Virginia Commonwealth University

Center for Innovative Technology

Chrysalis Technologies Incorporated

Philip Morris USA Inc.

Dura Pharmaceuticals, Inc.

Philip Morris Products S.a.

Peter R Byron

Michael Hindle

Richard N Dalby

Billy R Martin

Frank E Blondino

Joanne Peart

Aron H Lichtman

Malcolm Hill

Rajiv Gupta

John N Hong

An aerosol is formed by supplying a material in liquid form to a flow passage and heating the flow passage such that the material volatizes and expands out of an open end of the flow passage. The volatized material combines with ambient air such that volatized material condenses to form the aerosol. An apparatus and method for generating such an aerosol are disclosed wherein the apparatus may include an electrically conductive sleeve at an open end of the flow passage, an electrically conductive flow passage and/or a spacer chamber. The volatilized material may contain a volatilized solute and vehicle such that the resulting aerosol particle sizes of the solute and the vehicle are either different or the same.

Method and apparatus for generating an aerosol

A method is provided for generating an aerosol. The method includes preparing a solution formed of a first component in a liquid component such that after volatilization of the liquid component by passing the solution through a flow passage while heating the solution, an aerosol is formed having a predetermined particle size distribution of the first component, wherein the solution is prepared such that the amount of the first component therein is sufficient to achieve the predetermined particle size distribution of the first component. The method also includes passing the solution through the flow passage while heating the solution to a temperature sufficient to volatilize the liquid component, wherein the flow passage comprises an outlet through which the first component and the volatilized liquid component flow, and wherein an aerosol is formed.

Method for generating an aerosol with a predetermined and/or substantially monodispersed particle size distribution

The present invention provides therapeutic formulations for solutions of &Dgr; -tetrahydrocannabinol (&Dgr; THC) to be delivered by metered dose inhalers. The formulations, which use, non-CFC propellants, provide a stable aerosol-deliverable source of &Dgr; THC for the treatment of various medical conditions, such as: nausea and vomiting associated with chemotherapy-muscle spasticity; pain; anorexia associated with AIDS wasting syndrome, epilepsy; glaucoma; bronchial asthma; and mood disorders.

&Dgr;9 tetrahydrocannabinol (&Dgr;9 THC) solution metered dose inhalers and methods of use

An aerosol generator includes a housing, a heater and a mouthpiece wherein the heater volatilizes liquid material within a flow passage and forms an aerosol in the mouthpiece. Mixing ambient air with the vaporized liquid material controls a droplet size of the aerosol. The ambient air can be directed into the mouthpiece by at least one air passageway in an airflow entrainment control member. The at least one air passageway provides a desired volume and/or velocity of ambient air entering into the mouthpiece thereby achieving a desired droplet size distribution of an aerosol. In an alternative arrangement, a funnel shaped airflow entrainment control member includes a narrow end proximate the outlet end of the flow passage. A cone angle of the funnel-shaped member can be selected to provide a desired volume of ambient air which mixes with the vaporized liquid material and achieves a desired aerosol droplet size distribution.

Mouthpiece entrainment airflow control for aerosol generators

The present invention provides therapeutic formulations for solutions of &Dgr; -tetrahydrocannabinol (&Dgr; THC) to be delivered by metered dose inhalers. The formulations, which utilize non-CFC propellants, provide a stable aerosol-deliverable source of &Dgr; THC for the treatment of various medical conditions, such as: nausea and vomiting associated with chemotherapy; muscle spasticity; pain; anorexia associated with AIDS wasting syndrome; epilepsy; glaucoma; bronchial asthma; and mood disorders.

&Dgr;9 Tetrahydrocannabinol (&Dgr;9 THC) solution metered dose inhaler

In a method for treating lung diseases, a drug formulation is prepared by combining micronized crystalline beclomethasone dipropionate and lactose. The drug formulation is placed into a dry powder inhaler which provides inhalable drug particles having a mass median diameter of about 0.5-5.8 microns. The inhaler is preferably largely flow rate independent. Drug and lactose particles are separated in the inhaler during inhalation, most desirably via a spinning element. Due to deep deposition, the drug particles persist in the lungs for a surprisingly long duration, increasing the therapeutic effect of each dose. The patient inhales the drug particles with an inspiratory flow rate of about 10-60 liters/minute, to produce a deep lung deposition of inhaled particles.

Pulmonary delivery of pharmaceuticals

1,1,1,2,3,3,3-heptafluoropropane (HFC-227) has been identified as a highly polar propellant. Surfactants which have an elevated value (9.6 or greater) for their hydrophilic-lipophilic balance (HLB) can be used as suspending, wetting, and lubricating agents or cosolvents in metered dose inhaler (MDI) formulations pressurized with HFC-227 or propellant blends that contain HFC-227. Particularly preferred surfactants include polyoxyethylene sorbitan monolaurate, polyoxyethylene sorbitan mono-oleate, polyethylene glycol 300, propoxylated polyethylene glycol, polyoxyethylene 4 lauryl ether, and diethylene glycol monoethyl ether.

Pharmaceutically acceptable agents for solubilizing, wetting,

Metered dose inhaler (MDI) formulations which utilize 1,1,1,2-tetrafluoroethane (HFC 134a) as the sole propellant are made practical by including a polar surfactant such as polyethylene glycol, diethylene glycol monoethyl ether, polyoxyethylene (20) sorbitan monolaurate, polyoxyethylene (20) sorbitan monooleate, propoxylated polyethylene glycol, and polyoxyethylene (4) lauryl ether for suspending, solubilizing, wetting and emulsifying the drug constituent and lubricating the valve components of the MDI.

Metered dose inhaler fomulations which include the ozone-friendly

Beclomethasone diproprionate (BDP) forms a clathrate with HCFC-123, dimethyl ether (DME) and HCFC-141b which are less harmful propellants than the CFC propellants currently used in metered dose inhalers (MDIs). The clathrate can be remicronized and suspended for use in an MDI. BDP also is completely dissolved by DME based propellant blends and certain HCFC 123 propellant blends. Using propellant blends which completely dissolve BDP will assure more efficient dosing with an MDI.

Formulations for delivery of beclomethasone diproprionate by metered

Aerosol formulations for use in metered dose inhalers are disclosed which include 1,1,1,2-tetrafluoroethane alone and in combination with other compounds as well as various hydrocarbon blends. The density, vapor pressure, flame extension characteristics, dispersability of medicant, dissolvability of surfactant, respirable fraction, and compatibility elastomer seals for the aerosol formulations have been examined. The aerosol formulations are attractive alternatives to chlorofluorocarbon based aerosols since they do not deplete the ozone layer.

Growing community of inventors

Richmond, VA, United States of America

Peter R Byron