treatment of respiratory system disorders comprising administering non-surfactant aerosols comprising sodium chloride as a diluent and drugs selected from antibiotics, antihistamines and/or antiviral agents
Inventors
Edwards, David A. • Man, Jonathan C. • Katstra, Jeffrey P. • Clarke, Robert W.
Assignees
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Publication Number
US-8187637-B2
Publication Date
2012-05-29
Expiration Date
Abstract
Formulations have been developed for pulmonary delivery to treat or reduce the infectivity of diseases such as viral infections, especially tuberculosis, SARS, influenza and respiratory synticial virus in humans and hoof and mouth disease in animals, or to reduce the symptoms of allergy or other pulmonary disease. Formulations for pulmonary administration include a material that significantly alters physical properties such as surface tension and surface elasticity of lung mucus lining fluid, which may be isotonic saline and, optionally, a carrier. The formulation may be administered as a liquid solution, suspension, aerosol, or powder where the particles consist basically of an osmotically active solute. Drugs, especially antivirals or antibiotics, may optionally be included with the formulation. These may be administered with or incorporated into the formulation.
Core Innovation
The invention relates to reducing exhalation of pulmonary infection particles in a subject having a pulmonary infection by administering a therapeutically effective amount of a non-surfactant aerosol formulation. The formulation comprises an active agent and a pharmaceutically acceptable diluent, where the diluent contains greater than 0.9% to 5% (w/w) NaCl, or alternatively is described as saline that is hypertonic. The active agent is not a bronchodilator, and administration is used to reduce exhalation of particles in the subject.
The invention further includes decreasing exhalation of particles in an individual by administering a biocompatible formulation comprising a solution of isotonic saline and an osmotically active material at a concentration from 0.9% to about 10% by weight. The osmotically active material is not a bronchodilator, and the formulation is administered in an amount effective to decrease exhalation of particles. The osmotically active material includes salt and/or sugar, with specific examples including mannitol.
The invention also covers treating a respiratory disease in an individual by administering a non-surfactant aerosol formulation comprising saline and an active agent, where the formulation is hypertonic and the active agent is not a bronchodilator. The treated respiratory diseases are selected from allergy, tuberculosis, SARS, influenza, cytomegalovirus, respiratory syncytial virus, African swine fever, coronavirus, rhinovirus, tularemia, bubonic plague, anthrax, bronchiolitis and foot and mouth disease. In some embodiments, the formulation results in a coating on respiratory tract lining fluid and is administered by a nebulizer.
Claims Coverage
The provided material includes independent claims directed to three main inventive features: non-surfactant aerosol formulations with defined saline or osmotically active material content, exclusion of bronchodilators, and use for reducing exhalation of particles and treating listed respiratory diseases.
Non-surfactant aerosol formulation with NaCl diluent to reduce exhalation
A method for reducing exhalation of pulmonary infection particles by administering a therapeutically effective amount of a non-surfactant aerosol formulation comprising an active agent and a pharmaceutically acceptable diluent, the diluent containing greater than 0.9% to 5% (w/w) NaCl, thereby reducing exhalation of particles, with the proviso that the active agent is not a bronchodilator.
Isotonic saline and osmotically active material formulation to decrease exhalation
A method of decreasing exhalation of particles by administering an effective amount of a biocompatible formulation comprising a solution that comprises isotonic saline and an osmotically active material in an amount from 0.9% to about 10% concentration by weight, with the proviso that the osmotically active material is not a bronchodilator.
Hypertonic non-surfactant aerosol with saline to reduce exhalation
A method for reducing exhalation of pulmonary infection particles by administering a therapeutically effective amount of a non-surfactant aerosol formulation comprising saline and an active agent, wherein the formulation is hypertonic and with the proviso that the active agent is not a bronchodilator.
Hypertonic non-surfactant aerosol for treating listed respiratory diseases
A method for treating a respiratory disease selected from allergy, tuberculosis, SARS, influenza, cytomegalovirus, respiratory syncytial virus, African swine fever, coronavirus, rhinovirus, tularemia, bubonic plague, anthrax, bronchiolitis and foot and mouth disease by administering a therapeutically effective amount of a non-surfactant aerosol formulation comprising saline and an active agent, wherein the formulation is hypertonic and the active agent is not a bronchodilator.
Hypertonic non-surfactant aerosol with osmotically active material concentration to treat respiratory disease
A method for treating a respiratory disease selected from allergy, tuberculosis, SARS, influenza, cytomegalovirus, respiratory syncytial virus, African swine fever, coronavirus, rhinovirus, tularemia, bubonic plague, anthrax, bronchiolitis and foot and mouth disease by administering a therapeutically effective amount of a non-surfactant aerosol formulation comprising an osmotically active material, the osmotically active material present at greater than 0.9% to about 10% by weight, wherein the formulation is hypertonic and the osmotically active material is not a bronchodilator.
Non-surfactant aerosol consisting essentially of active agent and NaCl diluent
A method for reducing the exhalation of pulmonary infection particles by administering a therapeutically effective amount of a non-surfactant aerosol formulation consisting essentially of an active agent and a pharmaceutically acceptable diluent, the diluent containing greater than 0.9% to 5% (w/w) NaCl and the active agent selected from an antibiotic, an antihistamine, a corticosteroid and an antiviral agent.
Biocompatible formulation consisting essentially of isotonic saline and osmotically active material
A method of decreasing exhalation of particles by administering an effective amount of a biocompatible formulation comprising solution that consists essentially of isotonic saline and an osmotically active material in an amount from 0.9% to about 10% concentration by weight, wherein the formulation is administered in an amount effective to decrease exhalation of particles in said individual.
Hypertonic saline non-surfactant aerosol consisting essentially of saline and active agent for treatment
A method for treating a respiratory disease selected from allergy, tuberculosis, SARS, influenza, cytomegalovirus, respiratory syncytial virus, African swine fever, coronavirus, rhinovirus, tularemia, bubonic plague, anthrax, bronchiolitis and foot and mouth disease by administering a therapeutically effective amount of a non-surfactant aerosol formulation consisting essentially of a hypertonic saline formulation containing an active agent selected from an antibiotic, an antihistamine, a corticosteroid and an antiviral agent.
Hypertonic non-surfactant aerosol consisting essentially of saline and selected active agent
A method for reducing the exhalation of pulmonary infection particles by administering a therapeutically effective amount of a non-surfactant aerosol formulation consisting essentially of saline and an active agent, wherein the formulation is hypertonic and the active agent is selected from an antibiotic, an antihistamine, a corticosteroid and an antiviral agent.
Across the independent claims, the common inventive thrust is administering non-surfactant aerosol formulations using saline that is isotonic or hypertonic, together with defined NaCl or osmotically active material concentration ranges, and excluding bronchodilators from the active agent. The claims cover both reducing exhalation of pulmonary infection particles and treating a listed set of respiratory diseases in an individual using these formulation constraints.
Stated Advantages
Reduce exhalation of pulmonary infection particles in a subject having a pulmonary infection.
Decrease exhalation of particles in an individual.
Treat a respiratory disease selected from the listed group of respiratory diseases.
Documented Applications
Reducing exhalation of pulmonary infection particles in a subject having a pulmonary infection, with example conditions including tuberculosis and viral respiratory infections such as SARS and influenza.
Decreasing exhalation of particles in an individual via isotonic saline plus an osmotically active material formulation.
Treating respiratory diseases selected from allergy, tuberculosis, SARS, influenza, cytomegalovirus, respiratory syncytial virus, African swine fever, coronavirus, rhinovirus, tularemia, bubonic plague, anthrax, bronchiolitis, and foot and mouth disease.
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