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Antipsychotic injectable depot composition

  • US 10,085,936 B2
  • Filed: 11/30/2012
  • Issued: 10/02/2018
  • Est. Priority Date: 05/31/2010
  • Status: Active Grant
First Claim
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1. An injectable depot composition consisting of:

  • drug, which is risperidone present as particles having a particle size distribution as follows;

    not more than 10% of the total volume of drug particles is less than 10 microns in size, not more than 10% of the total volume of drug particles is greater than 225 microns in size, and the d0.5 of the size distribution is in the range of about 60-130 microns; and

    polymeric solution consisting of;

    DMSO; and

    biocompatible poly(lactide-co-glycolide) (PLGA) copolymer comprising lactic acid and glycolic acid monomers, wherein the monomers are present at a monomer ratio of lactic to glycolic acid of 48;

    52 to 52;

    48, the copolymer has an inherent viscosity in the range of 0.25-0.48 dl/g as measured in chloroform at 25°

    C. and at a concentration of 0.1% wt/v with a Ubbelohde size 0c glass capillary viscometer;

    whereinthe polymeric solution has a viscosity in the range of about 0.7 Pa.s to about 3.0 Pa.s; and

    whereinthe drug content is about 13% wt with respect to the total composition weight;

    the DMSO to drug mass ratio is about 4;

    1 to 5;

    1;

    the polymeric solution to drug mass ratio is about 6.5;

    1 to 7;

    1.

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