Reconstitution made fast and simple with nextaro®

Simplifying the reconstitution of lyophilized pharmaceutical drugs

With the nextaro ® product line sfm has introduced a new solution to optimize the reconstitution of lyophilisates. The modular design that is exceptionally straightforward and safe to use makes nextaro® highly customizable to meet the individual requirements of each drug.

Challenges in reconstituting sensitive active ingredients

Highly sensitive pharmaceutical and biotechnological active ingredients can be damaged by sunlight, oxygen, fluctuating pH values, heat and numerous other factors. Many of these ingredients are preserved by freeze drying, also known as lyophilization, enabling them to be stored and kept stable for several years. Protein-based active ingredients that offer inadequate bioavailability when taken orally must normally be administered by parenteral (subcutaneous, intramuscular or intravenous) means. Freeze-dried drugs therefore need to be reconstituted before they can be administered to the patient by injection. Lyophilisate reconstitution is usually a highly complex and error-prone process. It requires particular care in order to avoid undesirable reactions when the reconstitution medium is added. Reactions can either be visible (increased clouding or discoloration of the solution, emergence of visible particles) or concealed (protein denaturation, oxidation, photolysis). Frothing often presents a particular challenge when dissolving the lyophilisate. Furthermore, many different materials are needed for the process, such as syringes, needles and filters, making it extremely complex and time consuming.

Reconstitution made fast and simple with nextaro®

With today’s market needs in mind, sfm medical devices GmbH has developed a new solution, nextaro®, that offers exceptional user convenience and simple handling. nextaro® is an integrated product containing most of the components needed to effectively and efficiently reconstitute lyophilized drugs. The transfer device facilitates the reconstitution process by reducing the number of individual products usually required, such as transfer needles and filters. The device transfers water or other solvents from one vial through a filter to a second vial that contains the lyophilized preparation. The transfer device is first attached to the solvent vial and then to the agent vial. The solvent is transferred and the ingredient reconstituted. The device can then be swirled in a gentle manner prior to removing the upper part of the nextaro® device by unscrewing the two halves. Finally, a single-use syringe with a Luer adapter can now be used to draw up the prepared drug solution through an additional integrated filter.

The reconstitution device offers numerous advantages compared to the conventional procedure. Since nextaro® combines multiple products in one, it is exceptionally easy to use and saves time. The filtration, as the solvent is transferred and during the aspiration of the solution, is carried out via two separate integrated filters. This ensures optimum protection against particles and eliminates the need for separate filters. The patented, ergonomic, robust, and user-friendly design with its threaded closure that prevents overtwisting makes nextaro® intuitive and safe to use, not just in clinical situations but also for at-home care and whenever speed is important. This needle-free product has a sturdy design combined with co-injection molded components that provide optimized haptics, making it easier to use for people with impaired dexterity. With its modular design, nextaro® can be adjusted to the customer’s specific needs and those of the relevant drug. This means that the device can be equipped with filters using different separation rates and materials. Various flow rates and transfer speeds can also be set based on the viscosity of the liquid. This high-quality product is delivered in sterile packaging and must be disposed of after first use to prevent infection. nextaro® was commended for its user friendliness at the 2018 Pharmapack Awards, where it won in the category “Patient centricity and customization”.