identical pH [Dissolution / BCS / IVIVC]

posted by Helmut Homepage – Vienna, Austria, 2019-09-10 10:58  – Posting: # 20571
Views: 2,241

Hi amer,

» I have constructed IVIVC using in vivo data and dissolution data done at pH 1.2. if i have a new dissolution data (say done at pH 2), how can i predict the in vivo concentrations based on the new dissolution…

[image]Dissolution at pH 2 is rather unusual. Recall the definition: pH = –log10[H+], where [H+] is the [image] activity of the H+ ion. Hence, at pH 2 you have 10–2/10–1.2 ~ 6.31× lower activity of H+ than at pH 1.2. Whether this is relevant, depends on the pKa of the drug. However, it might lead to wrong conclusions.

Valid predictions based on IVIVC require dissolution at identical pH values. Repeat the exercise at pH 1.2.

Cheers,
Helmut Schütz
[image]

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