FORMULATION

CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application is a continuation-in-part application of the earlier U.S. Utility Patent Application to Joshua Ryan Quick, entitled "System and Method for Delivering an Inhalable Sugar Formulation," Application Serial No, 14/228,293, filed March 28, 2014, now pending, the disclosure of which is hereby incorporated entirely herein by reference.

BACKGROUND

1. Technical Field

[0002] Aspects of this document relate generally to medicines and treatments delivered to the bloodstream through the lungs. Aspects of this document relate generally to medicines and treatments for the treatment of low blood sugar.

2. Background Art

[0003] Medicines and treatments exist for the treatment of low blood sugar. Low blood sugar can be caused by a variety of factors. For example, diabetics can experience low blood sugar as a result of the amount of insulin in the blood. Treating low blood sugar often involves introducing sugar into the bloodstream through one or more mechanisms, such as by needle injection or by orally taking a medicine or treatment or a food item having a sugar substance therein.

SUMMARY

[0004] Implementations of methods for delivering a sugar formulation for inhalation by a user may include: formulating a sugar formulation having at least one sugar substance, wherein a concentration of the sugar substance in the sugar formulation is at least 20 percent weight per volume (w/v); and delivering, by a spray delivery apparatus, one of an aerosol and a suspension mist of the sugar formulation to lungs of the user.

[0005] Implementations of a method for delivering a sugar formulation for inhalation by a user may include one, all, or any of the following:

[0006] Converting, by the spray conversion apparatus, a portion of the sugar formulation into one of the aerosol and the suspension mist.

[0007] Providing the specified portion of the sugar formulation to the spray conversion apparatus.

[0008] Providing the specified portion of the sugar formulation may further include wherein the specified portion of the sugar formulation has a volume of at least 0.2 cubic centimeters.

[0009] Providing the specified portion of the sugar formulation may further include wherein the specified portion of the sugar formulation has a mass of at least 0.2 grams.

[0010] Formulating the sugar formulation having at least one sugar substance may further include wherein the concentration of the sugar substance in the sugar formulation is at least 30 percent w/v.

[0011] Providing the specified portion of the sugar formulation to the spray conversion apparatus may further include wherein the spray conversion apparatus and the spray delivery apparatus are included in a metered dose inhaler.

[0012] Delivering at least 0.2 cubic centimeters of the sugar formulation to the lungs of the user using the spray conversion apparatus. [0013] Providing the specified portion of the sugar formulation to the spray conversion apparatus may further include wherein the spray conversion apparatus includes a nebulizer and the spray delivery apparatus includes a bag-valve mask.

[0014] Delivering, by the spray delivery apparatus, one of the aerosol and the suspension mist of the sugar formulation to lungs of the user may further include wherein the spray delivery apparatus includes a dry powder inhaler.

[0015] Implementations of a system for delivering a sugar formulation for inhalation by a user may include: a sugar formulation having at least one sugar substance, wherein a concentration of the sugar substance in the sugar formulation is at least 20 percent w/v; and a spray delivery apparatus configured to receive the sugar formulation and deliver one of an aerosol and a suspension mist of the sugar formulation to lungs of the user.

[0016] Implementations of a method for delivering a sugar formulation for inhalation by a user may include one, all, or any of the following:

[0017] The spray conversion apparatus may be configured to receive the sugar formulation and transform it into one of the aerosol and the suspension mist, and the spray delivery apparatus may be configured to receive the one of the aerosol and the suspension mist and deliver it to the lungs of the user.

[0018] The spray conversion apparatus may be configured to receive a volume of at least 0.2 cubic centimeters of the sugar formulation.

[0019] The spray conversion apparatus may be configured to receive a mass of at least 0.2 grams of the sugar formulation.

[0020] The concentration of the sugar substance in the sugar formulation may be at least 30 percent w/v.

[0021] The concentration of the sugar substance in the sugar formulation may be 100 percent w/v. [0022] The spray conversion apparatus and the spray delivery apparatus may be included in a metered dose inhaler.

[0023] The spray delivery apparatus may be configured to deliver at least 0.2 cubic centimeters of the sugar formulation in a single spray.

[0024] The spray conversion apparatus may include a nebulizer and the spray delivery apparatus may include a bag-valve mask.

