Terazosin capsules

  • US 6,110,493 A
  • Filed: 05/18/1999
  • Issued: 08/29/2000
  • Est. Priority Date: 08/01/1996
  • Status: Expired due to Term
First Claim
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1. A pharmaceutical solid-filled capsule dosage form containing a fill which consists of a pharmaceutically effective amount of anhydrous terazosin hydrochloride, and a solid carrier, which solid-filled capsule dosage form is therapeutically equivalent to a reference liquid-filled terazosin hydrochloride capsule which is the subject of FDA-approved New Drug Application N20347 comprising an equivalent amount of terazosin and a non-aqueous liquid carrier, and which solid-filled capsule dosage form has an average dissolution at 30 minutes measured according to U.S.P. Method II at 50 r.p.m. in water of at least 85 percent of the label amount with no individual capsule below 80 percent of the label amount after being maintained in a high density polyethylene bottle closed with a screw cap at about 40°

  • C. and 85 percent relative humidity for twelve weeks.

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