Injectable formulation is the development of a drug product for entrance to the body via an injection.
Delivery via an injectable route is often the preferred method when rapid absorption is required, to avoid first-pass metabolism via an oral route, or when patient adherence needs to be ensured. When delivering a drug via injection, the most common routes are;
- Intravenous (injection directly to the bloodstream)
- Subcutaneous (injection into the subcutaneous fatty layer under the skin)
- Intramuscular (injection into the muscle)
- Intradermal (injection into the dermis, the middle layer of the skin)
When injecting a drug into the human body, there are many different stresses imposed which may influence its overall bioavailability in vivo.
The challenge for scientists is understanding what happens upon injection in vivo in humans, why this happens, and what this may mean for the drug performance. Pion aims to answer these questions.
When formulating a sample for injectable administration, it’s important to look at the pharmacokinetic (PK) and Pharmacodynamic (PD) properties of a drug, as well as the interplay between possible precipitation events, dissolution, and absorption, and the overall drug efficiency, can be predicted.
Pion’s instruments provide a variety of techniques to help with this, ranging from a platform directly simulating subcutaneous injection stresses in vitro to an instrument helping scientists understand the ‘why’ factor after injection by knowing the physicochemical properties of their drug as well as platforms to investigate solubility and dissolution.
Our solutions are designed to simulate the stress conditions and environmental transitions that a biopharmaceutical, peptide or small molecule drug experiences when injected into a subcutaneous environment. These include chemical stresses - such as buffer composition, pH change and loss of excipients - and physical stresses - such as temperature and pressure changes. With that considered, there are also non-specific interactions with extracellular matrix components and aggregation events to contend with upon injection.