Inhale Therapeutic Systems, Inc.

Nektar Therapeutics

Scios Nova, Inc.

Naktar Therapeutics

Inhale Therapeutics Systems, Inc.

Linda C Foster

Robert M Platz

John S Patton

Mohammed Eljamal

Mei-chang Kuo

Mohammad Eljamal

Yu-ichiro Satoh

Shigenobu Kimura

Shelia R Billingsley

David Lechuga-Ballesteros

Kirsten M Cabot

David B Bennett

Stewart A Thompson

S Joseph Tarnowski

Trixie K Tan

Sheila R Billingsley

A powdered, dispersible composition having stable dispersibility over time is provided. The composition exhibits a characteristic glass transition temperature (T ) and a recommended storage temperature (T ), wherein the difference between T and T is at least about 10&deg; C. (i.e. T &minus;T is greater than 10&deg; C.). The composition comprises a mixture of a pharmaceutically-acceptable glassy matrix and at least one pharmacologically active material within the glassy matrix. It may be further mixed with a powdered, pharmaceutically-acceptable carrier. It is particularly valuable in unit dosage form having a moisture barrier, in combination with appropriate labelling instructions. A process for producing a powdered dispersible composition is also provided, wherein the process comprises removing the solvent from a solution comprising a solvent, a glass former and a pharmacologically active material under conditions sufficient to form a glassy matrix having the pharmacologically active material within the matrix.

Stable glassy state powder formulations

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

Powered pharmaceutical formulations having improved dispersibility

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 present invention, methods and compositions are provided for spray-dried, interferon-based dry powder compositions, particularly interferon-beta. The compositions are useful for treating conditions in humans that are responsive to treatment with interferons. In particular, the methods of the present invention rely on spray drying to produce stable, high-potency dry powder formulations of interferons, including but not limited to IFN-beta. Surprisingly, it has been found that IFN can be prepared in high potency, dry powder formulations by spray drying. Such dry powder formulations find particular utility in the pulmonary delivery of IFN.

Methods and compositions for the dry powder formulation of interferons

This invention relates to novel, liquid crystal forms of the cyclic peptide cyclosporin and to novel powder formulations of cyclosporin prepared using this novel liquid crystal form of the drug. Methods for preparing and using these formulations are also provided. In particular, the present invention relates to dispersible spray dried particles of cyclosporin suitable for pulmonary delivery.

Liquid crystal forms of cyclosporin

Powdered pharmaceutical formulations having improved dispersibility

A powdered, dispersible composition having stable dispersibility over time is provided. The composition exhibits a characteristic glass transition temperature (T,) and a recommended storage temperature (T,), wherein the difference between T,and T,is at least about 10&deg; C. (i.e. T,&minus;T,is greater than 10&deg; C.). The composition comprises a mixture of a pharmaceutically-acceptable glassy matrix and at least one pharmacologically active material within the glassy matrix. It may be further mixed with a powdered, pharmaceutically-acceptable carrier. It is particularly valuable in unit dosage form having a moisture barrier, in combination with appropriate labelling instructions. A process for producing a powdered dispersible composition is also provided, wherein the process comprises removing the solvent from a solution comprising a solvent, a glass former and a pharmacologically active material under conditions sufficient to form a glassy matrix having the pharmacologically active material within the matrix.

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

Dispersible antibody compositions and methods for their preparation and

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Mountain View, CA, United States of America

Linda C Foster