WO2015187356A1 - Système et procédé de distribution de préparation de sucre pouvant être inhalée - Google Patents
Système et procédé de distribution de préparation de sucre pouvant être inhalée Download PDFInfo
- Publication number
- WO2015187356A1 WO2015187356A1 PCT/US2015/031506 US2015031506W WO2015187356A1 WO 2015187356 A1 WO2015187356 A1 WO 2015187356A1 US 2015031506 W US2015031506 W US 2015031506W WO 2015187356 A1 WO2015187356 A1 WO 2015187356A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- sugar
- formulation
- sugar formulation
- spray
- user
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Ceased
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
- A61M16/10—Preparation of respiratory gases or vapours
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
- A61M16/10—Preparation of respiratory gases or vapours
- A61M16/14—Preparation of respiratory gases or vapours by mixing different fluids, one of them being in a liquid phase
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2202/00—Special media to be introduced, removed or treated
- A61M2202/04—Liquids
- A61M2202/0468—Liquids non-physiological
- A61M2202/0486—Glucose
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2202/00—Special media to be introduced, removed or treated
- A61M2202/06—Solids
- A61M2202/064—Powder
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2210/00—Anatomical parts of the body
- A61M2210/10—Trunk
- A61M2210/1025—Respiratory system
- A61M2210/1039—Lungs
Definitions
- 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.
- 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.
- 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.
- Implementations of a method for delivering a sugar formulation for inhalation by a user may include one, all, or any of the following:
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Implementations of a method for delivering a sugar formulation for inhalation by a user may include one, all, or any of the following:
- 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.
- the spray conversion apparatus may be configured to receive a volume of at least 0.2 cubic centimeters of the sugar formulation.
- the spray conversion apparatus may be configured to receive a mass of at least 0.2 grams of the sugar formulation.
- the concentration of the sugar substance in the sugar formulation may be at least 30 percent w/v.
- the concentration of the sugar substance in the sugar formulation may be 100 percent w/v.
- the spray conversion apparatus and the spray delivery apparatus may be included in a metered dose inhaler.
- the spray delivery apparatus may be configured to deliver at least 0.2 cubic centimeters of the sugar formulation in a single spray.
- the spray conversion apparatus may include a nebulizer and the spray delivery apparatus may include a bag-valve mask.
- the spray delivery apparatus may include a dry powder inhaler.
- FIG. 1 is a block diagram of stages of an implementation of a method of delivering a sugar formulation for inhalation
- FIG. 2 is a flowchart of an implementation of a method of delivering a sugar formulation for inhalation
- FIG. 3 is a flowchart of an implementation of a method of delivering a sugar formulation for inhalation using a metered dose inhaler
- FIG. 4 is a flowchart of an implementation of a method of delivering a sugar formulation for inhalation using a dry powder inhaler.
- FIG. 5 is a flowchart of an implementation of a method of delivering a sugar formulation for inhalation using a bag valve mask
- 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.
- a sugar formulation to be delivered to the lungs of a recipient is mixed.
- 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).
- a monosaccharide such as glucose, fructose, and galactose
- a disaccharide such as sucrose, maltose, and lactose
- an oligosaccharide or other polysaccharide such as glycogen
- 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).
- 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).
- 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 :
- 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.
- 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.
- 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.
- 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.
- the sugar formulation includes a simple sugar liquid suspension having an identical concentration range.
- the sugar formulation includes a simple sugar liquid suspension having an identical concentration range.
- the sugar formulation includes a blood sugar raising hormone, such as glucagon.
- a blood sugar raising hormone such as glucagon.
- glucose can be absorbed directly into the bloodstream, when a direct impact on blood sugar is desired, glucose is typically desirable.
- 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.
- 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.
- 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.
- the dosage stage 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
- a relatively higher dosage may be utilized to ensure a sufficient amount of sugar is received by the patient.
- a relatively lower dosage may be utilized in sugar formulations having a higher concentration of sugar and/or in implementations wherein a spontaneous delivery apparatus (as discussed below) is employed.
- 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.
- the dosage stage enables the sugar formulation to be customized for specific conditions in individual patients.
- 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.
- the dosage is calculated by the amount provided to the patient for each respiratory cycle.
- 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.
- 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.
- 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.
- a per deployment dosage in the range of 0.2 grams for higher sugar concentrations and 1 gram for lower sugar concentrations is provided.
- 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.
- 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.
- certain spontaneous delivery apparatuses may enable a predetermined dosage to be availed for conversion to an aerosol at the time of use.
- metered dose inhalers are constructed to dispense a fixed quantity of aerosolized substance.
