Technology

Our formulation technology platforms enable injectable products that are easier to use for patients and caregivers while reducing costs for payors and the health care system.

The Xeris Solution for Conventional Formulation Limitations

Our proprietary formulation platforms

XeriSol®     XeriJect®

These non-aqueous formulation platforms address the limitations of aqueous formulations by delivering ready-to-use, highly stable, highly-concentrated and easily injectable solutions and suspensions.

HIGH STABILITY

READY TO USE Injectables

No reconstitution or resuspension required.

ROOM-TEMPERATURE STABLE

No refrigeration required for most small molecules and peptides, and some biologics.

HIGH CONCENTRATION

SMALL INJECTION VOLUMES

Improved solubility and particle packing.

CONVENIENT SELF-ADMINISTRATION

Rapid subcutaneous (SC) or intramuscular (IM) administration through standard delivery systems.

Our biocompatible non-aqueous injectable solutions and suspensions can be delivered through various commercially available container closure systems.

Vial
Single-use auto-injector
Prefilled syringe
Multi-dose pen

XeriSol® enables ready-to-use, room-temperature stable, small-volume solutions of poorly soluble or unstable SMALL MOLECULES and PEPTIDES

How it works

  1. A peptide or small molecule formulation is created at an optimal, specific ionization profile. This allows the molecule to remain soluble at high concentrations.
  2. The aprotic, polar solution prevents aggregation and fibrillation of the drug substance, enabling its stability in solution.
  3. When a ready-to-use XeriSol formulation is injected into a patient, it is effectively placed back into an aqueous environment, where it behaves appropriately.

XeriJect® enables small-volume, ready-to-use, non-settling, self-administerable suspensions for rapid SC or IM delivery of large doses of BIOLOGICS

How it works

  1. Specialized particle engineering techniques are employed to create powders for optimal drug loading.
  2. The powders are “wetted” with biocompatible diluents, creating ultra-concentrated, ready-to-use, injectable viscoelastic suspensions.
  3. The viscoelastic suspensions can be administered IM or SC, using syringes, autoinjectors, pen-injectors and on-body injectors.

We have successfully tested XeriJect® on multiple large molecules, including monoclonal antibodies and proteins, consistently producing stable, non-settling and easily-injectable suspensions at concentrations in excess of 450 mg/mL, which far exceeds the capabilities of current aqueous formulation systems that operate in the range of 50-250 mg/mL.  We have further tested our XeriJect® suspensions in multiple animal models, demonstrating excellent safety and tolerability, and aqueous-like pharmacokinetics.

Conventional Formulation Limitations

Injectable pharmaceuticals typically rely on aqueous solutions (primarily water) to deliver drugs and biologics (liquid parenterals), but many drugs and biologics have low solubility in water and are not stable. There are a number of conventional approaches to addressing these barriers.

LOW STABILITY

Reconstitution

Products are freeze-dried into a powder that must be reconstituted with a liquid diluent prior to use. This is often a challenging multi-step and time consuming procedure, especially in emergency situations.

Refrigeration

Reconstituted products may either need to be used immediately or refrigerated because they begin to break down once combined with water.

LOW SOLUBILITY AND INJECTABILTY LIMITATIONS

Complicated formulations

Products may require a complicated formulation process and additional excipients to make them soluble.

LARGE injection volumes

Products may require doses and injection volumes that are too large for SC or IM delivery and therefore necessitate intravenous (IV) infusion.