Formulation of diclofenac

  • US 8,679,544 B2
  • Filed: 01/25/2013
  • Issued: 03/25/2014
  • Est. Priority Date: 04/24/2009
  • Status: Active Grant
First Claim
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1. A unit dose of a pharmaceutical composition containing 18 mg of diclofenac acid and comprising lactose monohydrate and sodium lauryl sulfate wherein the particles of diclofenac acid have a median particle size on a volume average basis of less than 500 nm and greater than 25 nm, wherein the unit dose when tested in vitro by USP Apparatus I (Basket) method of U.S. Pharmacopoeia at 100 rpm at 37°

  • C. in 900 ml of 0.05% sodium lauryl sulfate in citric acid solution buffered to pH 5.75 has a dissolution rate of diclofenac acid such that at least 91%, by weight, is released by 45 minutes.

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