Form and Formulation
At Sygnature Discovery, we’re not just a lab or another pair of hands.
We’re a specialist development partner with decades of early-stage drug development expertise which can be accessed to help you rapidly progress your candidate compounds through all stages of preclinical studies and de-risk entry into clinical development. We can work with you as part of an integrated project, or stand alone.
Our talented team of scientists can help you create robust preclinical development strategies tailored to the characteristics of each individual API and through access to our well-equipped form and formulation development laboratories rapidly and unbiasedly identify the most phase-appropriate development approach to overcome even the most complex of bioavailability challenges.
De-Risk Your Early Phase Programs
Rapidly Assess Molecule Developability, Investigate Alternatives and Select the Best Candidate Formulations for in Vivo Studies
Our range of services include:
- Candidate compound profiling, including early solid-form selection and optimisation
- Compound DMPK/pharmacology properties review, including estimated human dose level prediction and human PK concentration/time profile to inform formulation strategy and theoretical gains in bioavailability
- Improve pre-clinical exposure for toxicology assessment and in vivo PD at lowest possible dose
- Where necessary, apply phase-appropriate bioavailability enhancing solutions from a variety of processing techniques that include:
- API modification (e.g. salt formation)
- solid form manipulation including particle size reduction (e.g. micronisation and nano-milling)
- use of kinetic forms (e.g. amorphous solid dispersions systems or spray-drying)
- permeation/absorption enhancement strategies
Our range of dosage forms supported include oral liquids / suspensions and solids, parenteral solutions and lyophilised powders for reconstition (IV, IM, IP, SubQ and IVT) and engineered particles for orally inhaled and nasal drug products (OINDPs).
- In-house pre-clinical experimental testing of formulations to allow for determination of fraction absorbed (Fabs) and bioavailability (F) assessment, including dose-linearity testing.
- In Silico simulation and modelling (using GastroPlusTM) of all relevant pre-clinical data to human output simulated plasma exposure/time data.
- Polymorphism studies to support IND filings
- CMC activities including proof of structure, absolute stereochemistry
- Morphology modification