Sustained release preparations

  • US 6,440,458 B1
  • Filed: 11/05/1999
  • Issued: 08/27/2002
  • Est. Priority Date: 03/26/1998
  • Status: Expired due to Term
First Claim
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1. A sustained-release formulation comprising tacrolimus or its hydrate wherein the time (T63.2%) required for 63.2% of the maximum amount of tacrolimus or its hydrate to be dissolved is 0.7 to 15 hours, as measured according to the Japanese Pharmacopoeia, the 13-th edition, Dissolution Test, No. 2 (Puddle method, 50 rpm) using a test solution which is an aqueous 0.005% hydroxypropyl cellulose solution adjusted to pH 4.5, which comprises a solid dispersion composition, wherein tacrolimus or its hydrate is present as an amorphous state in water-insoluble polymer.

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