”15~20min达到85%以上的溶出量的情况，无需测定溶出度“有相关指导原则吗?Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System ... ”An IR drug product is considered rapidly dissolving when 85 percent or more of the labeled amount 98 of the drug substance dissolves within 30 minutes, using United States Pharmacopeia (USP) 99 Apparatus I at 100 rpm (or Apparatus II at 50 rpm or at 75 rpm when appropriately justified (see 100 section III.C.)) in a volume of 500 mL or less in each of the following media: (1) 0.1 N HCl or 101 Simulated Gastric Fluid USP without enzymes; (2) a pH 4.5 buffer; and (3) a pH 6.8 buffer or 102 Simulated Intestinal Fluid USP without enzymes“. “An IR product is considered very rapidly dissolving when 85 percent or more of the labeled amount 105 of the drug substance dissolves within 15 minutes using the above mentioned conditions” 这篇文章里也只是提到极快速释放，也是在15min，500ml的介质，没有说是在15~20min中。查看更多
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