Inhale Therapeutic Systems, Inc.

Nektar Therapeutics

Mohammed Eljamal

John S Patton

Robert M Platz

Linda S Foster

Linda C Foster

According to the subject invention, dispersible dry powder pharmaceutical-based compositions are provided, including methods for their manufacture and dry powder dispersion devices. A dispersible dry powder pharmaceutical-based composition is one having a moisture content of less than about 10% by weight (% w) water, usually below about 5% w and preferably less than about 3% w; a particle size of about 1.0-5.0 &#x3bc;m mass median diameter (MMD), usually 1.0-4.0 &#x3bc;m MMD, and preferably 1.0-3.0 &#x3bc;m MMD; a delivered dose of about &#x3e;30%, usually &#x3e;40%, preferably &#x3e;50%, and most preferred &#x3e;60%; and an aerosol particle size distribution of about 1.0-5.0 &#x3bc;m mass median aerodynamic diameter (MMAD), usually 1.5-4.5 &#x3bc;m MMAD, and preferably 1.5-4.0 MMAD. Such composition are of pharmaceutical grade purity.

Devices, compositions and methods for the pulmonary delivery of aerosolized medicaments

According to the subject invention, dispersible dry powder pharmaceutical-based compositions are provided, including methods for their manufacture and dry powder dispersion devices. A dispersible dry powder pharmaceutical-based composition is one having a moisture content of less than about 10% by weight (% w) water, usually below about 5% w and preferably less than about 3% w; a particle size of about 1.0-5.0 &#x3bc;m mass median diameter (MMD), usually 1.0-4.0 &#x3bc;m MMD, and preferably 1.0-3.0 &#x3bc;m MMD; a delivered dose of about &#x3e;30%, usually &#x3e;40%, preferably &#x3e;50%, and most preferred &#x3e;60%; and an aerosol particle size distribution of about 1.0-5.0 &#x3bc;m mass median aerodynamic diameter (MMAD), usually 1.5-4.5 &#x3bc;m MMAD, and preferably 1.5-4.0 &#x3bc;m MMAD. Such compositions are of pharmaceutical grade purity.

Composition for pulmonary administration comprising a drug and a hydrophobic amino acid

According to the subject invention, dispersible dry powder pharmaceutical-based compositions are provided, including methods for their manufacture and dry powder dispersion devices. A dispersible dry powder pharmaceutical-based composition is one having a moisture content of less than about 10% by weight (% w) water, usually below about 5% w and preferably less than about 3% w; a particle size of about 1.0-5.0 &mgr;m mass median diameter (MMD), usually 1.0-4.0 &mgr;m MMD, and preferably 1.0-3.0 &mgr;m MMD; a delivered dose of about >30%, usually >40%, preferably >50%, and most preferred >60%; and an aerosol particle size distribution of about 1.0-5.0 &mgr;m mass median aerodynamic diameter (MMAD), usually 1.5-4.5 &mgr;m MMAD, and preferably 1.5-4.0 &mgr;m MMAD. Such compositions are of pharmaceutical grade purity.

Compositions and methods for the pulmonary delivery of aerosolized macromolecules

According to the subject invention, dispersible dry powder pharmaceutical-based compositions are provided, including methods for their manufacture and dry powder dispersion devices. A dispersible dry powder pharmaceutical-based composition is one having a moisture content of less than about 10% by weight (%w) water, usually below about 5%w and preferably less than about 3%w; a particle size of about 1.0-5.0 &mgr;m mass median diameter (MMD), usually 1.0-4.0 &mgr;m MMD, and preferably 1.0-3.0 &mgr;m MMD; a delivered dose of about >30%, usually >40%, preferably >50%, and most preferred >60%; and an aerosol particle size distribution of about 1.0-5.0 &mgr;m mass median aerodynamic diameter (MMAD), usually 1.5-4.5 &mgr;m MMAD, and preferably 1.5-4.0 &mgr;m MMAD. Such compositions are of pharmaceutical grade purity.

