In some embodiments, ambient temperature is 20° C. In some embodiments, ambient temperature is 21° C. In some embodiments, ambient temperature is 22° C. In some embodiments, ambient temperature is 23° C. In some embodiments, ambient temperature is 24° C. In some embodiments, ambient temperature is 25° C. In some embodiments, ambient temperature is 26° C. In some embodiments, ambient temperature is 27° C. In some embodiments, ambient temperature is 28° C. In some embodiments, ambient temperature is 29° C. In some embodiments, ambient temperature is 30° C. In some embodiments, ambient may be used to describe outdoor conditions, and may include temperatures ranging from about 15° C to about 40° C, or from about 25° C to about 40° C. In some embodiments, ambient humidity is within a range of about 35% to about 45%. In some embodiments, ambient temperature is 35%. In some embodiments, ambient temperature is 36%.In some embodiments, ambient temperature is 37%. In some embodiments, ambient temperature is 38%. In some embodiments, ambient temperature is 39%. In some embodiments, ambient temperature is 40%. In some embodiments, ambient temperature is 41%. In some embodiments, ambient temperature is 42%. In some embodiments, ambient temperature is 43%. In some embodiments, ambient temperature is 44%. In some embodiments, ambient temperature is 45%.

[0067] Beverage: As used herein, the term “beverage” is used to refer to a potable liquid (e.g., that can be ingested, swallowed, drunk, or consumed by a person or animal without material risk to the person or animal). For example, a beverage can be or include an energy drink, water, carbonated drink, sports drink, coffee, tea, juice, milk, milk alternative, or baby formula. In some embodiments, a “beverage” may be or comprise a formulation of the present disclosure in liquid form.

[0068] Biocompatible: As used herein, the term “biocompatible” is used to describe a characteristic of not causing significant detectable harm to living tissue when placed in contact therewith e.g., in vivo. In certain embodiments, materials are “biocompatible” if they are not significantly toxic to cells, e.g., when contacted therewith in a relevant amount and / or under relevant conditions such as over a relevant period of time. In certain embodiments, materials are “biocompatible” if their addition to cells in vitro results in less than or equal to 20% cell death, and / or their administration in vivo does not induce significant inflammation or other adverse effects.

[0069] Comparable: As used herein, the term “comparable” refers to two or more agents, entities, situations, sets of conditions, etc., that may not be identical to one another but that are sufficiently similar to permit comparison therebetween so that one skilled in the art will appreciate that conclusions may reasonably be drawn based on differences or similarities observed. In some embodiments, comparable sets of conditions, circumstances, individuals, or populations are characterized by a plurality of substantially identical features and one or a small number of varied features. Those of ordinary skill in the art will understand, in context, what degree of identity is required in any given circumstance for two or more such agents, entities, situations, sets of conditions, etc. to be considered comparable. For example, those of ordinary skill in the art will appreciate that sets of circumstances, individuals, or populations are comparable to one another when characterized by a sufficient number and type of substantiallyidentical features to warrant a reasonable conclusion that differences in results obtained or phenomena observed under or with different sets of circumstances, individuals, or populations are caused by or indicative of the variation in those features that arc varied.

[0070] Cryoprotectant: As used herein the term “cryoprotectant” refers to a chemical or compound that is used to prevent the formation of ice crystals during the supercooling of a water containing sample.

[0071] Degradation; As used herein, the term “degradation” refers to a change in chemical structure and often involves breakage of at least one chemical bond. To say that a chemical compound is degraded typically means that the chemical structure of the chemical compound has changed (e.g., a chemical bond is broken). Common mechanisms of degradation include, for example, oxidation, hydrolysis, isomerization, fragmentation, or a combination thereof.

[0072] Diameter; As used herein, the term “diameter” is used to refer to the longest distance from one end of a particle to another end of the particle. Those skilled in the art will appreciate that a variety of techniques are available for use in characterizing particle diameters (i.e., particle sizes). In some instances, for example, size of particles (e.g., diameter of particles) can be measured by a Coulter Counter. In some instances, for example, size of particles (e.g., diameter of particles) can be measured by a Malvern Mastersizer. In some embodiments, a population of particles is characterized by an average size (e.g., D[3,2], D[4,3], etc.) and / or by particular characteristics of size distribution (e.g., absence of particles above or below particular sizes [e.g., DvlO, Dv20, Dv30, Dv40, Dv50, Dv60, Dv70, Dv80, Dv90, Dv99, etc.], a unimodal, bimodal, or multimodal distribution, etc.).

[0073] Dispersity: As used herein, the term “dispersity” is used to refer to the breadth of particle size distribution relative to the average particle size. In some instances, for example, size of particles (e.g., diameter of particles) can be measured by a Coulter Counter. In some instances, for example, size of particles (e.g., diameter of particles) can be measured by a Malvern Mastersizer. In some embodiments, the population of particles is characterized by, for example, an average size (e.g., Dv50) and, for example, a corresponding standard deviation. In some instances, the dispersity of a population of particles refers to double (e.g., 2-fold) the ratio of standard deviation (e.g., G) to average particle diameter (e.g., Dv50).

[0074] Encapsulated: As used herein, the term “encapsulated” is used to refer to a characteristic of being physically associated with, and in some embodiments partly or wholly covered or coated. For example, in many embodiments of the present disclosure, a payload component (e.g., a microbe component and / or a nutrient component) is described as being encapsulated by a polymer component.

[0075] HLB: As used herein, the term “HLB” is used to refer to the hydrophilic lipophilic balance that is an inherent property of, for example, a nonionic surfactant. In some instances, the HLB value of a given non-ionic surfactant is obtained from a commonly accessible tabular source. In some embodiments, non-ionic surfactants characterized as having a low HLB value (e.g., < 8) are compatible emulsifiers for lipid systems. In some embodiments, nonionic surfactants characterized as having a high HLB value (e.g., >15) are compatible emulsifiers for aqueous systems. In some embodiments, non-ionic surfactants characterized as having an intermediate HLB value (e.g., >8 and < 15) are compatible emulsifiers with both lipid and aqueous systems.

[0076] Homogenous: As used herein, the term “homogenous” means of substantially uniform structure and / or composition throughout.

[0077] Hydrophobic: As used herein, the term “hydrophobic” is used to refer to the propensity of a material to reject association, chemically and / or physically, with water. In some instances, a material characterized as being hydrophobic is biologically derived and / or synthetically derived. In some instances, a material characterized as being hydrophobic is a lipid, protein, and / or carbohydrate. In some instances, a material characterized as being hydrophobic is a polymer and / or small molecule. Alternatively, or additionally, in some embodiments, composites, mixtures, blends, or super- structures of several materials are collectively referred to as hydrophobic based on their observed propensity to reject association, chemically and / or physically, with water.

[0078] Hydrophilic: As used herein, the term “hydrophilic” is used to refer to the propensity of a material to associate, chemically and / or physically, with water. In some instances, a material characterized as being hydrophilic is biologically derived and / or synthetically derived. In some instances, a material characterized as being hydrophilic is a protein, and / or carbohydrate. In some instances, a material characterized as being hydrophilic isa polymer and / or small molecule. Alternatively, or additionally, in some embodiments, composites, mixtures, blends, or super- structures of several materials arc collectively referred to as hydrophilic based on their observed propensity to associate, chemically and / or physically, with water.

[0079] Incorporation: As used herein, the term “incorporation” is used to refer to a characteristic of being physically associated with, and in some embodiments, dispersed within, embedded within, or mixed in a bulk material (e.g., a lipid component).

[0080] Layer: As used herein, the term “layer” typically refers to a material disposed above or below a distinguishable material. In some embodiments, a particular entity or preparation (e.g., particle preparation) is described as “layered” if it is prepared via a process in which a first material is laid down and then a second material is applied atop or underneath the first material(e.g., as by dipping or spraying, etc.); in some such embodiments, physical or chemical distinctness of layers may be maintained over time, whereas in some such embodiments, physical or chemical distinctness of layers may decay over time, at least at layer interface(s). Alternatively or additionally, in some embodiments, a particular sample or preparation may be described as layered, independent of its mode of preparation, so long as at a particular point in time and / or using a particular mode of assessment, distinct materials can be identified in a layered structure. In some embodiments, a “layered” particle may include one or more layers that wholly encapsulate a material below. In some embodiments, a “layered” particle may include one or more layers that does not wholly encapsulate a material below. In some embodiments, at least one layer of a layered preparation is or comprises a polymer, e.g., a hydrophobic polymer or hydrophilic polymer. In some embodiments, each layer of a layered preparation is or comprises a polymer, e.g., a pH responsive polymer or a temperature- responsive polymer.

[0081] Lipid: As used herein, the term “lipid” is used to refer to a class of chemical structures characterized as hydrophobic materials. In some instances, a lipid material is derived from a biological source. In other instances, a lipid material is derived from a synthetic source. In some instances, a lipid comprises one or more aliphatic alcohols and / or acids linked by glycerol and / or glycol moieties. In other instances, a lipid comprises aliphatic chains, linear conjugated, aromatic, and / or cyclic aliphatic moieties. In some embodiments, a lipid refers to a purechemical entity. In other embodiments, a lipid refers to a mixture of several pure chemical entities. For example, lipids include, but arc not limited to: paraffin wax, montan wax, microcrystalline wax, polyethylene wax, petrolatum wax, ozokerite wax, ceresin wax, beeswax, lanolin wax, spermaceti wax, tallow wax, lac wax, Chinese insect wax, ambergris wax, soy wax, carnauba wax, candelilla wax, coconut wax, palm kernel wax, rice bran wax, butyric acid, n- butanol, pentanoic acid, n-pentanol, hexanoic acid, n-hexanol, heptanoic acid, n-heptanol, caprylic acid, n-octanol, nonanoic acid, n-nonanol, capric acid, zz-decanol, lauric acid, n- dodecanol, myristic acid, n-tetradecanol, palmitic acid, n-hexadecanol, stearic acid, n- octadecanol, arachidonic acid, n-icosanol. fatty alcohol monoglyceride ethers, fatty acid monoglyceride esters, fatty alcohol diglyceride ethers, fatty acid diglyceride esters, fatty alcohol triglyceride ethers, fatty acid triglyceride esters, fatty alcohol glycol monoether, fatty acid glycol monoesters, fatty alcohol glycol diethers, fatty acid glycol diesters, fatty alcohol poly(glycerol) ethers, fatty acid poly(glycerol) esters, fatty alcohol poly(glycol) ethers, fatty acid poly(glycol) esters, coconut oil, corn oil, cottonseed oil, olive oil, palm oil, peanut oil, rapeseed oil, safflower oil, sesame oil, soybean oil, sunflower oil, almond oil, pine nut oil, cashew oil, fully hydrogenated palm oil, partially hydrogenated palm oil, fully hydrogenated sunflower oil, partially hydrogenated sunflower oil, fully hydrogenated soybean oil, partially hydrogenated soybean oil, fully hydrogenated vegetable oil, partially hydrogenated vegetable oil, fully hydrogenated cottonseed oil, partially hydrogenated cottonseed oil, cholesterol, cholenic acid, ursolic acid, or betulinic acid.

[0082] Lipid Particle: As used herein, the term “lipid particle” is used to refer to a particle having a lipid membrane (e.g., a lipid monolayer, lipid bilayer, etc.) encapsulating an aqueous / hydrophilic core. As used herein, a lipid particle includes, but is not limited to, a liposome, a solid lipid particle, micelle, a lipid nanoparticle (LNP), a solid lipid nanoparticle (SLN), a nanostructured lipid carrier (NLC), a noisome, a transferosome, a cubosome, a lipidpolymer hybrid particle, a lipid emulsion, small unilamellar vesicle (SUV), a large unilamellar vesicle, a multilamellar vesicle (MLV), or a multivesicular vesicle (MW).

[0083] Lyophilized: As used herein, the term “lyophilized” is used to refer to the endproduct of a process by which water is removed from a material via sublimation. In some instances, prior to sublimation of water, the material is cooled to < -10 °C, < -20 °C, < -30 °C, < -40°C, < -50°C, < -60°C, and / or < -70 °C. In some instances, prior to the sublimation of water, the pressure is lowered to < 200 torr, < 150 torr, < 100 torr, < 50 torr, < 10 torr, < 5 torr, and / or < 1 toir. Those skilled in the art recognize that the cooling temperature and pressure influence the physicochemical properties of the end product; it is understood that “lyophilized” encompasses all suitable manners of cooling and vacuum protocol.

[0084] Particle: As used herein, the term “particle” is used to refer to a discrete physical entity, typically having a size (e.g., a longest cross-section, such as a diameter) within a range. For example, a particle can have a size of 5 nm to 150 nm, about 10 nm to 150 nm, about 15 nm to 150 nm, about 20 nm to 150 nm, about 25 nm to 150 nm, about 30 nm to 150 nm, about 35 nm to 150 nm, about 40 nm to 150 nm, about 45 nm to 150 nm, about 50 nm to 150 nm, about 55 nm to 150 nm, about 60 nm to 150 nm, about 65 nm to 150 nm, about 70 nm to 150 nm, about 75 nm to 150 nm, about 80 nm to 150 nm, about 85 nm to 150 nm, about 90 nm to 150 nm, about 95 nm to 150 nm, about 100 nm to 150 nm, about 105 nm to 150 nm, about 110 nm to 150 nm, about115 nm to 150 nm, about 120 nm to 150 nm, about 125 nm to 150 nm, about 130 nm to 150 nm, about 135 nm to 150 nm, about 140 nm to 150 nm, about 145 nm to 150 nm, about 5 nm to 125 nm, about 10 nm to 125 nm, about 15 nm to 125 nm, about 20 nm to 125 nm, about 25 nm to 125 nm, about 30 nm to 125 nm, about 35 nm to 125 nm, about 40 nm to 125 nm, about 45 nm to 125 nm, about 50 nm to 125 nm, about 55 nm to 125 nm, about 60 nm to 125 nm, about 65 nm to 125 nm, about 70 nm to 125 nm, about 75 nm to 125 nm, about 80 nm to 125 nm, about 85 nm to 125 nm, about 90 nm to 125 nm, about 95 nm to 125 nm, about 100 nm to 125 nm, about 105 nm to 125 nm, about 110 nm to 125 nm, about 115 nm to 125 nm, about 120 nm to 125 nm, about 5 nm to 100 nm, about 10 nm to 100 nm, about 15 nm to 100 nm, about 20 nm to 100 nm, about 25 nm to 100 nm, about 30 nm to 100 nm, about 35 nm to 100 nm, about 40 nm to 100 nm, about 45 nm to 100 nm, about 50 nm to 100 nm, about 55 nm to 100 nm, about 60 nm to 100 nm, about 65 nm to 100 nm, about 70 nm to 100 nm, about 75 nm to 100 nm, about 80 nm to 100 nm, about 85 nm to 100 nm, about 90 nm to 100 nm, about 95 nm to 100 nm, about 5 nm to 75 nm, about 10 nm to 75 nm, about 15 nm to 75 nm, about 20 nm to 75 nm, about 25 nm to 75 nm, about 30 nm to 75 nm, about 35 nm to 75 nm, about 40 nm to 75 nm, about 45 nm to 75 nm, about 50 nm to 75 nm, about 55 nm to 75 nm, about 60 nm to 75 nm, about 65 nm to 75 nm, about 5 nm to 50 nm, about 10 nm to 50 nm, about 15 nm to 50 nm, about 20 nm to 50 nm, about 25 nm to 50 nm, about 30 nm to 50 nm, about 35 nm to 50 nm, about 40 nm to 50 nm, about 45 nm to 50 nm, about 5 nmto 25 nm, about 10 nm to 25 nm, about 15 nm to 25 nm, or about 20 nm to 25 nm. A “particle” is not limited to a particular shape or form, for example, having a cross-section shape of a sphere, an oval, a triangle, a square, a hexagon, or an irregular shape. In some embodiments, particles can be solid particles. In some embodiments, particles can be liquid particles. In some embodiments, particles can be gel or gel-like particles. In some embodiments, particles may have a particle-in-particle structure wherein a layer of one material (e.g., one type of polymer component) encapsulates another material (e.g., another type of polymer component, which may itself encapsulate yet another, or rather may be or comprise a “core” - e.g., a polymer matrix core - of the particle).

