US 6,012,450 AGranted

Intrapulmonary delivery of hematopoietic drug

AssigneeAradigm Corporation

InventorReid M. Rubsamen

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Abstract

A method of treating human patients is provided by the intrapulmonary delivery of a formulation containing a hematopoietic drug. The formulation is automatically released in an aerosolized form from a hand-held, self-contained, portable device comprised of a means for automatically releasing a measured amount of drug into the inspiratory flow path of a patient in response to information obtained from a means for measuring the inspiratory flow rate and determining the inspiratory volume of a patient. Reproducible dosing is obtained by providing for automatic release at the same inspiratory flow rate and inspiratory volume each time drug is released. The device includes a timer to enable a patient to take a drug at the same time each day. Further, overadministration of a hematopoietic drug formulation is avoided by providing a pre-programmed microprocessor designed to avoid overdosing.

Claims18

Dependent claims

A method of administering a therapeutically effective amount of a hematopoietic drug to a patient with a hand-held, self-contained, reusable device, the method comprising:

(a) determining the patient's inspiratory flow profile based on real time values of both said patient's inspiratory flow rate and inspiratory volume;
(b) determining a drug release point of said inspiratory flow profile, wherein at said drug release point said patient's inspiratory flow rate is in a range of about 0.10 to about 2.0 liters/second and inspiratory volume is in a range of about 0.15 to about 0.8 liters;
(c) releasing an aerosolized dose of a hematopoietic drug containing 100 to 1,000,000 units of drug in a 0.01 to 1 ml of drug formulation within the determined ranges of inspiratory flow rate and inspiratory volume combinations, wherein the aerosolized dose comprises aerosolized particles having a diameter in the range of 1.0 to 12.0 microns and is released from a package comprising a porous membrane with pores having a diameter in the range of 0.5 to 6.0 microns;
(d) repeating steps (a), (b) and (c) in a manner such that the releasing repeatedly occurs within substantially the same ranges of inspiratory flow rate and inspiratory flow volume combinations;
(e) monitoring the amount of drug released and preventing overdosing by preventing further release of drug beyond a given amount within a given period of time;
and
(f) providing a visual display to the patient of the amount of drug released.

4 more elements

Dependencies are inferred from the claim text.

Facts

Application: 08/673,963Filed 1 Jul 1996 · continuation
Priority: 29 Jan 1993
Granted: 11 Jan 2000
Term ends: Not estimatedThe source records don’t support an estimate.

Classification16 codes

A61M 15/009
Inhalators: using medicine packages with incorporated spraying means, e.g. aerosol cans
A61M 15/001
With means for agitating the medicament: using ultrasonic means
A61M 15/0045
Using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up: using multiple prepacked dosages on a same…
A61M 15/0048
Characterized by the type of carrier: the dosages being arranged in a plane, e.g. on diskettes

Family

Serial010,989Parent of this continuation · filed 29 Jan 1993
Serial279,720Parent of this continuation-in-part · filed 25 Feb 1994
Serial330,971Parent of this continuation-in-part · filed 28 Oct 1994
Serial414,762Parent of this continuation · filed 31 Mar 1995
US 5,419,315 AParent of this continuation-in-part · filed 30 May 1995
US 5,558,085 AParent of this continuation-in-part
US 6,012,450 AThis patent

From the US filing history. Foreign family members aren’t listed.