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About Plastic
Materials, Components &
Packaging Used For Drug Device Combination Medical
Devices
Combination products are becoming increasingly important
and are predicted to become market leaders in the future
with the growing trends towards home healthcare and
self-care. It is to improve patient outcomes, reduce
length of hospital stays, reduce procedure times and
promote recovery. It is believed to reduce practitioner
errors.
As per US FDA, Combination Products are therapeutic and
diagnostic products that combine drugs, devices, and/or
biological products.
An array of combination products fall into various
categories including Cardiovascular, Non-Cardiovascular,
Urological, Bone Treatment, Antimicrobial Treatment,
Cancer Treatment, Ophthalmic Treatment, and Diabetes
Treatment and more. Some of commonly used products
include prefilled syringes, pen injectors, inhalers,
drug-eluting stents, orthopaedic products, infusion
pumps, wound care products, transdermal patches, and
more.
The maturity of combination products as a market
category has led to 3 key global trends: expanding
adoption of medical devices for drug delivery,
increasing complexity and growing awareness of product
experience and risk. Integrated product risk management
enables robust product development and manufacturing
strategies as well as efficient regulatory pathways.
Complex generic drug-device combination products are
typically difficult to develop, which means that many of
these products face less competition than non-complex
products, and therefore can be more expensive and less
accessible to the patients who need them.
Combination products are developed using plastics raw
materials to which active pharmaceutical ingredients
(APIs) are added during the manufacturing process.
The complex combination of polymers and plastics
materials with APIs can often be achieved only by
overcoming a variety of technological challenges
associated with determining drugelution rates,
preventing mechanical stresses, and avoiding excessive
heat.
Solving these issues requires not only expertise in
unifying materials and drugs but also the active
collaboration of materials experts and medical device
manufacturers.
The addition of a drug to a medical device can greatly
enhance the safety and efficacy of products, providing
differentiated product performance. Drugs have allowed
devices to last longer in the body, perform therapeutic
actions more effectively, and mitigate unwanted effects.
As long as drugs continue to improve the safety and
efficacy of both existing and novel medical devices,
combination products will remain an area of significant
growth.
Since combination products involve components requiring
different types of regulatory authorities, they raise
challenging regulatory, policy, and review management
challenges. Differences in regulatory pathways for each
component can impact the regulatory processes for all
aspects of product development and management, including
preclinical testing, clinical investigation, marketing
applications, manufacturing and quality control, adverse
event reporting, promotion and advertising, and
post-approval modifications.
Plastics Materials & Components Used In Drug Device
Combination Products
Drug-device combination products (DDCs) can include a
variety of plastics, including those used for packaging
and other components.
Plastic parts used in these products are made up of
multiple components, combine multiple products, or may
only use a specific separate drug or device.
Medical device manufacturers and design engineers can
greatly narrow the field of polymer alternatives by
carefully arriving at end-use requirements and matching
performance requirements with polymer capabilities. This
helps them to focus on other critical aspects of
bringing a device to market.
Apart from performance properties including
disinfection or sterilization requirements, the most
important material consideration is biocompatibility
(ISO 10993 test results). The selection of materials
also depends on on the level and duration of body
contact. Raw materials suppliers are not required to
submit Master Access Files, but many have done so to
help bolster their customer’s confidence in using their
materials for medical device applications.
It is important to consider the potential interaction
(desired or undesired) between the device and the
drug/biological constituents. For example, it may be
required to conduct studies to evaluate the potential
for the following:
• Leachables/extractables of the device materials
including plastics into the drug/biologic substance or
final combination product;
• Changes in stability of the drug constituent when
delivered by the device or when used as a coating on the
device;
• Drug adhesion/absorption to the device materials that
could change the delivered dose;
• Presence of inactive breakdown products or
manufacturing residues from device manufacture that may
affect safety, or device actions that could change the
drug performance characteristics at the time of use; or
• Changes in the stability or activity of a drug
constituent when used together with an energy emitting
device.
Likewise, similar consideration should be given to the
effects a drug or biological product may have on the
device constituent. For example, the plastic material
properties of a delivery catheter may be adversely
affected by some drug/biologic products but not others.
Partnering with the manufacturer during the design
process, or working with a device development company that
truly understands manufacturing, ensures early concepts
aren’t reliant on component features that can’t be
produced in higher volumes. When making a single, or a low
volume of components, smaller tolerances can often be
achieved. However, in higher volumes, more variation is
inserted into the manufacturing process. Plastic materials
used in products like Drug-eluting stents, implantable
drug delivery devices and the packaging needs of
Drug-Device Combination products are discussed below.
Drug-eluting stents
These stents are coated with a thin, non-degradable
polymer, such as poly-isobutylene or polymethacrylate, to
control the release of a drug. More biodegradable
polymers, like poly-lactic acid or
polylactide-co-glycolide, are also being developed. |