[0085] Parts per million (ppm): As used herein, 1 ppm (“parts per million”) is equivalent to 1 milligram per liter (mg / L) or 1 milligram per kilogram (mg / kg).

[0086] pH Responsive: The term “pH-responsive” is used to refer to certain polymer component(s) as described herein, and in particular means that the relevant polymer component is characterized in that one or more aspects of its structure or arrangement is altered when exposed to a change in pH condition (e.g., to a particular pH and / or to a pH change of particular magnitude). In some embodiments, a polymer component is considered to be “pH-responsive” if, when the relevant polymer component is associated with a payload component in a particle preparation as described herein, the particle preparation releases the payload component under specific pH condition(s). In some embodiments, >90% of payload component is released from a particle preparation that includes a pH-responsive polymer component within 15 minutes when the particle preparation is exposed to a particular defined pH condition (e.g., within a range of defined pH values and / or at a specific pH value); in some embodiments, such release results when such contacting occurs at temperatures between 33-40 °C, and in aqueous-based buffers of ionic strength ranging from 0.001-0.151 M (e.g., water, simulated gastric fluid, gastric fluid, simulated intestinal fluid, intestinal fluid) with osmolality between 1-615 mOsm / kg. In some embodiments, a pH-responsive polymer component is one that degrades when exposed to a particular pH or pH change. Alternatively or additionally, in some embodiments, a pH- responsive polymer component is one that becomes soluble, or significantly (e.g., by at least about 5%) increases its solubility when exposed to a particular pH level, or pH change. In some embodiments, a pH-responsive polymer component includes one or more moieties whoseprotonation state changes at the relevant pH or in response to the relevant pH change. For example, in some embodiments, a pH responsive polymer component includes one or more amine moieties that become protonated upon exposure to a relevant pH or pH chance.

[0087] Reference: As used herein describes a standard or control relative to which a comparison is made. For example, in some embodiments, an agent, animal, individual, population, sample, sequence or value of interest is compared with a reference or control agent, animal, individual, population, sample, sequence or value. In some embodiments, a reference or control is tested and / or determined substantially simultaneously with the testing or determination of interest. In some embodiments, a reference or control is a historical reference or control, optionally embodied in a tangible medium. Typically, as would be understood by those skilled in the art, a reference or control is determined or characterized under comparable conditions or circumstances to those under assessment. Those skilled in the ail will appreciate when sufficient similarities are present to justify reliance on and / or comparison to a particular possible reference or control.

[0088] Residual solvent: As used herein, the term “residual solvent” refers to a solvent that remains in a material after manufacture or processing of the material. In some embodiments, the level of residual solvent is assessed by HPLC, mass spec, NMR, FTIR, and / or gas chromatography .

[0089] Stable: The term “stable,” when applied to compositions herein, means that the compositions maintain (e.g., as determined by one or more analytical assessments) one or more aspects of their physical structure and / or performance characteristic(s) (e.g., activity) over a period of time and / or under a designated set of conditions. When an assessed composition is a particle composition, in some embodiments, as will be clear from context to those skilled in the art, the term “stable” refers to maintenance of a characteristic such as average particle size, maximum and / or minimum particle size, range of particle sizes, and / or distribution of particle sizes (i.e., the percentage of particles above a designated size and / or outside a designated range of sizes) over a period of time and / or under a designated set of conditions.

[0090] Temperature-responsive: As used herein, the term “temperature-responsive” is used to refer to certain polymer component(s) as described herein, and in particular means that the relevant polymer component is characterized in that one or more aspects of its structure orarrangement is altered when exposed to a change in temperature condition (e.g., to a particular temperature and / or to a temperature change of particular magnitude). In some embodiments, a polymer component is considered to be “temperature-responsive” if, when the relevant polymer component is associated with a pay load component in a particle preparation as described herein, amorphous regions of the polymer component experience a transition from a rigid state (e.g., glassy state) to a more fluid-like flexible state (e.g., more conducive to flow), at a temperature close to the point of transition from the solid state to rubbery state (e.g., glass transition).

[0091] Water activity: As used herein, “water activity” of a material is an indication (e.g., a measurement) of how much free (i.e., available to bind or react) water is present in the material and is typically determined as the ratio of the vapor pressure of water in a material (p) to the vapor pressure of pure water (po) at the same temperature. For example, a water activity of 0.80 means the vapor pressure is 80 percent of that of pure water. Water activity typically increases with temperature. Those skilled in the art will be familiar with three basic water activity measurement systems: Preventive Electrolytic Hygrometers (PEH), Capacitance Hygrometers, and Dew Point Hygrometers (sometimes called chilled mirror).DETAILED DESCRIPTION OF CERTAIN EMBODIMENTS

[0092] It is contemplated that systems, devices, methods, and processes of the disclosure encompass variations and adaptations developed using information from the embodiments described herein. Adaptation and / or modification of the systems, devices, methods, and processes described herein may be performed by those of ordinary skill in the relevant art.

[0093] Throughout the description, where articles, devices, and systems are described as having, including, or comprising specific components, or where processes and methods are described as having, including, or comprising specific steps, it is contemplated that, additionally, there are articles, devices, and systems according to certain embodiments of the present disclosure that consist essentially of, or consist of, the recited components, and that there are processes and methods according to certain embodiments of the present disclosure that consist essentially of, or consist of, the recited processing steps.

[0094] It should be understood that the order of steps or order for performing certain action is immaterial so long as operability is not lost. Moreover, two or more steps or actions may be conducted simultaneously. As is understood by those skilled in the art, the terms “over”,“under”, “above”, “below”, “beneath”, and “on” are relative terms and can be interchanged in reference to different orientations of the layers, elements, and substrates included in the present disclosure. For example, a first layer on a second layer, in some embodiments means a first layer directly on and in contact with a second layer. In other embodiments, a first layer on a second layer can include another layer there between.

[0095] Headers are provided for the convenience of the reader and are not intended to be limiting with respect to the claimed subject matter.Lipid Particle FormulationsCompositions

[0096] The present disclosure provides formulations including one or more lipid particles wherein the one or more lipid particles incorporate a pay load component, an organic solvent extract of a lipid containing food ingredient, and a beverage component.

[0097] In some embodiments, a payload component incorporated in a lipid particle of the present disclosure includes a hydrophobic payload, a hydrophilic payload, or both a hydrophobic and hydrophilic pay load. In some embodiments, a pay load component incorporated in a lipid particle of the present disclosure includes a macronutrient and / or a micronutrient. In some embodiments, a payload component incorporated in a lipid particle of the present disclosure includes, but is not limited to, an antioxidant, a vitamin, a stimulant, an energy source or supplement, a polyphenol, a carotenoid, an herbal supplement, a flavonoid, or a combination thereof. For example, in some embodiments, a payload component includes lutein, vitamin D, vitamin B12, caffeine, creatine, tannic acid, gallic acid, glucose, zeaxanthin, curcurmin, quercetin, rutin, naringenin, fatty acids, ketone esters, or a combination thereof. In some embodiments, a payload component provides a nutritional, health, and / or stimulatory benefit to a subject when the formulation is consumed by the subject.

[0098] In some embodiments, a lipid particle of the present disclosure includes about 0.01 wt% to 20.0 wt% of a pay load component. For example, in some embodiments, a lipid particle of the present disclosure includes about 0.01 wt% to 20.0 wt%, about 0.05 wt% to 20.0 wt%, about 0.1 wt% to 20.0 wt%, about 0.5 wt% to 20.0 wt%, about 1.0 wt% to 20.0 wt%, about 5.0 wt% to 20.0 wt%, about 10.0 wt% to 20.0 wt%, about 0.01 wt% to 15.0 wt%, about 0.05wt% to 15.0 wt%, about 0.1 wt% to 15.0 wt%, about 0.5 wt% to 15.0 wt%, about 1 .0 wt% to 15.0 wt%, about 5.0 wt% to 15.0 wt%, about 10.0 wt% to 15.0 wt%, about 0.01 wt% to 10.0 wt%, about 0.05 wt% to 10.0 wt%, about 0.1 wt% to 10.0 wt%, about 0.5 wt% to 10.0 wt%, about 1.0 wt% to 10.0 wt%, about 5.0 wt% to 10.0 wt%, about 0.01 wt% to 5.0 wt%, about 0.05 wt% to 5.0 wt%, about 0.1 wt% to 5.0 wt%, about 0.5 wt% to 5.0 wt%, about 1.0 wt% to 5.0 wt%, about 0.01 wt% to 1.0 wt%, about 0.05 wt% to 1.0 wt%, about 0.1 wt% to 1.0 wt%, about 0.5 wt% to 1.0 wt%, about 0.01 wt% to 0.5 wt%, about 0.05 wt% to 0.5 wt%, about 0.1 wt% to 0.5 wt%, about 0.01 wt% to 0.1 wt%, about 0.05 wt% to 0.1 wt%, or about 0.01 wt% to 0.05 wt% of a payload component. For example, in some embodiments, a lipid particle of the present disclosure includes about 0.06 wt% to 14.0 wt %, about 0.08 wt% to 14.0 wt%, about 0.1 wt% to 14.0 wt%, about 0.12 wt% to 14.0 wt%, about 0.14 wt% to 14.0 wt%, about 0.16 wt% to 14.0 wt%, about 0.18 wt% to 14.0 wt%, about 0.2 wt% to 14.0 wt%, about 0.22 wt% to 14.0 wt%, about 0.24 wt% to 14.0 wt%, about 0.06 wt% to 13.8 wt %, about 0.08 wt% to 13.8 wt%, about 0.10 wt% to 13.8 wt%, about 0.12 wt% to 13.8 wt%, about 0.14 wt% to 13.8 wt%, about 0.16 wt% to 13.8 wt%, about 0.18 wt% to 13.8 wt%, about 0.20 wt% to 13.8 wt%, about 0.22 wt% to 13.8 wt%, about 0.24 wt% to 13.8 wt%, about 0.06 wt% to 13.6 wt %, about 0.08 wt% to 13.6 wt%, about 0.10 wt% to 13.6 wt%, about 0.12 wt% to 13.6 wt%, about 0.14 wt% to 13.6 wt%, about 0.16 wt% to 13.6 wt%, about 0.18 wt% to 13.6 wt%, about 0.20 wt% to 13.6 wt%, about 0.22 wt% to 13.6 wt%, about 0.24 wt% to 13.6 wt%, about 0.06 wt% to 13.4 wt %, about 0.08 wt% to 13.4 wt%, about 0.1 wt% to 13.4 wt%, about 0.12 wt% to 13.4 wt%, about 0.14 wt% to 13.4 wt%, about 0.16 wt% to 13.4 wt%, about 0.18 wt% to 13.4 wt%, about 0.2 wt% to 13.4 wt%, about 0.22 wt% to 13.4 wt%, about 0.24 wt% to 13.4 wt%, about 0.06 wt% to 13.2 wt %, about 0.08 wt% to 13.2 wt%, about 0.1 wt% to 13.2 wt%, about 0.12 wt% to 13.2 wt%, about 0.14 wt% to 13.2 wt%, about 0.16 wt% to 13.2 wt%, about 0.18 wt% to 13.2 wt%, about 0.2 wt% to 13.2 wt%, about 0.22 wt% to 13.2 wt%, about 0.24 wt% to 13.2 wt%, about 0.06 wt% to 13.0 wt %, about 0.08 wt% to 13.0 wt%, about 0.1 wt% to 13.0 wt%, about 0.12 wt% to 13.0 wt%, about 0.14 wt% to 13.0 wt%, about 0.16 wt% to 13.0 wt%, about 0.18 wt% to 13.0 wt%, about 0.2 wt% to 13.0 wt%, about 0.22 wt% to 13.0 wt%, or about 0.24 wt% to 13.0 wt% of a payload component. In some embodiments, a lipid particle of the present disclosure includes about 0.12 wt% to 13.4 wt% of a payload component. In some embodiments, a lipid particle of the present disclosure includes about 0.12 wt% to 13.4 wt% of lutein.

[0099] In some embodiments, a lipid particle of the present disclosure includes an organic solvent extract of a lipid-containing food ingredient. In some embodiments, ethanol (EtOH), tetrahydrofuran (THF), methanol, isopropanol, 1,4 dioxane, methyl tert-butyl ether (MTBE), acetonitrile, acetone, transcutol, or a combination thereof is used as an organic solvent to extract lipids from a lipid-containing food ingredient. In some embodiments, a lipid particle of the present disclosure includes an ethanol extract of a lipid-containing food ingredient.

[0100] In some embodiments, a lipid particle of the present disclosure includes an organic solvent extract of a lipid-containing food ingredient selected from, but not limited to, buttermilk, milk, egg yolk, beef brain, pig liver, chicken liver, herring dark muscle, soybean, dehulled oat, rapeseed, lecithin, or a combination thereof.

[0101] In some embodiments, a lipid particle of the present disclosure includes about 0.1 wt% to 10.0 wt% of an organic solvent extract of a lipid-containing food ingredient. For example, in some embodiments, a lipid particle of the present disclosure includes about 0.1 wt% to 10.0 wt%, about 0.5 wt% to 10.0 wt%, about 1.0 wt% to 10.0 wt%, about 5.0 wt% to 10.0 wt%, about 0.1 wt% to 5.0 wt%, about 0.5 wt% to 5.0 wt%, about 1.0 wt% to 5.0 wt%, about 0.1 wt% to 1.0 wt%, about 0.5 wt% to 1.0 wt%, or about 0.1 wt% to 0.5 wt% of an organic solvent extract of a lipid-containing food ingredient. In some embodiments, a lipid particle of the present disclosure includes about 0.1 wt% to 8.0 wt%, about 0.2 wt% to 8.0 wt%, about 0.3 wt% to 8.0 wt%, about 0.4 wt% to 8.0 wt%, about 0.5 wt% to 8.0 wt%, about 0.6 wt% to 8.0 wt%, about 0.7 wt% to 8.0 wt%, about 0.8 wt% to 8.0 wt%, about 0.9 wt% to 8.0 wt%, about 1.0 wt% to 8.0 wt%, about 0.1 wt% to 7.8 wt%, about 0.2 wt% to 7.8 wt%, about 0.3 wt% to 7.8 wt%, about 0.4 wt% to 7.8 wt%, about 0.5 wt% to 7.8 wt%, about 0.6 wt% to 7.8 wt%, about 0.7 wt% to 7.8 wt%, about 0.8 wt% to 7.8 wt%, about 0.9 wt% to 7.8 wt%, about 1.0 wt% to 7.8 wt%, about 0.1 wt% to 7.6 wt%, about 0.2 wt% to 7.6 wt%, about 0.3 wt% to 7.6 wt%, about 0.4 wt% to 7.6 wt%, about 0.5 wt% to 7.6 wt%, about 0.6 wt% to 7.6 wt%, about 0.7 wt% to 7.6 wt%, about 0.8 wt% to 7.6 wt%, about 0.9 wt% to 7.6 wt%, about 1.0 wt% to 7.6 wt%, about 0.1 wt% to 7.4 wt%, about 0.2 wt% to 7.4 wt%, about 0.3 wt% to 7.4 wt%, about 0.4 wt% to 7.4 wt%, about 0.5 wt% to 7.4 wt%, about 0.6 wt% to 7.4 wt%, about 0.7 wt% to 7.4 wt%, about 0.8 wt% to 7.4 wt%, about 0.9 wt% to 7.4 wt%, about 1.0 wt% to 7.4 wt%, about 0.1 wt% to 7.2 wt%, about 0.2 wt% to 7.2 wt%, about 0.3 wt% to 7.2 wt%, about 0.4 wt% to 7.2 wt%, about 0.5 wt%to 7.2 wt%, about 0.6 wt% to 7.2 wt%, about 0.7 wt% to 7.2 wt%, about 0.8 wt% to 7.2 wt%, about 0.9 wt% to 7.2 wt%, about 1.0 wt% to 7.2 wt%, about 0.1 wt% to 7.0 wt%, about 0.2 wt% to 7.0 wt%, about 0.3 wt% to 7.0 wt%, about 0.4 wt% to 7.0 wt%, about 0.5 wt% to 7.0 wt%, about 0.6 wt% to 7.0 wt%, about 0.7 wt% to 7.0 wt%, about 0.8 wt% to 7.0 wt%, about 0.9 wt% to 7.0 wt%, or about 1.0 wt% to 7.0 wt% of an organic solvent extract of a lipid-containing food ingredient. In some embodiments, a lipid particle of the present disclosure includes about 0.2 wt% to 7.4 wt% of an EtOH extract of buttermilk. In some embodiments, a lipid particle of the present disclosure includes about 0.2 wt% to 7.4 wt% of an EtOH extract of lecithin.

