Aerosolized active agent delivery

a technology formulations, which is applied in the direction of aerosol delivery, parathyroid hormones, extracellular fluid disorder, etc., can solve the problems of undesirable insulin injection, low patient acceptance, and inability to adequately process, so as to increase the bioavailability of aerosolized active agents, increase the flow rate, and increase the resistance

Inactive Publication Date: 2005-04-28
NOVARTIS FARMA
View PDF99 Cites 53 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • Aerosolized active agent delivery
  • Aerosolized active agent delivery
  • Aerosolized active agent delivery

Examples

Experimental program
Comparison scheme
Effect test

example 1

Insulin Powders

[0070] Insulin powders were prepared as described above and administered to patients also as described above. The bioavailibilities, peak insulin concentrations and time to peak insulin concentrations were as shown in Table I below. The figures show, surprisingly, that inspiratory flow rates of 10 liters per minute or less achieved higher bioavailabilities of insulin (AUC), and higher peak concentrations of insulin (Cmax) than did inspiratory flow rates of 17.0 liters per minute or greater. Further, blood glucose level control (AUC) was greater for an inspiratory flow rate of 9.1 liters per minute than for the higher flow rates, and the maximum concentration (Cmax) was lower for the lower flow rate. Accordingly, a flow rate below 17 liters per minute, preferably 10 liters per minute or less is desired for optimal insulin delivery and glucose blood level control.

TABLE 1Summary of Pharmacokinetics and Pharmacodynamic Factors for Insulin aerosolInhaled at Different In...

example 2

Human Calcitonin Powders

[0071] Human calcitonin powders are prepared as described above. Upon administration to patients, flow rates below 17 liters per minute will result in higher bioavailabilities and lower times to peak concentration than those above 17 liters per minutes.

example 3

Heparin Powders

[0072] Low molecular weight heparin powders are prepared as described above. Upon administration to patients, flow rates below 17 liters per minute will result in higher bioavailabilities and lower times to peak concentration than those above 17 liters per minutes.

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to view more

PUM

PropertyMeasurementUnit
Diameteraaaaaaaaaa
Volumeaaaaaaaaaa
Volumeaaaaaaaaaa
Login to view more

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...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to view more

Application Information

Patent Timeline
no application Login to view more
IPC IPC(8): A61K9/12A61K9/00A61K9/22A61M11/00A61M15/00
CPCA61K9/0073A61M15/002A61M15/00
Inventor CLARK, ANDREWFOULDS, GEORGE H.
Owner NOVARTIS FARMA
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Try Eureka
PatSnap group products

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic.

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap