Nebulizers News and Articles

Return to Library

Recent Nebulizers News and Articles

• Studies from Department of Anesthesiology Have Provided New Data on Anesthesiology
• Patent Issued for Systems and Methods for Delivery of a Therapeutic Agent
• Research Reports from Georgia State University Provide New Insights into Aerosol Medicine
• Researchers from Justus-Liebig-University Report Recent Findings in Pharmaceutics and Biopharmaceutics
• Patent Application Titled \"Apparatus and Methods for Microparticle Dry Coating of Surfaces\" Under Review
• PARI Unveils New Ordering Website
• Data from Aix-Marseille University Provide New Insights into Cystic Fibrosis
• Enhanced Capital Provides $4.0 Million in Financing to HomeTown Oxygen
• Patent Application Titled \"Dry Powder Nebulizer\" Under Review

---

Agency Reviews Patent Application Approval Request for "Bronchodilating Beta-Agonist Compositions and Methods"

2012 DEC 26 (NewsRx) -- By a News Reporter-Staff News Editor at Biotech Week -- A patent application by the inventors Banerjee, Partha S. (Wynnewood, PA); Chaudry, Imtiaz A. (American Canyon, CA); Pham, Stephen (Sacramento, CA), filed on December 23, 2011, was cleared for further review on December 13, 2012, according to news reporting originating from Washington, D.C., by NewsRx correspondents.

Patent application serial number 336972 has not been assigned to an institution or company.

The following quote was obtained by the news editors from the background information supplied by the inventors: "Bronchoconstrictive disorders affect millions worldwide. Such disorders include asthma (including bronchial asthma, allergic asthma and intrinsic asthma, e.g., late asthma and airway hyper-responsiveness), chronic bronchitis and other chronic obstructive pulmonary diseases. Compounds having .beta..sub.2-adrenoreceptor agonist activity have been developed to treat these conditions. Such compounds include, but are not limited to, Albuterol (.alpha..sup.1-(((1,1-dimethylethyl)amino)methyl)-4-hydroxy-1,3-benzencdn- imethanol); Bambuterol (dimethylcarbamic acid 5-(2-((1,1-dimethylethyl)amino)-1-hydroxyethyl)-1,3-phenylene ester); Bitolterol (4-methylbenzoic acid 4-(2-((1,1-dimethylethyl)amino)-1-hydroxyethyl)-1,2-phenylene ester); Broxaterol (3-bromo-.alpha.-(((1,1-dimethylethyl)amino)methyl)-5-isoxazolemethanol); Isoproterenol (4-(1-hydroxy-2-((1-methylethyl)amino)ethyl)-1,2-benzenediol); Trimetoquinol (1,2,3,4-tetrahydro-1-((3,4,5-trimethoxyphenyl)methyl)-6,7-isoquinolinedi- ol); Clenbuterol (4-amino-3,5-dichloro-.alpha.-(((1,1-diemethylethyl)amino)-methyl)benzene- methanol); Fenoterol (5-(1-hydroxy-2-((2-(4-hydroxyphenyl)-1-methylethyl)-amino)ethyl)-1,3-ben- zenediol); Formoterol (2-hydroxy-5-((1RS)-1-hydroxy-2-(((1RS)-2-(p-methoxyphenyl)-1-methylethyl- )amino)ethyl)formanilide); (R,R)-Formoterol; Desformoterol ((R,R) or (S,S)-3-amino-4-hydroxy-.alpha.-(((2-(4-methoxyphenyl)-1-ethylethyl)amino- )methyl)-benzene-methanol); Hexoprenaline (4,4'-(1,6-hexanediyl)-bis(imino-(1-hydroxy-2,1-ethanc-diyl)))bis-1,2-ben- zenediol); Isoetharine (4-(1-hydroxy-2-((1-methylethyl)amino)butyl)-1,2-benzenediol); Isoprenaline (4-(1-hydroxy-2-((1-methylethyl)amino)ethyl)-1,2-benzenediol); Metaproterenol (5-(1-hydroxy-2-((1-methylethyl)amino)ethyl)-1,3-benzenediol); Picumeterol (4-amino-3,5-dichloro-.alpha.-(((6-(2-(2-pyridinyl)ethoxy)hexyl)-amino)me- thyl)benzenemethanol); Pirbuterol (.alpha..sup.1-(((1,1-dimethylethyl)amino)methyl)-3-hydroxy-2,6-pyridinem- ethanol); Procaterol (((R*,S*)-(.+-.)-8-hydroxy-5 (1-hydroxy-2-((1-methylethyl)amino)butyl)-2(1H)-quinolinone); Reproterol ((7-(3-((2-(3,5-dihydroxy-phenyl)-2-hydroxyethyl)amino)propyl)-3,7-dihydr- o-1,3-dimethyl-1H-purine-2,6-dione); Rimiterol (4-(hydroxy-2-piperidinylmethyl)-1,2-benzenediol); Salbutamol ((.+-.)-.alpha..sup.1-(((1,1-dimethylethyl)amino)methyl)-4-hydroxy-1,3-be- nzenedimethanol); ®-Salbutamol; Salmeterol ((-)-4-hydroxy-.alpha..sup.1-(((6-(4-phenylbutoxy)hexyl)amino)methyl)-1,3- -benzenedimethanol); ®-Salmeterol; Terbutaline (5-(2-((1,1-dimethylethyl)amino)-1-hydroxyethyl)-1,3-benzenediol); Tulobuterol (2-chloro-.alpha.-(((1,1-dimethyl-ethyl)amino)-methyl)benzenemethanol); and TA-2005 (8-hydroxy-5-((1R)-1-hydroxy-2-(N-((1R)-2-(4-methoxyphenyl)-1-methylethyl- )amino)ethyl)carbostyril hydrochloride).

