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Crystalline form of estradiol and pharmaceutical formulations comprising same

  • US 5,928,666 A
  • Filed: 11/10/1997
  • Issued: 07/27/1999
  • Est. Priority Date: 11/12/1996
  • Status: Expired due to Term
First Claim
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1. A method for preparing a crystalline form of estradiol characterized by possessing at least one diffraction peak having a 2θ

  • angle of 11.2°

    ±

    0.2°

    , 12.7°

    ±

    0.2°

    , 17.4°

    ±

    0.2°

    or 19.6°

    ±

    0.2°

    , said method comprising the steps of;

    a) preparing a supersaturated suspension of estradiol hemihydrate crystals in an adhesive and solvent;

    b) removing the solvent;

    c) heating the suspension to a temperature sufficient to dissolve the estradiol hemihydrate crystals in the adhesive; and

    d) transferring the suspension to conditions wherein the supersaturation ratio is greater than or equal to about 12.

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