Igor D Gonda, 76120 E 81St St APT 16F, New York, NY 10028

6349719, Feb 26, 2002

Feb 26, 2001

09/795025

Igor Gonda - San Francisco CA

Aradigm Corporation - Hayward CA

A61M 1100

12820014, 12820423

Aerosolizable formulations are disclosed comprised of a pharmaceutically acceptable carrier, a pharmaceutically active drug or detectably labeled compound and a compound which is recognized by its distinct color, taste and/or smell even when present in a small amount and a low concentration. Examples of such compounds include menthol, peppermint, cinnamon and vanilla flavors and water soluble dyes. The compounds can be designed so that they are only detectable by a specific area of the tongue or seen under a certain wavelength of light. The degree of detection of the color, taste or smell of the compound is an indication of the degree of success in the delivery of an aerosolized formulation to a patient. The formulation is preferably delivered from a device which monitors and records information relating to the patients respiratory movement and also scans and analyzes the aerosol prior to inhalation. The device sends the user a visual and/or audible signal which informs the user about the character of the aerosol formed.

6383788, May 7, 2002

Dec 3, 1996

08/696955

Hak-Kim Chan - North Sydney, AU
Igor Gonda - San Francisco CA
Steven J. Shire - Belmont CA
Suzanne Sin-Mui Lo Weck - Mountain View CA

Genentech, Inc. - South San Francisco CA

C12N 996

435188, 435196

The present invention relates to the use of calcium ion and/or sugars to minimize thermal aggregation of DNase and to the use of calcium ion to stabilize liquid solutions of DNase, the solutions having a pH of less than neutral. DNase is the active pharmaceutical principle and the solutions may contain other pharmaceutically acceptable excipients making them suitable for pharmaceutical administration. In the first instance, calcium ion/sugar minimizes the effects of thermal aggregation in the solution. In the second aspect, calcium ion stabilizes the lower pH solutions from protein precipitation.

6408854, Jun 25, 2002

Apr 21, 2000

09/553693

Igor Gonda - San Francisco CA
Reid M. Rubsamen - Oakland CA

Aradigm Corporation - Hayward CA

A61B 1900

128898, 12820014

The need for the delivery of insulin by injection can be reduced or eliminated by a method whereby an aerosolized insulin formulation is delivered to a patients lungs and the rate at which the insulin is absorbed into the blood is increased by the use of an inhale-exhale breathing maneuver. Particles of insulin delivered to the surface of lung tissue will be absorbed into the circulatory system. The rate of absorption is enhanced by instructing the patient to inhale maximally and thereafter exhale maximally. This maneuver causes a spike in the rate at which insulin enters the circulatory system thereby increasing the rate at which glucose is removed from the circulatory system. The insulinmay be a dry powder but is preferably in a liquid formulation delivered to the patient from a hand-held, self-contained device which automatically releases an aerosolized burst of formulation. The device includes a sensor which is preferably electronic which measures inspiratory flow and volume which measurement can be used to control the point of drug release. The sensor can also assist the patient in the inhale-exhale maneuver.

6427681, Aug 6, 2002

Jun 21, 2001

09/888094

Igor Gonda - San Francisco CA
Reid M. Rubsamen - Oakland CA
Stephen J. Farr - Orinda CA

Aradigm Corporation - Hayward CA

A61M 1100

12820014, 12820022, 12820423

The need for the delivery of insulin by injection can be reduced or eliminated by delivering an aerosolized monomeric insulin formulation. Repeatability of dosing and more particularly the repeatability of the blood concentration versus time profile is improved relative to regular insulin. The blood concentration versus time profile is substantially unaffected by specific aspects of the patients breathing maneuver at delivery. Further, the rate at which blood glucose is lowered is increased by the use of monomeric insulin. Particles of insulin and in particular monomeric insulin delivered to the surface of lung tissue will be absorbed into the circulatory system. The monomeric insulin may be a dry powder but is preferably in a liquid formulation delivered to the patient from a hand-held, self-contained device which automatically releases an aerosolized burst of formulation. The device includes a sensor which is preferably electronic which measures inspiratory flow and volume which measurement can be used to control the point of drug release.