[0025] The spray delivery apparatus may include a dry powder inhaler.

[0026] The foregoing and other aspects, features, and advantages will be apparent to those artisans of ordinary skill in the art from the DESCRIPTION and DRAWINGS, and from the CLAIMS.

BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Implementations will hereinafter be described in conjunction with the appended drawings, where like designations denote like elements, and:

[0028] FIG. 1 is a block diagram of stages of an implementation of a method of delivering a sugar formulation for inhalation;

[0029] FIG. 2 is a flowchart of an implementation of a method of delivering a sugar formulation for inhalation;

[0030] FIG. 3 is a flowchart of an implementation of a method of delivering a sugar formulation for inhalation using a metered dose inhaler;

[0031] FIG. 4 is a flowchart of an implementation of a method of delivering a sugar formulation for inhalation using a dry powder inhaler; and

[0032] FIG. 5 is a flowchart of an implementation of a method of delivering a sugar formulation for inhalation using a bag valve mask

DESCRIPTION

[0033] This disclosure, its aspects and implementations, are not limited to the specific components, assembly procedures or method elements disclosed herein. Many additional components, assembly procedures and/or method elements known in the art consistent with the intended system and method for delivering an inhalable sugar formulation will become apparent for use with particular implementations from this disclosure. Accordingly, for example, although particular implementations are disclosed, such implementations and implementing components may comprise any shape, size, style, type, model, version, measurement, concentration, material, quantity, method element, step, and/or the like as is known in the art for such systems and methods for delivering an inhalable sugar formulation, and implementing components and methods, consistent with the intended operation and methods.

[0034] Referring now to the drawings and in particular Figure 1, the four interdependent stages of the process of delivering a sugar formulation for inhalation include a formulation stage, a dosage stage, a conversion stage, and a delivery stage. The formulation stage and dosing stages include the provision and mixing of a sugar, as an active ingredient, with any inactive ingredients to be utilized in the conversion or delivery stages to enable a desired amount of sugar to be delivered for inhalation. In the formulation stage, a sugar formulation to be delivered to the lungs of a recipient is mixed. Generally, the sugar formulation includes a formulation having a monosaccharide (such as glucose, fructose, and galactose), a disaccharide (such as sucrose, maltose, and lactose), or an oligosaccharide or other polysaccharide (such as glycogen). In implementations, the sugar formulation includes a monosaccharide (or simple sugar) solution having a concentration of between about 20% w/v and about 100% weight per volume (w/v). In other implementations, the sugar formulation includes a sugar solution and/or a sugar substance having a concentration of at least 30% w/v, at least 40% w/v, at least 50% w/v, at least 60% w/v, at least 70% w/v, at least 80% w/v, at least 90% w/v, or at least 100% w/v (pure sugar).

[0035] In implementations the sugar formulation may include a sugar dissolved in water to form a liquid solution. Various sugars may have approximately the maximum solubilities in water in g/mL at about room temperature (25 Celsius) described in TABLE 1 :

TABLE 1

[0036] In implementations in which a sugar substance is used in a liquid solution for the sugar formulation, the w/v % of the sugar in the liquid sugar formulation may have any of the values indicated above in TABLE 1 and, accordingly, may range anywhere from 0.1 % w/v or about 0.1 % w/v to 375 % w/v or about 375 % w/v in g/mL. In implementations in which the sugar formulation is in a liquid form the concentration of the sugar substance in the sugar formulation may be within the range of 38-50% w/v, 50-100% w/v, 100-200% w/v, 200-300% w/v, 300-375% w/v, 38-100% w/v, 38-200% w/v, 38-300% w/v, 38-375% w/v, 50-200% w/v, 50-300% w/v, 50-375% w/v, 100-300% w/v, 100-375% w/v, 200-375% w/v, 80-375% w/v, and so forth, as measured in g/mL.

[0037] In implementations in which the sugar formulation is in a solid, powdered form instead of a liquid form, the maximum grams per milliliter (g/mL) of a pure sugar- substance powder may be lg/2mL or about lg/2mL for a weight per volume percentage of 50% w/v or about 50 % w/v. In implementations in which the sugar formulation is in a solid, powdered form the concentration of the sugar substance in the sugar formulation may within the range of 38-40% w/v, 40-45% w/v, 45-50% w/v, 38-45% w/v, 38-50% w/v, 40-50% w/v, 45-50% w/v, and so forth, as measured in g/mL.