- 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.
- a modified MDI 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.
- 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.
- 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
- 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.
- 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.
- 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.
- the desired dose may be provided for during conversion and delivery.
- 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.
- 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.
- 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.
- conversion may be accomplished through the provision of an inhalable powder or the manual powdering of a solid sugar formulation.
- conversion may be accomplished through a nebulizer.
- 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.
- the specific process for delivering a sugar formulation through an MDI begins with the preparation of a liquid sugar formulation.
- 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).
- 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.
- 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.
- 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.
- the specific process for delivering a sugar formulation through a dry powder inhaler 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.
- the solid is converted to an inhalable powder prior to delivery by crushing it.
- 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.
- 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.
- the desired dosage of sugar formulation is controlled by the quantity of sugar formulation 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.
- 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.
- a sugar formulation converted into aerosol form could be introduced to a user through other conventional ventilation devices.
- 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.
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- Health & Medical Sciences (AREA)
- Emergency Medicine (AREA)
- Pulmonology (AREA)
- Engineering & Computer Science (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Hematology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
L'invention concerne un système et un procédé qui permettent de distribuer une préparation de sucre à inhaler et qui comprennent quatre étapes : la préparation, le dosage, la conversion et la distribution. Les étapes de préparation et de dosage consistent à fournir et à mélanger la quantité souhaitée d'un sucre, en tant que principe actif, dans une préparation solide ou liquide qui comprend en outre des principes inactifs quelconques que l'on souhaite utiliser dans les étapes de conversion ou de distribution pour permettre à une quantité souhaitée de sucre d'être distribuée en vue d'une inhalation. Les étapes de conversion et de distribution consistent à convertir la préparation de sucre en une suspension sous forme d'aérosol ou de gaz, et à la distribuer à la région de la bouche ou du nez d'un utilisateur, de façon à être inhalée dans les poumons de l'utilisateur, la suspension pouvant être absorbée et utilisée par le corps de l'utilisateur d'une manière qui contourne le système digestif et ne nécessite pas d'injection.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201414296221A | 2014-06-04 | 2014-06-04 | |
| US14/296,221 | 2014-06-04 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2015187356A1 true WO2015187356A1 (fr) | 2015-12-10 |
Family
ID=54767175
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/US2015/031506 Ceased WO2015187356A1 (fr) | 2014-06-04 | 2015-05-19 | Système et procédé de distribution de préparation de sucre pouvant être inhalée |
Country Status (1)
| Country | Link |
|---|---|
| WO (1) | WO2015187356A1 (fr) |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5988162A (en) * | 1995-11-09 | 1999-11-23 | Retallick, Iii; Donald L. | Apparatus and method for treating the lungs |
| US20010038825A1 (en) * | 2000-02-04 | 2001-11-08 | Hite Robert Duncan | Method and compositions for enhancing pulmonary function and treating pulmonary disorders |
| CA2562821A1 (fr) * | 2006-10-06 | 2008-04-06 | Generex Pharmaceuticals Inc. | Composition et methode pour elever le taux de glucose |
| US20080226736A1 (en) * | 2005-10-21 | 2008-09-18 | Eratech S.R.L. | Inhalatory Pharmaceutical Compositions in Form of Dry Powders, Solutions or Suspensions Obtained From the Same and Process for their Preparation |
| WO2012051426A2 (fr) * | 2010-10-15 | 2012-04-19 | Glaxo Group Limited | Formulations de médicament sous forme d'agrégats de nanoparticules, leur fabrication et leur utilisation |
-
2015
- 2015-05-19 WO PCT/US2015/031506 patent/WO2015187356A1/fr not_active Ceased
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5988162A (en) * | 1995-11-09 | 1999-11-23 | Retallick, Iii; Donald L. | Apparatus and method for treating the lungs |
| US20010038825A1 (en) * | 2000-02-04 | 2001-11-08 | Hite Robert Duncan | Method and compositions for enhancing pulmonary function and treating pulmonary disorders |
| US20080226736A1 (en) * | 2005-10-21 | 2008-09-18 | Eratech S.R.L. | Inhalatory Pharmaceutical Compositions in Form of Dry Powders, Solutions or Suspensions Obtained From the Same and Process for their Preparation |
| CA2562821A1 (fr) * | 2006-10-06 | 2008-04-06 | Generex Pharmaceuticals Inc. | Composition et methode pour elever le taux de glucose |
| WO2012051426A2 (fr) * | 2010-10-15 | 2012-04-19 | Glaxo Group Limited | Formulations de médicament sous forme d'agrégats de nanoparticules, leur fabrication et leur utilisation |
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