Unlike oral drugs, a significant number of injectables are supplied in powder form. These drugs have undergone a process called lyophilization, a type of drying process. Drugs in dry form are more stable at room temperature than drugs in solution or suspension.
The number of drugs supplied in lyophilized form has been growing at an increased rate over the past several years, mirroring the increase in the introduction of biological drugs. Because of stability and shelf life factors, therapeutic proteins must either be stored under special conditions or formulated to retain their efficacy from the time of manufacture until they are dispensed. Liquid protein drugs require refrigeration until dispensed – a distribution strategy referred to as the ‘Cold Chain’. Alternatively, proteins can be formulated as powders. These lyophilized proteins must be reconstituted prior to injection.
Currently only a small number of lyophilized drugs are packaged, or bundled, with reconstitution devices – most lyophilized drugs for injection are typically sold in vials packaged with a diluent syringe - but this number is expanding. While high cost-per-unit-dose drugs such as recombinant proteins can easily absorb the incremental cost of point-of-delivery reconstitution technology, for other drug types such as generic drugs the incremental cost of bundling a reconstitution device with the drug can be a major sales hurdle for device suppliers.
A growing number of drugs supplied in powder form are including reconstitution vial systems that incorporate a vial adapter or vial transfer device. Dual chamber drug cartridges and syringes go a step further and allow reconstitution to take place within the device immediately prior to injection.
For lyophilized drugs intended for self-administration, reconstitution must occur at the point of use. To address this requirement, a number of adaptive devices and systems have been designed to reconstitute lyophilized drugs immediately prior to delivery. Reconstitution time of powder for injection is affected by several parameters that must be precisely controlled to develop a product with short and reproducible reconstitution time, thus ensuring patient safety.
Detailed analysis of components and systems for reconstituting drugs at the point-of-care is included in a new and comprehensive report. The report – Drug Reconstitution at the Point-of-Care: Therapeutic Markets, Technologies, Strategies and Prospects – includes assessments of therapeutic market segments, market factors, as well as profiles of market participants.
Greystone Associates (greystoneassociates.org) is a medical technology consulting firm focused on the areas of medical market strategy, product commercialization, venture development, and market research. We assist medical and healthcare market participants in achieving their business objectives through the creation of detailed development strategies, product commercialization programs, and comprehensive market and technology research and analysis. Our market research publications are designed, researched and written to provide timely and insightful information and data on focused market segments, with the aim of providing market participants with the essential knowledge to refine and execute their marketing plans and financial targets.