Compositions and methods for the pulmonary delivery of aerosolized medicaments

According to the subject invention, dispersible dry powder pharmaceutical-based compositions are provided, including methods for their manufacture and dry powder dispersion devices. A dispersible dry powder pharmaceutical-based composition is one having a moisture content of less than about 10% by weight (%w) water, usually below about 5%w and preferably less than about 3%w; a particle size of about 1.0-5.0 &mgr;m mass median diameter (MMD), usually 1.0-4.0 &mgr;m MMD, and preferably 1.0-3.0 &mgr;m MMD; a delivered dose of about >30%, usually >40%, preferably >50%, and most preferred >60%; and an aerosol particle size distribution of about 1.0-5.0 &mgr;m mass median aerodynamic diameter (MMAD), usually 1.5-4.5 &mgr;m MMAD, and preferably 1.5-4.0 MMAD. Such composition are of pharmaceutical grade purity.

Spray drying of macromolecules to produce inhaleable dry powders

This invention relates to dispersible antibody compositions and methods for preparing and using these compositions. In particular, the present invention relates to dry powder dispersible antibody compositions wherein antibody conformation is preserved. The compositions have good powder dispersibility and other desirable characteristics for pulmonary delivery of therapeutic antibodies.

Dispersible antibody compositions and methods for their preparation and use

According to the subject invention, dispersible dry powder pharmaceutical-based compositions are provided, including methods for their manufacture and dry powder dispersion devices. A dispersible dry powder pharmaceutical-based composition is one having a moisture content of less than about 10% by weight (% w) water, usually below about 5% w and preferably less than about 3% w; a particle size of about 1.0-5.0 &mgr;m mass median diameter (MMD), usually 1.0-4.0 &mgr;m MMD, and preferably 1.0-3.0 &mgr;m MMD; a delivered dose of about >30%, usually >40%, preferably >50%, and most preferred >60%; and an aerosol particle size distribution of about 1.0-5.0 &mgr;m mass median aerodynamic diameter (MMAD), usually 1.5-4.5 &mgr;m MMAD, and preferably 1.5-4.0 MMAD. Such composition are of pharmaceutical grade purity.

Devices compositions and methods for the pulmonary delivery of aerosolized medicaments

Methods of spray-drying a drug and a hydrophobic amino acid

A dry powder composition comprises nucleic acid constructs dispersed within with a hydrophilic excipient material, where the powder particles have an average size in the range from 0.5 &mgr;m to 50 &mgr;m. Nucleic acid constructs may comprise bare nucleic acid molecules, viral vectors, or vesicle structures. The hydrophilic excipient material will be selected to stabilize the nucleic acid molecules in the constructs, enhance dispersion of the nucleic acid in dry powder aerosols, and enhance wetting of the nucleic acid constructs as they are delivered to moist target locations within the body.

Compositions and methods for nucleic acid delivery to the lung

Dispersibility of a respirable powder, administrable by inhalation, is increased by including a pharmaceutically acceptable water-soluble polypeptide.

Powdered pharmaceutical formulations having improved dispersibility

Dispersible antibody compositions and methods for their preparation and

A dry powder composition comprises insoluble nucleic acid constructs dispersed within with a hydrophilic excipient material, where the powder particles have an average size in the range from 0.5 .mu.m to 50 .mu.m. Nucleic acid constructs may comprise bare nucleic acid molecules, viral vectors, or vesicle structures. The hydrophilic excipient material will be selected to stabilize the nucleic acid molecules in the constructs, enhance dispersion of the nucleic acid in dry powder aerosols, and enhance wetting of the nucleic acid constructs as they are delivered to moist target locations within the body.

Dry powders of .alpha.1-antitrypsin are administered pulmonarily to patients to treat, for example, certain types of emphysema. The dry powder compositions may comprise aggregates of fine particles, which aggregates are friable and break-up upon dispersion in a flowing gas stream. Typically, the dispersed powders are captured in a chamber and subsequently inhaled by a patient for pulmonary treatment of emphysema and other conditions.

Method and apparatus for pulmonary administration of dry powder

Methods are provided for administering .alpha.1-antitrypsin dry powder pulmonarily to a patient. In these methods, .alpha.1-antitrypsin is provided in a dry powder form which is aerosolized and administered to the patient. Apparatus are also provided for carrying out these methods. These methods and apparatus are may generally be used in the treatment of patients suffering from .alpha.1-antitrypsin deficiency and the functional derangements of emphysema.

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San Jose, CA, United States of America

Mohammed Eljamal