Applications of IVIVC in Formulation Development - PQRI
Applications of IVIVC in Formulation Development - PQRI
Applications of IVIVC in Formulation Development - PQRI
Create successful ePaper yourself
Turn your PDF publications into a flip-book with our unique Google optimized e-Paper software.
Practical Application: In Vivo and In Vitro Data<br />
Required<br />
<br />
<br />
In Vivo Data – Bioavailability Studies<br />
At least 2 test formulations with different release rates (3 or more<br />
recommended)<br />
Solution, immediate release, or IV reference (unit impulse response)<br />
Crossover studies <strong>in</strong> fasted subjects<br />
Parallel studies acceptable (common treatment across studies)<br />
In Vitro Data – Dissolution Studies<br />
Test formulations should exhibit at least 10% difference <strong>in</strong> dissolution<br />
USP apparatus I (basket @ 100 rpm) or II (paddle @ 50 rpm) preferred<br />
Adjust dissolution conditions to fit <strong>in</strong> vivo data/obta<strong>in</strong> proper discrim<strong>in</strong>ation<br />
If dissolution is faster or slower than <strong>in</strong> vivo absorption, adjust the time scale
Change language