Patent Description:
A colicky baby is a very stressful situation for new parents. Colic generally occurs when the baby is very young, before solid food is introduced. Parents try to eliminate the source of the discomfort. If the baby is on formula, parents try different formulas including those that do not have cow's milk as a basis. Breastfeeding moms begin elimination diets, abstaining from foods known to produce gas in adults.

A growing amount of evidence suggests that infants may have problems digesting lactose, a sugar found both in cow's milk and breast milk. To digest lactose, the stomach must have an enzyme called lactase.

It is rare that infants are born without the ability to produce lactase, whereas colic is not uncommon. It is suspected that the gassiness may be caused by the naturally occurring lactase being overwhelmed by an excess of lactose or that lactase production is insufficient.

Unfortunately, most lactase products on the market are not suitable for infants because of the liquids that it is dissolved in. Lactase is not stable in most liquids that are suitable for infants, such as water. Powders mixed with food are not suitable for infants who have not started eating solid foods. Infants and young children cannot be dosed with tablets or capsules because of choking hazards.

Additionally, while lactase may be stable in glycerol, glycerol is known to have laxative properties. As an osmotic laxative, glycerol promotes the retention of fluid in the bowel by increasing osmotic pressure in the intestine. Alternatively, glycerol may also, acting through its local irritant effects, have a lubricating and softening effect.

<CIT> and <CIT> disclose a system and a kit comprising a receptacle and a cap with a plunger and a frangible seal. A dropper is also provided.

<CIT> discloses stable lactase drops for infants.

While these units may be suitable for the particular purpose employed, or for general use, they would not be as suitable for the purposes of the present disclosure as disclosed hereafter.

An aspect of an example embodiment in the present disclosure is to provide a method for storage and delivery of shelf-stable lactase in neutral oil to infants as a dietary aid. Accordingly, an aspect of an example embodiment in the present disclosure provides a shelf-stable dispersion of lactase powder and a neutral oil.

Another aspect of an example embodiment in the present disclosure is to provide a shelf-stable form of lactase. Accordingly, the present disclosure provides a pre-measured dosage of lactase powder in a push cap that dispels the powder into a bottle containing a neutral oil.

A further aspect of an example embodiment in the present disclosure is to provide delivery of the shelf-stable lactase mixture to an infant. Accordingly, the present disclosure provides a dropper that is loaded with the prepared mixture of lactase powder in a neutral oil that is delivered to the infant either directly or with their breast milk or formula.

Accordingly, the present disclosure describes a method for the storage and delivery of self-stable lactase to infants as a dietary aid. A bottle of neutral oil is fixed with a cap containing pre-measured lactase powder. The plunger on the cap is pressed and the pre-measured lactase powder is deposited into the neutral oil. The container is agitated to dissolve the pre-measured lactase in the neutral oil. A dropper is used to deliver the known concentration of lactase in oil to the infant.

The present disclosure addresses at least one of the foregoing disadvantages. However, it is contemplated that the present disclosure may prove useful in addressing other problems and deficiencies in a number of technical areas. Therefore, the claims should not necessarily be construed as limited to addressing any of the particular problems or deficiencies discussed hereinabove. To the accomplishment of the above, this disclosure may be embodied in the form illustrated in the accompanying drawings.

In the drawings, like elements are depicted by like reference numerals. The drawings are briefly described as follows.

The present disclosure now will be described more fully hereinafter with reference to the accompanying drawings, which show various example embodiments. However, the present disclosure may be embodied in many different forms and should not be construed as limited to the example embodiments set forth herein. Rather, these example embodiments are provided so that the present disclosure is thorough, complete and fully conveys the scope of the present disclosure to those skilled in the art.

<FIG> illustrate a method of storing and then delivering a lactase dietary supplement to an infant. More specifically, the method stores and delivers a shelf-stable lactase (Beta-galactosidase) to an infant or individual in need of same. In particular, the method employs a system comprising a bottle <NUM> having a receptacle <NUM> containing a plurality of neutral oils <NUM>, a push cap <NUM> holding a powder <NUM> in a compartment <NUM>, the powder further comprising the shelf-stable lactase, a flow agent and a release agent, and a dropper <NUM>.

The term "neutral oils" refers to edible oils generally recognized as safe for human consumption that have a neutral flavor. In other words, these neutral oils have little or no distinctive flavor.

The shelf-stable lactase is provided as a system that includes at least one bottle <NUM> with a receptacle <NUM> containing an anhydrous mixture of a plurality of neutral oils <NUM> , such as but not limited to sunflower oil and Vitamin E. The plurality of neutral oils <NUM> totals about <NUM> milliliters ("ml"). The bottle is sealed with a first cap <NUM>, a standard fitting cap that is selectively removed when the dietary supplement is being prepared for delivery and replace after preparation for storage.

