Tiotropium Inhalation Solution for Nebulization
AssigneeNephron Pharmaceuticals Corporation
InventorAshley Daugherty
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Abstract
The present invention relates to a sterile pharmaceutical composition comprising tiotropium or a pharmaceutically acceptable salt thereof, for inhalation via nebulization to a subject (e.g. a human). The invention also relates to a process for preparing the pharmaceutical composition and its use in the treatment of respiratory diseases such as chronic obstructive pulmonary disease (COPD) in a subject.
Claims20
An benzalkonium chloride-free, EDTA-free pharmaceutical composition comprising:
- i) 0.0007-0.00088 wt. % tiotropium;
- ii) 0.08-0.2 wt. % sodium citrate;
- iii) 0.2-0.6 wt. % citric acid;
- iv) 0.6-0.9 wt. % sodium chloride;
- and
- v) 97-99.2 wt. % water.
A pharmaceutical product, comprising:
- i) a container having a volume in the range of 0.25-6 mL and;
- ii) a volume of a benzalkonium chloride-free, EDTA-free complexing agent-free pharmaceutical composition contained in the container, the pharmaceutical composition comprising:
- a) tiotropium;
- b) 0.08-0.2 wt. % sodium citrate;
- c) 0.2-0.6 wt. % citric acid;
- and
- d) at least 97 wt. % water,
- the pharmaceutical product administrable by a nebulizer to provide a nebulized dose of the pharmaceutical composition that is bioequivalent to an inhaler-administered dose of a tiotropium solution.
A method of treating a human COPD patient, comprising administering, once daily, a unit dose of a benzalkonium chloride-free, EDTA-free pharmaceutical composition, the composition comprising:
- i) 0.0007-0.00088 wt. % tiotropium;
- ii) 0.08-0.2 wt. % sodium citrate;
- iii) 0.2-0.6 wt. % citric acid;
- iv) 0.6-0.9 wt. % sodium chloride;
- and
- v) 97-99.2 wt. % water,
- wherein a 2 mL dose of the benzalkonium chloride-free, EDTA-free pharmaceutical composition containing 14-17.6 mcg of tiotropium dispensed through a nebulizer is bioequivalent to a dose of a tiotropium solution containing 5 mcg of tiotropium dispensed through an inhaler, the tiotropium solution comprising water, tiotropium bromide monohydrate, edetate disodium, benzalkonium chloride and hydrochloric acid.
Dependencies are inferred from the claim text.