Strategy. Development. Execution. Done.
Dosage Form Strategy
How much work should go into dosage form development at each stage? For an oral drug, Phase 1 trials may be conducted with powder in a bottle or a capsule, yet that is not always the fastest or least expensive path in the long run. For other routes of administration, formulation work is often required, but it may or may not be wise to invest a lot of effort in the early stage.
Every project is unique and requires experience and knowledge to know which path to take, which is where we come in and provide support.
It doesn’t take much expertise to formulate a stable and highly soluble compound. But when a project requires you to inject brick dust, achieve a reasonable level of bioavailability, or attain a release profile that prevents multiple daily doses, you need a formulation expert to guide development early in the process. We are that expert!
Getting your product to approval does not always mean that you’ve crossed the finish line. PharmaDirections will work with you to develop follow-through opportunities such as controlled release dosage forms, extending your edge on the market.
Drugs take a long time to get to market and by this time, the patent life on your compound may be looking pretty narrow. Also, if you are repurposing an old drug, as many of our clients are, you may be starting with little or no protection from competitors.
Our team has a long history of generating dosage form-related patent protection to ensure the continued valuation of your asset. Read more on our Intellectual Property page.
PK modeling is yet another powerful tool in dosage form design as well as in IP generation designed to protect your product.
Early on, it is not always evident what release profile will yield the optimal plasma concentration profile. Relying on PK modeling opens opportunities to not only design the best dosage form but also generate a strong patent position around it. Read more on our Pharmacokinetic Modeling page.