Formulation and analytical consulting for oral solid dosage forms.
Kace Sciences gives small molecule drug developers a senior scientist to own the program’s direction, from first prototype to commercial launch.
Strategy, study design, partner selection, and interpretation of the results. Both disciplines are run as one program — not two vendors passing a sample back and forth.
Formulation development
Dosage form design for immediate- and extended-release products — including the delivery systems that make a differentiated product possible — grounded in the molecule's actual behavior and in what will run on a press.
- i.Oral solid dosage form development, IR and ER
- ii.Osmotic and controlled-release delivery systems
- iii.Film and enteric coating development and troubleshooting
- iv.505(b)(2) and lifecycle formulation strategy
- v.Tablet compaction, tooling, and manufacturability
Analytical testing & method development
Method strategy and protocol design, with development and validation run at the partner laboratory — so the methods discriminate, hold up, and transfer.
- i.Assay and content uniformity methods
- ii.Stability-indicating method design
- iii.Dissolution method design & discriminating power
- iv.Forced degradation & stress study design
- v.Method troubleshooting & data review
The scientist who designs the formulation program also directs the analytical work that proves it — one point of accountability, with the bench work placed at partners chosen for the job.
For oral solid dosage programs
Drug developers building a tablet or capsule product who need senior scientific direction without hiring it.
Directed here, run at partners
Kace Sciences is not a laboratory or a CDMO. It sets the strategy and stays on the work; partner labs and manufacturers carry it out.
Sized to the engagement
From a focused formulation or method question to full development program support.
Discovery
A working session to understand the program and the actual question that needs answering.
Plan
A scoped plan: what will be studied, at which partner, what data it produces, and what decision it supports.
Execution
Work runs at the partner laboratory or CDMO under direct technical oversight, with data reviewed as it arrives rather than only at the end.
Report & handoff
A clear written report and a direct conversation about what the data means for the next step.
Kevin C. Edwards
Kevin has spent more than twenty-five years in pharmaceutical development, working on oral solid dosage products from bench formulation to commercial launch. His career runs through four vantage points on the same dosage form: specialty pharma at Shire Laboratories and Supernus, where he developed Oxtellar XR and Orenitram and is a named inventor on formulation patents; excipients and coatings at Colorcon and Dow; big pharma at Merck, where he led the scale-up and commercial launch of Prevymis, and at Organon; and tooling and equipment at Natoli Scientific, where he is currently Principal Scientist.
Kace Sciences is his independent practice — the judgment from all four seats, brought to bear on your program.
Start a conversation about your program.
A short note on the molecule, the stage, and what is not working is enough to start.