[0102] In some embodiments, a lipid particle of the present disclosure includes a beverage component. In some embodiments, the beverage component is selected from, but not limited to an energy drink, water, a carbonated drink, a sports drink, coffee, tea, juice, milk, milk alternative, or baby formula. In some embodiments, the beverage component is selected from, but not limited to, a Monster™ Energy Drink, a Red Bull™ Energy Drink, or a Rockstar™ Energy Drink. In some embodiments, the beverage component is selected from, but not limited to, a nut milk. For example, in some embodiments, the beverage component is selected from, but not limited to, oatmilk, or Oatly™ beverage.

[0103] In some embodiments, a lipid particle of the present disclosure includes at least 70% (e.g., at least 70%, at least 71%, at least 72%, at least 73%, at least 74%, at least 75%, at least 76%, at least 77%, at least 78%, at least 79%, at least 80%, at least 81 %, at least 82%, at least 83%, at least 84%, at least 85%, at least 86%, at least 87%, at least 88%, at least 89%, at least 90%, at least 91%, at least 92%, at least 93%, at least 94%, at least 95%, at least 96%, at least 97%, at least 98%, or at least 99%) of a beverage component.

[0104] In some embodiments, a lipid particle of the present disclosure includes a stabilizing component. In some embodiments, a stabilizing component preserves the structural integrity of a payload component and / or prevents degradation of the payload component. In some embodiments, a stabilizing component promotes encapsulation of a payload component in the lipid particle. In some embodiments, a stabilizing component preserves the structural integrity of the lipid particle. In some embodiments, a lipid particle of the present disclosure includes a stabilizing component selected from, but not limited to, cholesterol, P-sitosterol, oleic acid, tetradecanol, hexadecanol, octadecanol, glycerol, or a combination thereof.

[0105] In some embodiments, a lipid particle of the present disclosure includes about 0 wt% to 2.0 wt% of a stabilizing component. For example, in some embodiments, a lipid particle of the present disclosure includes about 0 wt% to 2.0 wt%, about 0.2 wt% to 2.0 wt%, about 0.4 wt% to 2.0 wt%, about 0.6 wt% to 2.0 wt%, about 0.8 wt% to 2.0 wt%, about 1.0 wt% to 2.0 wt%, about 1.2 wt% to 2.0 wt%, about 1.4 wt% to 2.0 wt%, about 1.6 wt% to 2.0 wt%, about 1.8 wt% to 2.0 wt%, about 0 wt% to 1.8 wt%, about 0.2 wt% to 1.8 wt%, about 0.4 wt% to 1.8 wt%, about 0.6 wt% to 1.8 wt%, about 0.8 wt% to 1.8 wt%, about 1.0 wt% to 1.8 wt%, about 1.2 wt% to 1.8 wt%, about 1.4 wt% to 1.8 wt%, about 1.6 wt% to 1.8 wt%, about 0 wt% to 1.6 wt%, about 0.2 wt% to 1.6 wt%, about 0.4 wt% to 1.6 wt%, about 0.6 wt% to 1.6 wt%, about 0.8 wt% to 1.6 wt%, about 1.0 wt% to 1.6 wt%, about 1.2 wt% to 1.6 wt%, about 1.4 wt% to 1.6 wt%, about 0 wt% to 1.4 wt%, about 0.2 wt% to 1.4 wt%, about 0.4 wt% to 1.4 wt%, about 0.6 wt% to 1.4 wt%, about 0.8 wt% to 1.4 wt%, about 1.0 wt% to 1.4 wt%, about 1.2 wt% to 1.4 wt%, about 0 wt% to 1.2 wt%, about 0.2 wt% to 1.2 wt%, about 0.4 wt% to 1.2 wt%, about 0.6 wt% to 1.2 wt%, about 0.8 wt% to 1.2 wt%, about 1.0 wt% to 1.2 wt%, about 0 wt% to 1.0 wt%, about 0.2 wt% to 1.0 wt%, about 0.4 wt% to 1.0 wt%, about 0.6 wt% to 1.0 wt%, about 0.8 wt% to 1.0 wt%, about 0 wt% to 0.8 wt%, about 0.2 wt% to 0.8 wt%, about 0.4 wt% to 0.8 wt%, about 0.6 wt% to 0.8 wt%, about 0 wt% to 0.6 wt%, about 0.2 wt% to 0.6 wt%, about 0.4 wt% to 0.6 wt%, about 0 wt% to 0.4 wt%, about 0.2 wt% to 0.4 wt%, or 0 wt% to 0.2 wt% of a stabilizing component. In some embodiments, a lipid particle of the present disclosure includes about 0 wt% to 1.8 wt% of a stabilizing component.

[0106] In some embodiments, a lipid particle of the present disclosure includes a surfactant component. In some embodiments, a lipid particle of the present disclosure includes a surfactant component selected from, but not limited to, polysorbate 80, saponin, or a combination thereof.

[0107] In some embodiments, a lipid particle of the present disclosure includes about 0.1 wt% to 2.0 wt% of a surfactant component. For example, in some embodiments, a lipid particle of the present disclosure includes about 0 wt% to 2.0 wt%, about 0.2 wt% to 2.0 wt%, about 0.4 wt% to 2.0 wt%, about 0.6 wt% to 2.0 wt%, about 0.8 wt% to 2.0 wt%, about 1.0 wt% to 2.0 wt%, about 1.2 wt% to 2.0 wt%, about 1.4 wt% to 2.0 wt%, about 1.6 wt% to 2.0 wt%, about 1.8 wt% to 2.0 wt%, about 0 wt% to 1.8 wt%, about 0.2 wt% to 1.8 wt%, about 0.4 wt% to 1.8 wt%,about 0.6 wt% to 1 .8 wt%, about 0.8 wt% to 1 .8 wt%, about 1 .0 wt% to 1 .8 wt%, about 1 .2 wt% to 1.8 wt%, about 1.4 wt% to 1.8 wt%, about 1.6 wt% to 1.8 wt%, about 0 wt% to 1.6 wt%, about 0.2 wt% to 1.6 wt%, about 0.4 wt% to 1.6 wt%, about 0.6 wt% to 1.6 wt%, about 0.8 wt% to 1.6 wt%, about 1.0 wt% to 1.6 wt%, about 1.2 wt% to 1.6 wt%, about 1.4 wt% to 1.6 wt%, about 0 wt% to 1.4 wt%, about 0.2 wt% to 1.4 wt%, about 0.4 wt% to 1.4 wt%, about 0.6 wt% to 1.4 wt%, about 0.8 wt% to 1.4 wt%, about 1.0 wt% to 1.4 wt%, about 1.2 wt% to 1.4 wt%, about 0 wt% to 1.2 wt%, about 0.2 wt% to 1.2 wt%, about 0.4 wt% to 1.2 wt%, about 0.6 wt% to 1.2 wt%, about 0.8 wt% to 1.2 wt%, about 1.0 wt% to 1.2 wt%, about 0 wt% to 1.0 wt%, about 0.2 wt% to 1.0 wt%, about 0.4 wt% to 1.0 wt%, about 0.6 wt% to 1.0 wt%, about 0.8 wt% to 1.0 wt%, about 0 wt% to 0.8 wt%, about 0.2 wt% to 0.8 wt%, about 0.4 wt% to 0.8 wt%, about 0.6 wt% to 0.8 wt%, about 0 wt% to 0.6 wt%, about 0.2 wt% to 0.6 wt%, about 0.4 wt% to 0.6 wt%, about 0 wt% to 0.4 wt%, about 0.2 wt% to 0.4 wt%, or 0 wt% to 0.2 wt% of a surfactant component. In some embodiments, a lipid particle of the present disclosure includes about 0 wt% to 1.8 wt% of a surfactant component.

[0108] In some embodiments, a lipid particle of the present disclosure includes an antioxidant component. In some embodiments, an antioxidant component prevents the oxidation of a lipid particle. In some embodiments, an antioxidant component prevents the oxidation of a payload component. In some embodiments, a lipid particle of the present disclosure includes an antioxidant component selected from, but not limited to, a-tocopherol, citric acid, ascorbic acid, butylated hydroxytoluene, or a combination thereof.

[0109] In some embodiments, a lipid particle of the present disclosure includes about 0.1 wt% to 2.0 wt% of an antioxidant component. For example, in some embodiments, a lipid particle of the present disclosure includes about 0 wt% to 2.0 wt%, about 0.2 wt% to 2.0 wt%, about 0.4 wt% to 2.0 wt%, about 0.6 wt% to 2.0 wt%, about 0.8 wt% to 2.0 wt%, about 1.0 wt% to 2.0 wt%, about 1.2 wt% to 2.0 wt%, about 1.4 wt% to 2.0 wt%, about 1.6 wt% to 2.0 wt%, about 1.8 wt% to 2.0 wt%, about 0 wt% to 1.8 wt%, about 0.2 wt% to 1.8 wt%, about 0.4 wt% to 1.8 wt%, about 0.6 wt% to 1.8 wt%, about 0.8 wt% to 1.8 wt%, about 1.0 wt% to 1.8 wt%, about 1.2 wt% to 1.8 wt%, about 1.4 wt% to 1.8 wt%, about 1.6 wt% to 1.8 wt%, about 0 wt% to 1.6 wt%, about 0.2 wt% to 1.6 wt%, about 0.4 wt% to 1.6 wt%, about 0.6 wt% to 1.6 wt%, about 0.8 wt% to 1.6 wt%, about 1.0 wt% to 1.6 wt%, about 1.2 wt% to 1.6 wt%, about 1.4 wt% to 1.6wt%, about 0 wt% to 1 .4 wt%, about 0.2 wt% to 1 .4 wt%, about 0.4 wt% to 1 .4 wt%, about 0.6 wt% to 1.4 wt%, about 0.8 wt% to 1.4 wt%, about 1.0 wt% to 1.4 wt%, about 1.2 wt% to 1.4 wt%, about 0 wt% to 1.2 wt%, about 0.2 wt% to 1.2 wt%, about 0.4 wt% to 1.2 wt%, about 0.6 wt% to 1.2 wt%, about 0.8 wt% to 1.2 wt%, about 1.0 wt% to 1.2 wt%, about 0 wt% to 1.0 wt%, about 0.2 wt% to 1.0 wt%, about 0.4 wt% to 1.0 wt%, about 0.6 wt% to 1.0 wt%, about 0.8 wt% to 1.0 wt%, about 0 wt% to 0.8 wt%, about 0.2 wt% to 0.8 wt%, about 0.4 wt% to 0.8 wt%, about 0.6 wt% to 0.8 wt%, about 0 wt% to 0.6 wt%, about 0.2 wt% to 0.6 wt%, about 0.4 wt% to 0.6 wt%, about 0 wt% to 0.4 wt%, about 0.2 wt% to 0.4 wt%, or 0 wt% to 0.2 wt% of an antioxidant component. In some embodiments, a lipid particle of the present disclosure includes about 0 wt% to 1.8 wt% of an antioxidant component.

[0110] In some embodiments, lipid particles of the present disclosure may have a distribution of diameters (e.g., Dv(10), Dv(20), Dv(30), Dv(40), Dv(50), Dv(60), Dv(70), Dv(80), Dv(90), Dv(99), etc.). In some embodiments, lipid particles of the present disclosure may have a distribution of diameters (e.g., Dv(10), Dv(20), Dv(30), Dv(40), Dv(50), Dv(60), Dv(70), Dv(80), Dv(90), Dv(99), etc.) of up to about 3000 pm, up to about 2000 pm, up to about 1000 pm, up to about 500 pm, up to about 400 pm, up to about 300 pm, up to about 200 pm, up to about 100 pm, up to about 50 pm, up to about 40 pm, up to about 30 pm, up to about 20 pm, up to about 10 pm, or up to about 5 pm.

[0111] In some embodiments, lipid particles of the present disclosure have an average diameter from about 5 nm to 150 nm, about 10 nm to 150 nm, about 15 nm to 150 nm, about 20 nm to 150 nm, about 25 nm to 150 nm, about 30 nm to 150 nm, about 35 nm to 150 nm, about 40 nm to 150 nm, about 45 nm to 150 nm, about 50 nm to 150 nm, about 55 nm to 150 nm, about 60 nm to 150 nm, about 65 nm to 150 nm, about 70 nm to 150 nm, about 75 nm to 150 nm, about 80 nm to 150 nm, about 85 nm to 150 nm, about 90 nm to 150 nm, about 95 nm to 150 nm, about100 nm to 150 nm, about 105 nm to 150 nm, about 110 nm to 150 nm, about 115 nm to 150 nm, about 120 nm to 150 nm, about 125 nm to 150 nm, about 130 nm to 150 nm, about 135 nm to 150 nm, about 140 nm to 150 nm, about 145 nm to 150 nm, about 5 nm to 125 nm, about 10 nm to 125 nm, about 15 nm to 125 nm, about 20 nm to 125 nm, about 25 nm to 125 nm, about 30 nm to 125 nm, about 35 nm to 125 nm, about 40 nm to 125 nm, about 45 nm to 125 nm, about 50 nm to 125 nm, about 55 nm to 125 nm, about 60 nm to 125 nm, about 65 nm to 125 nm, about 70 nmto 125 nm, about 75 nm to 125 nm, about 80 nm to 125 nm, about 85 nm to 125 nm, about 90 nm to 125 nm, about 95 nm to 125 nm, about 100 nm to 125 nm, about 105 nm to 125 nm, about 110 nm to 125 nm, about 115 nm to 125 nm, about 120 nm to 125 nm, about 5 nm to 100 nm, about10 nm to 100 nm, about 15 nm to 100 nm, about 20 nm to 100 nm, about 25 nm to 100 nm, about30 nm to 100 nm, about 35 nm to 100 nm, about 40 nm to 100 nm, about 45 nm to 100 nm, about50 nm to 100 nm, about 55 nm to 100 nm, about 60 nm to 100 nm, about 65 nm to 100 nm, about70 nm to 100 nm, about 75 nm to 100 nm, about 80 nm to 100 nm, about 85 nm to 100 nm, about90 nm to 100 nm, about 95 nm to 100 nm, about 5 nm to 75 nm, about 10 nm to 75 nm, about 15 nm to 75 nm, about 20 nm to 75 nm, about 25 nm to 75 nm, about 30 nm to 75 nm, about 35 nm to 75 nm, about 40 nm to 75 nm, about 45 nm to 75 nm, about 50 nm to 75 nm, about 55 nm to 75 nm, about 60 nm to 75 nm, about 65 nm to 75 nm, about 5 nm to 50 nm, about 10 nm to 50 nm, about 15 nm to 50 nm, about 20 nm to 50 nm, about 25 nm to 50 nm, about 30 nm to 50 nm, about 35 nm to 50 nm, about 40 nm to 50 nm, about 45 nm to 50 nm, about 5 nm to 25 nm, about 10 nm to 25 nm, about 15 nm to 25 nm, or about 20 nm to 25 nm. For example, in some embodiments, lipid particles of the present disclosure have an average diameter of about 35 nm, about 36 nm, about 37 nm, about 38 nm, about 39 nm, about 40 nm, about 41 nm, about 42 nm, about 43 nm, about 44 nm, about 45 nm, about 46 nm, about 47 nm, about 48 nm, about 49 nm, about 50 nm, about 51 nm, about 52 nm, about 53 nm, about 54 nm, or about 55 nm.