[0038] In an alternate implementation, the sugar formulation includes a simple sugar liquid suspension having an identical concentration range. In another alternate

implementation, the sugar formulation includes a blood sugar raising hormone, such as glucagon. As glucose can be absorbed directly into the bloodstream, when a direct impact on blood sugar is desired, glucose is typically desirable. As a simple sugar, glucose it is well established that introducing it to a user's lung tissue will result in an increase of glucose in the user's blood through direct action. It is contemplated, however, that other simple sugars which are directly absorbed into the bloodstream and which directly or indirectly affect a user's blood sugar may be employed in implementations of the simple sugar solution.

[0039] In alternate implementations, the sugar formulation may include another carbohydrate substance, such as sucrose, to be directly or indirectly absorbed by the lungs to raise the user's blood sugar. In such implementations, the conversion stage of the sugar formulation may additionally include the introduction of enzymes which will break down the carbohydrate substance into simple sugars in the lungs so as to enable absorption into the bloodstream.

[0040] In various implementations, occurring in parallel with the formulation stage is the dosage stage. Because the sugar formulation is intended to be delivered to the lungs of a user, whether nasally or orally, under typical circumstances, controlling the dosage to be provided to a user in implementations will determine the concentration of the sugar in the formulation and the manner in which the formula will be converted and delivered in order for it to determine the appropriate quantity of sugar formulation to avail for conversion and delivery. In sugar formulations having a lower concentration of sugar and/or in

implementations wherein a continuous delivery apparatus (as discussed below) is employed, a relatively higher dosage may be utilized to ensure a sufficient amount of sugar is received by the patient. Conversely, in sugar formulations having a higher concentration of sugar and/or in implementations wherein a spontaneous delivery apparatus (as discussed below) is employed, a relatively lower dosage may be utilized.

[0041] It is appreciated that the quantity of sugar necessary to elicit a desired rise in blood sugar may vary across different patients. For example, for patients with higher insulin sensitivity and/or who require a significant rise in blood sugar, the delivery of a higher quantity of sugar is desirable. On the other hand, for patients with lower insulin sensitivity and/or who require a minimal rise in blood sugar, the delivery of a lower quantity of sugar is desirable. In this regard, the dosage stage enables the sugar formulation to be customized for specific conditions in individual patients.

[0042] In implementations wherein a continuous delivery apparatus is employed, a dosage in the range of at least 0.2 cubic centimeters for higher sugar concentrations and 1 cubic centimeter for lower sugar concentrations may be used. For continuous delivery apparatus deployments, it is contemplated that the dosage is calculated by the amount provided to the patient for each respiratory cycle. In alternate implementations, it is contemplated that dosages of at least 0.3 cubic centimeters, at least 0.4 cubic centimeters, at least 0.5 cubic centimeters, at least 0.75 cubic centimeters, and/or at least 1 cubic centimeter may be provided.

[0043] In implementations wherein a spontaneous delivery apparatus is employed with a liquid formulation, however, a per spray dosage in the range of at least 0.2 cubic centimeters for higher sugar concentrations and 1 cubic centimeters for lower sugar concentrations is provided. In alternate implementations, it is contemplated that dosages of at least 0.3 cubic centimeters, at least 0.4 cubic centimeters, at least 0.5 cubic centimeters, at least 0.75 cubic centimeters, and/or at least 1 cubic centimeter will be provided.

[0044] In implementations wherein a spontaneous delivery apparatus is employed with a dry powder formulation, a per deployment dosage in the range of 0.2 grams for higher sugar concentrations and 1 gram for lower sugar concentrations is provided. In alternate implementations, it is contemplated that dosages of at least 0.3 grams, at least 0.4 grams, at least 0.5 grams, at least 0.75 grams, and/or at least 1 gram may be provided. As previously discussed, a range of dosages for varying sugar concentrations may be used, even if the conversion and delivery mechanisms are constant, to account for varying levels of insulin sensitivity/resistance in the target patient.