"These compounds are typically formulated for inhalation therapy. Aqueous or liquid formulations are preferred over solid formulations. Powdered formulations are more difficult to administer, particularly to the young and elderly who are most often the patients in need of such therapy. Compounds, such as formoterol are not adequately stable in aqueous solutions to be formulated as liquids. Hence there is a need for formulations of compounds, such as formoterol, in a form that can be conveniently administered and that are stable for extended periods of time."

Supplementing the background information on this patent application, NewsRx reporters also obtained the inventors' summary information for this patent: "Compositions and methods for treatment, prevention, or amelioration of one or more symptoms of bronchoconstrictive disorders are provided. The compositions provided herein are stable solutions of a bronchodilating agent, or a derivative thereof, in a pharmacologically suitable fluid that contains water, that are stable during long term storage. The compositions are suitable for direct administration to a subject in need thereof. Pharmacologically suitable fluids include, but are not limited to, polar fluids, including protic fluids. In certain embodiments herein, the compositions are aqueous solutions.

"The compositions provided herein possess an estimated shelf-life of greater than 1, 2 or 3 months usage time at 25.degree. C. and greater than or equal to 1, 2 or 3 years storage time at 5.degree. C. In certain of these embodiments, using Arrhenius kinetics, >80% or >85% or >90% or >95% estimated bronchodilating agent remains after such storage. These compositions are particularly useful, for administration via nebulization. In certain embodiments herein, the subject is a mammal. In other embodiments, the subject is a human.

"The compositions provided herein are formulated to remain stable over a relatively long period of time. For example, the compositions provided herein are stored between -15.degree. C. and 25.degree. C., or between 2.degree. C. and 8.degree. C., and remain stable for the desired time. In one embodiment, the compositions are stored at 5.degree. C. In other embodiment, the compositions are stored at 25.degree. C.

