Comprehensive Assessment of Drug-Coated Stents Packaging Barrier Properties

Drug-coated stents (DCS) have transformed the treatment of coronary artery disease, significantly reducing the risk of re-narrowing after angioplasty. The effectiveness of these life-saving devices depends not only on their intricate design and controlled drug delivery, but also critically on the integrity of their packaging.

Given the inherent sensitivity of the drug coating, drug-coated stents packaging is of paramount importance. It must provide a robust shield against environmental factors, notably moisture and oxygen, which can degrade the drug and compromise its therapeutic efficacy, and maintain sterility as drug-coated stents are implanted medical devices susceptible to contamination.

DCS packaging employs a combination of specialized materials designed to ensure both protection and sterility. Foil pouches, renowned for their exceptional barrier properties, are frequently utilized to effectively prevent moisture and oxygen ingress. Thermoformed trays are employed to securely hold and protect the delicate stent from physical damage during storage and transport. Medical-grade polymers are used for internal trays and protective layers, adding an extra layer of safeguarding for the sensitive device.

To guarantee the safety and efficacy of DCS, their packaging must adhere to stringent quality standards. The packaging must exhibit exceptional barrier properties, effectively preventing moisture and oxygen from permeating and degrading the drug coating. The packaging must provide robust physical protection, safeguarding the delicate stent from damage during storage and transport.

To validate these requirements, rigorous testing is conducted, focusing on:

• Moisture Vapor Transmission Rate (MVTR): This test quantifies the rate at which water vapor permeates the packaging material, directly assessing its effectiveness in preventing moisture from reaching and potentially degrading the sensitive drug coating on the stent.
• Oxygen Transmission Rate (OTR): This test quantifies the rate at which oxygen passes through the packaging.It ensures the packaging's effectiveness in preventing oxidation and degradation of the drug.
• Seal Integrity Testing confirms the strength and reliability of the packaging seals.Methods like dye penetration, burst testing, and vacuum leak testing are employed.

These tests, conducted under controlled conditions, provide critical data to ensure the packaging's ability to maintain the stability and efficacy of the DCS throughout its shelf life.

Labthink C403H Oxygen /Water Vapor Transmission Rate Test System is based on the testing principle of Coulometric oxygen sensor and infrared water vapor sensor. It is designed and manufactured according to ASTM D3985、ASTM F1249，ISO 15106-2 and others to provide high precision and high efficiency OTR and WVTR tests for high barrier materials. It is suitable for testing the oxygen and water vapor transmission performance of films, sheets and related materials in the fields of food, medicine and medical devices.

Drug-coated stents represent a significant advancement in interventional cardiology. Rigorous barrier testing and adherence to stringent quality requirements are essential to ensure these life-saving devices reach patients in optimal condition, delivering the intended therapeutic benefit.