Aerosolized active agent delivery

Abstract

The present invention is directed to methods and devices for delivering an active agent formulation to the lung of a human patient. The active agent formulation may be in dry powder form, it may be nebulized, or it may be in admixture with a propellant. The active agent formulation is delivered to a patient at an inspiratory flow rate of less than 17 liters per minute. The bioavailability of the active agent was found to increase at these flow rates when compared to inspiratory flow rates of 17 liters per minute or more.

Description

FIELD OF THE INVENTION [0001] The present invention is related to the pulmonary delivery of an active agent formulation. More particularly, it is a method and device for pulmonary delivery of an active agent formulation for increased systemic bioavailability of the active agent via absorption in the deep lung. Average inspiratory flow rates of less than 17 liters per minute of active agent formulation must be maintained in order to achieve increased bioavailability. BACKGROUND OF THE INVENTION [0002] Effective delivery to a patient is a critical aspect of any successful drug therapy. Various routes of delivery exist, and each has its own advantages and disadvantages. Oral drug delivery of pills, capsules, elixirs, and the like is perhaps the most convenient method, but many drugs are degraded in the digestive tract before they can be absorbed. Subcutaneous injection is frequently an effective route for systemic drug delivery, including the delivery of proteins, but enjoys a low pati...

AI Technical Summary

Benefits of technology

[0011] In yet another aspect, the present invention is directed to a device for increasing the bioavailability of an aerosolized active agent, said device comprising a flow restricter for limiting the flow of the aerosolized active agent formulation to below 17 liters per minute. The flow restricter may be in the form of a simple orifice, a valve that provides for increasing resistance with increasing flow rate, a valve that provides for decreasing resistance with increasing flow rate, or a valve that provides for high resistance at all f

Problems solved by technology

Subcutaneous injection is frequently an effective route for systemic drug delivery, including the delivery of proteins, but enjoys a low patient acceptance.

Since injection of drugs, such as insulin, one or more times a day can frequently be a source of poor patient compliance, a variety of alternative routes of administration have also been developed, including transdermal, intranasal, intrarectal, intravaginal, and pulmonary delivery.

In Type II, either the body produces insulin but in quantities that are insufficient to regulate blood sugar levels to within a normal range or the insulin receptors are unable to adequately process the insulin in the blood.

The administration of insulin by injection is undesirable in a number of respects.

First, many patients find it difficult and burdensome to inject themselves as frequently as necessary to maintain acceptable blood glucose levels.

Such reluctance can lead to non-compliance with recommended therapeutic regimens, which in the most serious cases can be life-threatening.

Moreover, systemic absorption of insulin from subcutaneous injection is relatively slow when compared to the normal release of insulin by the pancreas, frequently requiring from 45 to 90 minutes, even when fast-acting insulin formulations are employed.

Even with the amount of work that has been done to optimize delivery of inhaled insulin, there has not been a system and method of delivery that has provided sufficient delivery of insulin to the lung for maintaining target blood glucose levels in diabetic patients.

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