[0045] It is contemplated that certain spontaneous delivery apparatuses may enable a predetermined dosage to be availed for conversion to an aerosol at the time of use. For example, metered dose inhalers ("MDI") are constructed to dispense a fixed quantity of aerosolized substance. Thus, when an MDI is used to deliver a sugar formulation in accordance with the present invention, a specific quantity of sugar formulation is not availed or set aside during the dosage stage— dosing is instead substantially accounted for through the concentration of the sugar formulation, as the dose which will be dispensed is a fixed variable.

[0046] In an alternate implementation of the present invention, a modified MDI is employed which includes an integrated titration component which enables a user to adjust the metering valve to control the how much formulation is allowed out on each actuation; thereby enabling a user to alter the quantity of aerosolized sugar formulation that is delivered. In such an implementation, the user can selectively increase or decrease the dosage of a sugar formulation of a fixed quantity and cause a higher or lower quantity of sugar to be delivered with each actuation of the MDI. A modified atomizer which includes an integrated titration component is operative in the same manner, wherein the amount of gas injected under pressure can be adjusted, enabling a user to control how much liquid sugar formulation is sucked up and projected with each pump.

[0047] Once an appropriate dosage of sugar formulation is availed for delivery, the sugar formulation is taken from a liquid or dry powder to an inhalable mist in a user's lungs in the conversion and delivery stages. The conversion stage in implementations includes the changing of a quantity of sugar formulation in a liquid or powder form into an inhalable aerosol mist (or gas suspension). The delivery stage in implementations includes the transport of the mist/suspension to the mouth or nose of the intended recipient for it to be inhaled. In some implementations, such as when an MDI, a dry powder inhaler, or a sprayer

(conventional pump or atomizer) are employed, the delivery and conversion stages occur through the same action. In other implementations, such as when a nebulizer and bag valve mask are employed, the conversion and delivery occur through distinct actions of different mechanisms.

[0048] Referring now to Figure 2, in implementations the process of delivering a sugar formulation begins with the preparation of a sugar formulation. The sugar formulation includes a sugar solution as an active ingredient and may also include one or more inactive ingredients to be utilized in the conversion or delivery stages. In implementations the composition of the sugar formulation is configured so that the aerosol or suspension mist created therefrom has a concentration of at least 20 % w/v of the sugar substance. Thus, in implementations any inactive components which are used up or otherwise are not inhaled by the patient will not be included in the calculation of the concentration of the sugar formulation, while components which are inhaled will be included in the calculation thereof.

[0049] Accounting for the composition of the sugar formulation, the desired dose may be provided for during conversion and delivery. In the alternative, a quantity of sugar formulation may be provided for conversion and delivery, with the entire quantity representing the dose desired to be converted and delivered.

[0050] Once the sugar formulation has been prepared and the desired dosing provided or accounted for, the sugar formulation can be converted to an aerosol or suspension mist and then delivered for inhalation. The conversion of the sugar formulation into an inhalable form may be accomplished through, by non-limiting example: an MDI, a dry powder inhaler, a nebulizer, a pump spray nozzle, an atomizer, and the like. The manner in which the conversion step is performed in implementations may directly depend on the manner in which the subsequent delivery step will be performed. The delivery step comprises placing the inhalable mist to the mouth or nose of the user so that it may be inhaled. Delivery in implementations is thus performed through, by non-limiting example: an MDI, a dry powder inhaler, a bag-valve mask, a manual pump spray apparatus, a pressurized aerosol spray apparatus, an atomizer spray apparatus, and the like. When delivery is performed through an MDI, manual pump spray apparatus, pressurized aerosol spray apparatus, or atomizer spray apparatus, the delivery apparatus may include an integrated nozzle which accomplishes the conversion and enables the delivery by a discharge nozzle, a spray nozzle, an aerosol nozzle, or an atomizer nozzle, respectively. When delivery is performed through a dry powder nozzle, conversion may be accomplished through the provision of an inhalable powder or the manual powdering of a solid sugar formulation. When delivery is performed though a bag- valve mask, conversion may be accomplished through a nebulizer.