[0112] In some embodiments, release of a payload component from a lipid particle described herein into a solution is delayed as compared to release of the payload component in an unformulated state.

[0113] In some embodiments, a lipid particle of the present disclosure contributes to the delayed release of a payload component into one or more gastrointestinal compartment of a subject that has ingested a formulation of the present disclosure. For example, in some embodiments, the release of a payload component from a lipid particle of the present disclosure is delayed until the lipid particle reaches the small intestine of a subject that has ingested a formulation of the present disclosure. In some embodiments, a lipid particle of the present disclosure contributes to the increased bioavailability of a payload component in a subject that has ingested a formulation of the present disclosure.

[0114] In some embodiments, a lipid particle of the present disclosure is pH responsive. For example in some embodiments, release of a payload component from a lipid particle of the present disclosure is enhanced when the lipid particle is exposed to a pH of about 5.5 to 7.5, about 5.75 to 7.5, about 6.0 to 7.5, about 6.25 to 7.5, about 6.5 to 7.5, about 6.75 to 7.5, about 7.0 to 7.5, about 7.25 to 7.5, about 5.5 to 7.25, about 5.75 to 7.25, about 6.0 to 7.25, about 6.25 to 7.25, about 6.5 to 7.25, about 6.75 to 7.25, about 7.0 to 7.25, about 5.5 to 7.0, about 5.75 to 7.0, about 6.0 to 7.0, about 6.25 to 7.0, about 6.5 to 7.0, about 6.75 to 7.0, about 5.5 to 6.75, about 5.75 to 6.75, about 6.0 to 6.75, about 6.25 to 6.75, about 6.5 to 6.75, about 5.5 to 6.5, about 5.75 to 6.5, about 6.0 to 6.5, about 6.25 to 6.5, about 5.5 to 6.25, about 5.75 to 6.25, about 6.0 to 6.25, about 5.5 to 6.0, about 5.75 to 6.0, or about 5.5 to 5.75. In some embodiments, release of a payload component from a lipid particle of the present disclosure is reduced when the lipid particle is exposed to a pH of about 1.5 to 3.5, about 1.75 to 3.5, about 2.0 to 3.5, about 2.25 to 3.5, about 2.5 to 3.5, about 2.75 to 3.5, about 3.0 to 3.5, about 3.25 to 3.5, about 1.5 to 3.25, about 1.75 to 3.25, about 2.0 to 3.25, about 2.25 to 3.25, about 2.5 to 3.25, about 2.75 to 3.25, about 3.0 to 3.25, about 1.5 to 3.0, about 1.75 to 3.0, about 2.0 to 3.0, about 2.25 to 3.0, about 2.5 to 3.0, about 2.75 to 3.0, about 1.5 to 2.75, about 1.75 to 2.75, about 2.0 to 2.75, about 2.25 to 2.75, about 2.5 to 2.75, about 1.5 to 2.5, about 1.75 to 2.5, about 2.0 to 2.5, about 2.25 to 2.5, about 1.5 to 2.25, about 1.75 to 2.25, about 2.0 to 2.25, about 1.5 to 2.0, about 1.75 to 2.0, or about 1.5 to 1.75.Fortified Beverages

[0115] The present disclosure additionally provides beverages that have been fortified with formulations including one or more lipid particles wherein the one or more lipid particles incorporate a payload component, an organic solvent extract of a lipid containing food ingredient, and a beverage component.

[0116] In some embodiments, a formulation of the present disclosure is added to a base beverage to produce a fortified beverage. In some embodiments, a base beverage is selected from, but not limited to, an energy beverage, water, a carbonated drink, a spoils drink, coffee, tea, juice, milk, a milk alternative, or baby formula. In some embodiments, a base beverage is Monster ™ or Red Bull™ energy drink. In some embodiments, a base beverage is oatmilk or Oatly™ beverage.

[0117] In some embodiments, a fortified beverage of the present disclosure includes about 0.1 to 20.0 w / v% of a payload component. In some embodiments, a fortified beverage of the present disclosure includes about 0.1 w / v% to 20.0 w / v%, about 0.5 w / v% to 20.0 w / v%, about 1.0 w / v% to 20.0 w / v%, about 5.0 w / v% to 20.0about 10 w / v% to 20.0 w / v%, about 0.1 w / v% to 10.0 w / v%, about 0.5 w / v% to 10.0 w / v%, about 1.0 w / v% to 10.0 w / v%, about 5.0 w / v% to 10.0 w / v%, about 0.1 w / v% to 5.0 w / v%, about 0.5 w / v% to 5.0 w / v%, about 1.0 to 5.0about 0.1 w / v% to 1.0 w / v%, about 0.5 w / v% to 1.0 w / v%, or about 0.1 w / v% to 0.5 w / v% of a payload component. For example, in some embodiments, a fortified beverage of the present disclosure includes about 0.1 IN% to 20.0 w / v%, about 0.2 w / v% to 20.0 w / v%, about 0.3 w / v% to 20.0 w / v%, about 0.4 w / v% to 20.0 w / v%, about 0.5 w / v% to 20.0 w / v%, about 0.6 w / v% to 20.0 w / v%, about 0.7 w / v% to 20.0 w / v%, about 0.8 w / v% to 20.0 w / v%, about 0.9 w / v% to 20.0 w / v%, about 1.0 !N% to 20.0 IN%, about 0.1 w / v% to 19.8 w / v%, about 0.2 w / v% to 19.8 w / v%, about 0.3 w / v% to 19.8 w / v%, about 0.4 w / v% to 19.8 w / v%, about 0.5 w / v% to 19.8 w / v%, about 0.6 w / v% to 19.8 w / v%, about 0.7 w / v% to 19.8 w / v%, about 0.8 w / v% to 19.8 w / v%, about 0.9 w / v% to 19.8 w / v%, about 1.0 w / v% to 19.8 w / v%, about 0.1 w / v% to 19.6 w / v%, about 0.2 w / v% to 19.6 w / v%, about 0.3 w / v% to 19.6 w / v%, about 0.4 w / v% to 19.6 w / v%, about 0.5 w / v% to 19.6 w / v%, about 0.6 w / v% to 19.6 w / v%, about 0.7 w / v% to 19.6 w / v%, about 0.8 / N% to 19.6 w / v%, about 0.9 w / v% to 19.6 about 1.0 w / v% to 19.6 w / v%, about 0.1 w / v% to 19.4 w / v%, about 0.2 w / v% to 19.4 w / v%, about 0.3 w / v% to 19.4 w / v%, about 0.4 w / v% to 19.4 w / v%, about 0.5 w / v% to 19.4 w / v%, about 0.6 w / v% to 19.4 w / v%, about 0.7 w / v% to 19.4 w / v%, about 0.8 w / v% to 19.4 w / v%, about 0.9 w / v% to 19.4 w / v%, about 1.0 w / v% to 19.4 w / v%, about 0.1 w / v% to 19.2 w / v%, about 0.2 w / v% to 19.2 w / v%, about 0.3 w / v% to 19.2 w / v%, about 0.4 w / v% to 19.2 w / v%, about 0.5 w / v% to 19.2 w / v%, about 0.6 w / v% to 19.2 w / v%, about 0.7 w / v% to 19.2 w / v%, about 0.8 w / v% to 19.2 w / v%, about 0.9 w / v% to 19.2 w / v%, about 1.0 w / v% to 19.2 w / v%, about 0.1 w / v% to 19.0 w / v%, about 0.2 w / v% to 19.0 w / v%, about 0.3 w / v% to 19.0 w / v%, about 0.4 w / v% to 19.0 w / v%, about 0.5 w / v% to 19.0 w / v%, about 0.6 w / v% to 19.0 w / v%, about 0.7 w / v% to 19.0 w / v%, about 0.8 w / v% to 19.0 vilv%, about 0.9 w / v% to 19.0 w / v%, about 1.0 w / v% to 19.0 w / v%, about 0.1 w / v% to 18.8 w / v%, about 0.2 w / v% to 18.8 w / v%, about 0.3 w / v% to 18.8 w / v%, about 0.4 w / v% to 18.8 w / v%, about 0.5 w / v% to 18.8 w / v%, about 0.6 w / v% to 18.8 w / v%, about 0.7 w / v% to 18.8 IN%, about 0.8w / v% to 18.8 w / v%, about 0.9 w / v% to 18.8 w / v%, about 1 .0 w / v% to 18.8 w / v%, about 0. 1 w / v% to 18.6 w / v%, about 0.2 w / v% to 18.6 w / v%, about 0.3 w / v% to 18.6 w / v%, about 0.4w / v% to 18.2 w / v%, about 0.6 w / v% to 18.2 w / v%, about 0.7 w / v% to 18.2 w / v%, about 0.8 w / v% to 18.2 w / v%, about 0.9 w / v% to 18.2 w / v%, about 1.0 w / v% to 18.2 w / v%, about 0.1 w / v% to 18.0 w / v%, about 0.2 w / v% to 18.0 w / v%, about 0.3 !N% to 18.0 IN%, about 0.4 w / v% to 18.0 w / v%, about 0.5 w / v% to 18.0 w / v%, about 0.6 w / v% to 18.0 w / v%, about 0.7 w / v% to 18.0 w / v%, about 0.8 w / v% to 18.0 w / v%, about 0.9 w / v% to 18.0 w / v%, or about 1.0 w / v% to 18.0 w / v% of a payload component.

[0118] In some embodiments, a payload component includes lutein, vitamin D, vitamin B12, caffeine, creatine, tannic acid, gallic acid, glucose, zeaxanthin, curcurmin, quercetin, rutin, naringenin, fatty acids, ketone esters or a combination thereof. In some embodiments, a payload component provides a nutritional, health, and / or stimulatory benefit to a subject when a formulation is consumed by a subject.

[0119] In some embodiments, a fortified beverage of the present disclosure has a turbidity no greater than about 25 NTU, about 50 NTU, about 75 NTU, about 100 NTU, about 125 NTU, about 150 NTU, about 175 NTU, about 200 NTU, about 225 NTU, about 250 NTU, about 275 NTU, about 300 NTU, about 325 NTU, about 350 NTU, about 375 NTU, about 400 NTU, about 425 NTU, about 450 NTU, about 475 NTU, about 500 NTU, about 525 NTU, about 550 NTU, about 575 NTU, about 600 NTU, about 625 NTU, about 650 NTU, about 675 NTU, about 700 NTU, about 725 NTU, or about 750 NTU.

[0120] In some embodiments, a fortified beverage includes about 0.001 to 0.1 mg / ml of a formulation having one or more lipid particles wherein the one or more lipid particles incorporate a payload component, an organic solvent extract of a lipid containing foodingredient, and a beverage component. In some embodiments, a fortified beverage of the present disclosure includes about 0.001 to 0.1 mg / ml, about 0.005 to 0.1 mg / ml, about 0.01 to 0.1 mg / ml, about 0.015 to 0.1 mg / ml, about 0.02 to 0.1 mg / ml, about 0.025 to 0.1 mg / ml, about 0.03 to 0.1 mg / ml, about 0.035 to 0.1 mg / ml, about 0.04 to 0.1 mg / ml, about 0.045 to 0.1 mg / ml, about 0.05 to 0.1 mg / ml, about 0.055 to 0.1 mg / ml, about 0.06 to 0.1 mg / ml, about 0.065 to 0.1 mg / ml, about 0.07 to 0.1 mg / ml, about 0.075 to 0.1 mg / ml, about 0.08 to 0.1 mg / ml, about 0.085 to 0.1 mg / ml, about 0.09 to 0.1 mg / ml, about 0.095 to 0.1 mg / ml, about 0.001 to 0.1 mg / ml, about 0.005 to 0.1 mg / ml, about 0.01 to 0.075 mg / ml, about 0.015 to 0.075 mg / ml, about 0.02 to 0.075 mg / ml, about 0.025 to 0.075 mg / ml, about 0.03 to 0.075 mg / ml, about 0.035 to 0.075 mg / ml, about 0.04 to 0.075 mg / ml, about 0.045 to 0.075 mg / ml, about 0.05 to 0.075 mg / ml, about 0.055 to 0.075 mg / ml, about 0.06 to 0.075 mg / ml, about 0.065 to 0.075 mg / ml, about 0.07 to 0.075 mg / ml, about 0.001 to 0.05 mg / ml, about 0.005 to 0.05 mg / ml, about 0.01 to 0.05 mg / ml, about 0.015 to 0.05 mg / ml, about 0.02 to 0.05 mg / ml, about 0.025 to 0.05 mg / ml, about 0.03 to 0.05 mg / ml, about 0.035 to 0.05 mg / ml, about 0.04 to 0.05 mg / ml, or about 0.045 to 0.05 mg / ml of a formulation having one or more lipid particles wherein the one or more lipid particles incorporate a payload component, an organic solvent extract of a lipid containing food ingredient, and a beverage component.

[0121] In some embodiments, a formulation of the present disclosure enhances the stability of a payload component when stored in a base beverage as compared to the stability of the payload component when stored in the base beverage in an unformulated state. In some embodiments, at least 70%, at least 71%, at least 72%, at least 73%, at least 74%, at least 75%, at least 76%, at least 77%, at least 78%, at least 79%, at least 80%, at least 81%, at least 82%, at least 83%, at least 84%, at least 85%, at least 86%, at least 87%, at least 88%, at least 89%, at least 90%, at least 91%, at least 92%, at least 93%, at least 94%, at least 95%, at least 96%, at least 97%, at least 98%, or at least 99% of a payload is recoverable from a fortified beverage having one or more lipid particles wherein the one or more lipid particles incorporate a payload component, an organic solvent extract of a lipid containing food ingredient, and a beverage component after about 2 weeks to 24 weeks, about 4 weeks to 24 weeks, about 6 weeks to 24 weeks, about 8 weeks to 24 weeks, about 10 weeks to 24 weeks, about 12 weeks to 24 weeks, about 14 weeks to 24 weeks, about 16 weeks to 24 weeks, about 18 weeks to 24 weeks, about 20 weeks to 24 weeks, about 22 weeks to 24 weeks, about 2 weeks to 20 weeks, about 4 weeks to20 weeks, about 6 weeks to 20 weeks, about 8 weeks to 20 weeks, about 10 weeks to 20 weeks, about 12 weeks to 20 weeks, about 14 weeks to 20 weeks, about 16 weeks to 20 weeks, about 18 weeks to 20 weeks, about 2 weeks to 16 weeks, about 4 weeks to 16 weeks, about 6 weeks to 16 weeks, about 8 weeks to 16 weeks, about 10 weeks to 16 weeks, about 12 weeks to 16 weeks, about 14 weeks to 16 weeks, about 2 weeks to 12 weeks, about 4 weeks to 12 weeks, about 6 weeks to 12 weeks, about 8 weeks to 12 weeks, about 10 weeks to 12 weeks, about 2 weeks to 8 weeks, about 4 weeks to 8 weeks, about 6 weeks to 8 weeks, or about 2 weeks to 4 weeks of storage in a base beverage. For example, in some embodiments, at least 75% of a payload component is recoverable from a base beverage after about 16 weeks of storage.

