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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.

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Drug Developers

We have seasoned experts in many different therapeutic moieties and indications that will strategize and build a full-spectrum team around your innovation to push it forward, into patients and toward approval.

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Program Managers

Our Program Leaders and Project Managers drive the execution of coordinated campaigns from drug discovery to preclinical research to clinical trials.

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Drug Discoverers

Our experts design and execute a variety of studies aimed at rational lead selection and optimization based on pre-established target product profiles.

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CMC Experts & Quality Managers

From sourcing starting materials to formulating your drug product, we provide expertise in chemistry, biology, formulation and manufacturing of both small and large molecules.

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Preclinical Experts

We design and oversee the in vivo and in vitro studies you need to assure regulators your molecule is safe enough to treat humans.

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Predictive Pharmacokinetic Modelers

We analyze PK data and use sophisticated computer tools to design dosage forms and optimize dosing regimens.

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Regulatory Experts & Managers

Our seasoned experts have helped advance countless new and repurposed drugs from investigational applications (e.g. INDs) through to marketing approval in the U.S. and abroad.

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Intellectual Property Inventors

Patent applications are part of regular routine. We generate your IP but we take no ownership stake in it.

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REQUEST A CONSULTATION

Contact Cathi Clark, our VP of Business Development to Get Started!

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