Gilead Sciences, Inc.

Mannkind Corporation

Activaero Gmbh Research & Development

Discovery Laboratories, Inc.

Vectura Gmbh

Thomas Hofmann

Alan Bruce Montgomery

Kevin Stapleton

William Baker

Stefan Ufer

Philipp Kroneberg

Bernard Muellinger

Gerhard Scheuch

Robert J Capetola

Robert Segal

Mark E Johnson

The present invention relates to pharmaceutical compositions for inhalation comprising a therapeutically effective dose of clofazimine wherein the clofazimine is provided in the form of a suspension, and processes for their preparation. Furthermore, the present invention provides pharmaceutical combinations comprising clofazimine in the form of an aerosol for pulmonary inhalation. The combinations and compositions provided by the present invention may be used in the treatment and/or prophylaxis of pulmonary infections caused by mycobacteria and other gram-positive bacteria, and of pulmonary fungal infections.

Compositions of clofazimine, combinations comprising them, processes for their preparation, uses and methods comprising them

A drug and device combination system used in a method for treatment of patients suffering from severe and oral corticosteroid-dependent asthma and other respiratory diseases requiring a treatment with orally administered steroids. The method for administration of the inhalable corticosteroid by a flow rate and volume regulated inhalation. The combination system of the inhalable corticosteroid and the device for regulating flow rate and volume of the inhalable corticosteroid and thus achieving delivery of said inhalable corticosteroid into the small airways of the lungs. The individually programmable device that assures safe and reproducible corticosteroid delivery compliant with treatment protocol.

Flow and volume regulated inhalation for treatment of severe oral corticosteroid-dependent asthma

Methods, devices and compositions for treatment of severe and uncontrolled asthma are provided by which high amounts of an inhaled corticosteroid are directed to the small airways of the lower lungs. The invention provides for a substantial decrease in the dose of concurrently administered oral corticosteroids. A particular advantage of the invention is the significant reduction in corticosteroid-related adverse effects.

Use of a glucocorticoid composition for the treatment of severe and uncontrolled asthma

Methods and compositions to enhance mucus clearance and to treat pulmonary lung disorders such as cystic fibrosis are disclosed. The methods utilize compositions including synthetic pulmonary surfactants having one or more phospholipids and a synthetic polypeptide, administered alone or combined with hyperosmotic agents, to patients in an amount effective to enhance mucus clearance.

Pulmonary surfactant formulations and methods for promoting mucus clearance

A method for improvement of tolerance for therapeutically effective agents delivered by inhalation comprising a pretreatment of a patient with a nebulized lidocaine or a lidocaine-like compound administered immediately or up to about thirty minutes before administration of the primary therapeutically effective agent. The pretreatment of the patient with the nebulized lidocaine or a lidocaine-like compound improves airway tolerance and deposition of the agent in the lungs and makes such deposition more safe, efficacious, controllable and predictable. The method of the invention is especially useful for enhancement of deposition of immunosuppressive agents in the lung(s) of transplant patients, improved tolerance of the drugs by reducing cough, and improving pulmonary drug deposition.

Method for improvement of tolerance for therapeutically effective agents delivered by inhalation

An anti-tussive nebulized solution for targeted delivery of lidocaine into conducting and central airways. A method for treatment of cough and tussive attacks or episodes using said lidocaine solution. A nebulized lidocaine solution administered in daily dose from about 10 mg to 80 mg of lidocaine dissolved in a saline and nebulized into an aerosol having a mass median aerodynamic diameter 3 &#x3bc;m to 10 &#x3bc;m and a geometric standard deviation less than 1.7 using an electronic nebulizer.

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Doylestown, PA, United States of America

Thomas Hofmann