[0122] In some embodiments, release of a payload component from a lipid particle described herein into a solution or a base beverage is delayed as compared to release of the payload component in an unformulated state. In some embodiments, a base beverage comprises a concentration of a payload component that is less than the concentration of the payload component in a lipid particle of the present disclosure, thereby establishing a concentration gradient across the liposomal membrane. In some embodiments, a concentration of the payload component in the beverage component is in equilibrium with a concentration of the payload component in a lipid particle of the present disclosure. In some embodiments, the concentration of a payload component in a base beverage contributes to delayed release of the payload component from a lipid particle of the present disclosure as compared to the release of the pay load component from the lipid particle into a base beverage that does not contain any concentration of the payload component.

[0123] In some embodiments, a fortified beverage of the present disclosure has an amount of payload component in a base beverage thereby establishing a payload component concentration gradient across liposomal membranes of its one or more constituent lipid particles. In some embodiments, a concentration gradient contributes to delayed release of a payload component from a lipid particle of the present disclosure into one or more gastrointestinal compartment of a subject that has ingested a fortified beverage. For example, in some embodiments, a payload component concentration gradient of a fortified beverage contributes to delayed release of the payload component from a lipid particle of the present disclosure into the small intestine of a subject that has ingested a fortified beverage. In some embodiments, apayload component concentration gradient of a fortified beverage contributes to the increased bioavailability of the payload component.Methods of Preparation

[0124] The present disclosure additionally provides methods of preparing a lipid particle described herein that incorporates a payload component, an organic solvent extract of a lipid containing food ingredient, and a beverage component.

[0125] In some embodiments, a lipid particle of the present disclosure is prepared by: i) vortexing and / or sonicating a lipid-containing food ingredient with an organic solvent; ii) heating the lipid-containing food ingredient and the organic solvent; iii) separating a lipid-containing phase from a solid precipitate or aqueous phase; iv) heating the lipid-containing phase; v) adding a hydrophobic payload to the lipid-containing phase or adding a hydrophilic payload to an aqueous beverage component; and vi) vortexing and / or sonicating the lipid-containing phase with the aqueous beverage component to form the lipid particle.

[0126] In some embodiments, a lipid-containing food ingredient is selected from, but not limited to, buttermilk, milk, egg yolk, beef brain, pig liver, chicken liver, herring dark muscle, soybean, de-hulled oat, rapeseed, lecithin, or a combination thereof.

[0127] In some embodiments, an organic solvent used to extract lipids from a lipid- containing food ingredient is selected from, but not limited to, ethanol, tetrahydrofuran (THF), methanol, isopropanol, 1,4 dioxane, methyl tert-butyl ether (MTBE), acetonitrile, acetone, acetic acid, 1 -butanol, 2-butanol, 3-methyl-l -butanol, methylethylketone, ethylformate, formic acid, triethylamine, transcutol, or a combination thereof.

[0128] In some embodiments, step ii) heating the lipid-containing food ingredient and the organic solvent is to a temperature above the glass transition temperature of a lipid in the lipid- containing food ingredient. In some embodiments, the temperature is about 50 to 100 °C, about 55 to 100 °C, about 60 to 100 °C, about 65 to 100 °C, about 70 to 100 °C, about 75 to 100 °C, about 80 to 100 °C, about 85 to 100 °C, about 90 to 100 °C, about 95 to 100 °C, about 50 to 95°C, about 55 to 95 °C, about 60 to 95 °C, about 65 to 95 °C, about 70 to 95 °C, about 75 to 95 °C, about 80 to 95 °C, about 85 to 95 °C, about 90 to 95 °C, about 50 to 90 °C, about 55 to 90 °C, about 60 to 90 °C, about 65 to 90 °C, about 70 to 90 °C, about 75 to 90 °C, about 80 to 90 °C, about 85 to 90 °C, about 50 to 85 °C, about 55 to 85 °C, about 60 to 85 °C, about 65 to 85 °C, about 70 to 85 °C, about 75 to 85 °C, about 80 to 85 °C, about 50 to 80 °C, about 55 to 80 °C, about 60 to 80 °C, about 65 to 80 °C, about 70 to 80 °C, about 75 to 80 °C, about 50 to 75 °C, about 55 to 75 °C, about 60 to 75 °C, about 65 to 75 °C, about 70 to 75 °C, about 50 to 70 °C, about 55 to 70 °C, about 60 to 70 °C, about 65 to 70 °C, about 50 to 65 °C, about 55 to 65 °C, about 60 to 65 °C, about 50 to 60 °C, about 55 to 60 °C, or about 50 to 55 °C.

[0129] In some embodiments, step ii) heating the lipid-containing food ingredient and the organic solvent is for about 0.5 hours to 96 hours, about 1.0 hour to 96 hours, about 1.5 hours to 96 hours, about 2.0 hours to 96 hours, about 2.5 hours to 96 hours, about 3.0 hours to 96 hours, about 3.5 hours to 96 hours, about 4.0 hours to 96 hours, about 4.5 hours to 96 hours, about 5.0 hours to 96 hours, about 5.5 hours to 96 hours, about 6 hours to 96 hours, about 12 hours to 96 hours, about 18 hours to 96 hours, about 24 hours to 96 hours, about 36 hours to 96 hours, about 48 hours to 96 hours, about 60 hours to 96 hours, about 72 hours to 96 hours, about 0.5 hours to 72 hours, about 1.0 hour to 72 hours, about 1.5 hours to 72 hours, about 2.0 hours to 72 hours, about 2.5 hours to 72 hours, about 3.0 hours to 72 hours, about 3.5 hours to 72 hours, about 4.0 hours to 72 hours, about 4.5 hours to 72 hours, about 5.0 hours to 72 hours, about 5.5 hours to 72 hours, about 6 hours to 72 hours, about 12 hours to 72 hours, about 18 hours to 72 hours, about 24 hours to 72 hours, about 36 hours to 72 hours, about 48 hours to 72 hours, about 60 hours to 72 hours, about 0.5 hours to 60 hours, about 1.0 hour to 60 hours, about 1.5 hours to 60 hours, about 2.0 hours to 60 hours, about 2.5 hours to 60 hours, about 3.0 hours to 60 hours, about 3.5 hours to 60 hours, about 4.0 hours to 60 hours, about 4.5 hours to 60 hours, about 5.0 hours to 60 hours, about 5.5 hours to 60 hours, about 6 hours to 60 hours, about 12 hours to 60 hours, about 18 hours to 60 hours, about 24 hours to 60 hours, about 36 hours to 60 hours, about 48 hours to 60 hours, about 0.5 hours to 48 hours, about 1.0 hour to 48 hours, about 1.5 hours to 48 hours, about 2.0 hours to 48 hours, about 2.5 hours to 48 hours, about 3.0 hours to 48 hours, about 3.5 hours to 48 hours, about 4.0 hours to 48 hours, about 4.5 hours to 48 hours, about 5.0 hours to 48 hours, about 5.5 hours to 48 hours, about 6 hours to 48 hours, about 12 hours to 48 hours, about 18 hours to 48 hours, about 24 hours to 48 hours, about 36 hours to 48 hours, about 60 hours to48 hours, about 72 hours to 48 hours, about 0.5 hours to 36 hours, about 1 .0 hour to 36 hours, about 1.5 hours to 36 hours, about 2.0 hours to 36 hours, about 2.5 hours to 36 hours, about 3.0 hours to 36 hours, about 3.5 hours to 36 hours, about 4.0 hours to 36 hours, about 4.5 hours to 36 hours, about 5.0 hours to 36 hours, about 5.5 hours to 36 hours, about 6 hours to 36 hours, about 12 hours to 36 hours, about 18 hours to 36 hours, about 24 hours to 36 hours, about 0.5 hours to 24 hours, about 1.0 hour to 24 hours, about 1.5 hours to 24 hours, about 2.0 hours to 24 hours, about 2.5 hours to 24 hours, about 3.0 hours to 24 hours, about 3.5 hours to 24 hours, about 4.0 hours to 24 hours, about 4.5 hours to 24 hours, about 5.0 hours to 24 hours, about 5.5 hours to 24 hours, about 6 hours to 24 hours, about 12 hours to 24 hours, about 18 hours to 24 hours, about 0.5 hours to 18 hours, about 1.0 hour to 18 hours, about 1.5 hours to 18 hours, about 2.0 hours to 18 hours, about 2.5 hours to 18 hours, about 3.0 hours to 18 hours, about 3.5 hours to 18 hours, about 4.0 hours to 18 hours, about 4.5 hours to 18 hours, about 5.0 hours to 18 hours, about 5.5 hours to 18 hours, about 6 hours to 18 hours, about 12 hours to 18 hours, about 0.5 hours to 12 hours, about 1.0 hour to 12 hours, about 1.5 hours to 12 hours, about 2.0 hours to 12 hours, about 2.5 hours to 12 hours, about 3.0 hours to 12 hours, about 3.5 hours to 12 hours, about 4.0 hours to 12 hours, about 4.5 hours to 12 hours, about 5.0 hours to 12 hours, about 5.5 hours to 12 hours, about 6 hours to 12 hours, about 0.5 hours to 6 hours, about 1.0 hour to 6 hours, about 1.5 hours to 6 hours, about 2.0 hours to 6 hours, about 2.5 hours to 6 hours, about 3.0 hours to 6 hours, about 3.5 hours to 6 hours, about 4.0 hours to 6 hours, about 4.5 hours to 6 hours, about 5.0 hours to 6 hours, or about 5.5 hours to 6 hours.

[0130] In some embodiments, a lipid-containing food ingredient is homogenized and / or lyophilized before step i) vortexing and / or sonicating.

[0131] In some embodiments, methods of the present disclosure further include removing an organic solvent from a lipid-containing phase before step v) vortexing and / or sonicating. In some embodiments, an organic solvent is removed using a rotary evaporator.

[0132] In some embodiments, step iv) heating the lipid-containing phase is to a temperature above the glass transition temperature of a lipid in the lipid-containing food ingredient. In some embodiments, the temperature is about 50 to 100 °C, about 55 to 100 °C, about 60 to 100 °C, about 65 to 100 °C, about 70 to 100 °C, about 75 to 100 °C, about 80 to 100 °C, about 85 to 100 °C, about 90 to 100 °C, about 95 to 100 °C, about 50 to 95 °C, about 55 to 95°C, about 60 to 95 °C, about 65 to 95 °C, about 70 to 95 °C, about 75 to 95 °C, about 80 to 95 °C, about 85 to 95 °C, about 90 to 95 °C, about 50 to 90 °C, about 55 to 90 °C, about 60 to 90 °C, about 65 to 90 °C, about 70 to 90 °C, about 75 to 90 °C, about 80 to 90 °C, about 85 to 90 °C, about 50 to 85 °C, about 55 to 85 °C, about 60 to 85 °C, about 65 to 85 °C, about 70 to 85 °C, about 75 to 85 °C, about 80 to 85 °C, about 50 to 80 °C, about 55 to 80 °C, about 60 to 80 °C, about 65 to 80 °C, about 70 to 80 °C, about 75 to 80 °C, about 50 to 75 °C, about 55 to 75 °C, about 60 to 75 °C, about 65 to 75 °C, about 70 to 75 °C, about 50 to 70 °C, about 55 to 70 °C, about 60 to 70 °C, about 65 to 70 °C, about 50 to 65 °C, about 55 to 65 °C, about 60 to 65 °C, about 50 to 60 °C, about 55 to 60 °C, or about 50 to 55 °C.

[0133] In some embodiments, step v) adding a hydrophobic payload to the lipid- containing phase or adding a hydrophilic payload to an aqueous beverage component includes adding a hydrophobic payload selected from, but not limited to, lutein, vitamin D, zeaxanthin, curcumin, quercetin, rutin, narigenin, fatty acids, or a combination thereof. In some embodiments, step v) adding a hydrophobic payload to the lipid-containing phase or adding a hydrophilic payload to an aqueous beverage component includes adding a hydrophilic payload selected from, but not limited to, vitamin B12, caffeine, creatine, tannic acid, gallic acid, glucose, or a combination thereof.

[0134] In some embodiments, an aqueous beverage component of steps v) and / or vi) is selected from, but not limited to, an energy beverage, water, carbonated drink, a sports drink, coffee, tea, juice, milk, milk alternative, or baby formula. In some embodiments, an aqueous beverage component is Monster ™ or Red Bull™ energy drink. In some embodiments, the aqueous beverage component is oatmilk or Oatly™ beverage.

[0135] In some embodiments, methods of preparing a lipid particle described herein further includes resizing the lipid particle by gas pressure extrusion, sonication, microfluidic mixing, or a combination thereof, after step vi) vortexing and / or sonicating.

[0136] In some embodiments, methods of preparing a lipid particle described herein further includes purifying the lipid particle by size-exclusion filtration, centrifugal filtration, tangential flow filtration, or a combination thereof, after step vi) vortexing and / or sonicating.

[0137] In some embodiments, methods of preparing a lipid particle described herein further includes concentrating the lipid particle by tangential flow filtration, rotary evaporation, centrifugal filtration, or a combination thereof.

[0138] In some embodiments, methods of preparing a lipid particle described herein further includes drying the lipid particle in the presence of a structural protectant. In some embodiments, the lipid particle is dried by lyophilization or spray-drying. In some embodiments, a lipid particle of the present disclosure is dried in the presence of sucrose, trehalose, sorbitol, or a combination thereof.Remote Loading

[0139] In some embodiments, a lipid particle of the present disclosure is prepared by: i) vortexing and / or sonicating a lipid-containing food ingredient with an organic solvent; ii) heating the lipid-containing food ingredient and the organic solvent; iii) separating a lipid-containing phase from a solid precipitate or aqueous phase; iv) heating the lipid-containing phase; v) adding an entrapping agent to the lipid-containing phase or adding the entrapping agent to an aqueous beverage component; vi) vortexing and / or sonicating the lipid-containing phase with the aqueous beverage component to form a lipid particle; vii) removing the entrapping agent by tangential flow filtration to establish an entrapping agent gradient across a lipid membrane of the lipid particle; viii) establishing a payload component gradient across the lipid membrane of the lipid particle to permeate the lipid particle with the payload component and form the lipid particle.

[0140] In some embodiments, a lipid-containing food ingredient is selected from, but not limited to, buttermilk, milk, egg yolk, beef brain, pig liver, chicken liver, herring dark muscle, soybean, de-hulled oat, rapeseed, lecithin, or a combination thereof.

[0141] In some embodiments, an organic solvent used to extract lipids from a lipid- containing food ingredient is selected from, but not limited to, ethanol, tetrahydrofuran (THF), methanol, isopropanol, 1,4 dioxane, methyl tert-butyl ether (MTBE), acetonitrile, acetone, acetic acid, 1 -butanol, 2-butanol, 3-methyl-l -butanol, methylethylketone, ethylformate, formic acid, triethylamine, transcutol, or a combination thereof.

[0142] In some embodiments, step ii) heating the lipid-containing food ingredient and the organic solvent is to a temperature above the glass transition temperature of a lipid in the lipid- containing food ingredient. In some embodiments, the temperature is about 50 to 100 °C, about 55 to 100 °C, about 60 to 100 °C, about 65 to 100 °C, about 70 to 100 °C, about 75 to 100 °C, about 80 to 100 °C, about 85 to 100 °C, about 90 to 100 °C, about 95 to 100 °C, about 50 to 95 °C, about 55 to 95 °C, about 60 to 95 °C, about 65 to 95 °C, about 70 to 95 °C, about 75 to 95 °C, about 80 to 95 °C, about 85 to 95 °C, about 90 to 95 °C, about 50 to 90 °C, about 55 to 90 °C, about 60 to 90 °C, about 65 to 90 °C, about 70 to 90 °C, about 75 to 90 °C, about 80 to 90 °C, about 85 to 90 °C, about 50 to 85 °C, about 55 to 85 °C, about 60 to 85 °C, about 65 to 85 °C, about 70 to 85 °C, about 75 to 85 °C, about 80 to 85 °C, about 50 to 80 °C, about 55 to 80 °C, about 60 to 80 °C, about 65 to 80 °C, about 70 to 80 °C, about 75 to 80 °C, about 50 to 75 °C, about 55 to 75 °C, about 60 to 75 °C, about 65 to 75 °C, about 70 to 75 °C, about 50 to 70 °C, about 55 to 70 °C, about 60 to 70 °C, about 65 to 70 °C, about 50 to 65 °C, about 55 to 65 °C, about 60 to 65 °C, about 50 to 60 °C, about 55 to 60 °C, or about 50 to 55 °C.

