AU2020103517A4 - Ibp- nebulizer: intelligent nebulizer for bronchitis patients - Google Patents
Ibp- nebulizer: intelligent nebulizer for bronchitis patients Download PDFInfo
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- AU2020103517A4 AU2020103517A4 AU2020103517A AU2020103517A AU2020103517A4 AU 2020103517 A4 AU2020103517 A4 AU 2020103517A4 AU 2020103517 A AU2020103517 A AU 2020103517A AU 2020103517 A AU2020103517 A AU 2020103517A AU 2020103517 A4 AU2020103517 A4 AU 2020103517A4
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- dose
- nebulizer
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- medicine
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- 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
- A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/46—8-Azabicyclo [3.2.1] octane; Derivatives thereof, e.g. atropine, cocaine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/007—Pulmonary tract; Aromatherapy
- A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
- A61K9/0078—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug solutions or dispersions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/06—Antiasthmatics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/08—Bronchodilators
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
Abstract
My Invention "BP- NEBULIZER "is The bronhcitis patients take nebulization on the
allergy attack and sometimes they are given steroids. At home the dose is
decided/performed/taken by the patient himself on his comfort. The present system may
be harmful for the patient if overdose is taken or if not harmful then not good in long run.
The concept envisions an artificial intelligence system which keeps an eye on extent of
bronchitis inflation and deflation. The dose can be fixed and advised by doctor. The
nebulizer would have also storage system for the liquid medicine and preserving the
medicine by vacuum pressure or preservation of medicine can be avoided.
12
FIG.1: BRONHCITIS PATIENTS
FIG.2: TAKE NEBULIZATION
FIG.3: ALLERGY ATTACK.
Description
FIG.1: BRONHCITIS PATIENTS
FIG.2: TAKE NEBULIZATION
FIG.3: ALLERGY ATTACK.
My invention" IBP- NEBULIZER"is related to a nebulizer formulation and a method of treatment for diseases such as Chronic Obstructive Pulmonary Disease (COPD), asthma, Lung Disease and Quit-Smoking Assessment.
The Nebulizers provide a means of administering drugs to the airways of a patient whilst the patient breathes at an approximately normal rate. They are particularly suitable for patients who are unable, whether due to age or injury or otherwise, to inhale at the much higher rates required for administration of drugs via metered dose inhalers or dry powder inhalers and for patients who cannot for whatever reason coordinate the activation of the metered dose inhaler with their inhalation of breath. The nebulizer apparatus creates a vapour containing drug particles and the patient breathes the vapour via a mouthpiece or mask attached to the nebulizer. Typically, nebulizers are used to deliver drugs for the treatment of airways disorders such as (COPD), asthma, Lung Disease and Quit-Smoking Assessment.
The bronhcitis patients take nebulization on the allergy attack and sometimes they are given steriods. At home the dose is decided/performed/taken by the patient himself on his comfort or as advised by docyor. The present system may be harmful for the patient if overdose is taken or if not harmful then not good in long run. The concept envisions an artificial intelligence system which keeps an eye on extent of bronchial inflation and deflation. The dose can be fixed and advised by doctor. The nebulizer would have also storage system for the liquid medicine and preserving the medicine by vacuum pressure or preservation of medicine can be avoided.
Most patients suffering from COPD have both emphysema and chronic bronchitis. The standard of treatment for COPD includes maintenance and/or rescue dosing of bronchodilator and/or anti-inflammatory aerosol drugs. While most patients respond to treatment with metered dose inhalers or dry powder inhalers, there is a subset of patients for whom such options are not well-suited. Older and sicker COPD patients, for example, often find it difficult to use, or do not experience therapeutic benefit from the use of, metered dose inhalers or dry powder inhalers. Dry powder inhalers are generally passive delivery devices, which patients actuate by forceful, controlled inhalation through the mouth. Metered dose inhalers, on the other hand, are in general active delivery devices, which create an atomized mist by forcing a drug solution or suspension through a nozzle under pressure. A patient activates the metered dose inhaler by pressing an actuator and simultaneously breathing in through the mouth in order to deposit the drug in the patient's lungs.
