Simeticone soft gel capsule dissolution problem [Dissolution / BCS / IVIVC]

posted by mahonny – India, 2015-03-31 13:12 (2235 d 17:42 ago) – Posting: # 14639
Views: 4,645

Hi all,

We are currently working on a new project in which reference product is a soft gel capsule (orally administered) and has 300 mg of simeticone (USP) and class III API in combination. Simeticone (viscous oily liquid, API grade) and class III API is mixed and filled into soft gel capsules in the reference product formulation. As generic, we are working on developing a tablet formulation. Considering information below we would like to develop a dissolution medium/method:
Since we know simeticone is not dissolved, only assay of this API for this solid dosage form will take place in specification of FDF. Nevertheless, class III compound is soluble in water and though it is not absorbed and locally acts, we believe that we have to develop a dissolution method for QC purposes while submitting our dossier to MoH. We tried a dozen of dissolution medium as stated below, however, we could not succeed 100% solubility of class III API due to the fact that class III API is mixed with simeticone in the soft gel capsule and though capsule shell is dissolved simeticone (and class III API) still looks like a capsule during dissolution test.

Dissolution rate of class III API after 45 minutes, Apparatus II, (900 or 1000 ml volume):As seen above, quite interesting and challenging media were studied.

Questions are:
  1. Can anyone give a clue to overcome this situation?
  2. Is it possible to give only disintegration test in specification for FDF? Can it be accepted by MoH?

Kind Regards,

Mahonny

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