Bioequivalence and Bioavailability Forum

Dear Dr_Dan,

API3 is class III according to literature, however, API1 which is dexketoprofen trometamol, is expected to be class I (or class III). We could not find any knowledge in the literature survey. Below is given 75 rpm dissolution data of reference product of API1. If we study at 75 rpm, %85 dissolution in 15 minutes is achived, however, i do think that 75 rpm dissolution might not reflect biorelevant conditions. What do you think? To consider 75 rpm data or 50 rpm? In the case of considering 75 rpm data, any formulation possessing >%85 dissolution in 15 minutes will be suitable but i am very suspicious that it is biorelevant. Besides, i believe that main reason for relatively low solubility at 50 rpm is the particle size of the API1 in reference product.

0.1 N HCl, 900 ml, 75 rpm, Pedal
API1
R
43.0
79.9
90.7
93.3
94.7
95.2
95.0

API2
R
54.3
92.3
95.0
94.2
93.4
92.2


pH 6.8, 900 ml, 75 rpm, Pedal
API1
R
43.6
77.1
99.6
99.5
98.5
97.4
96.4

API2
R
32.1
57.7
74.0
83.9
91.4
93.5

Regards,

Mahonny

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Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]