The prefilled liquid syringe is becoming the preferred container-closure system for the industry due to its very easy-to-use, straight-forward, injection process. As a consequence of this, liquid formulations are subsequently being favored in the industry over lyophilized formulations as marketing and convenience considerations for the patient become more prominent. Unfortunately, however, many proteins and peptide products that are formulated into a liquid state are simply not stable enough to maintain their stability during refrigerated storage for extended periods of time and their respective shelf life is far less than similarly formulated lyophilized formulations.

While there have been numerous products introduced to assist in the reconstitution and delivery of lyophilized formulations, most have experienced limited commercial success due to the inherently difficult requirement of "mixing" or reconstituting the product prior to delivery, or due to complex and costly manufacturing processes.

In addition, the LyoTip™ device components have been designed such that standard, existing pharmaceutical manufacturing equipment and processes can be utilized to fill, lyophilize, close and finish the LyoTip™.

LyoTip™ technology will not only make lyophilized formulations as attractive as liquid formulations due to its comparable convenience feature set but will also maximize and realize the inherent benefits of lyophilized formulations, e.g., improved stability and shelf life.

At this time, most commercial lyophilized formulations developed for glass vial-stopper systems can also be used in the LyoTip™ device with little to no reformulation requirements. However, Integrity Biosolution stands ready and willing to assist you in the development or optimization of the formulation and lyophilization processes to maximize the benefits of the LyoTip™ device.