The dosage form is a bit like the end of a long road that winds through discovery, API scale-up, preclinical, and regulatory. In one form it is what the first clinical subject will receive and in a form that may be quite different it is what the retail pharmacist will eventually dispense. PharmaDirections will help you make the most out of it at every step.
Dosage Form Strategy
How much work should you put into dosage form development at each stage? For an oral drug, Phase 1 trials can be conducted with powder in a bottle or a capsule, but that is not always the fastest, cheapest path in the long run. For other routes of administration some formulation work is required, but it may or may not be wise to put in a lot of effort early on. Every project is different, and it takes a lot of experience and knowledge to choose the best path.
The reality is that “easy” drugs are getting harder to come by. You don’t need much expertise to formulate a stable and highly soluble compound, but if you need to inject “brick dust” or get bioavailability to a reasonable level or attain a release profile gets you away from multiple daily doses, you need an expert to guide the development work.
Getting your product approved is not necessarily the end of the road. PharmaDirections will help you develop follow on products, such as controlled release dosage forms, to extend your edge on the market.
Drugs take a long time to get onto the market, and by the time you get there, the patent life on your compound may be looking pretty slim. If you are repurposing an old drug, as many of our clients are, you may be starting with little or no protection from competitors. PharmaDirections has a long history of generating dosage form-related patent protection to ensure the valuation of your asset. Read more on our Intellectual Property page.
Predictive Pharmacokinetic Modeling
PK modeling is a powerful tool in dosage form design and in generating solid IP to protect your product. It is not always obvious what release profile will yield the optimal plasma concentration profile, and using modeling to figure this out opens up opportunities to not only design the best dosage form but also to generate a strong patent position around it. Read more on our Pharmacokinetic Modeling page.