Drug – bio-affecting and body treating compositions – Effervescent or pressurized fluid containing – Organic pressurized fluid
Reexamination Certificate
2000-10-30
2003-07-22
Hartley, Michael G. (Department: 1616)
Drug, bio-affecting and body treating compositions
Effervescent or pressurized fluid containing
Organic pressurized fluid
C424S043000, C514S002600, C514S003100, C514S012200, C514S866000, C128S200140
Reexamination Certificate
active
06596261
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to a method of administering a medicinal aerosol formulation, and more particularly, to a method of administering a medicinal aerosol formulation where the amount of drug delivered to the lungs of a patent is maximized.
2. Description of the Related Art
Delivery of drugs to the lung by way of inhalation is an important means of treating a variety of conditions, including such common local conditions as cystic fibrosis, pneumonia, bronchial asthma and chronic obstructive pulmonary disease and some systemic conditions, including hormone replacement, pain management, immune deficiency, erythropoiesis, diabetes, etc. Steroids, &bgr; agonists, anti-cholinergic agents, proteins and polypeptides are among the drugs that are administered to the lung for such purposes. Such drugs are commonly administered to the lung in the form of an aerosol of particles of respirable size (less than about 10 &mgr;m in diameter). The aerosol formulation can be presented as a liquid or a dry powder. In order to assure proper particle size in a liquid aerosol, particles can be prepared in respirable size and then incorporated into a colloidial dispersion either containing a propellant as a metered dose inhaler (MDI) or air, such as in the case of a dry powder inhaler (DPI). Alternatively, formulations can be prepared in solution form in order to avoid the concern for proper particle size in the formulation. Solution formulations must nevertheless be dispensed in a manner that produces particles or droplets of respirable size.
For MDI application, once prepared an aerosol formulation is filled into an aerosol canister equipped with a metered dose valve. In the hands of the patient the formulation is dispensed via an actuator adapted to direct the dose from the valve to the patient.
What is needed and desired is a method of administering a medicinal aerosol formulation under conditions where a maximum amount of drug contained within the aerosol is delivered to the site to be acted upon, e.g. the lungs.
SUMMARY OF THE INVENTION
A method of treating in a patient a condition capable of treatment by oral or nasal inhalation by administering to the patient an aerosol formulation, comprising a medicament, has been found. In particular, the administration of the medicament is carried out under conditions where the maximum amount of the administered drug is delivered to the site to be acted upon.
REFERENCES:
patent: 5889042 (1999-03-01), MacLean et al.
patent: 6051551 (2000-04-01), Hughes et al.
Adjei Akwete L.
Stefanos Simon
Zhu Yaping
Aeropharm Technology Incorporated
Frommer Lawrence & HaugLLP
Haghightian M.
Hartley Michael G.
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