Novel blister primary pack development

Challenge

Development of novel blister primary packaging in parallel with device technology to unlock innovative solutions for enhanced drug delivery performance.

Approach

Using our expertise in the development of drug devices, we have innovated the design of conventional mono-dose blisters to enhance the delivery performance for a range of dry powder and aqueous drug formulations.

Outcome

We develop and prove novel blister solutions through a combination of advanced analytical simulation, high-quality in-house blister prototyping and testing capability. Our cost-saving process has ensured that the development of blister containers can rapidly take place ‘under one roof’ in combination with the development of a device.

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Sector
Drug delivery

Services
Mechanical eng.
Analytical design
Rapid prototyping
POC testing

Innovation in blister design

During the development of new drug delivery technology, the conventional approach is to innovate around the device functions but to avoid novelty in the primary drug container. This caution is largely related to concerns around affecting the critical physical and chemical barrier properties that the drug container provides and the costs and timescales of developing and proving new solutions.

With fresh thinking around the physical design of the primary packaging it is possible to unlock smart solutions that enhance both the drug delivery performance while maintaining the critical drug protection properties of the blister.

Unit dose blisters are often used in combination with drug delivery such as in dry powder inhalers or specialist ophthalmic devices, where the amount of drug that is dosed is critical to the treatment regime. The drug formulation is packaged in sealed, cold-formed, aluminium-laminate blisters providing a protective barrier between the drug and the environment during storage. For these devices, the design challenge is often to develop reliable solutions for effective access and release of the drug from the blister packaging with maximum efficiency.

By considering the blister in combination with the device development we can create novel blister solutions to aerosolise dry powders and disperse liquids directly from a primary blister container within tightly controlled limits.

Our approach

We have established an in-house capability to rapidly create cost-effective, concept solutions and high-resolution blister prototypes that can be tested directly with target formulations. By designing unique features into the blister such as the addition of gauze layers, laser drilled features, pressurised cavities, or controllable bursting seals, we can improve the drug release and delivery performance.

During the development process we use analytical tools such as advanced finite element analysis (FEA) software and mathematical modelling to assess critical aspects of the design. The structure of the blister is examined to make sure that it can be formed and manufactured within the allowable stress levels of the material. This is crucial to highlight any future risk of ‘pin-holing’ and cracking which would compromise the integrity of the protective barrier between the drug formulation and the environment.

Once the design has been optimised, rapid prototyping of blister concepts begins using modular style rigs with bespoke but relatively low-cost forming and sealing tools. These are used to construct physical blisters for empirical testing. These high-fidelity prototypes allow key metrics to be measured such as the delivered mass and dispersion rate to inform further iterations and improve the design. Our state-of-the-art high-speed video captures plume/spray for analysis, including the characteristics of shape, size and velocity of the delivered medium.

The final component for a successful blister development programme is a close working relationship with suppliers. Over multiple projects, we have forged strong relationships with both foil and film manufacturers, laser micro-machinists and ultrasonic specialists. When a concept is ready to enter detailed design, good connections with multiple providers who specialise in production scale-up allows us to get early production input which further alleviates the risks involved with a novel blister development programme.

Primary packaging development programs always have inherent challenges associated with them. The team’s focus on early prototyping combined with analytical methods and strong supplier relationships allows us to de-risk the journey and to deliver excellent and robust solutions for our clients.
Brennan Miles, Head of Drug Delivery, Team Consulting