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Methods of manufacturing viscous liquid pharmaceutical formulations

  • US 9,724,293 B2
  • Filed: 08/29/2012
  • Issued: 08/08/2017
  • Est. Priority Date: 11/17/2003
  • Status: Expired due to Fees
First Claim
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1. A method of manufacturing a viscous, non-aqueous, liquid pharmaceutical formulation, comprising:

  • applying a shear rate to a viscous, non-aqueous, liquid-based suspending vehicle sufficient to produce a reduced viscosity liquid-based suspending vehicle;

    mixing particles comprising a pharmaceutically active agent into the reduced viscosity liquid-based suspending vehicle at a temperature from 80°

    C. to 120°

    C., wherein the particles further comprise sucrose, methionine, and citrate buffer; and

    processing the reduced viscosity liquid-based suspending vehicle to manufacture the viscous, non-aqueous, liquid pharmaceutical formulation,wherein the viscous, non-aqueous, liquid-based suspending vehicle comprises;

    an amphiphilic molecule; and

    a solvent selected from the group consisting of;

    lauryl lactate, lauryl alcohol, benzyl alcohol, benzyl benzoate, 1;

    1 benzyl benzoate;

    benzyl alcohol, ethyl hexyl lactate, glycerol formal, tetraglycol, N-1-methyl-2-pyrrolidone, dimethyl sulfoxide, polyethyleneglycol, triglycerides, ethanol, isopropanol, t-butyl alcohol, cyclohexanol, glycerin, glycerol, alpha-tocopherol, vegetable oil, sesame oil, soybean oil, cottonseed oil, and peanut oil wherein the pharmaceutically active agent is selected from the group consisting of a protein or a peptide.

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