How to show similarity if solubility is low? [Dissolution / BCS / IVIVC]

posted by luvblooms  – India, 2015-03-20 05:34 (3763 d 19:05 ago) – Posting: # 14583
Views: 9,767

Hi Nobody

❝ This here looks quite experimental: http://www.ncbi.nlm.nih.gov/pubmed/23058042

❝

❝ Any experience on regulatory acceptance for this approach yet?


as per "Guidance for Industry Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations" page 8 of 27

"In general, nonaqueous and hydroalcoholic systems (apart from alcohal dose dumping) are discouraged unless all attempts with aqueous media are unsuccessful. Appropriate review staff in CDER should be consulted before using any other media" so we never tried them for submission purpose but yes, have used this extensively for discrimination of CR products.

do check
  1. this and
  2. this
—
~A happy Soul~

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