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Container Closure and Delivery Considerations for Intravitreal Drug Administration.
Ashwin C Parenky1, Saurabh Wadhwa1, Hunter H Chen2
1Formulations Development, Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road Tarrytown, New York, 10591, USA.
AAPS Pharmscitech
|March 12, 2021
Summary
Intravitreal injections require careful container and device selection to ensure drug stability and accurate dosing. Optimizing these elements is crucial for preventing adverse events and improving treatment outcomes for back-of-eye disorders.
Area of Science:
- Ophthalmology
- Pharmaceutics
- Biomedical Engineering
Background:
- Intravitreal (IVT) injections are standard for back-of-eye disorders but face challenges in drug product, device, and procedure, potentially causing adverse events.
- Container closure systems are vital for drug stability, safety, and efficacy throughout the shelf-life.
- Accurate delivery of small volumes (10-100 μL) is critical; incorrect dosing can lead to variable clinical responses.
Purpose of the Study:
- To review the literature on container closure systems and devices for intravitreal administration.
- To identify key considerations for product development and administration procedures.
- To guide successful development of IVT therapeutics.
Main Methods:
- Systematic literature review of container closure and devices for IVT administration.
- Analysis of factors influencing drug product stability, safety, and efficacy.
- Evaluation of administration procedures and ancillary components.
Main Results:
- Traditional glass vials are being supplemented by pre-filled syringes for improved convenience.
- Critical product development aspects include container characterization, material compatibility, formulation stability, and sterilization.
- Despite improvements, ocular safety concerns like endophthalmitis and silicone floaters persist.
Conclusions:
- Careful selection and design of container closure systems and administration devices are essential for IVT therapeutics.
- Addressing challenges in drug product and administration can mitigate adverse events.
- A systematic approach to container closure and device development is necessary for safe and effective IVT drug delivery.
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