Biology 2581B Study Guide - Quiz Guide: Intravenous Therapy, Excipient, Freeze-Drying
3 Jun 2020
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Stability (half life) in gi tract (ph, proteolysis) or blood serum. Ability to penetrate membranes / cellular uptake. Location of disease (mouth, muscle, blood etc) Volume of liquid form (injection vs infusion) + total dosage required, protein conc achievable and injection frequency. Viscosity of liquid form (is it injectable ?) Cost of peripheral healthcare (nursing cost, bed use etc) Final dosage forms : bulk product -> formulate -> concentrate -> vialing (fill) -> (freeze or spray dry ?) > seal and label -> transport and storage -> administration. Liquid (ready to go but protein may be unstable, aggregates can form) Freeze-dried (protein more stable but reconstitution required) Spray-dried (must be reconstituted before injection as well) Stability (2yrs) of protein, of excipients, of packaging. High protein conc to achieve required dosage in low volume. Low viscosity to ensure its injectable (it increases with protein conc) Ease of use to ensure patient compliance and minimise dose variability.
