US5522385A — Dynamic particle size control for aerosolized dru…

Claim 1

Independent Claim 114 words

A method of drug delivery, comprising: (a) providing a disposable porous membrane having pores with a diameter in the range of about 0.25 to about 6.0 microns; (b) forming aerosolized particles of a formulation comprised of a carrier and a drug which particles have a diameter in the range of about 0.5 to about 12.0 microns by moving the formulation through the disposable porous membrane; (c) adding energy to the aerosolized particles by actively heating air brought into contact with the particles; (d) inhaling the particles into the lungs of a patient; and (e) repeating (a)-(d) wherein a new disposable membrane is provided in each step (a) and used for each forming step (b).

Claim 2

Independent Claim 114 words

A method of drug delivery, comprising: (a) providing a disposable porous membrane having pores with a diameter in the range of about 0.25 to about 6.0 microns; (b) forming aerosolized particles of a formulation comprised of a carrier and a drug which particles have a diameter in the range of about 0.5 to about 12.0 microns by moving the formulation through the disposable porous membrane; (c) adding energy to the aerosolized particles by actively heating air brought into contact with the particles; (d) inhaling the particles into the lungs of a patient; and (e) repeating (a)-(d) wherein a new disposable membrane is provided in each step (a) and used for each forming step (b).

Claim 3

Dependent Claim 47 words

The method of claim 1, comprising evaporating 50% or more of the carrier in the particles prior to the particles reaching the patient and wherein said adding occurs by actively heating air by moving air through a heated material which material is heated prior the patient's inhalation.

Claim 4

Dependent Claim 23 words

The method of claim 1, comprising evaporating 80% or more of the carrier in the particles prior to the particles reaching the patient.

Claim 5

Dependent Claim 10 words

The method of claim 1, comprising evaporating substantially all carrier.

Claim 6

Dependent Claim 20 words

The method of claim 1, wherein the carrier is selected from the group consisting of water, ethanol and mixtures thereof.

Claim 7

Dependent Claim 30 words

The method of claim 1, wherein the porous membrane has from 10 to 10,000 pores over an area of from about 1 mm 2 to about 1 cm 2 .

Claim 8

Dependent Claim 20 words

The method of claim 1, further comprising: actively heating the formulation prior to moving the formulation through the porous membrane.

Claim 9

Dependent Claim 12 words

The method of claim 1, wherein the carrier is comprised of water.

Claim 10

Dependent Claim 76 words

The method of claim 8, further comprising: providing a channel having a first opening into which air is inhaled, a second opening from which a patient withdraws air and a third opening through which the aerosolized particles enter the channel; and providing a desiccator in the channel at a point after the first opening and prior to the second and third openings in a direction of flow from the first to second to the third opening.

Claim 11

Dependent Claim 41 words

The method of claim 9, wherein the desiccator is selected from the group consisting of P 2 O 5 , Mg(ClO 4 ), KOH, H 2 5O 4 , NaOH, CaO, CaCl 2 , ZnCl 2 , and CaSO 4 .

Claim 12

Independent Claim 103 words

A method of drug delivery, comprising: providing a volume of air; inhaling the volume of air through a desiccator into a channel wherein the desiccator absorbs water vapor from air to obtain a volume of dried air; providing a formulation comprised of a pharmaceutically active drug and a water carrier; moving the formulation through pores of a porous membrane into the volume of dried air in a manner so as to form aerosolized particles and the aerosolized particles are drawn into the channel; and continuing to inhale so as to draw the aerosolized particles and dried air into the lungs of a patient.

Claim 13

Independent Claim 103 words

A method of drug delivery, comprising: providing a volume of air; inhaling the volume of air through a desiccator into a channel wherein the desiccator absorbs water vapor from air to obtain a volume of dried air; providing a formulation comprised of a pharmaceutically active drug and a water carrier; moving the formulation through pores of a porous membrane into the volume of dried air in a manner so as to form aerosolized particles and the aerosolized particles are drawn into the channel; and continuing to inhale so as to draw the aerosolized particles and dried air into the lungs of a patient.

Claim 14

Dependent Claim 41 words

The method of claim 11, wherein the desiccator is selected from the group consisting of P 2 O 5 , Mg(ClO 4 ), KOH, H 2 5O 4 , NaOH, CaO, CaCl 2 , ZnCl 2 , and CaSO 4 .

Claim 15

Dependent Claim 32 words

The method of claim 11, further comprising: adding energy to the volume of dried air so as to increase the ability of the air to held a higher concentration of water vapor.