Patients whose motor skills are impaired or not fully developed will often have trouble activating the device, coordinating their breathing, and generally using metered dose inhalers. Patients who also have poor inhalation capacity and control find dry powder inhalers to be difficult to operate as well. Newer inhaler devices that are breath-actuated or produce a soft mist are easier for patients to operate; but these newer devices still require coordination and a breath-hold; and achievement of sufficient lung deposition and distribution is reliant on only one or two inhalations. For sicker and older COPD patients, nebulizer delivery of their medicines is an important delivery option, since they can generally receive a full dose regardless of disease state, because all that is required is normal (tidal) breathing over multiple minutes.
According to the U.S. Centers for Disease Control and Prevention, COPD is currently the fourth leading cause of death in the U.S. (behind heart disease, cancer and stroke), claiming the lives of in excess of 100,000 Americans annually. An estimated 16 million Americans have been diagnosed with some form of COPD, and as many as 16 million others have the condition but have not yet been diagnosed. COPD is hence regarded as a major and growing health care threat in the U.S. and throughout the rest of the world.
A known formulation for treatment of COPD comprises albuterol (also known as salbutamol) and ipratropium in an ampoule containing 3.0 ml of solution, and is described in WO 03/037159 and the equivalent US patent 6632842. In use, the contents of the ampoule are poured into the chamber of the nebulizer and the patient then breathes the vapour generated until the ampoule contents are used. Treatment is typically required up to 4 times per day, at regular intervals.
According to the U.S. Centers for Disease Control and Prevention, COPD is currently the fourth leading cause of death in the U.S. (behind heart disease, cancer and stroke), claiming the lives of in excess of 100,000 Americans annually. An estimated 16 million Americans have been diagnosed with some form of COPD, and as many as 16 million others have the condition but have not yet been diagnosed. COPD is hence regarded as a major and growing health care threat in the U.S. and throughout the rest of the world.
A known formulation for treatment of COPD comprises albuterol (also known as salbutamol) and ipratropium in an ampoule containing 3.0 ml of solution, and is described in WO 03/037159 and the equivalent US patent 6632842. In use, the contents of the ampoule are poured into the chamber of the nebulizer and the patient then breathes the vapour generated until the ampoule contents are used. Treatment is typically required up to 4 times per day, at regular intervals.
Low patient compliance is a known problem with nebulized drugs generally, as the period of nebulizing required to administer a dose is long, typically tens of minutes, perhaps half-an-hour for a typical dose. Children and adults can become bored during this period. Patients who stop nebulizing prematurely do not receive a full dose. This can in turn lead to further reduced patient compliance as the inadequate dose fails to provide adequate therapy, discouraging further use. 0
This application claims priority under 35 U.S.C. §120 from U.S. nonprovisional patent application Ser. No. 12/393,709, filed Feb. 26, 2009, and claims priority under 35 U.S.C. §119(e) from U.S. provisional patent application 61/031,639, filed Feb. 26, 2008, and from U.S. provisional patent application 61/080,184, filed Jul. 11, 2008, each of which applications is incorporated herein by reference in its entirety.
1. The objective of the invention is to meter and provide a system for regulation of dose of steroids and asthalin type medicines to patients. 2. The other objective of the invention is to make an arrangement of preservation of left over medicine without any affect either by air tight vacuum system for particular small time of less than 1 hr. 3. The other objective of the invention is to display the metered dose with date and time on the nebulizer machine. 4. The other objective of the invention is to detect composition of medicine (not mixture of medicine and compare it with standard graphs provided by company on website. IOT. 5. The other objective of the invention is to detect the bar code on medicine and send it to company website using internet for knowing counterfieting 6. The other objective of the invention is to take visual pics and by sound of patient detect the level of bronchial inflammation and advise dose of medicine. The advice is optional one since inflammation of patient is subjective matter 7. The other objective of the invention is to detect the cleanliness of mask used and advise patient to clean or change.
The present invention provides novel, sterilized nebulizer formulations, suitable for treatment of COPD, asthma and other conditions associated with reversible obstruction of the airways. The formulations can be utilized in a variety of known nebulizer apparatus, with potential reduced wastage of ingredients and/or an anticipated increase in patient compliance. The invention provides a method of treatment of COPD, asthma and other conditions associated with reversible obstruction of the airways comprising administering, via a nebulizer, a sterilized formulation containing both formoterol and budesonide in a pharmaceutically acceptable carrier.
