Commercialization of a SASY™ Safety Syringe for a Highly Viscous Lanreotide Injection

A big Indian pharmaceutical company required a safety syringe solution for its Lanreotide drug product.

The company sought a delivery system that could support a highly viscous deep SC injection, provide a passive safety mechanism, minimize dead volume, and offer an equivalent solution compared to the Lanreotide RLD (Reference Listed Drug) – such as same usability, etc.’ – already used in the market.

At the same time, the device needed to be designed in a way that does not infringe active patents around the originator delivery system.

DALIMED customized its SASY platform for this program, adapting the device to the specific characteristics of the Lanreotide formulation and to the requirements of a passive safety syringe for this therapy.

Lanreotide (the active ingredient in Somatuline®) is a long acting somatostatin analogue used to treat acromegaly and gastroenteropancreatic neuroendocrine tumors (GEP NETs).

It is administered via deep subcutaneous (deep SC) injection monthly in several dose strengths.

The formulation is a highly viscous, gel like depot.

It requires a slow manual injection of an 18G × 20 mm needle, creating a demanding set of constraints for a safety syringe solution.

The combination of high viscosity and deep SC route determines essential requirements for the device.

SASY-G1 is a passive safety device for 1 mL ISO glass prefilled syringes with staked needles.

It is designed to maintain the familiar usability of standard prefilled syringe, with no change to injection technique: the plunger is pressed in the same way.

At the end of injection, the syringe automatically retracts into the device and the needle is covered and locked for sharps protection.

For the Lanreotide program, these characteristics made SASY-G1 a suitable base. The platform already supported complete dose delivery and passive sharps protection, and it could be customized in terms of syringe&needle configuration, ergonomics and injection performance.

To meet the demands of Lanreotide, DALIMED implemented a focused set of engineering modifications:

• Syringe change The delivery configuration was adapted from a glass prefilled syringe with a staked needle to a polymer syringe with an appropriate connection for the 18G × 20 mm needle used for deep‑SC Lanreotide injection.
• Device design changes to fit the needle The SASY-G1 device was modified in length and size, and its external&internal components were adjusted, to accommodate the polymer syringe and the large‑gauge needle. Despite the increased size, the goal was to keep the device ergonomic and user‑friendly, preserving SASY-G1’s intuitive handling, complete dose delivery and reliable passive safety mechanism after injection.

Because an injectable Lanreotide product was already available on the market, the generic program followed an ANDA 505(b)(j) pathway in the United States, with this customized safety syringe included as part of the drug–device combination product.

DALIMED supported the partner by providing the device‑related documentation required for the submission, including development information, verification data and safety‑related materials.

In parallel, DALIMED prepared the customized SASY-G1 configuration for commercial manufacture, developing the molds and tooling and setting up the production line so that the device would be ready for supply at commercial scale.