Page 33 - Assurance of Sterility for Sensitive Combination Products and Materials

Sensitive combination products 21

if not developed with the appropriate attention to the chemistry (Fig. 2.4).
Solutions must therefore be sought, especially as it is predicted that ad-
vances in bioresorbable implant technologies will drive further combina-
tion product market expansion in the near future. Notable is the acquisition
of TYRX Inc. by Medtronic in early 2014. With a recently FDA cleared
AIGISRx combination product based on a resorbable antibacterial enve-
lope to reduce surgical site infections associated with cardiac implantable
electronic devices, AIGISRx R antibacterial envelope for use with spinal
cord stimulators, and Pivitab antibiotic impregnated resorbable hernia mesh
in development, Medtronic have signaled a clear investment in bioabsorb-
able polymer technologies.
And where is all of this heading? The most likely scenario is an
ever-increasing degree of product functionality and complexity. A new class
of combination products known as ‘Multipurpose Prevention Technologies
(MPTs)’ [19] are under development that are gels, intravaginal rings (IVRs),
or barrier devices used with a gel or film that have a combination of con-
traceptive, microbiocidal, and/or anti-sexually transmitted infection (STI)
properties with different mechanisms of action that act to prevent pregnancy,
HIV, and/or STIs. For example, novel IVRs that combine contraceptive
hormones (e.g., Levonorgestrol) with Tenofovir, a drug shown to prevent
both HIV and HSV-2 are being developed. This is just one example of a
combination product in which two or more different drug types are com-
bined with a single delivery device in order to address multiple therapeutic
indications where targeted locoregional delivery from the device makes
sense. Obviously, attention to drug-drug interactions will be important
consideration for such products, but again, one of the biggest challenges in
their development process will be the identification of an appropriate route
to sterilization that maintains individual component integrity.

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