"Among the bronchodilating agents for use herein are Albuterol (.alpha..sup.1-(((1,1-dimethylethyl)-amino)methyl)-4-hydroxy-1,3-benzened- imethanol); Bambuterol (dimethylcarbamic acid 5-(2-((1,1-dimethylethyl)amino)-1-hydroxyethyl)-1,3-phenylene ester); Bitolterol (4-methylbenzoic acid 4-(2-((1,1-dimethylethyl)amino)-1-hydroxyethyl)-1,2-phenylene ester); Broxaterol (3-bromo-.alpha.-(((1,1-dimethylethyl)amino)-methyl)-5-isoxazolemethanol)- ; Isoproterenol (4-(1-hydroxy-2-((1-methylethyl)amino)ethyl)-1,2-benzenediol); Trimetoquinol (1,2,3,4-tetrahydro-1-((3,4,5-trimethoxyphenyl)methyl)-6,7-isoquinolinedi- ol); Clenbuterol (4-amino-3,5-dichloro-.alpha.-(((1,1-dimethylethyl)amino)methyl)benzeneme- thanol); Fenoterol (5-(1-hydroxy-2-((2-(4-hydroxyphenyl)-1-methylethyl)amino)ethyl)-1,3-benz- enediol); Formoterol (2-hydroxy-5-((1RS)-1-hydroxy-2-(((1RS)-2-(p-methoxyphenyl)-1-methylethyl- )amino)ethyl)-formanilide); (R,R)-Formoterol; (S,S)-Formoterol; Desformoterol ((R,R) or (S,S)-3-amino-4-hydroxy-.alpha.-(((2-(4-methoxyphenyl)-1-methylethyl)amin- o)methyl)benzene-methanol); Hexoprenaline (4,4'-(1,6-hexanediyl)-bis(imino(1-hydroxy-2,1]-ethane-diyl)-))bis-1,2-be- nzenediol); Isoetharine (4-(1-hydroxy-2-((1-methylethyl)amino)-butyl)-1,2-benzenediol); Isoprenaline (4-(1-hydroxy-2-((1-methylethyl)amino)ethyl)-1,2-benzenediol); Metaproterenol (5-(1-hydroxy-2-((1]-methylethyl)-amino)ethyl)-1,3-benzenediol); Picumeterol (4-amino-3,5-dichloro-.alpha.-(((6-(2-(2-pyridinyl)-ethoxy)hexyl)-amino)m- ethyl)benzenemethanol); Pirbuterol (.alpha..sup.1-(((1,1-dimethylethyl)amino)-methyl)-3-hydroxy-2,6-pyridine- methanol); Procaterol (((R*,S*)-(.+-.)-8-hydroxy-5-(1-hydroxy-2-((1-methylethyl)amino)butyl)-2(- 1H)-quinolinone); Reproterol ((7-(3-((2-(3,5-dihydroxyphenyl)-2-hydroxyethyl)amino)propyl)-3,7-dihydro- -1,3-dimethyl-1H-purine-2,6-dione); Rimiterol (4-(hydroxy-2-piperidinylmethyl)-1,2-benzenediol); Salbutamol ((.+-.)-.alpha..sup.1-(((1,1-dimethylethyl)-amino)methyl)-4-hydroxy-1,3-b- enzenedimethanol); ®-Salbutamol; Salmeterol ((.+-.)-4-hydroxy-.alpha..sup.1-(((6-(4-phenylbutoxy)hexyl)amino)methyl)-- 1,3-benzenedimethanol); ®-Salmeterol; Terbutaline (5-(2-((1,1-dimethylethyl)amino)-1-hydroxyethyl)-1,3-benzenediol); Tulobuterol (2-chloro-.alpha.-(((1,1-dimethyl-ethyl)amino)methyl)benzenem-ethanol); and TA-2005 (8-hydroxy-5-((1R)-1-hydroxy-2-(N-((1R)-2-(4-methoxy-phenyl)-1-methylethy- l)amino)ethyl)carbostyril hydrochloride).