Claim 16

Independent Claim 155 words

A method of drug delivery, comprising: inhaling air into a channel which channel leads to an inhaling patient; moving formulation through pores of a disposable porous membrane wherein the pores have a diameter of about 0.25 to about 6.0 microns in a manner so as to form aerosolized particles having a diameter in the range of from about 0.5 to about 12.0 microns wherein the formulation is comprised of a pharmaceutically active drug and a water carrier and the aerosolized particles are drawn in to the channel; introducing water in the form of water vapor or aerosolized water particles into the air in the channel; and continuing to inhale so as to draw the aerosolized particles into the lungs of the patient; wherein the water is substantially pure and is introduced in an amount sufficient to substantially saturate air inhaled into the channel and thereby substantially eliminate evaporation of water carrier from the aerosolized particles.

Claim 17

Independent Claim 155 words

A method of drug delivery, comprising: inhaling air into a channel which channel leads to an inhaling patient; moving formulation through pores of a disposable porous membrane wherein the pores have a diameter of about 0.25 to about 6.0 microns in a manner so as to form aerosolized particles having a diameter in the range of from about 0.5 to about 12.0 microns wherein the formulation is comprised of a pharmaceutically active drug and a water carrier and the aerosolized particles are drawn in to the channel; introducing water in the form of water vapor or aerosolized water particles into the air in the channel; and continuing to inhale so as to draw the aerosolized particles into the lungs of the patient; wherein the water is substantially pure and is introduced in an amount sufficient to substantially saturate air inhaled into the channel and thereby substantially eliminate evaporation of water carrier from the aerosolized particles.

Claim 18

Independent Claim 98 words

A method of drug delivery, comprising: heating a formulation wherein the formulation is comprised of a pharmaceutically active drug and a water carrier; moving the heated formulation through a nozzle in a manner so as to form aerosolized particles; adding energy to the aerosolized articles by actively heating air surrounding the particles; inhaling air into a channel which leads to the aerosolized particles and to an inhaling patient wherein the inhaled air is drawn through a desiccator to the channel wherein the desiccator absorbs water vapor from air; and inhaling the particles into the lungs of a patient.

Claim 19

Independent Claim 98 words

A method of drug delivery, comprising: heating a formulation wherein the formulation is comprised of a pharmaceutically active drug and a water carrier; moving the heated formulation through a nozzle in a manner so as to form aerosolized particles; adding energy to the aerosolized articles by actively heating air surrounding the particles; inhaling air into a channel which leads to the aerosolized particles and to an inhaling patient wherein the inhaled air is drawn through a desiccator to the channel wherein the desiccator absorbs water vapor from air; and inhaling the particles into the lungs of a patient.

Claim 20

Dependent Claim 115 words

A drug delivery device, comprising: a channel having a first opening into which air can be inhaled, a second opening from which a patient can withdraw air and a third opening through which aerosolized particles enter the channel; a container having a formulation therein; a means for applying physical force to the formulation upon actuation; a disposable porous membrane through which the formulation is forced through the membrane having pores with a diameter of about 0.25 to about 6.0 microns; an air-heating device which adds energy to air inhaled into the channel; and a means for moving disposable membranes into a drug release position for use and out of the drug release position after use.

Claim 21

Dependent Claim 115 words

A drug delivery device, comprising: a channel having a first opening into which air can be inhaled, a second opening from which a patient can withdraw air and a third opening through which aerosolized particles enter the channel; a container having a formulation therein; a means for applying physical force to the formulation upon actuation; a disposable porous membrane through which the formulation is forced through the membrane having pores with a diameter of about 0.25 to about 6.0 microns; an air-heating device which adds energy to air inhaled into the channel; and a means for moving disposable membranes into a drug release position for use and out of the drug release position after use.

Claim 22

Dependent Claim 69 words

The drug delivery device of claim 16, further comprising: a desiccator positioned in the channel at a point after the first opening and prior to the second and third in a direction of flow from the first opening to the second and third opening; wherein the desiccator absorbs water vapor from air; wherein the device is a hand-held self-contained device having a total weight of 1 kilogram or less.

Claim 23

Dependent Claim 30 words

The drug delivery device of claim 16, wherein the means for applying physical force to the formulation is selected from the group consisting of a piston and a vibration device.

Annuity Stage	Window Opens	Payment Deadline	Surcharge Period Until	Estimated Fee	Status
3.5 Years (Year 4)	1999-06-04	1999-12-04	2000-06-04	$2000.00	Window Closed / Lapsed
7.5 Years (Year 8)	2003-06-04	2003-12-04	2004-06-04	$3760.00	Window Closed / Lapsed
11.5 Years (Year 12)	2007-06-04	2007-12-04	2008-06-04	$7700.00	Window Closed / Lapsed

Dynamic particle size control for aerosolized drug delivery

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