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e1
QUESTION
In deciding between a non-degradable versus a degrad-
able polymer for an implantable drug delivery system,
what would you need to know before proceeding with
the selection? List the questions would you have, includ-
ing tests that would need to be carried out.
ANSWER
1. How has this disease been treated before, if at all?
What were the advantages and disadvantages of the
current treatment and what disadvantages need to be
overcome? Is there an unmet medical or technological
component?
potential disadvantages listed in Table II.5.16.D.3,
while emphasizing the benefits highlighted in Table
II.5.16.D.2?
8. Review the stability of the drug and polymer in
its anticipated environment. Are the degradation
byproducts, if any, known and acceptable? What is
the interaction between the drug and the polymer?
Obtain an understanding of the controlled release
and then diffuses through the polymer. This is best
done by developing a phase diagram and understand-
ing what polymer–drug concentrations are miscible.
Then fine-tune to obtain the desired drug release pro-
file by varying the drug–polymer ratio, the glass tran-
sition, and possibly the crystallinity.
If the polymer cannot be tuned to dissolve the drug,
the release has to be controlled by a porous mecha-
nism is a combination of more than one system.
After this paper exercise, it is best to start bench
testing with a focus on drug release mechanism and
CHAPTER II.5.16.D
Implants and Inserts
