We have the experience to evaluate the results of preclinical testing to determine how to best formulate a drug for its intended clinical use. You have probably already tested absorption and degradation ex vivo.  If you now need assistance deciding the route to go with for ease at which the chemical characteristics of the compound mesh with the desired delivery route and ability to reach the specific systemic target or even specific cell type.

Regulatory agencies require testing that documents the characteristics — chemical composition, purity, quality and potency — of the drug’s active ingredient and of the other chemical substances that must be included for optimal delivery.  Drug formulation and delivery technologies modify drug release profile, absorption, distribution and elimination for the benefit of improving product efficacy and safety, as well as patient convenience and compliance.

The choices you must consider in optimizing the formulation of your compound could be one or more of the following characteristics: diffusion, degradation, and affinity-based mechanisms.  Most common routes of administration include the preferred non-invasive mouth, skin, or transmucosal.  Pharmacokinetics/dynamics are generally accomplished starting with the least expensive, easiest preclinical protocols after your cell culture work to monitor compartmentalization and elimination in vivo.  This is a service we can provide either just at the consulting level or deciding at which point you will want protocols outsourced from your lab.

Similarly, Medical Devices must be carefully designed to deliver optimal therapeutic benefit to the patient while also providing ease of use and appropriate durability.