Pharmaceutical forms with improved pharmacokinetic properties

  • US 8,613,950 B2
  • Filed: 02/16/2006
  • Issued: 12/24/2013
  • Est. Priority Date: 03/01/2005
  • Status: Active Grant
First Claim
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1. A drug formulation of vardenafil which disintegrates rapidly in the mouth, comprising:

  • an uncoated tablet which disintegrates rapidly in the mouth and which releases the vardenafil in the mouth without swallowing the tablet, said tablet comprising vardenafil hydrochloride trihydrate, andat least one sugar alcohol,and wherein at least 80% of the vardenafil hydrochloride trihydrate in the drug formulation dissolves at 25°

    C. in 10 ml of physiological saline, and further wherein the rate of release of the vardenafil hydrochloride trihydrate from the drug formulation in 900 ml of physiological saline within the first 5 minutes in the USP pedal stirrer apparatus at 50 rotations per minute at 37°

    C. is at least 70%.

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