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Quality by Design: Next Steps to Realize Opportunities? - page 18 / 37

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NDA #X: Bioequivalent?

Drug X  (100 mg dose, volume required to dissolve the dose at pH 8, lowest solubility, is 230 ml, extent of absorption from a solution is 95%)

Weak base exhibits a sharp decline in solubility with increasing pH above 3

Clinical-trial formulation: Wet granulation, drug particle size (D50%) 80 microns, lactose MCC, starch, Mg-stearte, silicon dioxide. Tablet weight 250 mg. Dissolution in 0.1 N HCl 65% in 15 min and 100 % in 20 minutes. Disintegration time 10 minutes.

The company wants to manufacture the product using direct compression.

To-Be-Marketed formulation: Direct compression, drug particle size (D50%) 300 microns, dicalcium phosphate, MCC, Mg-stearate, silicon dioxide. Tablet weight 500 mg. Dissolution in 0.1 N HCl - 85% in 15 min., and 95% in 20 min. Disintegration 1 min.

Clincal product exhibits poor dissolution in pH 7.4 media (about 30% in 60 minutes). Data for T-b-M not available.

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