Harsh thermal environment:
Although drug delivery devices are a popular way to administer drugs, they
expose these drugs to a very harsh environment. The drugs can be
subjected to both thermal cycling, and other uncontrolled temperature
extremes. The thermal cycling issues are particularly bad for prefilled pen delivery devices (injection pens). Prefilled pens can contain a up to
month's worth of medication, and are often used by unskilled patients in a
home environment. The same pen may be cycled in and out of a refrigerator
every day for a month. What if the patient leaves the pen out for too
long, or accidentally puts it in the freezer? What if the patient
wants to travel, and isn't meticulous about temperature control?
Some of these drugs are temperature
sensitive:
Drug delivery devices are used for therapeutic proteins, emergency medical drugs
1,
2,3,
4,
5, continuous
ambulatory infusion antibiotics
1,
2,
3,
4, chemotherapy
1,
2, and other small-molecule drugs. A number
of these drugs, in particular β-lactam
antibiotics such as the
carbapenems, are more temperature sensitive than standard pharmaceuticals.
The result, deteriorated drugs, and
sometimes even anti-drug antibodies:
In certain cases, patients receiving therapeutic
proteins by subcutaneous injection from drug delivery devices can have an
elevated risk of developing antibodies against the
biotherapeutic
1,
2,
3,
4,
5,
6,
7. In other cases, the drug may have lower therapeutic effectiveness.
The solution: build stability monitoring
into the drug delivery device. Fortunately there is a way to
address these issues -- incorporate LifeTrack stability monitoring
technology into the drug delivery device. The LIfeTrack technology can
continually monitor the storage history of the drug, and can warn patients
if the drug is unfit due to an improper thermal storage history.
LifeTrack
stability technology, incorporated into a prefilled pen delivery device
for a biotherapeutic or temperature sensitive drug. Here the "+"
on the pen's embedded LifeTrack LCD display lets the user know that the
drug is still OK to use. A generic pen can be made, and programmed
to fit multiple types of drugs.
LifeTrack
stability technology, incorporated into a continuous ambulatory infusion
device such as an insulin pump. Here the output from the LifeTrack
stability monitor is displayed along with the other pump parameters, and
can even be used to automatically shut the pump down in the event of
stability failure.
