Module 3 Presentations

14/05/2024

What could possibly go wrong?

The need to fully understand your DS and DP processes

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Changing DS Particle Size Distribution  Digoxin from the white foxglove digitalis lanata or purple foxglove digitalis purpurea – cardiac glycoside used to control atrial fibrillation, atrial flutter and heart failure  Narrow therapeutic index o Therapeutic plasma levels ~ 1 – 2 ng/ml o Toxic plasma levels > 2 ng/ml  In mid 1970s Lanoxin (UK brand leader) manufactured with reduced particle size drug sold – patients experienced toxicity due to more rapid dissolution and greater bioavailability compared to old formulation (pre 1972)

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