[0143] In some embodiments, step ii) heating the lipid-containing food ingredient and the organic solvent is for about 0.5 hours to 96 hours, about 1.0 hour to 96 hours, about 1.5 hours to 96 hours, about 2.0 hours to 96 hours, about 2.5 hours to 96 hours, about 3.0 hours to 96 hours, about 3.5 hours to 96 hours, about 4.0 hours to 96 hours, about 4.5 hours to 96 hours, about 5.0 hours to 96 hours, about 5.5 hours to 96 hours, about 6 hours to 96 hours, about 12 hours to 96 hours, about 18 hours to 96 hours, about 24 hours to 96 hours, about 36 hours to 96 hours, about 48 hours to 96 hours, about 60 hours to 96 hours, about 72 hours to 96 hours, about 0.5 hours to 72 hours, about 1.0 hour to 72 hours, about 1.5 hours to 72 hours, about 2.0 hours to 72 hours, about 2.5 hours to 72 hours, about 3.0 hours to 72 hours, about 3.5 hours to 72 hours, about 4.0 hours to 72 hours, about 4.5 hours to 72 hours, about 5.0 hours to 72 hours, about 5.5 hours to 72 hours, about 6 hours to 72 hours, about 12 hours to 72 hours, about 18 hours to 72 hours, about24 hours to 72 hours, about 36 hours to 72 hours, about 48 hours to 72 hours, about 60 hours to 72 hours, about 0.5 hours to 60 hours, about 1.0 hour to 60 hours, about 1.5 hours to 60 hours, about 2.0 hours to 60 hours, about 2.5 hours to 60 hours, about 3.0 hours to 60 hours, about 3.5 hours to 60 hours, about 4.0 hours to 60 hours, about 4.5 hours to 60 hours, about 5.0 hours to 60 hours, about 5.5 hours to 60 hours, about 6 hours to 60 hours, about 12 hours to 60 hours, about 18 hours to 60 hours, about 24 hours to 60 hours, about 36 hours to 60 hours, about 48 hours to 60 hours, about 0.5 hours to 48 hours, about 1.0 hour to 48 hours, about 1.5 hours to 48 hours, about 2.0 hours to 48 hours, about 2.5 hours to 48 hours, about 3.0 hours to 48 hours, about 3.5 hours to 48 hours, about 4.0 hours to 48 hours, about 4.5 hours to 48 hours, about 5.0 hours to 48 hours, about 5.5 hours to 48 hours, about 6 hours to 48 hours, about 12 hours to 48 hours, about 18 hours to 48 hours, about 24 hours to 48 hours, about 36 hours to 48 hours, about 60 hours to 48 hours, about 72 hours to 48 hours, about 0.5 hours to 36 hours, about 1.0 hour to 36 hours, about 1.5 hours to 36 hours, about 2.0 hours to 36 hours, about 2.5 hours to 36 hours, about 3.0 hours to 36 hours, about 3.5 hours to 36 hours, about 4.0 hours to 36 hours, about 4.5 hours to 36 hours, about 5.0 hours to 36 hours, about 5.5 hours to 36 hours, about 6 hours to 36 hours, about 12 hours to 36 hours, about 18 hours to 36 hours, about 24 hours to 36 hours, about 0.5 hours to 24 hours, about 1.0 hour to 24 hours, about 1.5 hours to 24 hours, about 2.0 hours to 24 hours, about 2.5 hours to 24 hours, about 3.0 hours to 24 hours, about 3.5 hours to 24 hours, about 4.0 hours to 24 hours, about 4.5 hours to 24 hours, about 5.0 hours to 24 hours, about 5.5 hours to 24 hours, about 6 hours to 24 hours, about 12 hours to 24 hours, about 18 hours to 24 hours, about 0.5 hours to 18 hours, about 1.0 hour to 18 hours, about 1.5 hours to 18 hours, about 2.0 hours to 18 hours, about 2.5 hours to 18 hours, about 3.0 hours to 18 hours, about 3.5 hours to 18 hours, about 4.0 hours to 18 hours, about 4.5 hours to 18 hours, about 5.0 hours to 18 hours, about 5.5 hours to 18 hours, about 6 hours to 18 hours, about 12 hours to 18 hours, about 0.5 hours to 12 hours, about 1.0 hour to 12 hours, about 1.5 hours to 12 hours, about 2.0 hours to 12 hours, about 2.5 hours to 12 hours, about 3.0 hours to 12 hours, about 3.5 hours to 12 hours, about 4.0 hours to 12 hours, about 4.5 hours to 12 hours, about 5.0 hours to 12 hours, about 5.5 hours to 12 hours, about 6 hours to 12 hours, about 0.5 hours to 6 hours, about 1.0 hour to 6 hours, about 1.5 hours to 6 hours, about 2.0 hours to 6 hours, about 2.5 hours to 6 hours, about 3.0 hours to 6 hours, about 3.5 hours to 6 hours, about 4.0 hours to 6 hours, about 4.5 hours to 6 hours, about 5.0 hours to 6 hours, or about 5.5 hours to 6 hours.

[0144] In some embodiments, a lipid-containing food ingredient is homogenized and / or lyophilized before step i) vortexing and / or sonicating.

[0145] In some embodiments, an entrapping agent of step v) is selected from, but not limited to, tannic acid.

[0146] In some embodiments, step iv) heating the lipid-containing phase is to a temperature above the glass transition temperature of a lipid in the lipid-containing food ingredient. In some embodiments, the temperature is about 50 to 100 °C, about 55 to 100 °C, about 60 to 100 °C, about 65 to 100 °C, about 70 to 100 °C, about 75 to 100 °C, about 80 to 100 °C, about 85 to 100 °C, about 90 to 100 °C, about 95 to 100 °C, about 50 to 95 °C, about 55 to 95 °C, about 60 to 95 °C, about 65 to 95 °C, about 70 to 95 °C, about 75 to 95 °C, about 80 to 95 °C, about 85 to 95 °C, about 90 to 95 °C, about 50 to 90 °C, about 55 to 90 °C, about 60 to 90 °C, about 65 to 90 °C, about 70 to 90 °C, about 75 to 90 °C, about 80 to 90 °C, about 85 to 90 °C, about 50 to 85 °C, about 55 to 85 °C, about 60 to 85 °C, about 65 to 85 °C, about 70 to 85 °C, about 75 to 85 °C, about 80 to 85 °C, about 50 to 80 °C, about 55 to 80 °C, about 60 to 80 °C, about 65 to 80 °C, about 70 to 80 °C, about 75 to 80 °C, about 50 to 75 °C, about 55 to 75 °C, about 60 to 75 °C, about 65 to 75 °C, about 70 to 75 °C, about 50 to 70 °C, about 55 to 70 °C, about 60 to 70 °C, about 65 to 70 °C, about 50 to 65 °C, about 55 to 65 °C, about 60 to 65 °C, about 50 to 60 °C, about 55 to 60 °C, or about 50 to 55 °C.

[0147] In some embodiments, methods of the present disclosure further include removing an organic solvent from a lipid-containing phase before step vi) vortexing and / or sonicating. In some embodiments, an organic solvent is removed using a rotary evaporator.

[0148] In some embodiments, an aqueous beverage component of steps v) and / or vi) is selected from, but not limited to, an energy beverage, water, carbonated drink, sports drink, coffee, tea, juice, milk, milk alternative, or baby formula. In some embodiments, an aqueous beverage component is Monster ™ or Red Bull™ energy drink. In some embodiments, an aqueous beverage component is Oatmilk or Oatly™ beverage.

[0149] In some embodiments, step viii) establishing a payload component gradient across the lipid membrane of the lipid particle includes placing a lipid particle in an aqueous beverage component having a concentration of a payload component that is higher than the concentration of the payload component in the lipid particle. In some embodiments, a lipid particle isincubated in an aqueous beverage component for a length of time sufficient to establish a concentration gradient equilibrium between the aqueous beverage component and the lipid particle. In some embodiments, a lipid particle is incubated in an aqueous beverage component for about 0.5 hours to 96 hours, about 1.0 hour to 96 hours, about 1.5 hours to 96 hours, about 2.0 hours to 96 hours, about 2.5 hours to 96 hours, about 3.0 hours to 96 hours, about 3.5 hours to 96 hours, about 4.0 hours to 96 hours, about 4.5 hours to 96 hours, about 5.0 hours to 96 hours, about 5.5 hours to 96 hours, about 6 hours to 96 hours, about 12 hours to 96 hours, about 18 hours to 96 hours, about 24 hours to 96 hours, about 36 hours to 96 hours, about 48 hours to 96 hours, about 60 hours to 96 hours, about 72 hours to 96 hours, about 0.5 hours to 72 hours, about 1.0 hour to 72 hours, about 1.5 hours to 72 hours, about 2.0 hours to 72 hours, about 2.5 hours to 72 hours, about 3.0 hours to 72 hours, about 3.5 hours to 72 hours, about 4.0 hours to 72 hours, about 4.5 hours to 72 hours, about 5.0 hours to 72 hours, about 5.5 hours to 72 hours, about 6 hours to 72 hours, about 12 hours to 72 hours, about 18 hours to 72 hours, about 24 hours to 72 hours, about 36 hours to 72 hours, about 48 hours to 72 hours, about 60 hours to 72 hours, about 0.5 hours to 60 hours, about 1.0 hour to 60 hours, about 1.5 hours to 60 hours, about 2.0 hours to 60 hours, about 2.5 hours to 60 hours, about 3.0 hours to 60 hours, about 3.5 hours to 60 hours, about 4.0 hours to 60 hours, about 4.5 hours to 60 hours, about 5.0 hours to 60 hours, about 5.5 hours to 60 hours, about 6 hours to 60 hours, about 12 hours to 60 hours, about 18 hours to 60 hours, about 24 hours to 60 hours, about 36 hours to 60 hours, about 48 hours to 60 hours, about 0.5 hours to 48 hours, about 1.0 hour to 48 hours, about 1.5 hours to 48 hours, about 2.0 hours to 48 hours, about 2.5 hours to 48 hours, about 3.0 hours to 48 hours, about 3.5 hours to 48 hours, about 4.0 hours to 48 hours, about 4.5 hours to 48 hours, about 5.0 hours to 48 hours, about 5.5 hours to 48 hours, about 6 hours to 48 hours, about 12 hours to 48 hours, about 18 hours to 48 hours, about 24 hours to 48 hours, about 36 hours to 48 hours, about 60 hours to 48 hours, about 72 hours to 48 hours, about 0.5 hours to 36 hours, about 1.0 hour to 36 hours, about 1.5 hours to 36 hours, about 2.0 hours to 36 hours, about 2.5 hours to 36 hours, about 3.0 hours to 36 hours, about 3.5 hours to 36 hours, about 4.0 hours to 36 hours, about 4.5 hours to 36 hours, about 5.0 hours to 36 hours, about 5.5 hours to 36 hours, about 6 hours to 36 hours, about 12 hours to 36 hours, about 18 hours to 36 hours, about 24 hours to 36 hours, about 0.5 hours to 24 hours, about 1.0 hour to 24 hours, about 1.5 hours to 24 hours, about 2.0 hours to 24 hours, about 2.5 hours to 24 hours, about 3.0 hours to 24 hours, about 3.5 hours to 24 hours, about 4.0hours to 24 hours, about 4.5 hours to 24 hours, about 5.0 hours to 24 hours, about 5.5 hours to 24 hours, about 6 hours to 24 hours, about 12 hours to 24 hours, about 18 hours to 24 hours, about 0.5 hours to 18 hours, about 1.0 hour to 18 hours, about 1.5 hours to 18 hours, about 2.0 hours to 18 hours, about 2.5 hours to 18 hours, about 3.0 hours to 18 hours, about 3.5 hours to 18 hours, about 4.0 hours to 18 hours, about 4.5 hours to 18 hours, about 5.0 hours to 18 hours, about 5.5 hours to 18 hours, about 6 hours to 18 hours, about 12 hours to 18 hours, about 0.5 hours to 12 hours, about 1.0 hour to 12 hours, about 1.5 hours to 12 hours, about 2.0 hours to 12 hours, about 2.5 hours to 12 hours, about 3.0 hours to 12 hours, about 3.5 hours to 12 hours, about 4.0 hours to 12 hours, about 4.5 hours to 12 hours, about 5.0 hours to 12 hours, about 5.5 hours to 12 hours, about 6 hours to 12 hours, about 0.5 hours to 6 hours, about 1.0 hour to 6 hours, about 1.5 hours to 6 hours, about 2.0 hours to 6 hours, about 2.5 hours to 6 hours, about 3.0 hours to 6 hours, about 3.5 hours to 6 hours, about 4.0 hours to 6 hours, about 4.5 hours to 6 hours, about 5.0 hours to 6 hours, or about 5.5 hours to 6 hours.

[0150] In some embodiments, methods of preparing a lipid particle described herein further includes resizing the lipid particle by gas pressure extrusion, sonication, microfluidic mixing, or a combination thereof, after step viii) establishing the payload component gradient.

[0151] In some embodiments, methods of preparing a lipid particle described herein further includes purifying the lipid particle by size-exclusion filtration, centrifugal filtration, tangential flow filtration, or a combination thereof, after step viii) establishing the payload component gradient.

[0152] In some embodiments, methods of preparing a lipid particle described herein further includes concentrating the lipid particle by tangential flow filtration, rotary evaporation, centrifugal filtration, or a combination thereof.

[0153] In some embodiments, methods of preparing a lipid particle described herein further includes drying the lipid particle in the presence of a structural protectant. In some embodiments, a lipid particle is dried by lyophilization or spray-drying. In some embodiments, a lipid particle of the present disclosure is dried in the presence of sucrose, trehalose, sorbitol, or a combination thereof.EXAMPLES

[0154] The following examples are provided as illustrations and are not intended to be limiting with respect to any subject matter disclosed herein.Example 1: Lipid particle Formulations

[0155] The present example describes certain lipid particle (e.g., liposome) formulations comprising exemplary payload components and beverage components.

[0156] Liposome formulations of the present example were prepared according to methods disclosed herein. In the present example, liposome formulations were prepared by lipid extraction and self-emulsification.

[0157] In one example, 180 ml of ethanol (EtOH) was added to 20 g of sunflower lecithin powder and heated to 70 °C in a sealed bottle overnight in an oven. 60 mg of cholesterol was added to the bottle and shaken. The EtOH containing dissolved components was decanted into a fresh bottle and the remaining solids were discarded. Next, 1.0 g of lutein crystal was added to the EtOH solution and heated to 70 °C in a sealed bottle in an oven until dissolved. The lutein solution was slowly added using a pipette into 720 ml of water while being stirred by an overhead mixer. 10 g of trehalose dissolved in 20 ml of water was added to the solution and stirring was continued for approximately 30 minutes. During this time, the mixture became transparent, indicating that a homogeneous suspension had formed.

[0158] In another example, 180 ml of ethanol (EtOH) was added to 20 g buttermilk and heated to 70 °C in a sealed bottle overnight in an oven. The EtOH containing dissolved components was decanted into a fresh bottle and the remaining solids were discarded. Next, 1.0 g of lutein crystal was added to the EtOH solution and heated to 70 °C in a sealed bottle in an oven until dissolved. The lutein solution was slowly added using a pipette into 720 ml of water while being stirred with an overhead mixer. Stirring of the solution was continued for approximately 30 minutes. During this time, the mixture became transparent, indicating that a homogeneous suspension had formed.

