Controlled Drug Delivery: Fundamentals and Applications, by Joseph Robinson, Vincent H. L. Lee

By Joseph Robinson, Vincent H. L. Lee

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T h e r a p e u t i c i n d e x = Median toxic dose/median effective dose = TD50/ED5Q (7) However, t h i s ratio p r o v i d e s no information on (a) t h e n a t u r e of t h e d i s t r i b u t i o n of toxicity and e f f e c t i v e n e s s , (b) t h e size of doses p r o d u c i n g t h e r a p e u t i c and toxic effects, and (c) plasma or serum d r u g c o n c e n t r a t i o n s c o r r e s p o n d i n g to toxic and t h e r a p e u t i c l e v e l s . Cons e q u e n t l y , it can only be u s e d as a c r u d e estimate of t h e r e l a t i v e safety of a d r u g .

In summary, no conclusion can be made on the relative importance of volume of distribution at steady state and the T/P ratio in estimating the distribution characteristics of a drug. Undoubtedly, both parameters contribute to this aspect of drug disposition. Perhaps mention should be made of the use of T/P ratio in conjunction with total body clearance at steady state to gain further insight into drug disposition. Table 4 gives an example of how this can be done. C. Metabolism Metabolism of a drug can either inactivate an active drug or convert an inactive drug to an active metabolite.

As an i l l u s t r a t i o n , Koch-Weser et al. [124,125] s u g g e s t e d t h a t dose of procainamide must be administered e v e r y 3 h r to p r e v e n t fluctuations of plasma level b y more t h a n 50%. S u s t a i n e d release formulations of procainamide a r e available a n d have been shown 28 I Li et al. 5 - 500 1 1000 - - - b Based on a one-compartment open model. C * m / * i ) m a x = ° / D i " *• Table 7 Examples of D r u g s with Extremely Short Half-Lives Drug Half-life (min) Ref.

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