PR5304_AY24-25 S1 Bioavailability In-Class Case Discussion PDF

In-class Case Discussion 26 FYI / Further reading on Amorphous Solid Dispersion here 27 Meloxicam (MLX) NSAID and also good analgesic BCS Class II drug Well absorbed (Absolute bioavailability = 89%) Slow in abso...

In-class Case Discussion 26 FYI / Further reading on Amorphous Solid Dispersion here 27 Meloxicam (MLX) NSAID and also good analgesic BCS Class II drug Well absorbed (Absolute bioavailability = 89%) Slow in absorption (tmax > 5h) >> Parenteral formulation was developed to obtain a faster analgesic response. Solid dispersion = drug (MLX) incorporated into water-soluble Research Question: polymer matrix (PEG) Possible to improve oral absorption rate? Aimed to increase solubility & rate of dissolution 28 Questions: 1. What kind of bioavailability study was this? Absolute or Relative? Relative (no IV route data) 2. Calculate the relative bioavailability of the ODT-MLX formulation. Dose of MLX given in ODT and in IRT was 15 mg. Rel bioavail = (AUC t / Dose t) / (AUC r / Dose r) Same dose for ODT and IRT, so Rel bioavail = AUC t /AUC r = 40.189/37.830 = 1.06 or 106% 3. Authors concluded ODT-MLX formulation would be useful to produce earlier onset of drug action than the IRT. Do you agree with their conclusion? Agree - the rate of absorption is reflected by the tmax and Cmax results, and the researchers have done statistical test to see if the tmax and Cmax are indeed statistically different (refer to the Statistical test column in table). Usually, for a difference to be statistically significant, the P-value should be < 0.05, which is the case for both tmax and Cmax. 29