The invention further provides a method of manufacturing sterile nebulizer formulations, by combining formoterol and budesonide under nitrogen gas before filling into ampoules. The present invention provides a method of treatment of COPD, asthma and other conditions associated with reversible obstruction of the airways, comprising providing a nebulizer and an ampoule containing not more than 2.2 ml of a formulation comprising formoterol and budesonide in a pharmaceutically acceptable carrier, and administering the formulation using the nebulizer.
BRIEF DESCRIPTION OF THE DIAGRAM FIG1: BRONHCITIS PATIENTS.
FIG.2: TAKE NEBULIZATION.
FIG.3: ALLERGY ATTACK.
FIG.4: STEROIDS
FIG.5: ARTIFICIAL INTELLIGENCE NEBULIZER SYSTEM.
FIG.6: BRONCHITIS INFLATION.
Administering the Formulation using the Nebulizer
Preferably, the invention provides and uses ampoules which contain not less than 0.5 ml of formulation, more preferably about 1.0 to 2 ml of said formulation, and very preferably about 1.5ml to 2 ml of said formulation. These reduced volumes can lead to significant reductions in treatment times, with the expected advantages explained. Formulations and compositions of the invention generally comprise a pharmaceutically acceptable carrier. The carrier is preferably a liquid carrier. Further, the earner preferably comprises water and may comprise other components.
A filled ampoule of the invention contains a formulation of formoterol and budesonide. This is generally in a pharmaceutically acceptable carrier and buffered for human use to a pH of about 3.5 - 5.5. The formulations of the examples are buffered to about pH 4. The formulations are optionally free of preservative, which is an advantage as some preservatives can be associated with bronchoconstriction effects - the opposite effect to that required by the formulation. Water is used to provide the carrier, and water for injection is preferred due to its purity.
One or more tonicity adjusting agents may be added to provide the desired ionic strength. Tonicity adjusting agents for use herein include those which display no or only negligible pharmacological activity after administration. Both inorganic and organic tonicity adjusting agents may be used. Compositions of the invention can also include excipients and/or additives. Examples of these are surfactants, stabilizers, complexing agents, antioxidants, or preservatives which prolong the duration of use of the finished pharmaceutical formulation, flavorings, vitamins, or other additives known in the art. Complexing agents include, but are not limited to, ethylenediaminetetraacetic acid (EDTA) or a salt thereof, such as the disodium salt, citric acid, nitrilotriacetic acid and the salts thereof. In one embodiment, the complexing agent is EDTA. Preservatives include, but are not limited to, those that protect the solution from contamination with pathogenic particles, including benzalkonium chloride or benzoic acid, or benzoates such as sodium benzoate. Antioxidants include, but are not limited to, vitamins, provitamins, ascorbic acid, vitamin E or salts or esters thereof.
Detailed Description of the Preferred
The invention enables use of nebulizer formulations without the lower limit on volume typically associated with the art. The beta agonist is formulated with and administered !0 with an anticholinergic agent, suitably selected from ipratropium, tiaproprium, cromolyn sodium and other anticholinergic agents.Reference to these active agents herein is intended to refer also to pharmaceutically acceptable derivatives thereof, such as but not limited to salts, esters, enol ethers, enol\5 esters, acids, bases, solvates, hydrates or prodrugs thereof. Ipratropium is an anticholinergic agent and has a bronchodilator effect, and can thus aid delivery of, and act in synergy with the bronchodilator effect of, levalbuterol. Reference to ipratropium thus includes, but is not limited to, any form of ipratropium which has an anticholinergic effect in patients suffering from COPD, including, but not limited to, all automatic forms, enantiomer forms, stereoisomer, anhydrides, acid addition salts, base salts, solvates, analogues and derivatives of ipratropium. Several acceptable salts of ipratropium exist and for the invention these may include, but are not limited to, halide salts such as bromide, chloride and iodide, described for example in U.S. Pat. No. 3,505,337, which is incorporated herein by reference. A method of treatment of (COPD), asthma, Lung Disease and Quit-Smoking Assessment.
using the teachings of the invention comprises administering to a human patient, via a nebulizer, a formulation containing effective amounts of both levalbuterol and ipratropium in a pharmaceutically acceptable carrier, and it is expected, using this ampoule formulation, to achieve improved acceptance of the medicine and better patient compliance. A further anticipated advantage is that the concentration of the active ingredients can be increased, with the result that ampoules of the invention can contain reduced volume whilst retaining substantially the same unit dosage of drug to be administered. In one embodiment of the invention overall ampoule concentration (ie. including active and inactive ingredients) is substantially the same as in previous formulations but ampoule volume is approximately half. With reduced volume, there is reduced nebulizing time. This will further improve patient compliance as there is less time e.g. for patients to become bored or distracted whilst using the nebulizer.
