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Long-acting semi-solid lipid formulations

  • US 10,220,093 B2
  • Filed: 12/06/2017
  • Issued: 03/05/2019
  • Est. Priority Date: 02/28/2013
  • Status: Active Grant
First Claim
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1. A pharmaceutical composition, comprising(i) a glyceride mixture comprising one or more glycerides selected from the group consisting of (a) a mixture of caprylic, capric, myristic, and stearic triglycerides (S378);

  • (b) a mixture of caprylic, capric, isostearic, hydroxyl-stearic, and adipic glycerides (S645);

    (c) a mixture of ricinoleic acid partial glycerides (S701);

    (d) a mixture of glycerides of C12-C18 fatty acids (G39/01);

    (e) a mixture of glycerides of C10-C18 fatty acids (Sup A); and

    (f) polyglyceryl-2-diisostearate (PGDS); and

    (ii) active agents consisting of (a) bupivacaine; and

    (b) a corticosteroid, an analgesic or an anti-inflammatory agent;

    wherein the active agents are solubilized in the glyceride mixture at a concentration of 0.01-60 wt %;

    wherein the pharmaceutical composition is a semi-solid gel which is a biocompatible, bioerodible, homogeneous, and single phase; and

    wherein the semi-solid gel consists of a soft paste with a viscosity of 50-2000 cPs at 30°

    C.; and

    wherein the semi-solid gel forms a depot releasing bupivacaine for at least five days when measured in vitro at 37°

    C.

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