Cambridge Consultants offers med-tech industry guidelines for reconstituted drug injection device development

• Requirements specification document outlines performance, regulatory, and design requirements for new generation of reconstitution injection devices

A comprehensive set of technology, regulatory, design, standards and patient-usability guidelines for developing single-use injection devices, capable of reconstituting a lyophilized drug, is being released today by Cambridge Consultants.

The ‘Reconstitution Injection Device Requirements Specification’ provides a template for drug delivery devices and pharmaceutical companies developing reconstitution injection devices, helping to document their development processes and specifications in compliance with FDA or other regulatory requirements.  The specification document covers areas ranging from drug delivery performance requirements and technology factors affecting reconstitution, to safety, non-clinical performance and regulatory qualifications.

The growing market for reconstitution of lyophilized medication is driving the development of new approaches for easy-to-use reconstitution and injection devices.  In an increasingly competitive marketplace, pharmaceutical companies are seeking delivery systems that offer longer shelf-life, reliable efficacy, and address many of the stability issues, such as protection against peptide denaturation caused by temperature changes.  This is important where the device will be used in the home setting or the distribution cold chain cannot be guaranteed.

The challenge, addressed in this new document from Cambridge Consultants, is creating simple, cost-effective, and reliable approaches to reconstituting and mixing the lyophilized drug with diluent and simplifying, or eliminating the need for the transferal of the reconstituted drug into a syringe or delivery device.

“Pharmaceutical companies are increasingly exploring device developments as a means of adding patient value and differentiating their drugs in an increasingly competitive arena,” said Ian Mawhinney, vice president at Cambridge Consultants, Inc.  Regulating the exact amount of diluent in the mix, and ensuring the drug is properly dissolved can affect dosage and efficacy.  Simplifying or reducing the number of material handling and mixing steps for patients self-administering the treatment will reduce errors and increase patient compliance.  “Pharma companies have long realised that patient compliance and performance are key to the success of their product.  Ensuring the effectiveness of the delivery device is therefore critical,” continued Mawhinney.

One approach to these new devices is a pre-dosed dual syringe that stores both the lyophilized drug and diluent in separate chambers, and accurately and reliably mixes the elements in the syringe just before use.  This greatly improves shelf-life and reduces the possibility of denaturing the drug through aggressive mixing.

“This requirement specification document incorporates the best practices we’ve assembled, developed and employed at Cambridge Consultants with our clients.  It will guide development managers to consider all relevant steps at the start of the project and act as a platform to develop improved devices that meet regulatory requirements,” said Mawhinney. 

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About Cambridge Consultants

Cambridge Consultants develops breakthrough products, creates and licenses intellectual property, and provides business consultancy in technology critical issues for clients worldwide. For nearly 50 years, the company has enabled its clients to turn business opportunities into commercial successes, whether launching first-to-market products, entering new markets or expanding existing markets through the introduction of new technologies.

With a team of over 250 engineers, designers, scientists and consultants, in offices in Cambridge (UK) and Boston (USA), Cambridge Consultants offers solutions across a diverse range of industries including medical technology, industrial and consumer products, automotive, transport, energy and wireless communications. For more information visit: www.CambridgeConsultants.com

Cambridge Consultants is part of the Altran group of companies. Altran Technologie, which is listed on the Paris Stock Exchange (FR:003463), employs over 17,000 consultants in 20 countries around the world. In 2006 the group generated a turnover of €1,495.6 million. For more information visit: www.altran.com