Patents Represented by Attorney Susan T. Evans
  • Patent number: 6673335
    Abstract: 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.
    Type: Grant
    Filed: July 14, 2000
    Date of Patent: January 6, 2004
    Assignee: Nektar Therapeutics
    Inventors: Robert M. Platz, John S. Patton, Linda Foster, Mohammed Eljamal
  • Patent number: 6630169
    Abstract: Compositions and methods are provided for the administration of particulates comprising at least one bioactive agent which, in selected embodiments, may comprise and immunoactive agent. In this respect, the invention provides for both topical and systemic delivery of the bioactive agent using, for example, the respiratory, gastrointestinal or urogenital tracts. The particulates may be in the form of dry powders or combined with a non-aqueous suspension medium to provide stabilized dispersions. In preferred embodiments, the disclosed compositions will be used in conjunction with inhalation devices such as metered dose inhalers, dry powder inhalers, atomizers or nebulizers for targeted delivery of the agent to mucosal surfaces.
    Type: Grant
    Filed: December 22, 2000
    Date of Patent: October 7, 2003
    Assignee: Nektar Therapeutics
    Inventors: Adrian I. Bot, Thomas E. Tarara, Jeffry G. Weers, Alexev Kabalnov, Ernest G. Schutt, Luis A. Dellamary
  • Patent number: 6589560
    Abstract: A powdered, dispersible composition having stable dispersibility over time is provided. The composition exhibits a characteristic glass transition temperature (Tg) and a recommended storage temperature (Ts), wherein the difference between Tg and Ts is at least about 10° C. (i.e. Tg−Ts is greater than 10° 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.
    Type: Grant
    Filed: June 11, 2001
    Date of Patent: July 8, 2003
    Assignee: Nektar Therapeutics
    Inventors: Linda C. Foster, Mei-chang Kuo, Shelia R. Billingsley
  • Patent number: 6582729
    Abstract: Dispersibility of a respirable powder, administrable by inhalation, is increased by including a pharmaceutically acceptable water-soluble polypeptide.
    Type: Grant
    Filed: August 15, 2000
    Date of Patent: June 24, 2003
    Assignee: Naktar Therapeutics
    Inventors: Mohammad Eljamal, John S. Patton, Linda C. Foster, Robert M. Platz
  • Patent number: 6582728
    Abstract: 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.
    Type: Grant
    Filed: April 14, 1995
    Date of Patent: June 24, 2003
    Assignee: Inhale Therapeutic Systems, Inc.
    Inventors: Robert M. Platz, John S. Patton, Linda Foster, Mohammed Eljamal
  • Patent number: 6569406
    Abstract: The present invention provides highly dispersible spray-dried powder compositions, and in particular, inhaleable dry powder compositions for aerosolized delivery to the lungs. The powders of the invention are produced by spray drying a 4 &agr;-helix bundle protein under conditions which both (i) protect the protein from aggregation and (ii) provide particles suitable for inhalation (i.e., demonstrating superior aerosol performance).
    Type: Grant
    Filed: August 7, 2001
    Date of Patent: May 27, 2003
    Assignee: Nektar Therapeutics
    Inventors: Cynthia Stevenson, Jayne E. Hastedt, S. Russ Lehrman, Hi-Shi Chiang, David B. Bennett, David Lesikar, Bing Yang, David Gong, Kirsten Cabot
  • Patent number: 6518239
    Abstract: The present invention provides a highly dispersible formulation comprising an active agent and a dipeptide or tripeptide comprising at least two leucyl residues. The composition of the invention possesses superior aerosol properties and is thus preferred for aerosolized administration to the lung. Also provided are a method for (i) increasing the dispersibility of an active-agent containing formulation for administration to the lung, and (ii) delivery of the composition to the lungs of a subject.
    Type: Grant
    Filed: April 13, 2000
    Date of Patent: February 11, 2003
    Assignee: Inhale Therapeutic Systems, Inc.
    Inventors: Mei-Chang Kuo, David Lechuga-Ballesteros
  • Patent number: 6503411
    Abstract: In a composition which has an amorphous, undercooled, glassy phase containing a water-soluble or water-swellable substance in an amorphous form, a sugar, which is capable of existing as a crystalline hydrate, is used as an agent to dehydrate the amorphous phase by crystallisation therefrom, and thereby enhance the glass transition temperature of the residual amorphous phase.
    Type: Grant
    Filed: May 22, 2000
    Date of Patent: January 7, 2003
    Assignee: Inhale Therapeutic Systems, Inc.
    Inventors: Felix Franks, Barry John Aldous, Anthony Auffret
  • Patent number: 6479049
    Abstract: 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.
    Type: Grant
    Filed: February 17, 2000
    Date of Patent: November 12, 2002
    Assignee: Inhale Therapeutic Systems, Inc.
    Inventors: Robert M. Platz, Shigenobu Kimura, Yu-ichiro Satoh, Linda C. Foster
  • Patent number: 6426210
    Abstract: Materials which are not themselves storage-stable at room temperature are made suitable for storage by mixing them with a carrier substance and spray drying the resulting mixture so as to form particles containing both the material and the carrier substance in which the carrier substance is in an amorphous, i.e. glassy or rubbery, state. Formation of such a composition greatly enhances stability. The material stored may be a biological material such as an enzyme, the components of a chemical reaction such as reagents for carrying out an assay, or even viable biological cells.
