A fixed dose combination dissolution evaluation [Dissolution / BCS / IVIVC]

posted by luvblooms  – India, 2014-04-07 10:28 (3457 d 15:18 ago) – Posting: # 12778
Views: 9,297

Dear Mahonny

❝ Any more comments from different point of views are highly appreciated...

  1. Was there any heap formation at 50 rpm? The difference between 50 and 75 rpm points towards.
  2. Why not trying basket apparatus and check?
  3. Is there any impact of DT or any formulation excipients on solubility or release? As the end release is different in different media, this could be because of differential solubility of some excipient in different pH conditions. For class I and III drug, particle size will not have major effect but excipients will have.
Generally For class III product the main factor will be the gastric emptying and one should try to release >85% drug in 15-30 min time points and later body will take care of things (as my professor say)

As said, you should look for some more solubility and dissolution tests. With the current data I would be worried for my BE out come.


~A happy Soul~

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