Method of use of monomeric insulin as a means for improving the reproducibility of inhaled insulin
First Claim
1. A method, comprising the steps of:
- (a) measuring a patient'"'"'s glucose level;
(b) aerosolizing a formulation comprising monomeric insulin;
(c) inhaling the aerosolized formulation into the lungs of the patient, the formulation being inhaled with a first total inhaled volume;
(d) allowing particles of formulation to settle in the lungs, migrate into the patient'"'"'s circulatory system and thereby increase the concentration to a first maximum level in the patient'"'"'s blood in a first period of time;
(e) repeating the aerosolizing of a formulation comprised of monomeric insulin;
(f) inhaling the aerosolized formulation of (e) into the lungs of a patient, the formulation being inhaled with a second total inhaled volume different from the first total inhaled volume;
(g) allowing particles of formulation to settle in the lungs, migrate into the patient'"'"'s circulatory system and thereby increase the concentration of formulation to a second maximum level in the patient'"'"'s blood in a second period of time;
whereby the difference between the first total inhaled volume and the second total inhaled volume effects the difference between the first maximum level of formulation and the second maximum level of formulation less than if the formulation were comprised of regular recombinant insulin.
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Accused Products
Abstract
The need for the delivery of insulin by injection can be reduced or eliminated by delivering an aerosolized monomeric insulin formulation. Repeatability of dosing and more particularly the repeatability of the blood concentration versus time profile is improved relative to regular insulin. The blood concentration versus time profile is substantially unaffected by specific aspects of the patient'"'"'s breathing maneuver at delivery. Further, the rate at which blood glucose is lowered is increased by the use of monomeric insulin. Particles of insulin and in particular monomeric insulin delivered to the surface of lung tissue will be absorbed into the circulatory system. The monomeric insulin may be a dry powder but is preferably in a liquid formulation delivered to the patient from a hand-held, self-contained device which automatically releases an aerosolized burst of formulation. The device includes a sensor which is preferably electronic which measures inspiratory flow and volume which measurement can be used to control the point of drug release.
50 Citations
19 Claims
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1. A method, comprising the steps of:
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(a) measuring a patient'"'"'s glucose level; (b) aerosolizing a formulation comprising monomeric insulin; (c) inhaling the aerosolized formulation into the lungs of the patient, the formulation being inhaled with a first total inhaled volume; (d) allowing particles of formulation to settle in the lungs, migrate into the patient'"'"'s circulatory system and thereby increase the concentration to a first maximum level in the patient'"'"'s blood in a first period of time; (e) repeating the aerosolizing of a formulation comprised of monomeric insulin; (f) inhaling the aerosolized formulation of (e) into the lungs of a patient, the formulation being inhaled with a second total inhaled volume different from the first total inhaled volume; (g) allowing particles of formulation to settle in the lungs, migrate into the patient'"'"'s circulatory system and thereby increase the concentration of formulation to a second maximum level in the patient'"'"'s blood in a second period of time; whereby the difference between the first total inhaled volume and the second total inhaled volume effects the difference between the first maximum level of formulation and the second maximum level of formulation less than if the formulation were comprised of regular recombinant insulin. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15)
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16. A method of treating a diabetic patient, comprising:
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(a) measuring a patient'"'"'s glucose level; (b) aerosolizing a formulation comprising monomeric insulin and a carrier to make an aerosol; (c) inhaling a volume of the aerosol into a patient'"'"'s lungs, thereby obtaining a maximum monomeric insulin concentration (CMAX) for the patient in a time needed to obtain a maximum concentration (TMAX) for the patient wherein said CMAX and TMAX are less affected by an amount of air inhaled during inhalation of or after aerosolizing the formulation as compared to an effect on CMAX and TMAX obtained with a formulation of regular hexameric recombinant insulin; (d) measuring the patient'"'"'s inspiratory flow rate and inspiratory volume; and (e) repeatedly aerosolizing the formulation at the same measured inspiratory flow rate and inspiratory volume as measured in step (d); and (f) maintaining serum glucose levels in the patient in a range of greater than 60 mg/dl and less than 125 mg/dl. - View Dependent Claims (17, 18, 19)
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Specification