Developing Drug /
Device Combination Products : Concept to Commissioning
Dr. Atul Sardana,
Chairman,
Alfa Corpuscles Pvt. Ltd., New Delhi |
Definition of Drug/ Device
Combination • A Drug
Device combination is a product comprising of active
pharmaceutical ingredient(s) and a medical device that
are physically or chemically combined to produce a
single product.
• Such combination products are emerging as innovative
medical products due to their contribution in
advancing medical care and are thus expected have an
impact in the coming years.
• These offer several advantages including reduced
adverse/side effects, improved patient compliance,
controlled release of drugs and targeted drug
delivery, overall reduction in healthcare expenses and
augmented performance. |
Classification of Drug/ Device Combination
• “Single Entity” or “Integral” product comprises of two
or more different regulated components (drug/device)
that are physically, chemically, or otherwise combined
or mixed.
• “Co-packaged” or “Kitted” unit in a single package
comprising of drug(s) and device(s).
• “Cross-Labelled” comprise of drug(s) or device(s)
packaged separately that according to its
investigational plan or proposed labelling is intended
for use only with another individually and where both
are required to achieve the intended use, indication, or
effect.
Examples of Drug/ Device
Combinations |
“Single
Entity” or “Integral”
• Prefilled Drug Delivery Systems
- Prefilled syringes
- Prefilled autoinjectors
- Prefilled pen injectors
- Prefilled on-body delivery systems
- Dry-powder inhalers
- Metered dose inhalers
- Prefilled nasal sprayers
- Transdermal patches
- Oral Vaccine Delivery Devices |
• Medicated
Devices
- Drug-coated stents
- Drug-coated catheters
- Drug-coated pacemaker leads
- Antimicrobial surgical scrubs
- Antimicrobial wound dressings
- Antimicrobial Sutures
- Drug impregnated surgical mesh
- Antibiotic bone cements
- Spermicidal condoms |
Examples of
Drug/ Device Combination
“Co-packaged” or “Kitted”
• Convenience kits
- Surgical trays with anaesthetic and/or surgical
scrub
- Vial and syringe packs
- Injector pen with userloaded prefilled cartridge
- Liquid medication with dose- dispenser |
• Other
- Collagen sponge with bone morphogenic protein
“Cross-Labelled”
• Companion diagnostics
• Photodynamic therapy (laser activated drug)
• Contrast agent and diagnostic imaging
• Iontophoretic delivery systems |
The Development of Drug/ Device Combination entails the
following steps :
1. Unmet Need Identification
• A Device may require a drug to
• Improve its Safety especially over long term
implantation or when being placed in pathological
conditions or challenging environments within the body.
• To augment the function of the device by providing
synergy
• To enhance the efficacy of the device by suitably
modifying the local or systemic conditions
• To reduce device associated co-morbidities and
complications.
• A Drug may need a Device in order to :
• Ensure or regulate proper dosing
• To provide a constant rate of drug elution and
sustained release
• To monitor drug release and concentration levels as in
a loop feedback
• Improve patient compliance
• To ease administration and make self administration
possible.
• To enhance the shelf life of the drug
• To reduce filling and administration losses and drug
contamination
• To improve drug safety
• To provide targeted drug delivery
2. Design Development
Design development of a drug device combination needs in
depth understanding and critical analysis of the
following :
• Understanding the drug device Interphase with the body
• Understanding the interactions between the drug and
the device throughout the product life cycle
Raw Material Selection for the device is based on the
following criterion that need to be evaluated in all
phases of the product development and use.
• Leachable interaction with the body and the drug
• Extractable interaction with the body and the drug
• Additives and Coatings to be used on the device and
their interactions with the drug.
• Barrier Properties of the Material and effects of
oxygen, moisture and other gases on the drug.
• Stability Testing of Drugs in the drug device
combination
• The effect on drug(s) on Polymer(s) properties and
function
• DMPK (Drug Metabolism and Phamacokinetics) Study
• Shelf life study and accelerated ageing of the drug
device combination
• Method of sterilization to be used for the combination
with respect to drug stability.
• Prototyping challenges for drug device combination
usually preclude 3D printing as the combination needs to
be tested with actual polymer proposed. Though it may be
used for mechanical and dimensional validation.
• A thorough understanding by the devices manufacturer
is required with regards to the drug filling lines and
due consideration should be given to the environmental
challenges of the aseptic conditions to be maintained. |
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