In preferred embodiments of the invention, both ampoule volume is reduced, enabling reduced nebulizing time, and ampoule concentration is reduced. The compositions provided herein are used for treating, preventing, or ameliorating one or more symptoms of a Broncho constrictive disorder or disease in a human subject. In one embodiment, the method includes nebulizer administration to a subject of an effective amount of a composition containing levalbuterol and an anticholinergic, whereby the disease or disorder is treated or prevented.
The invention relates in particular to formulations for treatment of (COPD), asthma, Lung Disease and Quit-Smoking Assessment including, but not limited to, chronic bronchitis, emphysema, and associated cor pulmonale (heart disease secondary to disease of the lungs and respiratory system) with pulmonary hypertension, right ventricular hypertrophy and right heart failure, and also bronchial asthma, allergic asthma and intrinsic asthma, e.g., late asthma and airway hyper-responsiveness.
Instructions on How the Dose Is to Be Used
The single unit dose is suitably as described elsewhere herein in relation to formulations of the invention. The instructions instruct the patient as to how the dose should be used in conjunction with a nebulizer, such as how to open it and transfer its contents into the nebulizer, how to operate the nebulizer and for how long nebulizing should be continued to complete administration of the dose.
Kits of the invention can contain a plurality of single unit doses. One kit comprises at least 120 or at least 125 single unit doses, being designed to provide one month's worth of doses to be taken 4 times per day. Another kit comprises at least 25 or at least 28 single unit doses, designed for a week's supply at 4 per day. Other kits may usefully contain 30 or 60 single unit doses.
The invention in which the extractable volume is 2.2ml or less, especially where the volume is 2.Oml or 1.5ml or lower, the instructions may explain that the present formulation can be administered in less time than a previously known formulation, such as a known 3ml formulation, hence reinforcing this advantage of the invention and improving the prospects for increased patient compliance. Preferably, the instructions explain that the patient should continue administering the dose until the complete dose has been administered. Formulations of the invention are suitable for filing into ampoules using "blow fill seal" (BFS) methods. The principle is that a plastic prison is extruded from polymer, formed into a container, filled and sealed in a single aseptic operation. BFS is now the preferred method for aseptic manufacture of ampoules due to the flexibility in container design, overall product quality, product output and low operational costs. Fill accuracies of better than ±5% have been demonstrated for container volumes as small as 0.5ml and hence BFS is suitable for manufacture of ampoules according to the invention.
One BFS operation includes the multi-step process of blow moulding, aseptic filling and hermetic sealing of liquid products with fill volumes ranging from 0.1ml to 1,000ml, though for ampoules volumes in the range O.5ml to 5ml are more common. A variety of polymers may be used in the process; low and high-density polyethylene and polypropylene are the most popular. Furthermore, the BFS process flow is normally impacted by only two raw materials - product and polymer - that are each processed inline, thereby making the process amenable to large uninterrupted batch sizes, some in excess of 500,000 or 1,000,000 units, and fill durations of up to 120 hours.
Claims (8)
1. My Invention "IBP- NEBULIZER "is The bronhcitis patients take nebulization on the allergy attack and sometimes they are given steroids. At home the dose is decided/performed/taken by the patient himself on his comfort. The present system may be harmful for the patient if overdose is taken or if not harmful then not good in long run. The concept envisions an artificial intelligence system which keeps an eye on extent of bronchitis inflation and deflation. The dose can be fixed and advised by doctor. The nebulizer would have also storage system for the liquid medicine and preserving the medicine by vacuum pressure or preservation of medicine can be avoided. A method of increasing patient compliance in use of a nebulizer formulation by reducing volume of said formulation, comprising (1) providing: - a) a nebulizer, and b) an ampoule containing said formulation, wherein said formulation comprises levalbuterol and an anticholinergic agent in a pharmaceutically acceptable carrier and wherein the ampoule contains not more than 2.22 ml and not less than 0.32ml of said formulation, and (2) administering the formulation to a patient using the nebulizer.
