Novartis Ag

Nektar Therapeutics

Alliance Pharmaceutical Corp.

Inhale Therapeutic Systems, Inc.

Other

Novartis Pharma Ag

Imcor Pharmaceutical Company

Thomas E Tarara

Jeffry G Weers

Luis A Dellamary

Ernest George Schutt

Alexey S Kabalnov

Jean G Riess

Leo A Trevino

David H Klein

Michael Steven Hartman

Danforth Miller

Michael A Eldon

Geraldine Venthoye

Helen M Ranney

Patrick Teung

John Douglas Lord

Carlos M Rodriguez

Daniel Huang

David Lechuga-Ballesteros

Sarvajna Kumar Dwivedi

Andrew Clark

Nagaraja P Rao

Marie-Pierre Krafft

Peter Bruce Challoner

Keith Washco

Sarma Duddu

Alan Kugler

Theresa D Sweeney

Srinivas Palakodaty

Trixie Tan

Richard Malcolmson

Adrian I Bot

Emil Samara

Jeffrey G Weers

Rangachari Narashimhan

Maria Geraldine Venthoye

Christopher Frantz

Jean Reiss

Alexev Kabalnov

Embodiments of the present invention provide a dry powder composition comprising porous carrier particles associated with one, two, three or more micronized drugs or APIs wherein an ordered mixture between the micronized drug or drugs and the carrier particle results, such that the micronized drug or drugs adhere strongly to the carrier particles forming a stable ordered mixture of respirable agglomerates. Embodiments of the present invention further comprise a spray-drying process to create the respirable agglomerates. Embodiments of the present invention further relate to the use of the dry powder formulation comprising respirable agglomerates for the treatment of a patient having a disease or condition which is treatable thereby.

Respirable agglomerates of porous carrier particles and micronized drug

A pulmonary delivery medicament comprises a plurality of particulates, the particulates comprising a structural matrix and a water insoluble and/or crystalline active agent. The particulates have a geometric diameter of 0.5 to 50 &#x3bc;m. The water insoluble active agent can be a fungicide, antibiotic, budesonide. A method of making the medicament comprises forming a liquid feedstock, and forming a feedstock suspension by suspending in the liquid feedstock, the active agent and an excipient capable of forming a structural matrix, such as a phospholipid. The feedstock suspension is spray dried to produce the particulates.

Pulmonary delivery particles comprising an active agent

Phospholipid based powders for drug delivery applications are disclosed. The powders comprise a polyvalent cation in an amount effective to increase the gel-to-liquid crystal transition temperature of the particle compared to particles without the polyvalent cation. The powders are hollow and porous and are preferably administered via inhalation.

Phospholipid-based powders for drug delivery

The present invention is directed to the administration of aminoglycosides. In particular, the present invention is directed to compositions and methods for the pulmonary administration of aminoglycosides. According to a preferred embodiment, compositions and methods are provided for the localized treatment of respiratory infections.

Pulmonary delivery of aminoglycoside

A composition for pulmonary administration comprises a fluoroquinolone betaine, such as ciprofloxacin betaine, and an excipient. In one version, the particles have a mass median aerodynamic diameter from about 1 &#x3bc;m to about 5 &#x3bc;m, and the fluoroquinolone has a half life in the lungs of at least 1.5 hours. The composition is useful in treating an endobronchial infection, such as, and is particularly useful in treating cystic fibrosis.

Pulmonary delivery of a fluoroquinolone

Dry powder formulations for inhalation comprising spray-dried particles and their use in the treatment of an obstructive or inflammatory airways disease. Each particle has a core of a first active ingredient in substantially crystalline form that is coated with a layer of a second active ingredient in substantially amorphous form that is dispersed in a pharmaceutically acceptable hydrophobic excipient. A process for preparing such formulations is also described.

Dry powder formulations of particles that contain two or more active ingredients for treating obstructive or inflammatory airways diseases

A microparticle for drug delivery comprises an active agent and an excipient, the excipient comprising a metal ion-lipid complex. The metal ion is chosen from the group consisting of lanthanide metals, actinide metals, group IIa and IIIb metals, transition metals or mixtures thereof. The lipid comprises a phospholipid. The complex results in a glass transition temperature increase of the microparticle.

Stable metal ion-lipid powdered pharmaceutical compositions for drug delivery

A dispersible powder composition comprises aminoglycoside for delivery to the lungs. The composition is effective to provide a therapeutically effective therapy via administration of less than 6 respirable unit doses by inhalation, wherein each unit dose comprises a volume of 0.30 to 0.95 mL.

Phospholipid based powders for drug delivery applications are disclosed. The powders may include a polyvalent cation in an amount effective to increase the gel-to-liquid crystal transition temperature of the particle compared to particles without the polyvalent cation. The powders are hollow and porous and are preferably administered via inhalation.

The present invention provides methods for the treatment of an endobronchial infection in a patient by administering to the endobronchial system of the patient a dry powder aerosol composition comprising from 90 to 130 mg of an aminoglycoside antibiotic one to three times a day for a first treatment period of 20 to 36 days.

Methods of treatment of endobronchial infections

Formulations are provided for pulmonary administration of an antifungal agent to a patient. Methods of using the formulations in the treatment of antifungal infections are also provided, including treatment of pulmonary aspergillosis with amphotericin B-containing formulations. Methods of manufacturing the formulations to achieve optimum properties are provided as well.

Formulation for pulmonary administration of antifungal agents, and associated methods of manufacture and use

Microparticle compositions comprising metal ion-lipid complexes for drug delivery are described including methods of making the microparticle compositions and methods of treating certain conditions and disease states by administering the microparticle compositions. The metal ion-lipid complexes can be combined with various drugs or active agents for therapeutic administration. The microparticle compositions of the present invention have superior stability to other microparticle compositions resulting in a microparticle composition with longer shelf life and improved dispersability. The microparticle compositions of the present invention have a transition temperature (T) of at least 20&#xb0; C. above the recommended storage temperature (Tst) for drug delivery.

Stable metal ion-lipid powdered pharmaceutical compositions for drug delivery and methods of use

A respiratory dispersion for pulmonary delivery comprises one or more bioactive agents, a suspension medium, and a plurality of perforated microstructures having a mean aerodynamic diameter of less than 5 &#x3bc;m. The suspension medium comprises at least one propellant and permeates the perforated microstructures.

Respiratory dispersion for metered dose inhalers comprising perforated microstructures

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Burlingame, CA, United States of America

Thomas E Tarara