Expert Injectable Pharmaceutical Formulation Development
Moving your lead candidates from research and development to clinical formulation comes with unique challenges, especially if your drug is a pharmaceutical injectable. Our team provides you with expert support no matter the route of administration.
We integrate molecular properties with formulation, delivery, and device systems to create patient-friendly products with optimal market potential.
ROUTES OF ADMINISTRATION
Subcutaneous administration involves an injection under the skin. This method is becoming an increasingly popular administration choice because it improves patient compliance and extends a therapeutic’s patent. When developing a subcutaneous injectable, you must ensure that your therapeutic remains stable under various constraints, including volume, pH, osmolality, and viscosity.
Intramuscular administration involves a deep injection into the muscle tissues that is rapidly adsorbed. Selecting an appropriate injection site is crucial for effective medication absorption and minimizing discomfort. Instramuscular injections are most often used for vaccines.
Most pharmaceuticals are administered systemically via intravenous infusion (IV). It is critical that your drug substance is compatible with the diluent to ensure accurate dosing and limit immunogenicity. As new safety guidelines are introduced, it's important to assess the need for additional tools, such as closed system transfer devices (CSTDs), when administering biotherapeutic products clinically.
LONG-ACTING INJECTABLES (LAIs)
We have formulated scores of peptides with tailored sustained-release profiles ranging from weeks to months.
Our team has successfully developed LAI insulin lipid and liposomal formulations. We have also partnered with clients to develop stable insulin formulations paired with glucose-responsive implantable devices.