Offered as part of our complete supply chain solution, masking or blinding your clinical trial supplies removes investigator and patient bias and limits a potential placebo effect.
Our over-encapsulation solutions can accommodate the ever-expanding range of tablet and capsule dosage forms in development. Through our vast experience and innovation, we are pioneers in the area of blinding inhaler devices for respiratory clinical studies.
We have a multitude of blinding possibilities and our team of experts are here to provide you with the best solution for your clinical trial.
Our expert solutions provide the knowledge and expertise so many of our clients have come to rely on:
- Extensive experience across a range of investigational products
- Expertise in over-encapsulation and inhaler blinding
- Consultancy on challenging scenarios such as vials, IV bags and syringes
- Solutions for challenging products
- Sourcing of comparator products and management of your packaging and distribution strategy
Download our ‘Blinding of Investigational Products’ eBook – Part 1 of Almac’s ‘Clinical Knowledge Sharing Series’.
Blinding innovator and comparator medication
We have the global capability and resource for the over-encapsulation of both innovator and comparator medication. Taking it a step further, we can also guide you in design and offer quick, actionable solutions to suit your study’s needs.
As part of our clinical packaging solution, a downstream assessment of your primary and secondary packaging options is offered – enhancing patient compliance, reducing waste and optimising the packaging campaign strategy.
From single tablet filling through to multiple mixed input units and controlled powder and excipient dosing, we have a range of state of the art, fully or semi-automated lines to fit your processing requirements:
- Fully automated over-encapsulation equipment with controlled powder filling
- Semi-automated, intermediate scale over-encapsulation lines
- Production of complex blinded comparators (1/2 tablets through to multiple mixed units)
- Production of placebo capsules
- Global capacity for efficient manufacturing of large and small-scale batches
- Accurate powder filling of placebo capsules to milligram doses, including accurate filling of inhalation capsules
- Automated de-blistering, high throughput check weighing, de-dusting and metal checking equipment to guarantee a quality product
- Global capacity for efficient over-encapsulation of small and large-scale batches
- Analytical services for stability testing, method development and validation
Over 20 years’ experience in supplying blinded or converted inhalation devices
The global market has a growing need for inhaled respiratory products and many comparative clinical studies against marketed products need to be conducted. When there is a marked difference between the devices, often a double dummy design is employed.
Within our pioneering innovator service, we offer blinding or conversion to placebo for many inhaler device types. When combined with our on-site analytical and QP services, our service is truly integrated and unique.
Devices and services include:
- MDI (metered dose inhaler)
- DPI (dry powder inhalers)
- DPI – capsule based
- DPI – reservoir based
- Various other formats
- Both blinding and conversion to placebo
- Innovator processes to disassemble / reassemble devices
- Production of specialised blisters in low RH for use as placebo
- Analytical services and testing to prove compliance
- Comparator procurement
Our knowledgeable specialists are available to provide guidance for your blinding or conversion, as we know that careful assessment is required for each device type.