    Type: Grant
    Filed: May 24, 1999
    Date of Patent: July 30, 2002
    Assignee: Inhale Therapeutic Systems, Inc.
    Inventors: Felix Franks, Ross Henry Hatley, Sheila Frances Mathias
  • Patent number: 6413547
    Abstract: 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.
    Type: Grant
    Filed: February 11, 1999
    Date of Patent: July 2, 2002
    Assignee: Inhale Therapeutic Systems, Inc.
    Inventors: David B. Bennett, Kirsten M. Cabot, Linda C. Foster, David Lechuga-Ballesteros, John S. Patton, Trixie K. Tan
  • Patent number: 6372258
    Abstract: 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.
    Type: Grant
    Filed: November 22, 1999
    Date of Patent: April 16, 2002
    Assignee: Inhale Therapeutic Systems
    Inventors: Robert M. Platz, John S. Patton, Linda Foster, Mohammed Eljamal
  • Patent number: 6358530
    Abstract: Dispersibility of a respirable powder, administrable by inhalation, is increased by including a pharmaceutically acceptable water-soluble polypeptide.
    Type: Grant
    Filed: September 25, 2000
    Date of Patent: March 19, 2002
    Assignee: Inhale Therapeutic Systems, Inc.
    Inventors: Mohammad Eljamal, John S. Patton, Linda Foster, Robert M. Platz
  • Patent number: 6309671
    Abstract: A powdered, dispersible composition having stable dispersibility over time is provided. The composition exhibits a characteristic glass transition temperature (Tg) and a recommended storage temperature (Ts), wherein the difference between Tg and Ts is at least about 10° C. (i.e. Tg−Ts is greater than 10° 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.
    Type: Grant
    Filed: October 14, 1997
    Date of Patent: October 30, 2001
    Assignee: Inhale Therapeutic Systems
    Inventors: Linda C. Foster, Mei-chang Kuo, Shelia R. Billingsley
  • Patent number: 6303582
    Abstract: 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.
    Type: Grant
    Filed: October 26, 1999
    Date of Patent: October 16, 2001
    Assignee: Inhale Therapeutic Systems, Inc.
    Inventors: Mohammed Eljamal, John S. Patton, Linda Foster, Robert M. Platz
  • Patent number: 6258341
    Abstract: A powdered, dispersible composition having stable dispersibility over time is provided. The composition exhibits a characteristic glass transition temperature (Tg) and a recommended storage temperature (Ts), wherein the difference between Tg and Ts is at least about 10° C. (i.e. Tg−Ts is greater than 10° 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 from having a moisture barrier, in combination with appropriate labelling instructions.
    Type: Grant
    Filed: October 17, 1996
    Date of Patent: July 10, 2001
    Assignee: Inhale Therapeutic Systems, Inc.
    Inventors: Linda C. Foster, Mei-chang Kuo, Sheila R. Billingsley
  • Patent number: 6231851
    Abstract: 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.
    Type: Grant
    Filed: July 14, 1997
    Date of Patent: May 15, 2001
    Assignee: Inhale Therapeutic Systems
    Inventors: Robert M. Platz, Shigenobu Kimura, Yu-ichiro Satoh, Linda C. Foster
  • Patent number: 6214548
    Abstract: Nucleic acid-based methods for the detection of Cyclospora are disclosed, including PCR-based and hybridization-based techniques.
    Type: Grant
    Filed: January 29, 1998
    Date of Patent: April 10, 2001
    Assignees: The United States of America as represented by the Secretary of the Army, Board of Trustees of Leland Stanford Jr. Univ.
    Inventors: David A. Relman, Peter Echeverria
  • Patent number: 6207135
    Abstract: The invention relates to gaseous microparticles for ultrasonic diagnosis, whose wall material is built up from block copolymers of polyesters of &agr;-, &bgr;- or &ggr;-hydroxycarboxylic acids with linear or star-shaped polyethylene glycols and optionally liquid crystals or whose wall material is built up from polyesters of &agr;-, &bgr;- or &ggr;-hydroxycarboxylic acids and liquid crystals, media that contain these particles for ultrasonic diagnosis, as well as a process for the production of the media and particles.
    Type: Grant
    Filed: March 30, 1999
    Date of Patent: March 27, 2001
    Assignee: Inhale Therapeutic Systems, Inc.
    Inventors: Georg Rössling, Celal Albayrak, Matthias Rothe
  • Patent number: RE37872
    Abstract: A material or mixture of materials which is not itself storage stable is rendered storage stable by incorporation into a water-soluble or swellable glassy or rubbery composition which can then be stored at ambient temperature. Recovery is by adding aqueous solution to the composition.
    Type: Grant
    Filed: March 17, 1999
    Date of Patent: October 8, 2002
    Assignee: Inhale Therapeutics Systems, Inc.
    Inventors: Felix Franks, Ross H. M. Hatley