[0159] In additional examples, 180 ml of ethanol (EtOH) was added to 20 g buttermilk and heated to 70 °C in a sealed bottle overnight in an oven. The EtOH containing dissolved components was decanted into a fresh bottle and the remaining solids were discarded. Next, 1.0 g of lutein crystal was added to the EtOH solution and heated to 70 °C in a sealed bottle in an oven until dissolved. The lutein solution was slowly added using a pipette into 720 ml ofOatmilk or Oatly ™ beverage while being stirred with an overhead mixer. Stirring of the solution was continued for approximately 30 minutes. During this time, the mixture became a homogeneous suspension. Oatmilk and Oatly™ formulations were maintained at 4°C.

[0160] In additional examples, 180 ml of ethanol (EtOH) was added to 20 g buttermilk and heated to 70 °C in a sealed bottle overnight in an oven. The EtOH containing dissolved components was decanted into a fresh bottle and the remaining solids were discarded. Next, 1.0 g of lutein crystal was added to the EtOH solution and heated to 70 °C in a sealed bottle in an oven until dissolved. The lutein solution was slowly added using a pipette into 720 ml of Red Bull™ or Monster ™ energy beverage while being stirred with an overhead mixer. Stirring of the solution was continued for approximately 30 minutes. During this time, the mixture became transparent, indicating that a homogeneous suspension had formed.

[0161] In additional examples, 180 ml of ethanol (EtOH) was added to 20 g buttermilk and heated to 70 °C in a sealed bottle overnight in an oven. The EtOH containing dissolved components was decanted into a fresh bottle and the remaining solids were discarded. Next, 1.0 g of vitamin D was added to the EtOH solution and heated to 70 °C in a sealed bottle in an oven until dissolved. The vitamin D solution was slowly added using a pipette into 720 ml of water, oatmilk, or Oatly™ beverage while being stirred with an overhead mixer. Stirring of the solution was continued for approximately 30 minutes. During this time, the mixture became transparent, indicating that a homogeneous suspension had formed. Oatmilk and Oatly™ formulations were maintained at 4°C.

[0162] In additional examples, 180 ml of ethanol (EtOH) was added to 20 g buttermilk and heated to 70 °C in a sealed bottle overnight in an oven. The EtOH containing dissolved components was decanted into a fresh bottle and the remaining solids were discarded. Next, 1.0 g of vitamin B12 was added to 720 mL of water or oatmilk and heated to 70 °C in a sealed bottle in an oven until dissolved. The EtOH solution was slowly added using a pipette into the vitamin B12 solution while being stirred with an overhead mixer. Stirring of the solution was continued for approximately 30 minutes. During this time, the mixture became a homogeneous suspension. Oatmilk formulations were maintained at 4°C.

[0163] In additional examples, 180 ml of ethanol (EtOH) was added to 20 g buttermilk and heated to 70 °C in a sealed bottle overnight in an oven. The EtOH containing dissolved components was decanted into a fresh bottle and the remaining solids were discarded. Next,1 .0 g of caffeine was added to 720 ml of water and heated to 70 °C in a sealed bottle in an oven until dissolved. The EtOH solution was slowly added using a pipette to the caffeine solution while being stirred with an overhead mixer. Stirring of the solution was continued for approximately 30 minutes. During this time, the mixture became transparent, indicating that a homogeneous suspension had formed.

[0164] These homogenous suspensions are liposome formulations in accordance with the present disclosure. Exemplary liposome formulations of the present example are presented in TABLE 1.TABLE 1: Exemplary Liposome Formulations

[0165] Spray Drying'. In some embodiments, exemplary liposome formulations of the present disclosure were spray dried using a Buchi B-290 instrument with an inlet temperature set at 135 °C and outlet temperature set to 58-60 °C. The instrument was set to a Q-flow of 40; pump set to 30% to achieve a flow rate of -10 ml / min; aspirator set to 100%, and attached with a nozzle cleaner 2.Example 2: Particle Sizes and Particle Size Distributions

[0166] Sizes and size distributions of particles in liposome formulations were characterized using a Nanotemper Prometheus Panta instrument. Samples of OmniActive Lutemax2020™ (i.e., non-liposomes) were also tested as a comparison to exemplary liposome formulations. Formulations were included in water or Red Bull.

[0167] 10 pl samples were placed in Prometheus NT.48 NANODSF grade capillaries and the capillaries were loaded on a NanTemper Panta instrument with particle sizing functionality. A discovery scan was then run to allocate samples. A size analysis was run using 5 acquisitions per replicate with each formulation having 3 replicates.

[0168] As shown in FIG. 3A and FIG. 4A, liposome formulation particles had a significantly lower average particle size as compared to OmniActive formulations. Exemplary liposome formulation particles as described herein had an average particle diameter less than 50 nm, whereas OmniActivc formulation particles had an average particle diameter of greater than 300 nm. As shown in FIG. 4A, the exemplary liposome formulation particles (GK115) maintained a constant average particle diameter less than 50 nm after 30 days, whereas OmniActive formulation particles included particle diameters in a range from about 200 nm to about 230 nm (i.e., after 30 days).

[0169] Whereas OmniActive Lutemax 2020™ formulations had variable particle sizes when prepared in water, liposome formulation particles as described herein had consistent particle sizes when prepared in the beverage components tested.

[0170] To determine if particle sizes changed during extended storage, liposome formulation particles and OmniActive formulation particles were prepared in water and stored for 30 days. Particle sizes were measured at the initial time of particle formation (i.e., day 0, shown in FIG. 4C) and at day 30 post-formation (as shown in FIG. 4D). As shown in FIG. 4A, exemplary liposome formulation particles described herein maintained their average particle diameter over the 30-day period, whereas the OmniActive formulation particles had a significant reduction in average particle diameter. Without wishing to be bound by any particular theory, it is proposed that the OmniActive particle formulations decrease over time due to their structure / composition causing dissolution and material loss, thereby causing particle size decrease.Particle Distribution Indices

[0171] As shown in the photograph of FIG. 5A, and the brightfield micrograph of FIG. 5B, exemplary spray-dried liposome formulations incorporating lutein payload had an orange color and uniform particle size. As shown in FIG. 5C, the exemplary spray-dried liposome formulations had Dx (10), Dx (50), and Dx (90) size distributions of 1.34 pm, 3.06 pm, and 51.1 pm, respectively.

[0172] When the exemplary spray-dried liposome formulation incorporating lutein payload was rehydrated in water, particle distributions were 3.29, 8.53, and 36.4 pm for Dx (10), Dx (50), and Dx (90), respectively (FIG. 5D).Example 3: Turbidity

[0173] The present example describes that lipid particles (e.g., liposome particles) described herein can be included in beverage components (e.g., fortified beverages), for example, water, energy drinks, nut milks, etc. without negatively impacting one or more beverage properties, such as, for example, one or more visual properties, e.g., turbidity. Characteristics of liposome formulation-fortified beverages were compared to beverages fortified with non-liposomal formulations (e.g., OmniActive Lutemax 2020™ particles).

[0174] In the present example, turbidity was assessed using a Thermo Scientific Orion AQUAfast AQ3010 Turbidity Meter. Samples whose turbidity were measured included (i) water, or (ii) Red Bull, each incorporating (a) a liposomal formulation, (b) an OmniActive formulation, or (c) no added formulation (i.e., the control). Prior to measuring turbidity, about 5mL of a sample was loaded into a clean and dry clear glass sample vial and tightly capped. The vial was inverted several times to coat the inside with sample and the sample was then discarded. The sample loading and inversion steps were repeated one additional time to ensure a uniform coating inside the vial. Next, each coated vial was filled with about 5 mL of the solution to be measured and the vial was then capped. The sample vials were placed in the turbidity meter sample well and covered with a rubber cap. Turbidity was then measured and recorded according to the operating instructions of the turbidity meter. Particle sizes of each sample were also characterized, for example, as presented in Example 2.

[0175] As shown in FIG. 3B, exemplary liposome formulation-fortified beverages had significantly lower turbidity (22.5 NTU and 173.0 NTU in water and Red Bull™, respectively)as compared to Omni Active formulations (696.0 NTU and 661 .0 NT in water and Red Bull™, respectively). The lower turbidity of fortified beverages which included an exemplary liposome formulation as described herein correlated with the lower particle sizes that were observed with these formulations.

[0176] To determine if fortified beverage turbidities changed during extended storage, water was fortified with exemplary liposome formulations of the present disclosure or OmniActive formulations were prepared and stored for 30 days. Beverage turbidities were measured at the initial time of particle formation (i.e., day 0, as shown in FIG. 4C) and at day 30 post-formation (as shown in FIG. 4D). As shown in FIG. 4B, exemplary liposome formulation particles described herein maintained their low turbidity measurements over the 30-day period in water, whereas the OmniActive formulation particles maintained significantly higher turbidity measurements (for example, above 600 NTU even after 30 days).

[0177] Similarly, Red Bull™ fortified with exemplary liposome formulations of the present disclosure or OmniActive formulations were prepared and stored for 30 days. Beverage turbidities were measured at the initial time of particle formation (i.e., day 0, as shown in FIG. 6B) and at day 30 post-formation (as shown in FIG. 6C). As shown in FIG. 6A, exemplary liposome formulation particles described herein maintained their low turbidity measurements over the 30-day period in Red Bull™, whereas the OmniActive formulation particles maintained significantly higher turbidity measurements (for example, above 600 NTU even after 30 days).

[0178] Thus, liposome formulations of the present disclosure enable payload components to be mixed with beverages in large amounts without impacting the visual properties of the final product i.e., a fortified beverage). Including payload components at high amounts in beverages without a loss in the aesthetics of the final product allows for higher dosed payloads in fortified beverages while maintaining a product which has aesthetic qualities that an end-consumer is comfortable and / or familiar with consuming (e.g., reasonably comparable and / or substantially identical to those of a reference product). Further, higher dosed payloads in fortified beverages can provide for products which have more appropriately dosed payloads.Example 4: Payload Stability

[0179] The present example demonstrates that exemplary lipid particle (e.g., liposome) formulations as provided herein preserve stability of pay load components (e.g., lutein, vitamin D, vitamin B12, and caffeine) in beverages (e.g., water, Red Bull™, Monster ™, oatmilk, orOatly™ beverage) over an extended period and, therefore, provide significant and desirable improvements over non-liposomal formulations, for example, OmniActivc formulations.

[0180] Lutein Recovery: To evaluate the stability that liposome formulations provide to lutein as a payload component, the percent recovery was determined by quantifying the amount of lutein in a sample at a particular time. 9.9 mL of a beverage was added to a 12 mL glass vial and 100 pL of an exemplary liposome formulation was then added to the 12 mL glass vial. The vial was covered with a rubber stopper and aluminum seal, crimped shut, and vortexed to ensure proper mixing. The contents of the vial were measured for lutein recovery in replicates of three at time intervals of 0 days, 7 days, 14 days, 28 days, and 56 days. After each timepoint sample replicates were taken, sample vials were stored in a cardboard storage box at 25 °C until the next timepoint was measured. To quantify lutein recovery, about 2 mL from each sample vial were transferred to a 2 mL Eppendorf™ tube and 500 pL aliquots for each sample were transferred into three (3) 2 mL Eppendorf™ tubes (z.e., 3 replicates, each containing 500 pL of sample). To each replicate, 500 pL of acetone was added and the respective Eppendorf™ tube was capped and vortexed for about 8-10 seconds. Then, to 500 pL of dichloromethane (DCM) was added to each Eppendorf™ tube containing a replicate, capped, and vortexed for about 8-10 seconds. All replicates were then added to a microcentrifuge and centrifuged for 5 minutes at 21,000 ref (max speed). After completing centrifugation, the top beverage layer (i.e., aqueous layer) was visibly separated from the bottom solvent layer (i.e., organic layer) comprising acetone and DCM. The top beverage layer was the same as the original color of the respective beverage being tested and the bottom solvent layer was yellow / orange in color. About 1 mL of the bottom solvent layer was transferred into a 2 mL glass high performance liquid chromatography (HPLC) vial and capped. Each replicate was then analyzed by HPLC to quantify the lutein in each sample by measuring the lutein peak area (mAU). HPLC phase parameters used are presented in TABLE 2. In cases where multiple lutein isomer peaks were present, the sum of these peaks was used. The average lutein peak area of the 3 replicates was then measured and used for quantifying lutein recovery and based relative to the amount of lutein recovered at the 0-day timepoint.Accordingly, lutein recovery was calculated as the percentage ratio of the average lutein peak area for each timepoint relative to the average lutein peak area at timepoint 0 days.TABLE 2: HPLC Parameters

[0181] As shown in FIG. 7A, exemplary liposome formulations comprising 75-125 pg / ml of lutein were compared to an OmniActive Lutemax 2020™ formulation (i.e. , a non- liposomal formulation) for lutein stability performance characteristics (as quantified by lutein recovery) at a high concentration (30 mg lutein I 250 mL of Red Bull™ beverage component) and low concentration (3 mg lutein 1250 mL of Red Bull™ beverage component). At each of 1 week, 2 week, 4 week, and 16 week timepoints, higher percentages of lutein were recoverable from Red Bull™ beverage samples containing exemplary liposome formulations described herein (99.9%, 98.5%, 99.3%, and 81.0%, respectively) as compared to Red Bull™ beverage samples containing the high lutein concentration OmniActive Lutemax 2020™ formulation (97.5%, 93.0%, 90.6%, and 30.6%, respectively). FIG. 7B is an image corresponding to the samples described in FIG. 7A showing the color and turbidity of OmniActive or exemplary liposome formulations provided herein as compared to non-fortified Red Bull™ beverage component.

[0182] Payload component (e.g., lutein) stability was also measured in other beverage components including water (room temperature), oatmilk (refrigerated), and Oatly™ (refrigerated). As shown in FIG. 8A, at the end of 1 week and 2 weeks of storage at room temperature, significant percentages of lutein were recoverable from water samples containing exemplary liposome formulations described herein. The percent of recoverable lutein was significantly greater than water samples fortified with the OmniActive formulation. As shown inFIG. 8B at the end of 4 weeks of storage at 4 °C, higher percentages of lutein were recoverable from beverage samples containing exemplary liposome formulations described herein as compared to Oatmilk samples containing the OmniActive formulation. As shown in FIG. 8C, at the end of 1 week, 2 weeks, and 8 weeks of storage at 4°C, significant percentages of lutein were recoverable from Oatly™ samples containing exemplary liposome formulations described herein. The percent of recoverable lutein was greater than Oatly™ samples fortified with the OmniActive Lutemax 220™ formulation.

[0183] Vitamin D Recovery: To evaluate the stability of a vitamin D payload component in exemplary liposome formulations described herein, 9.9 mL of a beverage (water, oatmilk, or Oatly™ beverage) was added to a 12 mL glass vial. 100 pL of an exemplary liposome formulation was then added to the 12 mL glass vial. The vial was covered with a rubber stopper and aluminum seal, crimped shut, and vortexed to ensure proper mixing. The contents of the vial were measured for vitamin D recovery in replicates of three at intervals of 0 days, 7 days, and 14 days. After each timepoint sample replicates were taken then sample vials were returned to a cardboard storage box at 25 °C (water) or 4 °C (oatmilk or Oatly™ beverage) until the next timepoint was measured. To quantify vitamin D recovery, about 2 mL from each sample vial were transferred to a 2 mL Eppendorf™ tube and 500 p L aliquots for each sample were transferred into three (3) 2 mL Eppendorf™ tubes (i.e., 3 replicates, each containing 500 pL of sample). To each replicate, 500 pL of ethanol was added and the respective Eppendorf™ tube was capped and vortexed for about 8-10 seconds. Then, 500 pL of hexane was added to each Eppendorf™ tube containing a replicate, capped, and vortexed for about 8-10 seconds. All replicates were then added to a microcentrifuge and centrifuged for 5 minutes at 21,000 ref (max speed). After completing centrifugation, the top solvent layer (i.e., organic phase) was visibly separated from the bottom beverage layer (i.e., aqueous phase). About 0.5 mL of the top solvent layer was transferred into a 2 mL glass HPLC vial and capped. Each replicate was then analyzed by HPLC to quantify the vitamin D in each sample by measuring the vitamin D peak area (mAU). HPLC parameters used are presented in TABLE 3. The average vitamin D peak area of the 3 replicates was then measured and used for quantifying vitamin D recovery. The timepoint at 0 days was used as the basis for quantifying vitamin D recovery. Accordingly, vitamin D recovery was calculated as the percentage ratio of the average vitamin D peak area for each timepoint relative to the average vitamin D peak area at timepoint 0 days.TABLE 3: HPLC Parameters

[0184] As shown in FIGs. 9A, 9B, and 9C, after 1 week and 2 weeks of storage in water, oatmilk, or Oatly™ beverage, vitamin D payload component formulated in an exemplary liposome formulation described herein was measured without any significant loss in recovery as compared to vitamin D levels measured in the samples at day 0.