2. According to claim 1 # The Invention is to meter and provide a system for regulation of dose of steroids and asthalin type medicines to patients and also the Invention is to display the metered dose with date and time on the nebulizer machine.
3. According to claim 1,2 # The Invention is to detect the bar code on medicine and send it to company website using internet for knowing counterfieting and also the Invention is to take visual pics and by sound of patient detect the level of bronchial inflammation and advise dose of medicine. The advice is optional one since inflammation of patient is subjective matter
4. According to claim 1,2 # The Invention is to, wherein the ampoule contains not more than 2.2ml and not less than 0.55 ml of said formulation and also the Invention is to wherein the formulation contains from 0.74 to 2.1 mg of levalbuterol.
5. According to claim 1,2,4 # The Invention is to wherein the formulation contains from 1.1 to 1.58 mg of levalbuterol and also the invention is to wherein the formulation contains from 0.24 to 1.1 mg of ipratropium and also According to claim 1,2 # The Invention is to wherein the formulation contains from 0.3 to 0.8 mg of ipratropium and a kit comprising: -(1) a container, containing a single unit dose of a therapeutically effective amount of levalbuterol and an anticholinergic agent, and a pharmaceutically acceptable carrier; and (2) instructions on how the dose is to be used.
6. According to claim 1,2,4 # The Invention is to wherein the single unit does is 2.2ml or less in volume, and the instructions explain that the single unit dose can be administered in less time than a previously known formulation and also the invention is to wherein the instructions explain that the patient should continue administering the dose until the complete dose has been administered. The method of treating a patient having chronic obstructive pulmonary disease (COPD), comprising administering to the patient, with a high efficiency nebulizer, a composition comprising a muscarinic antagonist that provides to the patient a respirable dose or deposited dose of a muscarinic antagonist, wherein achievement of said respirable dose or deposited dose with said high efficiency nebulizer provides to the patient: (1) a similar or an increased magnitude and/or duration of therapeutic effect; and (2) reduced or acceptable side effects, compared to achievement of the same respirable dose or deposited dose of the muscarinic antagonist with a conventional nebulizer.
7. According to claim 1,2,5 # The Invention is to wherein achievement of the respirable dose or deposited dose with the high efficiency nebulizer produces in the patient an increased duration of therapeutic effect of at least 24 hours after administration of the nominal dose and also the invention is to wherein the therapeutic effect comprises an improvement of FEV.
8. According to claim 1,2,5,6 # The Invention is to east about 100 mL above baseline when adjusted for placebo or at least about 10% above baseline, when adjusted for placebo, 24 hours after the composition is administered with the high efficiency nebulizer.
FIG.1: BRONHCITIS PATIENTS
FIG.2: TAKE NEBULIZATION
FIG.3: ALLERGY ATTACK.
FIG.4: STEROIDS
FIG.5: ARTIFICIAL INTELLIGENCE NEBULIZER SYSTEM
FIG.6: BRONCHITIS INFLATION
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| AU2020103517A AU2020103517A4 (en) | 2020-11-18 | 2020-11-18 | Ibp- nebulizer: intelligent nebulizer for bronchitis patients |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| AU2020103517A AU2020103517A4 (en) | 2020-11-18 | 2020-11-18 | Ibp- nebulizer: intelligent nebulizer for bronchitis patients |
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| Publication Number | Publication Date |
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| AU2020103517A4 true AU2020103517A4 (en) | 2021-01-28 |
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| AU2020103517A Ceased AU2020103517A4 (en) | 2020-11-18 | 2020-11-18 | Ibp- nebulizer: intelligent nebulizer for bronchitis patients |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US11839716B2 (en) | 2016-07-08 | 2023-12-12 | Trudell Medical International | Smart oscillating positive expiratory pressure device |
-
2020
- 2020-11-18 AU AU2020103517A patent/AU2020103517A4/en not_active Ceased
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US11839716B2 (en) | 2016-07-08 | 2023-12-12 | Trudell Medical International | Smart oscillating positive expiratory pressure device |
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| MK22 | Patent ceased section 143a(d), or expired - non payment of renewal fee or expiry |