Drug – bio-affecting and body treating compositions – Effervescent or pressurized fluid containing – Organic pressurized fluid
Reexamination Certificate
2000-10-31
2003-04-15
Krass, Frederick (Department: 1614)
Drug, bio-affecting and body treating compositions
Effervescent or pressurized fluid containing
Organic pressurized fluid
C424S044000, C424S043000, C514S004300, C514S866000, C128S200140, C128S200210, C128S200230
Reexamination Certificate
active
06548049
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to a medicinal aerosol formulation, and more particularly, to a medicinal aerosol formulation comprising a pioglitazone hydrochloride.
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. Anti-diabetic drugs, e.g. an insulin, 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 stable aerosol formulation for the treatment of diabetes and conditions related thereto.
SUMMARY OF THE INVENTION
It has surprisingly been found that a novel and stable medicinal aerosol formulation of an anti-diabetic medicament can be obtained without the use of a surfactant, such as sorbitan trioleate. The medicament is pioglitazone and its salts or esters such as, for example maleate, hydrochloride, etc., or other pharmaceutically acceptable forms. This medicament may be used alone or combined with a suitable &bgr;-cell hypoglycemic selected from the group consisting of an amylin and insulin, as well as, other medicament agents possessing antidiabetic activity, including the &agr;-cell hypoglycemic glucagon, acetohexamide, chlorpropamide, tolazamide, tolbutamide, and glipizide, as well as inclusion of any mixture of any two or three of the foregoing &bgr;-cell hypoglycemic medicaments.
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Evans, A. J., Krentz, A. J.; Recent Developments and Emerging Therapies for Type 2 Diabetes Mellitus; Aug., 1999; Drugs in R&D; 2(2), 75-94; See: abstract.*
Reasner, C. A. II, Promising New Approaches, Blackwell Science Ltd., Diabetes, Obes. Metab., 1 (Suppl. 1), S41-S48, (1999) See: Abstract.*
Patton et al., Advanced Drug Delivery Reviews, 8(1992) 179-196.
Adjei Akwete L.
Cutie Anthony J.
Sexton Frederick A.
Aeropharm Technology Incorporated
Frommer & Lawrence & Haug LLP
Krass Frederick
Ostrup Clinton
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