Medical Plastic Data Service Magazine

 
 

A TECHNO-ECONOMIC NEWS MAGAZINE FOR MEDICAL PLASTICS AND PHARMACEUTICAL INDUSTRY

Our 32nd Year of Publication
Page  1 of 3

 

Cover Story

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.

Advertisers' Index

Accuprec Research Labs Pvt. Ltd., India
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