Cambridge Consultancy unveil drug device guidelines

A leading US business consultancy company has developed a set of new guidelines aimed at developing single-use injection devices capable of reconstituting a lyophilised drug.

The "Reconstitution Injection Device Requirements Specification" from Cambridge Consultants provides a template for drug delivery devices and pharmaceutical companies developing reconstitution injection devices.

The guidelines help these companies document these 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 lyophilised 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 and reliable efficacy, and with the emerging biopharmaceuticals, protection against peptide denaturation caused by temperature changes, which is important where the device will be used in the home setting or the distribution cold chain cannot be guaranteed.

"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. "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."

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 inefficient or aggressive mixing.