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PRESERVED ETHERIFIED CYCLODEXTRIN DERIVATIVES CONTAINING LIQUID AQUEOUS PHARMACEUTICAL COMPOSITION

  • US 20150025082A1
  • Filed: 07/18/2014
  • Published: 01/22/2015
  • Est. Priority Date: 07/19/2013
  • Status: Active Grant
First Claim
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1. A preserved liquid aqueous pharmaceutical composition comprising:

  • a. one or more etherified cyclodextrin derivatives;

    b. one or more water-soluble preservatives;

    preferably selected from the group consisting of sorbic acid or salts thereof, preferably sodium sorbate, potassium sorbate, calcium sorbate;

    benzoic acid or salts thereof, preferably sodium benzoate;

    benzalkonium chloride;

    benzethonium chloride;

    cetylpyridinium chloride;

    sodium metabisulfite;

    sodium acetate;

    parabenes and salts thereof, preferably methylparabene, ethylparabene, propylparabene, butylparabene, butylparabene sodium;

    or combinations thereof;

    more preferably selected from the group consisting of sorbic acid or salts thereof, preferably sodium sorbate, potassium sorbate, calcium sorbate;

    benzoic acid or salts thereof, preferably sodium benzoate;

    benzalkonium chloride;

    benzethonium chloride;

    cetylpyridinium chloride;

    sodium metabisulfite;

    sodium acetate;

    or combinations thereof; and

    c. at least one pharmaceutically active compound which is poorly water-soluble, very poorly water-soluble or water-insoluble, wherein preferably the solubility of the at least one pharmaceutically active compound in water in the range of 15 to 25°

    C. is defined as follows;

    i. the at least one pharmaceutically active compound is poorly water-soluble if more than 100 mL of water per gram compound have to be used;

    it is very poorly water-soluble if more than 1,000 mL of water per gram compound have to be used; and

    it is water-insoluble if more than 10,000 mL water per gram compound has to be used to solubilize the compound, andii. preferably with the proviso that corticosteroids, in particular prednisolone and its prodrug prednisolone acetate, and fluoroquinolones, in particular ciprofloxacin, gatifloxacin, moxifloxacin, sitafloxacin, lomefloxacin, grepafloxacin, gemifloxacin, norfloxacin, ofloxacin, levofloxacin and trovafloxacin, are independently from each other excluded as pharmaceutically active compound which is poorly water-soluble, very poorly water-soluble or water-insoluble.

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