TH59260A - Administration of active ingredients in aerosol form. - Google Patents

Abstract

DC60 (09/04/46) This invention is intended to describe a method and device for the delivery of an active drug formulation to the lungs of a human patient. The active drug formulation may be in powder form, it may be aerosolized, or it may be in a mixture with a propellant. The active drug formulation is administered to patients with a respiratory flow rate of less than 17 liters per minute. The required body dose of such active drug is found to increase at these flow rates when compared to respiratory flow rates of 17 liters per minute or more. This invention is intended to describe a method and device for the delivery of an active drug formulation to the lungs of a human patient. The active drug formulation may be in powder form, it may be aerosolized, or it may be in a mixture with a propellant. The active drug formulation is administered to patients with a respiratory flow rate of less than 17 liters per minute. The required body dose of such active drug is found to increase at these flow rates when compared to respiratory flow rates of 17 liters per minute or more.

Claims (22)

1. Method for aerosolizing the active ingredient: This method involves restricting the flow of the aerosolized active ingredient to a rate of less than 17 liters per minute. 2. The method of claim 1 in which the flow rate is limited to less than or equal to 10 liters per minute. 3. Method of Claim 1, whereby the aerosol formulation contains the active ingredient in dry powder form. 4. Method of Claim 1, whereby the aerosol formulation contains the active ingredient in aerosol form. 5. Method of Claim 1, whereby the aerosol formulation contains the active ingredient mixed with a propellant. 6. Method of Claim 1, whereby the aerosol formulation of the active ingredient consists of a solution of the active ingredient. 7. Method of Claim 1, whereby the aerosol formulation contains a suspension of the active ingredient. 8. Method of Claim 1, whereby the aerosol formulation of the active ingredient contains a viscous substance of the active ingredient. 9. The method of claim 1, whereby the active ingredient is selected from a group comprising cyclosporine, parathyroid hormone, follicle-stimulating hormone, alpha-I, antitrypsin butyzonite, human growth hormone (HGH), growth-releasing hormone, interferon alpha, growth-stimulating factors, luteinizing hormone-releasing hormone, calcitonin, low molecular weight heparin, somatostatin, respiratory syncytial virus antibody, erythropoietin factor VIII, factor IX, seredase, serezyme and its analogs, atontists and antagonists. 10. Methods for aerosolizing insulin: This involves restricting the flow rate of the aerosol insulin formulation to less than 17 liters per minute. 11. Devices for increasing the desired amount of active ingredient in the body. These devices include a flow restrictor for limiting the flow of aerosol formulations to below 17 liters per minute. 12. Device of claim 11, whereby the flow restrictor is a simple air vent. 13. Device of claim 12 where the flow restrictor consists of an opening with a diameter of 0.5 to 0.5 mm. 14. Device of claim 11, whereby a flow restrictor is a valve that provides increasing resistance with increasing flow rate. 15. Device of claim 11 where the flow restrictor is a valve that provides reduced resistance as the flow rate increases. 16. The device of claim 11, whereby the flow restrictor is a valve that provides high resistance at all flow rates except the desired flow rate. 17. Devices of claim 11 whereby the active ingredient is selected from a group comprising cyclosporine, parathyroid hormone, follicle-stimulating hormone, alpha-1 antitrypsin, butysonite, human growth hormone (HGH), growth-releasing hormone, interferon alpha, growth-stimulating factors, luteinizing hormone-releasing hormone, calcitonin, low molecular weight heparin, somatostatin, respiratory natibodevirus zingestial, erythropoietin, factor VIII, factor IX, seredase, serizyme and its agonist and antagonist analogs. 18. Devices for delivering active substances to the lungs of human patients, whereby such devices deliver an aerosol formulation of the active substance at a respiratory flow rate limited to less than 17 liters per minute. 19. Equipment of claim 18 whereby the active ingredient, an aerosol, is in dry powder form. 20. Equipment under claim 18 where the respiratory flow rate is 10 liters/minute or less. 21. A device for delivering insulin to the lungs of a human patient, whereby the device delivers an aerosol insulin formulation at a respiratory flow rate limited to less than 17 liters per minute. 22. Equipment under claim 21 where the respiratory flow rate is 10 liters/minute or less (Clause 22, page 2, figure 14).