6431166, Aug 13, 2002

Feb 15, 2001

09/784861

Igor Gonda - San Francisco CA
Reid M Rubsamen - Oakland CA
Stephen J. Farr - Orinda CA

Aradigm Corporation - Hayward CA

A61M 1100

12820014, 12820022, 12820423

The need for the delivery of insulin by injection can be reduced or eliminated by delivering an aerosolized monomeric insulin formulation. Repeatability of dosing and more particularly the repeatability of the blood concentration versus time profile is improved relative to regular insulin. The blood concentration versus time profile is substantially unaffected by specific aspects of the patients breathing maneuver at delivery. Further, the rate at which blood glucose is lowered is increased by the use of monomeric insulin. Particles of insulin and in particular monomeric insulin delivered to the surface of lung tissue will be absorbed into the circulatory system. The monomeric insulin may be a dry powder but is preferably in a liquid formulation delivered to the patient from a hand-held, self-contained device which automatically releases an aerosolized burst of formulation. The device includes a sensor which is preferably electronic which measures inspiratory flow and volume which measurement can be used to control the point of drug release.

6431167, Aug 13, 2002

Oct 9, 2001

09/975085

Igor Gonda - San Francisco CA
Reid M. Rubsamen - Oakland CA
Stephen J. Farr - Orinda CA

Aradigm Corporation - Hayward CA

A61M 1100

12820014, 12820022, 12820423

The need for the delivery of insulin by injection can be reduced or eliminated by delivering an aerosolized monomeric insulin formulation. Repeatability of dosing and more particularly the repeatability of the blood concentration versus time profile is improved relative to regular insulin. The blood concentration versus time profile is substantially unaffected by specific aspects of the patients breathing maneuver at delivery. Further, the rate at which blood glucose is lowered is increased by the use of monomeric insulin. Particles of insulin and in particular monomeric insulin delivered to the surface of lung tissue will be absorbed into the circulatory system. The monomeric insulin may be a dry powder but is preferably in a liquid formulation delivered to the patient from a hand-held, self-contained device which automatically releases an aerosolized burst of formulation. The device includes a sensor which is preferably electronic which measures inspiratory flow and volume which measurement can be used to control the point of drug release.

6543442, Apr 8, 2003

Mar 2, 2001

09/798083

Igor Gonda - San Francisco CA
Jeffrey A. Schuster - Berkeley CA
Rajesh S. Patel - Fremont CA

Aradigm Corporation - Hayward CA

A61M 1100

12820014, 12820312

A nozzle comprised of a thin, flexible membrane material having a plurality of pores is disclosed. In one embodiment, the pores have an unflexed exit aperture diameter in the range of about 0. 5 to about 2 microns (preferably about 1 micron) and are positioned substantially uniformly in the material, preferably about 50 microns apart. The nozzle preferably has a conical or trumpet-shaped cross-section. In another aspect of the invention, the exit aperture of the nozzle is surrounded by an elevated area protruding above the substantially planar exit side of the membrane in order to prevent intrusion of liquid back into the nozzle. The nozzle can be used to form an aerosol containing a pharmaceutical composition from the exit side of the nozzle upon forcible application of the composition to the entrance side of the nozzle. This aerosol can be used to administer the pharmaceutical composition, for example, to the eye or to a selected portion of the respiratory tract. The nozzle is preferably a component of a container which holds a formulation of drug.

6551542, Apr 22, 2003

Nov 8, 2000

09/710612

Rajesh S. Patel - Fremont CA
Sudarsan Srinivasan - Fremont CA
Russell M. Pon - Danville CA
Jeffrey A. Schuster - Berkeley CA
Igor Gonda - San Francisco CA

Aradigm Corporation - Hayward CA

B23K 2600

264400, 21912167, 21912171, 21912172, 12820022, 12820023, 12820024

A method for producing a nozzle useful in generating a fine aerosol for delivery of therapeutic or diagnostic agents is provided. The method comprises focusing a laser source onto a thin, preferably flexible material so as to form pores substantially through the material. The pores are formed to have an unflexed exit aperture diameter in the range of about 0. 5 to about 25 microns, depending on the size of the aerosol particles desired for a particular application. The nozzle may have a variety of shapes and be distributed in a variety of patterns. An elevated area can be formed around the exit aperture of the nozzle in order to prevent intrusion of liquid into the nozzle.