Inhale Therapeutic Systems, Inc.

Nektar Therapeutics

Novartis Ag

Amgen Inc.

Sri International

Novartis Pharma Ag

Other

Naktar Therapeutics

Robert M Platz

John S Patton

Linda C Foster

Mohammed Eljamal

Linda S Foster

Thomas K Brewer

Terence D Boardman

Yu-ichiro Satoh

Shigenobu Kimura

Mohammad Eljamal

Yigal Dov Blum

David B Bennett

Colin G Pitt

Richard M Laine

Adrian Edward Smith

John D Burr

George S Axford

David J Rowcliffe

Herman E Snyder

Daryl L Roberts

Shirley W Lyons

Herman Snyder

Allen L Dodge

Mark A Winters

Clyde L Whitham

Anna Ip

Terrence Boardman

Kenneth B Schwartz

Jonathan M McLeod

Jeffery W Etter

The present invention provides exemplary systems and methods for producing dry powder formulations. In one embodiment, a system () includes at least one conditioning zone () having an inlet () to introduce an atomized formulation () into the conditioning zone. A controller () controls temperature and relative humidity of the airflow into the conditioning zone to allow amorphous-to-crystalline transformation of the atomized formulation. In another embodiment, the formulation is suspended in the conditioning zone for a residence time of sufficient duration to allow surface orientation of surface active components. A dryer () is coupled to the conditioning zone to dry the atomized formulation, and a collector () collects the formulation in powder form.

Spray drying process control of drying kinetics

A process for preparing ultrafine powders of biological macromolecules comprises atomizing liquid solutions of the macromolecules, drying the droplets formed in the atomization step, and collecting the particles which result from drying. By properly controlling each of the atomization, drying, and collection steps, ultrafine dry powder compositions having characteristics particularly suitable for pulmonary delivery for therapeutic and other purposes may be prepared.

Dispersible macromolecule compositions and methods for their preparation and use

Systemic delivery of insulin to a mammalian host is accomplished by inhalation of a dry powder of insulin. It has been found that dry insulin powders are rapidly absorbed through the alveolar regions of the lungs.

Methods and compositions for pulmonary delivery of insulin

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

Methods and compositions for the pulmonary delivery insulin

A device for accurately delivering aerosolized doses of a medicament disperses a measured amount of drug in a measured volume of carrier gas and transfers the resulting aerosol to a chamber prior to inhalation by a patient. The chamber is filled efficiently with the aerosol, and inhalation by the patient draws the aerosol dose into the lungs. This is followed by the inhalation of atmospheric air that will push the initial dose well into the lung interiors. The apparatus optimally includes a dose regulator, a counter, a clock, a dose memory and a signal to indicate when a dose is ready for inhalation. Optimal chamber designs are disclosed.

Method and device for delivering 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 &mgr;m MMAD. Such compositions are of pharmaceutical grade purity.

Compositions and methods for the pulmonary delivery of aerosolized medicaments

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

Powered pharmaceutical formulations having improved dispersibility

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

Growing community of inventors

Half Moon Bay, CA, United States of America

Robert M Platz