Stable tablet formulation

  • US 7,566,462 B2
  • Filed: 04/21/2008
  • Issued: 07/28/2009
  • Est. Priority Date: 11/17/2004
  • Status: Active Grant
First Claim
Patent Images

1. A stable tablet formulation comprising an initial amount of a crystalline polymorph, designated polymorph B, of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride, an antioxidant, and a pharmaceutically acceptable excipient, diluent, or carrier in the form of a tablet,wherein the weight ratio of the antioxidant to the (6R)-L-erythro-tetrahydrobiopterin dihydrochloride is about 1:

  • 5 to about 1;

    30;

    wherein after six months in a container at room temperature and about 60% humidity the stable tablet formulation retains at least about 95% of the initial amount of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride,and wherein said crystalline polymorph B exhibits an X-ray powder diffraction pattern with the following characteristic peaks expressed in d-values (Å

    );

    8.7 (vs), 5.63 (m), 4.76 (m), 4.40 (m), 4.00 (s), 3.23 (s), and 3.11 (vs).

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