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Bronchodilating β-agonist compositions and methods

DC CAFC
  • US 7,348,362 B2
  • Filed: 07/09/2004
  • Issued: 03/25/2008
  • Est. Priority Date: 07/10/2003
  • Status: Active Grant
First Claim
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1. A sterile unit dose, comprising:

  • (a) about 0.1 mL to about 3.0 mL of a pharmaceutical composition comprising formoterol or a salt thereof at a concentration of from about 0.08 μ

    g/mL to about 34 μ

    g/mL based on formoterol free base, in a pharmacologically suitable solution, wherein the composition further comprises water and a buffer selected from the group consisting of citric acid/phosphate buffer, acetate buffer, citrate buffer and phosphate buffer at a concentration of from about 1 mM to about 20 mM, said composition having a pH of between about 4.5 and about 5.5 and having an estimated shelf life of greater than 90% after 3 months storage at 25°

    C. and after 3 years storage at 5°

    C.;

    (b) packaged in pharmaceutical packaging material.

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