The drug delivery device is a critical component of the container and package system. Its ability to consistently and accurately deliver an intended dose to the patient plays a key role in patient safety and drug product efficacy. Manufacturers have a regulatory responsibility to ensure the product delivery devices meet specific standards of actual (intended) deliverable volume. Examples of package systems that incorporate delivery devices include:
- Dose Cups for Liquid Products
- Pre-Filled Syringes
- Auto Injectors
- Metered Dose Systems
- Graduated Syringes for Multiple Dose Levels
There is “no one size fits all” regulatory guidance document or prescribed test method that addresses the accuracy testing of delivered volumes and in many cases, test methods to verify accuracy of dose delivered and consistency of graduated markings must be developed and validated specific the product-package system. There are critical reference documents that play a key role in development of a custom designed test protocol that include:
- USP <698> Deliverable Volume
- USP <755> Minimum Fill
- USP <905> Uniformity of Dosage Units
- ISO 11608: Needle-based Injections for Medical Use
As highlighted in each of these methods, there are a number of factors that can impact the accuracy of the delivered dose. Density and viscosity of a liquid drug products effects flow rate and residual (non-delivered) volumes. Content uniformity and weight variation of a solid product will play a pivotal role in the actual volume of dose delivered to the end user.
While the USP <905> Uniformity of Dosage Units does not prescribe specific test methods, it clearly states that “To ensure the consistency of dosage units, each unit in a batch should have a drug substance content within a narrow range around the label claim.” The USP <698> Deliverable Volume chapter provides more detailed test steps and addresses product type (solid or liquid) and outlines specific parameters that may impact volume discrepancies.
The CS Analytical team has the experience and knowledge across multiple product types and unique delivery systems to ensure an effective “dose delivery” test program can be developed and implemented specific to your drug products. The laboratory is equipped with all the necessary tools required to include a variety of NIST traceable standards, balances covering a range of weight requirements, and enhanced digital and optical measurement systems that ensure quality control testing of dose and delivered volume accuracy exceeds regulatory expectations to safeguard patient safety.