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Lyophilized Drugs Focus of Delivery Device Suppliers

Lyophilized Drugs a Focus of Delivery Device Suppliers as Point-of-Use Reconstitution and Self-Administration Converge

Greystone Research Associates Finds High-Growth Markets Hinge on the Ability of Users to Safely and Reliably Reconsitute Solid Injectable Formulations

(Amherst, NH) – The ability of a growing number of New Chemical Entities (NCEs) to have commercial value as therapeutic drugs rests in the capability of developers to create formulations that render them stable at ambient temperatures. Once created, end users – caregivers and patients – must have a way to reconstitute them prior to administration. These requirements have fostered two industry segments designed to address the growing need for creating powder forms of injectables, and for developing devices that allow them to be reconstituted simply and without introducing medication errors.

Growth in the number of injectable drugs supplied in solid form for reconstitution prior to administration is being driven by the increase in drugs based on biologicals. These drugs are typically unstable at ambient temperatures and to preserve their shelf life must be either stored at low temperature (the so-call 'cold chain') or processed into a form that will preserve their pharmacological efficacy until they are ready for use. Because the cost of transporting and storing drugs using refrigeration is expensive and requires constant temperature monitoring to insure that the drug has not been exposed to environmental conditions that render it unsafe for use as a therapeutic product, technologies such as lyophilization are becoming more prevalent.

The packaging and technologies developed and marketed for safe and reliable reconstitution at the point of administration are benefiting from this market trend. Innovation and growth in drug reconstitution systems is being driven by two significant markets. The first is the self-administration of injectable biologicals. Several innovative injection devices package the drug powder and diluent in separate chambers within a single device. This allows the patient to reconstitute medication without the need for handling, measuring, and/or separate mixing steps, and enables biological drug developers to create lyophilized drug products indicated for chronic conditions that can be self-administered safety and reliably.

Another important trend is aimed at improving the safety of cytotoxic drug reconstitution. The focus here is on antineoplastics, a class that includes alkylating agents and antimetabolites, to treat a wide range of cancers. Several companies are responding to this unmet need by commercializing systems for closed transfer of these drugs.

Detailed analysis of the devices and systems for reconstituting drugs at the point-of-care is included in a new and comprehensive report. The report – Point-of-Delivery Drug Reconstitution Systems - includes assessments of devices and therapeutic market segments, analysis of market factors, and profiles of market participants.

More information is available at

About Greystone

Greystone Associates 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.

Source: Greystone Research Associates

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