Pharmaceutical semi-solid composition of isotretinoin

  • US 9,078,925 B2
  • Filed: 12/18/2013
  • Issued: 07/14/2015
  • Est. Priority Date: 06/18/2012
  • Status: Active Grant
First Claim
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1. An oral pharmaceutical composition, comprising isotretinoin, and at least an oil and a glycerol macrogolglyceride of HLB of at least 10, wherein said oral pharmaceutical composition is substantially devoid of food effect when the amount of isotretinoin dissolved attains at least 70% of the oral pharmaceutical composition after about four hours of dissolution in a USP dissolution apparatus number 2 at a paddle speed of 100 rpm, and a dissolution media composed of 900 ml of pH 7.5 buffer containing 0.11% pancreatin, 4.7% cholic acid, 0.14% sodium dihydrogen phosphate and 0.5% sodium hydroxide at 37°

  • C.

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