[0051] As the delivery step is performed, the sugar formulation in an inhalable form is provided to the user's mouth or nose, or in the immediate vicinity thereof. The user is then able to inhale the sugar formulation, receive the desired quantity of sugar in his lungs, and have that sugar be delivered to his bloodstream in a manner which bypasses the digestive system and does not require the user to be conscious. [0052] Referring now to Figure 3, the specific process for delivering a sugar formulation through an MDI begins with the preparation of a liquid sugar formulation. In implementations, the dosage delivered by the MDI will be fixed and the quantity of sugar desired to be delivered through an MDI will be controlled through the concentration and composition of the sugar in the sugar formulation (for example, a quantity of pure sucrose would potentially deliver the same amount of glucose as half of that quantity of pure glucose). For an MDI delivery, the sugar formulation comprises a sugar solution, an inert dilution agent, such as water (for implementations wherein the desired concentration of sugar is less than 100%), a liquefied gas propellant, and when desired, stabilizer excipients. As such, providing a desired concentration in implementations may include an accounting for every substance in the formulation which will not dissipate upon actuation of the MDI, which in implementations may be the sugar solution, any dilution agent, and any other excipients.

[0053] Once the formulation is complete, the sugar formula is then placed in a pressurized container with a propellant. This pressurized container is then engaged with the MDI and, when it is desired to inhale the sugar formulation, the MDI placed to the user's mouth and actuated, causing a dose of the sugar formulation to be delivered in an aerosol form into the user's mouth for inhalation.

[0054] Referring now to Figure 4, the specific process for delivering a sugar formulation through a dry powder inhaler ("DPI") begins with the preparation of a powdered sugar formulation having a desired composition of sugar and concentration of sugar. A desired dose of the powdered sugar formulation is then loaded into the DPI and the DPI is actuated, customarily by the user placing his mouth thereon and inhaling, delivering the dose of powdered sugar formulation as a suspension.

[0055] In implementations wherein the sugar formulation is provided as a solid but not as a powder, the solid is converted to an inhalable powder prior to delivery by crushing it. [0056] In implementations wherein the DPI is constructed to hold more than one dose of powdered sugar formulation or to convert a dose of a solid, non-powdered material, the DPI may be actuated to avail a dose as opposed to a user manually loading a single dose prior to the conversion (if necessary) and the delivery of the powder suspension to the user for inhalation.

[0057] Referring now to Figure 5, the specific process for delivering a sugar formulation through a bag-valve mask again commences with the preparation of a sugar formulation. As the bag-valve mask is typically to be used with the nebulizer so that a constant stream of aerosolized sugar formulation can be availed and inhaled, in

implementations the sugar formulation would be in a liquid form. It is understood, however, that due to the nature of bag-valve masks, any conversion apparatus which could prepare an aerosol mist that could be directed into the bag-valve mask could be employed.

[0058] When a nebulizer is known to be the delivery apparatus, the desired dosage of sugar formulation is controlled by the quantity of sugar formulation placed in the nebulizer. Once the desired dose of sugar formulation is placed in the nebulizer, the nebulizer is activated to convert the liquid sugar formulation into an inhalable mist. The inhalable mist is delivered directly from the output of the nebulizer to the air chamber of the bag-valve mask, which would customarily be done through the medication delivery port on the bag- valve mask. In this regard, the sugar formulation mist is delivered with the air forced into the user's lungs when the bag-valve mask is actuated, and the sugar formulation can be delivered whether the user is conscious or not, or even having problems breathing.

[0059] It is contemplated that beyond a bag-valve mask, a sugar formulation converted into aerosol form could be introduced to a user through other conventional ventilation devices. [0060] In alternate implementations, a dose of a sugar formulation may be converted by a pump spray nozzle, an aerosol nozzle, or an atomizer nozzle, either of which may direct an aerosol or suspension in the vicinity of, or directly into the mouth or nose of, a user, to deliver the sugar formulation to that user for inhalation.

[0061] In places where the description above refers to particular implementations of systems and methods for delivering an inhalable sugar formulation and implementing components, sub-components, methods and sub-methods, it should be readily apparent that a number of modifications may be made without departing from the spirit thereof and that these implementations, implementing components, sub-components, methods and sub-methods may be applied to other systems and methods for delivering an inhalable sugar formulation.