[0185] Vitamin B12 Recovery': To evaluate the stability of a vitamin B12 payload component in exemplary liposome formulations described herein, 9.9 mL of a beverage (water at room temperature, or oatmilk at 4 °C) was added to a 12 mL glass vial. 100 pL of an exemplary liposome formulation was then added to the 12 mL glass vial. The vial was covered with a rubber stopper and aluminum seal, crimped shut, and vortexed to ensure proper mixing. The contents of the vial were measured for vitamin B12 recovery in replicates of three at intervals of 0 days, 7 days, 14 days, and 56 days. After each timepoint sample replicates were taken then sample vials were returned to a cardboard storage box at 25 °C (water) or 4 °C (oatmilk) until the next timepoint was measured. To quantify vitamin B12 recovery, about 2 mL from each sample vial were transferred to a 2 mL Eppendorf™ tube and 500 pL aliquots for each sample were transferred into three (3) 2 mL Eppendorf™ tubes (i.e., 3 replicates, each containing 500 pL of sample). To each replicate, 500 pL of ethanol was added and the respective Eppendorf™ tube was capped and vortexed for about 8-10 seconds. Then, 500 pL of hexane was added to each Eppendorf™ tube containing a replicate, capped, and vortexed for about 8-10 seconds. All replicates were then added to a microcentrifuge and centrifuged for 5 minutes at 21,000 ref (max speed). After completing centrifugation, the top solvent layer (i.e., organic phase) was visibly separated from the bottom beverage layer (i.e., aqueous phase). About 0.5 mL of the bottomaqueous layer was transferred into a 2 mL glass HPLC vial and capped. Each replicate was then analyzed by HPLC to quantify the vitamin B12 in each sample by measuring the vitamin B12 peak area (mAU). HPLC parameters used arc presented in TABLE 4. The average vitamin B 12 peak area of the 3 replicates was then measured and used for quantifying vitamin B12 recovery. The timepoint at 0 days was used as the basis for quantifying vitamin B 12 recovery.Accordingly, vitamin B12 recovery was calculated as the percentage ratio of the average vitamin B12 peak area for each timepoint relative to the average vitamin B12 peak area at timepoint 0 days.TABLE 4: HPLC Parameters

[0186] As shown in FIGs. 10A, and 10B, after 1 week, and 2 weeks of storage in water (at room temperature), or oatmilk (at 4 °C), vitamin B12 payload component formulated in an exemplary liposome formulation described herein was measured without any significant loss in recovery as compared to vitamin B12 levels measured in the samples at day 0. The vitamin B12 control was prepared by suspending a competitor product at the matching concentration in water, oatmilk, or Oatly™ beverage. At 2 weeks, the percent of vitamin B12 recovered wassignificantly higher in water and oatmilk samples fortified with exemplary liposome formulations of the present disclosure, as compared to in water and oatmilk samples fortified with vitamin B12 controls.Example 5: Delayed payload release

[0187] The present example demonstrates that exemplary lipid particle (e.g., liposome) formulations as provided herein facilitate delayed release of payload components (e.g., caffeine) into solution.

[0188] Caffeine Release'. To evaluate the release of caffeine from exemplary liposome formulations of the present disclosure, 1 mL of exemplary liposome formulation was added to a 50KD dialysis membrane in a Float-A-Lyzer dialysis device (Repligen™) and placed in 100 mL of water and simulated gastric fluid (SGF) mixture at a 1:1 ratio. Samples were collected after 2 hours, 4 hours, and 24 hours, and measured for the amount of caffeine that diffused out of the dialysis membrane. To quantify caffeine recovery, about 2 mL from each sample vial were transferred to a 2 mL Eppendorf™ tube and 500 pL aliquots for each sample were transferred into three (3) 2 mL Eppendorf™ tubes (z.e., 3 replicates, each containing 500 pL of sample). To each replicate, 500 pL of DCM was added and the respective Eppendorf™ tube was capped and vortexed for about 8-10 seconds. All replicates were then added to a microcentrifuge and centrifuged for 5 minutes at 21,000 ref (max speed). After completing centrifugation, the top beverage layer (i.e., aqueous phase) was visibly separated from the bottom solvent layer (i.e., organic phase) comprising DCM. About 0.5 mL of the bottom solvent layer was transferred into a 2 mL glass HPLC vial and capped. Each replicate was then analyzed by HPLC to quantify the caffeine in each sample by measuring the caffeine peak area (mAU). HPLC parameters used are presented in TABLE 5. In cases where multiple caffeine isomer peaks were present, the sum of these peaks was used. The average caffeine peak area of the 3 replicates was then measured and used for quantifying caffeine recovery. The timepoint at 0 days was used as the basis for quantifying caffeine recovery. Accordingly, caffeine recovery was calculated as the percentage ratio of the average caffeine peak area for each timepoint relative to the average caffeine peak area at timepoint 0 days.TABLE 5: HPLC Parameters

[0189] As shown in FIG. 11, exemplary liposome formulations of the present disclosure (e.g., GKLP4, GKLP5, GKLP6, and GKLP7) delayed caffeine release into solution as compared to the free diffusion of un-formulated caffeine in solution. These data indicate that exemplary liposome formulations of the present disclosure can delay payload component release to achieve sustained payload component bioavailability following ingestion of the formulation by a subject.

[0190] Certain embodiments of the present disclosure were described above. It is, however, expressly noted that the present disclosure is not limited to those embodiments, but rather the intention is that additions and modifications to what was expressly described in the present disclosure are also included within the scope of the disclosure. Moreover, it is to be understood that the features of the various embodiments described in the present disclosure were not mutually exclusive and can exist in various combinations and permutations, even if such combinations or permutations were not made express, without departing from the spirit and scope of the disclosure. The disclosure has been described in detail with particular reference to certain embodiments thereof, but it will be understood that variations and modifications can be effected within the spirit and scope of the claimed invention.

Claims

CLAIMSLISTING OF THE CLAIMSWHAT IS CLAIMED IS:

1. A formulation comprising one or more lipid particle, wherein the one of more lipid particle comprises:0.1 wt% to 13.4 wt% of a payload component;0.2 wt% to 7.4 wt% of an organic solvent extract of a lipid-containing food ingredient;0.1 wt% to 1.8 wt% of a stabilizing component;0.1 wt% to 1.8 wt% of a surfactant component;0.1 wt% to 1.8% of an antioxidant component; and at least 70% of a beverage component.

2. The formulation of claim 1, wherein the pay load component comprises lutein, vitamin D, vitamin B12, caffeine, creatine, tannic acid, gallic acid, glucose, zeaxanthin, curcurmin, quercetin, rutin, naringenin, fatty acids, ketone esters, or a combination thereof.

3. The formulation of claim 1 or 2, wherein the lipid extract is an organic solvent extract of the lipid-containing food ingredient.

4. The formulation of any one of claims 1-3, wherein the organic solvent extract comprises an ethanol extract, a tetrahydrofuran (THF) extract, a methanol extract, an isopropanol extract, a 1 ,4-dioxane extract, a methyl term-butyl ether (MTBE) extract, an acetonitrile extract, an acetone extract, a transcutol extract, or a combination thereof.

5. The formulation of any one of claims 1-4, wherein the lipid-containing food ingredient comprises buttermilk, milk, egg yolk, beef brain, pig liver, chicken liver, herring dark muscle, soybean, de-hulled oat, rapeseed, lecithin, or a combination thereof.

6. The formulation of any one of claims 1-5, wherein the stabilizing component comprises cholesterol, P-sitostcrol, oleic acid, tctradccanol, hcxadccanol, octadccanol, glycerol, or a combination thereof.

7. The formulation of any one of claims 1-6, wherein the surfactant component comprises polysorbate 80, saponin, or a combination thereof.

8. The formulation of any one of claims 1-7, wherein the antioxidant component comprises a- tocopherol, citric acid, abscorbic acid, butylated hydroxytoluene, or a combination thereof.

9. The formulation of any one of claims 1-8, wherein the beverage component comprises an energy beverage, carbonated drink, sports drink, coffee, tea, juice, milk, milk alternative, or baby formula.

10. The formulation of any one of claims 1-9, wherein the one or more lipid particle comprises a diameter in a range from 5 nm to 150 nm, 10 nm to 125 nm, 20 nm to 100 nm, or 25 nm to 75 nm.

11. A fortified beverage comprising: the formulation of any one of claims 1-10; and a base beverage.

12. The fortified beverage of claim 11, wherein both the beverage component and base beverage comprise the energy beverage, carbonated drink, sports drink, coffee, tea, juice, milk, milk alternative, or baby formula.

13. The fortified beverage of claim 12, wherein the beverage comprises 0.1 % w / v to 18.2 % w / v of the payload component.

14. The fortified beverage of any one of claims 11-13, wherein the beverage comprises a turbidity no greater than 600 NTU, no greater than 575 NTU, no greater than 550 NTU, nogreater than 525 NTU, no greater than 500 NTU, no greater than 400 NTU, no greater than 300 NTU, no greater than 200 NTU, no greater than 100 NTU, or no greater than 50 NTU.

15. The fortified beverage of any one of claims 11-14, wherein the beverage comprises 0.001 to 0.075 mg / ml, 0.01 to 0.075 mg / ml, 0.02 mg / ml to 0.075 mg / ml, 0.04 mg / ml to 0.075 mg / ml, or 0.06 mg / ml to 0.075 mg / ml of the formulation.

16. The fortified beverage of any one of claims 11-15, wherein at least 75% of the pay load component is recoverable from the beverage after 16 weeks of storage.

17. A method of preparing a lipid particle, the method comprising: i) vortexing and / or sonicating a lipid- containing food ingredient with an organic solvent; ii) heating the lipid-containing food ingredient and the organic solvent; iii) separating a lipid-containing phase from a solid precipitate or aqueous phase; iv) heating the lipid-containing phase; v) adding a hydrophobic payload to the lipid-containing phase or adding a hydrophilic payload to an aqueous beverage component; and vi) vortexing and / or sonicating the lipid-containing phase with the aqueous beverage component to form the lipid particle.

18. The method of claim 17, wherein the lipid-containing food ingredient comprises buttermilk, milk, egg yolk, beef brain, pig liver, chicken liver, herring dark muscle, soybean, de-hulled oat, rapeseed, lecithin, or a combination thereof.

19. The method of claim 17 or 18, wherein the organic solvent comprises ethanol, tetrahydrofuran (THF), methanol, isopropanol, 1,4 dioxane, methyl tert-butyl ether (MTBE), acetonitrile, acetone, acetic acid, 1-butanol, 2-butanol, 3-methyl-l-butanol, methylethylketone, ethylformate, formic acid, triethylamine, transcutol, or a combination thereof.

20. The method of any one of claims 17-19, wherein step ii) heating the lipid-containing food ingredient and the organic solvent is to a temperature above the glass transition temperature of a lipid in the lipid-containing food ingredient.

21. The method of any one of claims 17-20, wherein step ii) heating the lipid-containing food ingredient and the organic solvent is to 55 to 85 °C, 60 to 80 °C, or 65 to 75 °C.

22. The method of any one of claims 17-21, wherein step ii) heating the lipid-containing food ingredient and the organic solvent is for 1 hour to 72 hours, 2 hours to 48 hours, or 3 hours to 24 hours.

23. The method of any one of claims 17-22, wherein the lipid-containing food ingredient is homogenized and / or lyophilized before step i) vortexing and / or sonicating.

24. The method of any one of claims 17-22, wherein the method further comprises removing the organic solvent from the lipid-containing phase before step v) vortexing and / or sonicating.

25. The method of claim 24, wherein the organic solvent is removed using a rotary evaporator.

26. The method of any one of claims 17-25, wherein step iv) heating the lipid-containing phase comprises heating the lipid-containing phase to a temperature above the glass transition temperature of a lipid in the lipid-containing food ingredient.

27. The method of any one of claims 17-26, wherein step iv) heating the lipid-containing phase comprises heating the lipid-containing phase to 55 to 85 °C, 60 to 80 °C, or 65 to 75 °C.

28. The method of any one of claims 17-27, wherein the hydrophobic pay load comprises lutein, vitamin D, zeaxanthin, curcumin, quercetin, rutin, narigenin, fatty acids, or a combination thereof.

29. The method of any one of claims 17-27, wherein the hydrophilic payload comprises vitamin B12, caffeine, creatine, tannic acid, gallic acid, glucose, or a combination thereof.

30. The method of any one of claims 17-29, wherein the aqueous beverage component comprises an energy beverage, carbonated drink, sports drink, coffee, tea, juice, milk, milk alternative, or baby formula.

31. The method of any one of claims 17-30, further comprising resizing the lipid particle by gas pressure extrusion, sonication, or microfluidic mixing after step vi) vortexing and / or sonicating.

32. The method of any one of claims 17-31, further comprising purifying the lipid particle by size-exclusion filtration, centrifugal filtration, or tangential flow filtration after step vi) vortexing and / or sonicating.

33. The method of any one of claims 17-32, further comprising concentrating the lipid particle by tangential flow filtration, rotary evaporation, or centrifugal filtration.

34. The method of any one of claims 17-32, further comprising drying the lipid particle in the presence of a structural protectant.

35. The method of claim 34, wherein drying comprises lyophilization or spray drying.

36. The method of claim 34 or 35, wherein the structural protectant is sucrose, trehalose, sorbitol, or a combination thereof.

37. A method of preparing a lipid particle, the method comprising: i) vortexing and / or sonicating a lipid-containing food ingredient with an organic solvent; ii) heating the lipid-containing food ingredient and the organic solvent; iii) separating a lipid-containing phase from a solid precipitate or aqueous phase; iv) heating the lipid-containing phase;v) adding an entrapping agent to the lipid-containing phase or adding the entrapping agent to an aqueous beverage component; vi) vortexing and / or sonicating the lipid-containing phase with the aqueous beverage component to form a lipid particle; vii) removing the entrapping agent by tangential flow filtration to establish an entrapping agent gradient across a lipid membrane of the lipid particle; viii) establishing a payload component gradient across the lipid membrane of the lipid particle to permeate the lipid particle with the payload component and form the lipid particle.

38. The method of claim 37, wherein the entrapping agent is tannic acid.

39. The method of claim 37, wherein establishing the payload component gradient comprises placing the lipid particle in the aqueous beverage component, the aqueous beverage component comprising a concentration of the payload component that is higher than the concentration of the payload component in the lipid particle.

40. The fortified beverage of claim 14, wherein the beverage comprises a turbidity in a range from about 15 NTU to about 30 NTU, or from about 18 NTU to about 27 NTU, or from about 20 to about 25 NTU.

41. The fortified beverage of claim 14, wherein the beverage comprises a turbidity in a range from about 150 NTU to about 200 NTU, or from about 160 NTU to about 190 NTU, or from about 170 NTU to about 180 NTU.

42. The fortified beverage of claim 14, wherein the beverage comprises a turbidity in a range from about 15 NTU to about 200 NTU, or from about 20 NTU to about 180 NTU.

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