Systems and methods for aerosolizing pharmaceutical formulations

Abstract

Systems and methods are provided for aerosolizing a pharmaceutical formulation. According to one method, respiratory gases are prevented from flowing to the lungs when attempting to inhale. Then, respiratory gases are abruptly permitted to flow to the lungs. The flow of respiratory gases may then be used to extract a pharmaceutical formulation from a receptacle and to place the pharmaceutical formulation within the flow of respiratory gases to form an aerosol.

Description

CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation in part application and claims the benefit of U.S. Provisional Patent Application Nos. 60 / 141,793, filed Jun. 30, 1999 and 60 / 198,060, filed Apr. 18, 2000, the complete disclosures of which are herein incorporated by reference.BACKGROUND OF THE INVENTION [0002] This invention relates generally to the field of drug delivery, and in particular to the delivery of pharmaceutical formulations to the lungs. More specifically, the invention relates to the aerosolization of pharmaceutical formulations using energy created by patient inhalation. [0003] Effective drug delivery to a patient is a critical aspect of any successful drug therapy, and a variety of drug delivery techniques have been proposed. For example, one convenient method is the oral delivery of pills, capsules, elixirs and the like. However, oral delivery can in some cases be undesirable in that many drugs are degraded in the digestive tract befo...

AI Technical Summary

Benefits of technology

[0008] The invention provides exemplary systems and methods to provide breath actuated, flow regulated aerosol delivery of pharmaceuticals. In one aspect, the invention utilizes the flow of respiratory gases produced by a patient to aerosolize a pharmaceutical formulation. In another particular aspect of the invention, the invention is able to extract a powdered pharmaceutical formulation from a receptacle, deagglomerate the formulation and deliver the formulation to the lungs using a wide range of patient inhalation flow rates. According to another aspect of the invention, devices and methods are provided which provide efficient delivery of a pharmaceutical aerosol to the deep lung.

[0009] According to the invention, the flow of respiratory gases may initially be prevented from flowing to the lungs until a predetermined vacuum is produced by the user, at which point the flow of respiratory gases is abruptly initiated. In one particular embodiment, the abrupt initiation of respiratory gas flow is utilized to aerosolize a pharmaceutical formulation. According to this embodiment, respiratory gases are initially prevented from flowing to the lungs when attempting to inhale through an open mouthpiece at one end of the device. The respiratory gases are then abruptly permitted to flow to the lungs after a predetermined vacuum is produced by the user. The flow of respiratory gases is utilized to extract a pharmaceutical formulation from a receptacle and to place the pharmaceutical formulation within the flow of respiratory gases to form an aerosol.

[0010] By initially preventing respiratory gases from flowing to the lungs when attempting to inhale, the devices and methods of the present invention provide a way to ensure that the resulting gas stream has sufficient energy to extract the pharmaceutical formulation from the receptacle. In one aspect, the flow of respiratory gases may initially be prevented from flowing to the lungs by placing a valve within an airway leading to the lungs and opening the valve to permit the flow of respiratory gases. According to the invention, the valve is opened when a threshold actuating vacuum caused by the attempted inhalation is exceeded. In this way, when the valve is opened, the resulting gas stream has sufficient energy to extract and aerosolize the pharmaceutical formulation.

Problems solved by technology

However, oral delivery can in some cases be undesirable in that many drugs are degraded in the digestive tract before they can be absorbed.

One disadvantage to this approach is low patient acceptance.

Utilization of the patient's inspired gases can be challenging in several respects.

Another challenge in utilizing the patient's inspired gases is that the inspiration flow rate can drastically vary between individuals.

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