"Of particular interest herein is formoterol, having the formula:

"##STR00001##

"Formoterol for use in the compositions and methods provided herein includes 2-hydroxy-5-((1RS)-1-hydroxy-2-(((1RS)-2-(p-methoxyphenyl)-1-met- hylethyl)amino)ethyl)formanilide; or a stereoisomer thereof; and also includes the single enantiomers 2-hydroxy-5-((1S)-1-hydroxy-2-(((1S)-2-(p-methoxyphenyl)-1-methylethyl)am- ino)ethyl)formanilide and 2-hydroxy-5-((1R)-1-hydroxy-2-(((1R)-2-(p-methoxyphenyl)-1-methylethyl)am- ino)ethyl)formanilide.

"In certain embodiments, the compositions are administered via nebulization. Administration of a nebulized aerosol is preferred over the use of dry powders for inhalation in certain subject populations, including pediatric and geriatric groups.

"In one embodiment, the compositions for use in the methods provided herein contain a pharmaceutically acceptable derivative of formoterol. In another embodiment, the compositions for use in the methods provided herein contain a pharmaceutically acceptable salt of formoterol. Pharmaceutically acceptable salts include, but are not limited to, salts of mineral acids, such as but not limited to hydrochlorides and sulfates; and salts of organic acids, such as but not limited to acetates, lactates, malates, tartrates, citrates, ascorbates, succinates, butyrates, valerates and fumarates. In one embodiment, the compositions for use in the methods provided herein contain formoterol fumarate or formoterol fumarate dihydrate. In another embodiment, the compositions for use in the methods provided herein contain formoterol tartrate.

"Also provided herein are combinations containing a composition provided herein and a nebulizer. The combinations can be packaged as kits, which optionally contain other components, including instructions for use of the nebulizer. Any nebulizer is contemplated for use in the kits and methods provided herein. In particular, the nebulizers for use herein nebulize liquid formulations, including the compositions provided herein, containing no propellant. The nebulizer may produce the nebulized mist by any method known to those of skill in the art, including, but not limited to, compressed air, ultrasonic waves, or vibration. The nebulizer may further have an internal baffle. The internal baffle, together with the housing of the nebulizer, selectively removes large droplets from the mist by impaction and allows the droplets to return to the reservoir. The line aerosol droplets thus produced are entrained into the lung by the inhaling air/oxygen.

"Methods for the treatment, prevention, or amelioration of one or more symptoms of bronchoconstrictive disorders, including, but not limited to, asthma, including, but not limited to, bronchial asthma, allergic asthma and intrinsic asthma, e.g., late asthma and airway hyper-responsiveness; chronic bronchitis; and other chronic obstructive pulmonary diseases are provided. The methods involve administering an effective amount of a pharmaceutical composition provided herein to a subject in need of such treatment.

"Articles of manufacture, containing packaging material, a composition provided herein, which is useful for treatment, prevention or amelioration of one or more symptoms of diseases or disorders associated with undesired and/or uncontrolled bronchoconstriction, and a label that indicates that the composition is used for treatment, prevention or amelioration of one or more symptoms of diseases or disorders associated with undesired and/or uncontrolled bronchoconstriction, are also provided."

For the URL and additional information on this patent application, see: Banerjee, Partha S.; Chaudry, Imtiaz A.; Pham, Stephen. Bronchodilating Beta-Agonist Compositions and Methods. U.S. Patent Serial Number 336972, filed December 23, 2011, and posted December 13, 2012. Patent URL: http://appft.uspto.gov/netacgi/nph-Parser'Sect1=PTO2&Sect2=HITOFF&u=%2Fnetahtml%2FPTO%2Fsearch-adv.html&r=1915&p=39&f=G&l=50&d=PG01&S1=20121206.PD.&OS=PD/20121206&RS=PD/20121206

Keywords for this news article include: Drugs, Asthma, Benzene, Patents, Therapy, Alcohols, Methanol, Allergies, Formoterol, Salmeterol, Pulmonology, Sympathomimetic, Allergy Medicine, Bronchial Diseases, Respiratory Agents, Aromatic Hydrocarbons, Immune System Diseases, Adrenergic beta-Agonist, Obstructive Lung Diseases, Adrenergic Bronchodilators.

Our reports deliver fact-based news of research and discoveries from around the world. Copyright 2012, NewsRx LLC