Method for preparing suspensions of low-solubility materials

  • US 9,775,802 B2
  • Filed: 10/21/2014
  • Issued: 10/03/2017
  • Est. Priority Date: 03/24/2009
  • Status: Active Grant
First Claim
Patent Images

1. A process for producing a pharmaceutical suspension that comprises an active pharmaceutical ingredient (“

  • API”

    ) having low solubility, the process comprising;

    (a) preparing a first solution comprising a carboxy-containing vinyl polymer and water, said first solution having an acidic pH;

    (b) adjusting said pH of said first solution to, and maintaining said pH at, 6.5-6.7;

    (c) adjusting a temperature of said first solution to, and maintaining said temperature at, 20-30°

    C.;

    (d) adding a compound of the API to said first solution under conditions of high-shear mixing for a time from about 5 minutes to about 5 hours, said compound of the API being soluble in water, thereby producing a suspension of particles of said API in a composition comprising said carboxy-containing vinyl polymer;

    (e) adjusting a pH of said suspension to, and maintaining said pH at, 6.5-6.7; and

    (f) adjusting a temperature of said suspension to, and maintaining said temperature at, 20-30°

    C. to produce said pharmaceutical suspension;

    wherein said API is a quinolone, said compound is added in amount sufficient to yield a concentration of said API in said suspension that is higher than a solubility of said API in water;

    said compound is a salt, a hydrate, or a solvate of said API; and

    said compound is added in step (d) as a neat, solid material.

View all claims
    ×
    ×

    Thank you for your feedback

    ×
    ×