Intrapulmonary delivery of hematopoietic drug
First Claim
1. 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.
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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.
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Citations
18 Claims
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1. 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:
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(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. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16)
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17. 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:
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(a) determining the patient'"'"'s inspiratory flow profile; (b) determining a drug release point of said inspiratory flow profile; (c) releasing an aerosolized dose of a hematopoietic drug at said drug release point, wherein said aerosolized dose comprises aerosolized particles having a diameter in the range of 1.0 to 12.0 microns and is released from a disposable drug containing package comprising a porous membrane with pores having a diameter in the range of 0.5 to 6.0 microns; and (d) repeating steps (a) thru (c) in a manner such that the releasing repeatedly occurs at substantially said drug release point. - View Dependent Claims (18)
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Specification