Early Development

Salt/cocrystal screening to produce crystalline material 

Goal: Find a crystalline material to take into early clinical studies. 

Action:  Worked with client and CRO on salt/cocrystal screen, and with client and API manufacturer in China on crystallization studies of amorphous API (active pharmaceutical ingredient).  

Result: Found crystalline API forms suitable for early clinical trials.

Determination and scale-up of most stable form for early clinical studies 

Goal: Determine most stable form and work with team to produce desired form at scale for clinical trials.

Action: Monitored abbreviated polymorph screening work at contract laboratory, interacted with API manufacturers in India and China during scale-up, compiled data for intellectual property filing. 

Result: Produced kilogram scale Phase I clinical trial material.

Goal: Choose an amorphous solid dispersion of a poorly soluble drug for Phase I clinical studies. 

Action: Reviewed characterization and preformulation data on multiple amorphous solid dispersions to find suitable dispersion for early development, interacted with contract laboratory to put together the best characterization methods.   

Result: Found a number of acceptable amorphous dispersions for development.

Survey solid forms for development of pediatric formulation for early clinical studies 

Goal: Choose an acceptable solid form for a pediatric suspension formulation. 

Action: Reviewed data on known forms including multiple anhydrous, solvated, and salt forms to suggest acceptable form for the formulation. 

Result: Compiled all solid form data in easy to reference format and recommended a suitable solid form for the suspension formulation.

Late Development/Marketed Products

Characterization of a natural product for new regulatory filing 

Goal: Collect additional data on a natural product for differentiation of materials and correlation to performance. 

Action: Worked with contract laboratory to develop a step wise approach for the physical characterization of the matrix of the natural product and its effect on performance, along with the level of the active ingredient. 

Result: New characterization methods for the matrix employed to show sameness of the natural product.

Review of data for investment opportunity  

Goal: Determine if natural product/device combination is feasible for development. 

Action: Reviewed scientific documents and compiled a list of considerations for a regulatory filing. 

Result: Additional work suggested to ensure success of the investment.

Development of a quantitative solid form method for release of API in a marketed drug product

Goal: Develop a robust quantitative method for the desired form in the presence of two other crystalline phases. 

Action: Worked with the client and CRO to develop and validate a quantitative method to submit to regulatory agencies.

Result: A robust quantitative solid form method was developed for API release and sucessfully submitted to regulatory agencies.

Review of physical stability data for NDA filing 

Goal: Determine if crystal form changes had occurred during stability studies. 

Action: Reviewed long term API stability data and compiled a statement for the regulatory filing.

Result: Documentation for NDA filing provided on the results of the physical stability study.

Compilation of solid-state data for patent application

Goal: Determine and compile the requisite solid-state form data to be included in patent.

Action: Reviewed screening, characterization, and crystallization reports to find suitable data for filing; interfaced with characterization laboratory and patent atttorneys to compile relevant data for patent application.

Result: Patent application on multiple solid forms was written and submitted.