The system also includes a push cap <NUM> containing a powder <NUM> comprising lactase, a release agent and a flow agent in a compartment <NUM>. The powder <NUM> comprises at least <NUM> milligrams ("mg") of powder <NUM>. The powder comprises a minimum of <NUM> of lactase, <NUM> - <NUM> of magnesium stearate, and <NUM> -<NUM> of bamboo fiber in a compartment <NUM>. Preferably, the powder has <NUM> of magnesium stearate and <NUM> of bamboo fiber. It is understood by those of ordinary skill in the art that a range of +/- <NUM>% of the targeted preferable amounts is acceptable for a product of this type. Finally, the system has a dropper <NUM> configured to deliver the finished lactase product <NUM> containing the lactase powder <NUM> in the neutral oil <NUM> to the infant.

It is further understood that magnesium stearate is an anti-adherent or release agent that aids in the dispersal of the powder into the oil. Other similar salts of fatty acids that are release agents that are generally recognized as safe are acceptable in this product.

Further, bamboo fiber aids in the flow of the powder but other cellulosic powders that are generally recognized as safe and aids the flow of powders are acceptable in this product.

The push cap has a plunger <NUM> that pushes through the compartment containing the powder creating a channel for the powder to enter the receptacle <NUM> holding the neutral oils <NUM>.

The push cap <NUM> is selectively affixed to the bottle <NUM> by screwing onto the bottle, the bottle have standard screw threads.

The user first removes the first cap <NUM> standard from the bottle <NUM> containing the <NUM> of the neutral oils <NUM>. Then the user replaces the first cap with the push cap <NUM> by affixing the push cap onto the bottle <NUM>. The next step is the user <NUM> presses the plunger <NUM> of the push cap <NUM> to dispel the powder <NUM> into the oil mixture of neutral oils <NUM> and agitates the bottle <NUM>, dispersing the powder <NUM> in the oil mixture of neutral oils <NUM>.

The resulting finished lactase product <NUM> contains lactase dissolved in the neutral oil <NUM>. The oil mixture of neutral oils <NUM> is necessary because lactase is not as stable in an aqueous solution. Additionally, some neutral oils such as glycerin are not used as a solvent due to its laxative properties. Finally, keeping the powder <NUM> removed from the oil mixture of neutral oils oil <NUM> further extends the stability of the lactase during storage prior to use, making the product more effective.

The finished lactase product <NUM> comprising the mixture of neutral oils <NUM> and the powder <NUM> containing lactase <NUM> may be drawn into the included dropper <NUM>. The dropper <NUM> delivers the finished lactase product <NUM> to an infant in <NUM> (<NUM> IU) doses <NUM>. The doses <NUM> is delivered directly to the infant before feeding or added to breast milk or formula.

The product has a greater shelf stability as a two component system than the currently available hydrophilic mixtures.

The finished lactase product <NUM> has greater shelf stability in neutral oils <NUM> than lactase in aqueous and more hydrophilic solvent systems. The greater stability allows the user to provide at least eight doses over as long as an eight-day period whereas hydrophilic solutions of lactase are only stable for a day or two.

To use the method as described hereinabove, the user has a kit. The kit comprises the bottle <NUM> having the receptacle <NUM> containing a plurality of anhydrous neutral oils <NUM>, the first cap <NUM> and the second cap <NUM> , the second cap configured as a push cap having a compartment <NUM> containing the powder <NUM> that further comprises a lactase, a release agent and a flow aid.

The kit may be further modified with a dropper <NUM> having a pipet <NUM> and a bulb <NUM>.

Physical stability of the lactase mixture in neutral oils as described hereinabove were performed under accelerated conditions <NUM>° C and <NUM>% relative humidity for <NUM> weeks. Evaluations were performed and the results are presented in Table <NUM> and Table <NUM>. The product maintained physical stability throughout the testing period.

Further shelf life studies were conducted at controlled room temperature (Temperature: <NUM> ± <NUM>. ; RH <NUM>% ± <NUM>% RH).

It is understood that when an element is referred hereinabove as being "on" another element, it can be directly on the other element or intervening elements may be present therebetween.

Moreover, any components or materials can be formed from a same, structurally continuous piece or separately fabricated and connected.

It is further understood that, although ordinal terms, such as, "first," "second," "third," are used herein to describe various elements, components, regions, layers and/or sections, these elements, components, regions, layers and/or sections should not be limited by these terms.

Spatially relative terms, such as "beneath," "below," "lower," "above," "upper" and the like, are used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It is understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. The device can be otherwise oriented (rotated <NUM> degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.

Example embodiments are described herein with reference to cross section illustrations that are schematic illustrations of idealized embodiments. Thus, example embodiments described herein should not be construed as limited to the particular shapes of regions as illustrated herein, but are to include deviations in shapes that result, for example, from manufacturing.

Claim 1:
A system for storing and delivering a lactase dietary supplement, comprising:
a bottle having a first cap and a receptacle, the receptacle containing a plurality of anhydrous neutral oils;
a second cap, said second cap further comprising a push cap having a plunger and a compartment containing a powder further comprising lactase, a release agent and a flow aid; and
a dropper configured for delivery of the powder dispersed in the neutral oils.