Bioequivalence and Bioavailability Forum

Dissolution [Dissolution / BCS / IVIVC]

posted by luvblooms  – India, 2014-08-28 10:21 (4308 d 14:46 ago) – Posting: # 13439
Views: 9,302

Hi John,

❝ My question to the formulators was that if the product leaves the stomach at less than 60 mins, and if you want a spec of >=80 at 60 mins, I see a potential problem of the remaining part of the product not dissolving at post gastric pH, which can affect PK. The knucklehead director wouldn't listen and insisted that there shouldn't be any effect on BE because the Tmax is so long because drug permeability is the rate limiting step in our case.

Can understand the frustration. Have to go through same situation almost everyday.

But such is life.

If possible try to look at the opening pattern or release profile in the viscous media. It might give you some idea about formulation behavior in fed situation.

Complete thread:

• Dissolution jag009 2014-08-22 16:47 
  • Dissolution Dr_Dan 2014-08-22 19:27
    • Dissolution jag009 2014-08-25 15:19
  • Dissolution luvblooms 2014-08-26 06:41
    • Dissolution jag009 2014-08-26 17:33
      • Dissolutionluvblooms 2014-08-28 08:21
        • Dissolution Samaya B 2014-09-01 07:48
          • Dissolution luvblooms 2014-09-01 14:09
            • Dissolution Samaya B 2014-09-04 06:54